Advance Usp Methods

1
USPmet hods
ADVANCED
2
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ADVANCED
4 Introduction
APPLICATION INDEX
COMPOUND PAGE NO.
Acetaminophen 10,11
Albuterol 14
Alprazolam 12,13,71
p-Aminobenzoic acid 65
Amitriptyline HCl 15
Amoxicillin 16, 72
Aspirin 10, 73
Atenolol 17, 18, 19
Benzalkonium chloride 20
Benzoic acid 10, 30, 38, 39
Benzophenone 48
Betamethasone 63, 64, 82
Butyrophenone 56
Caffeine 10
Cefuroxime axetil 21
Cephalexin 22, 23, 24, 74, 75
Cephradine 24, 75
Chloramphenicol 25, 76
Cortisone acetate 26, 27
Desipramine 50, 51
Dextroamphetamine 61
Dextromethorphan HBr 28
Diphenhydramine 29
Dopamine HCl 30
Doxepin HCl 31
Doxylamine succinate 32
Epinephrine bitartrate 60
Estradiol 33
Estrone 33
Ethinyl estradiol 34
Ethyl paraben 33, 34, 57
Fluoxetine HCl 35
Glyburide 36, 37
COMPOUND PAGE NO.
Guaifenesin 38, 39
Hydrocodone bitartrate 40
Hydrocortisone 41, 42, 77
Hydrocortisone acetate 43, 78
Hydrocortisone cream 44, 45
1-Hydroxybenzatriazole 22, 23, 74
Ibuprofen 46, 47, 48, 79
Imipenem (sterile) 49
Imipramine 50, 51
Lidocaine HCl 52, 80
Lorazepam 53
Medroxyprogesterone 54, 55
Methyl paraben 52, 80
Minoxidil 54, 55
Naproxen 56, 57
Nortriptyline 58, 59
Oxacillin 81
Phenylephrine HCl 60
Phenylpropanolamine 61
Prednisolone 63, 64, 82
Prednisone 41, 42, 62, 77
Procainamide HCl 65, 67
Progesterone 36, 37
Propoxyphene 66
Propranolol 67
Pseudoephedrine HCl 29
Reserpine 68
Salicylic acid 10, 73
Tetracaine 69
Thiamphenicol 83
Triazolam 12, 13, 71
Valerophenone 46, 47, 79
5 Introduction
TABLE OF CONTENTS
Application Index ----------------------------------------------- 4
About this guide ------------------------------------------------- 6
I. Method Validation --------------------------------------- 7
II. Adjusting USP Methods -------------------------------- 8
USP Methods ---------------------------------------------------- 9
Alternative Methods -------------------------------------------- 70
Notes --------------------------------------------------------------- 84
USPmet hods
ADVANCED
APPLICATIONS SUPPLIED BY
6
Our goal in developing this guide was to illustrate
some of the ways which USP/NF methods may be
"modified" in order to improve system performance or
increase sample throughput. The requirements of
many of the validated HPLC methods have been left
intentionally vague in order to allow some room for
modification to fit specific circumstances. For instance,
a method may state that the flow rate should be
"around 1 mL/min". This vagueness would imply that
modifications to the flow rate are acceptable, so long
as the modified method still meets system suitability
requirements. This can be a great advantage to
analysts who, for whatever reason, are unable to meet
system suitability requirements under the specified
method. For instance, closely eluting peaks which fail
system suitability resolution requirements may be
resolved through slight modifications to mobile phase
pH, or even by going to a longer column or smaller
particle size packing for a higher efficiency separation.
In addition, simple modifications such as increasing
flow rate or reducing column length can significantly
increase sample throughput over the long run.
ABOUT THIS GUIDE
However, this vagueness has also led to considerable
confusion as to exactly what is considered "modified"
versus "changed". In response to this, several articles
have been published, and the USP itself has pub-
lished a proposed list of acceptable system modifica-
tions in Pharmacopeial Forum vol. 25(2) and vol. 26(5).
This list, once approved, will be added to the System
Suitability section of the USP.
Although we cannot perform your validations for you,
we can act as a resource for columns and information
to better utilize USP methods. With this guide and our
Luna HPLC columns you will be able to comply with
USP requirements, as well as modernize and optimize
your methods for improved performance and in-
creased productivity.
Introduction
7
Chromatographic methods are routinely employed in labs
around the world for a variety of analytical and preparatory
purposes. Due to the relative ease with which most samples
can be analyzed and the robustness of many chromato-
graphic analyses, these techniques have become the
methods of choice for combinatorial screening of potential
drug products to routine QA/QC analysis of nutritional
products.
In order to ensure the reproducibility and ruggedness of
developed methods, a process known as method validation
is carried out. Validation, as defined by the USP is "the
process of providing documented evidence that the method
does what it is intended to do" and is performed on all
instruments and methods used in an analytical method.
Thus, everything from the software and hardware system to
the method itself must be validated before the analytical
method is considered "validated". However, the focus of this
guide is specifically on the validation of HPLC methods as
defined in the USP/NF.
Method validation for HPLC methods consists of a process
designed to provide documentation that the method will
perform as intended. This process of 8 steps or "Analytical
Performance Parameters" (USP {1225}) which must be
determined in order for a method to be considered "vali-
dated". The parameters to be determined are:
1. The accuracy of a method refers to "the closeness of test
results obtained by that method to the true value" (USP
XXIII). In most cases an accuracy value of 98-102%,
determined by calculating percent recovery values of a
known standard or against a second technique, is required.
In most pharmaceutical analyses, accuracy is determined
against a standard curve generated using known amounts
of target analyte.
2. Precision represents the degree of variability in your
results using the same method. This is normally expressed
as relative standard deviation (RSD%) and must be less
than 2% for most methods. There are three different levels
of precision:
a. Method precision (repeatability) is determined by
multiple analyses of the same sample over a short
period of time.
I. METHOD VALIDATION
b. Intermediate precision is the precision of the method
when run on different days by different operators using
different instruments.
c. Reproducibility is the variability when the same
method is performed by different labs.
3. Specificity is the "ability to measure accurately and
specifically the analyte in the presence of components that
may be expected to be present in the sample matrix" (USP
XXIII). In other words, the ability to separate your target
compound from interfering components. There can be no
interference from known impurities or degradation/stress
products.
4. The linearity or range of a method refers to the ability of
a method to give accurate results over a given range of
analyte concentrations. Generally, your assay must have a
correlation coefficient >0.997 for 5 points over 50-150% of
your expected target analyte concentration.
5. Limit of detection is a value given to the lowest amount
of analyte that can be detected, but not quantified, using a
given method. Often, this minimum value is specified as
three times the signal-to-noise ratio.
6. Limit of quantitation, as the name implies, represents
the lowest concentration of analyte which can be accurately
quantified using a given method. This value is usually a
minimum of 10 times the signal-to-noise ratio.
7. The ruggedness of a method is "the degree of repro-
ducibility of the test results obtained by the analysis of the
same sample under a variety of normal test conditions,
such as different laboratories, different analysts, different
instruments, different lots of reagents, different elapsed
assay times, different assay temperatures, different days,
etc." (USP XXIII). In other words, will other labs be able to
reproduce your results? Typically, a valid method must have
an RSD% of less than 2% between labs.
8. Method robustness is a measure of the ability of a
method to withstand small changes in running conditions.
You demonstrate method robustness by varying factors
such as mobile phase pH, flow rate, temperature, etc.
Introduction
8
Why should I make modifications to USP methods?
Although the methods written in the USP compendia have
all gone through the validation process and so should, in
the best of circumstances, represent methods which will
reliably and reproducibly produce acceptable results for the
methods, there are instances where it may be worth
investigating changing or modifying existing methods. For
instance, it could be that a particular formulation for a drug
substance gives co-elution with an excipient under the USP
conditions. A method which was validated using one
particular formulation cannot take into account all of the
possible excipients which may be present in future formula-
tions. Thus, it may be possible that a given USP method
simply will not resolve the target analyte with acceptable
specificity due to excipient compounds present in a
formulation.
Productivity issues / saving time may also be valid
considerations for USP methods. Many of these methods
were written using very old HPLC technology, and thus may
depend on the use of long columns (300 mm) with large
particle sizes (10). Given the numerous advances in
column technology, many of these older methods could be
more efficiently performed using modern HPLC columns
with smaller, more highly efficient (3) particles and shorter
column lengths. Over the long run, the time savings
resulting from using shorter columns can be substantial.
Improved results can also be an added benefit of using
more modern, state-of-the-art HPLC column technologies.
The vast advances in silica quality and bonding techniques
have resulted in columns which, for many applications, will
perform substantially better than their older predecessors.
For example, columns packed with low-purity silicas may
display extensive tailing with basic or acidic compounds,
and failure of the column to meet system suitability require-
ments for a given assay may delay production and product
release.
As stated previously, many USP HPLC methods are left
intentionally vague. This may be advantageous in that it
allows some flexibility in a method, allowing the analyst to
"fine-tune" and adjust it to certain situations. If you do make
adjustments which are within a reasonable range, you do
not have to entirely revalidate, although you must show an
improvement in chromatography using reference standards.
In addition, it may be advisable to show equivalence to an
existing, validated method. The problem arises in determin-
ing just what an "acceptable" modification to a method
consists of, and when a modification becomes a "change"
II. ADJUSTING USP METHODS
which would warrant re-validation of a method. For instance,
if a method calls for a 300 x 4.6mm column, do I have to re-
validate if I choose to use a 250 x 4.6mm? What about a
150 x 4.6mm column?
In response to these types of questions, several adjustment
limits have been proposed and reviewed in recent publica-
tions. At this point, minor modifications to USP methods are
commonly used and accepted so long as they conform to
the method in intent. The following acceptable method
"modifications" have been proposed (Pharmocopeial Forum
25(2) and 26(5)) and are as follows :
1. Mobile phase pH: 0.2 units
pH of 7.6 can be adjusted from 7.4-7.8
2. Concentration of salts in buffer: 10%
20mM Potassium phosphate can be 18-22mM, as
long as proper pH is maintained as above.
3. Ratio of components in mobile phase: 30%
of the minor component(s), or 2% absolute of that
component, whichever is greater. However a change in
any component cannot exceed 10% absolute, nor
can the final concentration be reduced to zero.
60:40 Acetonitrile/Water can be adjusted to 12%
water (=30% of 40), but this exceeds the 10%
maximum absolute change, so can range from 30%
to 50% water in this case
4. Wavelength of UV-Visible Detector: no deviations
permitted
5. Column length: 70%
150 x 4.6 mm column can be varied 105 mm in
length
6. Column inner diameter: 50%
150 x 4.6 mm column can be varied 2.3 mm
7. Particle size: can be reduced as much as 50%
10 can be switched with a 5 particle
8. Flow rate: 50%
1 mL/min can be varied from 0.5 to 1.5 mL/min
9. Injection volume: increased to as much as twice the
volume specified, provided no adverse effects
Must be within stated linearity range of method!
10. Column temperature: 20C
Introduction
9
USP METHODS
USP Methods
10
Standard prep: Benzoic acid 0.36mg/mL, all others at 0.1mg/mL
Mobile phase: Water / Methanol / Glacial acetic acid (69:28:3)
Flow rate: 2.0 mL/min
Detection: UV @ 275nm
Temperature: 45C
Injection: 10 L
Sample: 1. Acetaminophen
2. Caffeine
3. Aspirin
4. Benzoic acid
5. Salicylic acid
0021
System Suitability Requirement
USP Tailing Factor for all < 1.2
Resolution between any analyte and I.S. is > 1.4
USP column specified: 100 x 4.6mm L1
Column used: 100 x 4.6mm LUNA
5m C18(2)
Part No.: 00D-4252-E0
USP/NF 23 page:
Acetaminophen
Caffeine
Aspirin
USP Methods
- Acetaminophen, aspirin and caffeine - USP Method 2A00710
APP. ID No 3270
Also See ALTERNATIVE METHOD page 73
11
USP/NF 23 page:
Standard prep: Acetaminophen - 0.01mg/mL in mobile phase
Mobile phase: Water / Methanol (75:25)
Injection: 10 L
0017
Efficiency(N) > 1000 plates
USP Tailing Factor < 2.0
Column Performance:
Efficiency(N) = 5047 plates/column
USP Tailing Factor = 1.14
Resolution = NA
5m C18(2)
Part No.: 00G-4252-E0
USP Methods
2A00200 - Acetaminophen capsules - USP Method
APP. ID No 3259
12
USP/NF 23 page:
USP Methods
APP. ID No 3262
Standard prep: Alprazolam and Triazolam
each 0.025mg/mL in mobile phase
Mobile phase: Acetonitrile / Chloroform / Butanol / Water / Acetic acid
(850 : 80 : 50 : 20 : 0.5)
Injection: 20 L
Sample: 1. Triazolam
2. Alprazolam
- Alprazolam - USP Method 2A03940
Resolution > 2.0
Column Performance:
Efficiency(N) = 8940
Resolution = 7.05
5m Silica
Part N0.:00G-4042-E0
0046
13
USP/NF 23 page:
USP Methods
APP. ID No 3276
Standard prep: Alprazolam and Triazolam
Mobile phase: Acetonitrile / Chloroform / Butanol / Water / Acetic acid
(850 : 80 : 50 : 20 : 0.5)
Injection: 40 L
2. Alprazolam
- Alprazolam - USP Acceptable Modified Method
NA
Resolution > 2.0
Column Performance:
Resolution = 5.89
5m Silica(2)
Part No.:00D-4274-E0
14
USP/NF 23 page:
USP Methods
APP. ID No 3260
- Albuterol Tablets - USP Method 2A02962
0039
5m C18(2)
Part No.:00F-4252-E0
Standard prep: Albuterol - 0.03mg/mL in mobile phase
Mobile phase: Methanol / Water with 5mM Hexane sulfonic
acid and 1% Glacial acetic acid (40 : 60)
Injection: 20 L
Efficiency(N) > 800 (was 5647)
Column Performance:
Efficiency(N) = 5647 Plates/column
Resolution = NA
15
USP/NF 23 page:
USP Methods
APP. ID No 3319
Standard prep: Amitriptyline 0.2 mg/mL in water
Mobile phase: Acetonitrile / 92 mM Monobasic
sodium phosphate pH 2.5 (42:58)
Flow rate: 2 mL/min
Detection: UV @ 254 nm
Injection: 20L
2A09600 - Amitriptyline Hydrochloride - USP Method
0093
USP Tailing Factor < 2.0 (was 1.56)
Efficiency(N) > 800
Column Performance:
Resolution = NA
Column used: 300 x 3.9mm Bondclone 10m C18
Part No.:00H-2117-C0
16
USP/NF 23 page:
- Amoxicillin - USP Method 2A11300
0100
5m C18(2)
Part No.:00G-4252-E0
Standard prep: Amoxicillin - 1.2mg/mL in phosphate buffer
Mobile phase: 50mM Potassium phosphate pH 5.0 /
Acetonitrile (96 : 4)
Injection: 10 L
USP Tailing Factor < 2.5 Efficiency(N) > 1700
k between 1.1-2.8
Column Performance:
Resolution = NA
USP Methods
APP. ID No 3258
17
Standard prep: Atenolol 0.2mg/mL in citrate buffer pH 6.0
Mobile phase: Acetonitrile / 5mM 1-Octanesulfonatic acid
with 38mM Sulfuric acid (25 : 75)
Detection: UV @ 275 nm
Injection: 10 L
2A17776 - Atenolol Injection - USP Method
NA
Column Performance:
Resolution = NA
USP column specified: 250 x 4.6mm 5m L1
5m C18(2)
USP/NF 23 page:
USP Methods
APP. ID No 3284
18
USP/NF 23 page:
Standard prep: Atenolol 0.01mg/mL in mobile phase
Mobile phase: Methanol / 5mM Dibasic sodium phosphate
with 7mM 1-Heptanesulfonate and 20mM
Dibutylamine, pH 3.0 (300 : 700)
Injection: 10 L
- Atenolol - USP Method 2A17774
NA
Efficiency(N) > 5000
Column Performance:
Resolution = NA
5m C18(2)
USP Methods
APP. ID No 3285
19
- Atenolol - USP Acceptable Modified Method
0320
5m C18(2)
Standard prep: Atenolol 0.01mg/mL in mobile phase
Mobile phase: Methanol / 5mM Dibasic sodium phosphate
with 7mM 1-Heptanesulfonate and 20mM
Dibutylamine, pH 3.0 (300 : 700)
Flow rate: 0.9 mL/min (was 0.6mL/min in USP)
Injection: 10 L
Column Performance:
Resolution = NA
USP/NF 23 page:
APP. ID No 3286
USP Methods
20
USP/NF 23 page:
USP Methods
APP. ID No 9300
- Benzalkonium Chloride - USP Acceptable Modified Method 7B00500
2218
USP column specified: L10
5m CN
Standard prep: Benzalkonium chloride - 4 mg/mL in water
Mobile phase: 100mM Sodium acetate pH 5.0 / Acetonitrile
(40 : 60)
Flow rate: 2 mL/min
Injection: 1 L (was 20L in USP)
Sample: 1. C12 peak
2. C14 peak
Efficiency(N) > 1000 plates
Resolution > 1.5
Column Performance:
USP Tailing Factor = 1.61 and 1.27
Resolution = 2.70
21
USP/NF 23 page:
APP. ID No 3318
USP Methods
Standard prep: Cefuroxime axetil 0.24mg/mL in mobile phase
and acetanilide 0.54mg/mL in mobile phase
Mobile phase: Methanol / 0.2M Monobasic Ammonium Phosphate (380 : 620)
Injection: 10 L
Sample: 1. Acetanilide
2&3. Cefuroxime axetil diastereomers
2C08820 - Cefuroxime Axetil - USP Acceptable Modified Method
0315
Resolution > 1.5
Column Performance:
Resolution = 2.69
Column used: 250 x 4.6mm Develosil TMS-UG 5m
Part No.: CH0-4230
22
USP/NF 23 page:
USP Methods
APP. ID No 3280
Standard prep: Cephalexin (0.2 mg/mL) and 1-hydroxybenzotriazole (0.1mg/mL)
in mobile phase
Mobile phase: Water / Acetonitrile / Methanol / Triethylamine (850 : 100 : 50 : 15)
with 5mM 1-Pentanesulfonic acid and adjusted to pH 3.0
Injection: 20 L
Sample: 1. 1-Hydroxybenzotriazole
2. Cephalexin
- Cephalexin - USP Method 2C09200
0320
Resolution > 5.0
Column Performance:
Resolution = 22.64
5m C18(2)
23
USP/NF 23 page:
APP. ID No 3279
USP Methods
Standard prep: Cephalexin (0.2mg/mL) and 1-hydroxybenzotriazole(0.1 mg/mL)
in mobile phase
Mobile phase: Water / Acetonitrile / Methanol /Triethylamine (850 : 100 : 50 : 15)
with 5mM 1-Pentanesulfonic acid and adjusted to pH 3.0
Injection: 20 L
2. Cephalexin
- Cephalexin - USP Acceptable Modified Method
0320
Resolution > 5.0
Column Performance:
Resolution = 17.61
5m C18(2)
24
USP/NF 23 page:
USP Methods
APP. ID No 3264
Standard prep: Mix of cephradine and cephalexin,
Mobile phase: Water / Methanol / 0.5 M Sodium acetate /
0.7 N Acetic acid (782 : 200 : 15 : 3)
Injection: 20 L
Sample: 1. Cephradine
2. Cephalexin
- Cephradine capsules - USP Acceptable Modified Method 2C10100
0326
Resolution cephalexin and cephradine must be > 2.0
Column Performance:
Resolution = 7.46
USP column specified:250 x 4.6mm 10m L1
5m C18(2)
25
USP/NF 23 page:
APP. ID No 3312
USP Methods
2C11500 - Chloramphenicol - USP Acceptable Modified Method
0332
USP Tailing Factor > 2.0
Column Performance:
Resolution = NA
5m C18(2)
Standard prep: Chloramphenicol at 80 g/mL in mobile phase
Mobile phase: Water / Methanol / Glacial acetic acid
(55 : 45 : 0.1)
Injection: 10 L
26
USP/NF 23 page:
Standard prep: Cortisone acetate - 0.1 mg/mL
Mobile phase: Water / Acetonitrile (55 : 45)
Flow rate: 2 mL/min
Injection: 35 L
- Cortisone acetate - USP Method 2C27200
0428
k > 2.0
Column Performance:
Resolution = NA
10m C18(2)
USP Methods
APP. ID No 8709
27
USP/NF 23 page:
- Cortisone acetate - USP Acceptable Modified Method
0428
k> 2.0
Column Performance:
Resolution = NA
5m C18(2)
Standard prep: Cortisone acetate 0.1 mg/mL
Injection: 20 L (was 35L in USP)
APP. ID No 8710
USP Methods
28
USP/NF 23 page:
USP Methods
APP. ID No 8711
Standard prep: Dextromethorphan HBr-0.1 mg/mL
in mobile phase
Mobile phase: Acetonitrile / Water (70 : 30), both with
7mM Docusate sodium and 7mM
Ammonium nitrate, pH 3.4 with acetic acid
Flow rate: 1 mL/min
Injection: 20 L
- Dextromethorphan HBr - USP Method 2D06700
0482
Column Performance:
Resolution = NA
5m C18(2)
29
USP/NF 23 page:
APP. ID No 11203
Standard prep: Diphenhydramine and Pseudoephedrine
@ 25ug/mL in 0.5% acetic acid
Mobile phase: Methanol / Acetonitrile / Water w/10mM Heptane
sulfonate and 13mM Triethylamine,
pH 3.3 (10 : 26 : 64)
Flow rate: 2 mL/min
Injection: 50 L
Sample: 1. Pseudoephedrine
2. Diphenhydramine
2D17030 - Diphenhydramine & Pseudoephedrine - USP Method
0534
Resolution between two > 3.0
Column Performance:
Efficiency(N) = 9460 plates/column for diphenhydramine,
8867 for pseudoephedrine
USP Tailing Factor = 1.16 for diphenhydramine,
0.96 for pseudoephedrine
Resolution = 21.96
5m CN
USP Methods
30
USP/NF 23 page:
USP Methods
APP. ID No 8712
- Dopamine HCl Injection - USP Acceptable Modified Method 2D0400
0549
Resolution > 4.0
Column Performance:
Resolution = 11.94
5m C18(2)
Standard prep: Dopamine 0.16mg/mL and benzoic acid 0.5mg/mL in mobile phase
Mobile phase: Water with 1% Acetic and 5mM
Octanesulfonic acid / Acetonitrile (87 : 13)
Flow rate: 2.0 mL/min (was 1.5 by USP)
Injection: 40 L (was 351 in USP)
Sample: 1. Benzoic acid
2. Dopamine
31
USP/NF 23 page:
APP. ID No 9230
USP Methods
Standard prep: Doxepin 100g/mL in mobile phase
Mobile phase: 0.2m Monobasic sodium phosphate / Methanol (61 : 39),
adjusted to pH2.5 with phosphoric acid (USP method was 70 : 30)
Flow rate: 1 mL/min
Injection: 20 L
Temperature: 50C
Sample: E and Z isomers of Doxepin
2D20800 - Doxepin HCl - USP Method
0551
Resolution > 1.5
Column Performance:
USP Tailing Factor = 1.16 and 1.31 for isomers
Resolution = 2.24
5m C8(2)
Part No.:00E-4249-E0
32
USP/NF 23 page:
USP Methods
APP. ID No 3274
Standard prep: Doxylamine 0.25mg/mL in mobile phase
Mobile phase: Acetonitrile / Water (37 : 63) with 25mM
Monobasic Potassium phosphate, 10mM
Triethylamine, and 5mM Sodium lauryl sulphate
Injection: 10 L
- Doxylamine succinate - USP Acceptable Modified Method 2D22300
0560
Resolution > 2.5
Column Performance:
Resolution = NA
3m C8(2)
Part No.: 00D-4248-E0
33
USP/NF 23 page:
APP. ID No 8713
USP Methods
2E07900 - Estradiol - USP Acceptable Modified Method
0622
Resolution between Estradiol and estrone > 2.0
Column Performance:
Efficiency(N) = 22223 plates/column for estradiol
USP Tailing Factor = 1.15 for estradiol
Resolution = 11.52 for 3/2, and 8.88 for 2/1
5m C18(2)
Standard prep: Ethyl paraben-0.75mg/mL
Estradiol-20g/mL
Estrone-33g/mL
Mobile phase: Acetonitrile / Water (55 : 45)
Flow rate: 1.0 mL/min (was 1.5 by USP)
Injection: 25 L
Sample: 1. Ethyl paraben
2. Estradiol
3. Estrone
34
USP/NF 23 page:
USP Methods
APP. ID No 3315
Standard prep: Ethinyl estradiol-200g/mL
Ethyl paraben-20g/mL
Injection: 25 L
Sample: 1. Ethinyl estradiol
2. Ethyl paraben
0638
Resolution > 4.5
Column Performance:
Efficiency(N) = 10128 plates/column for ethinylestradiol
Resolution = 13.30
5m C18(2)
- Ethinyl estradiol - USP Method 2E10800
35
USP/NF 23 page:
APP. ID No 3273
USP Methods
Standard prep: Fluoxetine HCl-110g/mL in mobile phase
Mobile phase: 10mM Triethylamine buffer pH 6.0 w/phosphoric acid /
Tetrahydrofuran / Methanol (60 : 30 : 10)
Injection: 10 L
2F04840 - Fluoxetine HCl - USP Method
Supplement No. 8p. 4210
Resolution > 2.0
Column Performance:
Resolution = NA
5m C8(2)
36
USP/NF 23 page:
USP Methods
APP. ID No 3316
Standard prep: Glyburide (0.5mg/mL) and progesterone
(0.2mg/mL) in mobile phase
Mobile phase: Acetonitrile / 10 mM Monobasic ammonium
phosphate, pH 5.25 (55 : 45)
Injection: 10 L
Sample: 1. Glyburide
2. Progesterone
- Glyburide - USP Method 2G2930
0713
Resolution > 5.0
Column Performance:
USP Tailing Factor = 1.0 for glyburide
Resolution = 6.57
5m C8(2)
37
USP/NF 23 page:
APP. ID No 3317
USP Methods
Standard prep: Glyburide (0.5mg/mL) and progesterone
Mobile phase: Acetonitrile / Water with 10mM Monobasic
ammonium phosphate, pH 5.25(550 : 450)
Injection: 10 L
Sample: 1. Glyburide
2. Progesterone
- Glyburide - USP Acceptable Modified Method
0713
Resolution > 5.0
Column Performance:
Efficiency(N) = 15428 plates/column for glyburide
Resolution = 8.08
3m C8(2)
Part No.:00E-4248-E0
38
USP/NF 23 page:
USP Methods
APP. ID No 3281
Standard prep: Guaifenesin-40g/mL
Benzoic acid-100g/mL
Mobile phase: Water / Methanol / Acetic acid (60 : 40 : 1.5)
Injection: 20 L
Sample: 1. Guaifenesin
2. Benzoic acid
- Guaifenesin Tablets - USP Method 2G05800
0724
Resolution > 3.0
Column Performance:
Efficiency(N) = 3734 plates/column for guaifenesin
Resolution = 10.83
10m C18(2)
39
USP/NF 23 page:
APP. ID No 3267
USP Methods
Standard prep: Guaifenesin-40g/mL Benzoic acid-100g/mL
Mobile phase: Water / Methanol / Acetic acid (60 : 40 :1.5)
Injection: 20 L
Sample: 1. Guaifenesin
2. Benzoic acid
- Guaifenesin Tablets - USP Acceptable Modified Method
0724
Resolution > 3.0
Column Performance:
Efficiency(N) = 3870 plates/column for guaifenesin
USP Tailing Factor = 1.23 for guaifenesin
Resolution = 10.83
5m C18(2)
40 USP Methods
USP/NF 23 page:
APP. ID No 9299
Standard prep: Hydrocodone 1mg/mL in methanol
Mobile phase: Acetonitrile / Water / Diethylamine / Methanol
(440 : 2.2 : 0.55 : 45)
Injection: 5 L(USP was 20L)
- Hydrocodone bitartrate - USP Acceptable Modified Method 2H06000
0751
Column Performance:
Resolution = NA
5m Silica(2)
41
USP/NF 23 page:
APP. ID No 9295
USP Methods
Standard prep: Hydrocortisone 0.1 mg/mL and prednisone 0.06 mg/mL in chloroform
Mobile phase: Butyl chloride / Water-saturated butyl chloride / THF / Methanol /
Glacial acetic acid (95 : 95 : 14 : 7 : 6)
Injection: 10 L
Sample: 1. Hydrocortisone
2. Prednisone
2H06200 - Hydrocortisone - USP Method
0753
Resolution > 3.0
Column Performance:
Resolution = 8.34
5m Silica(2)
42 USP Methods
USP/NF 23 page:
APP. ID No 3287
Standard prep: Hydrocortisone 0.1 mg/mL and prednisone 0.06 mg/mL in chloroform
Mobile phase: Butyl chloride / Water-saturated butyl chloride / THF / Methanol /
Glacial acetic acid (95 : 95 : 14 : 7 : 6)
Injection: 10 L
2. Prednisone
- Hydrocortisone - USP Acceptable Modified Method 2H06200
0753
Resolution > 3.0
Column Performance:
Resolution = 5.98
5m Silica(2)
43
USP/NF 23 page:
APP. ID No 9298
USP Methods
Standard prep: Hydrocortisone acetate 0.1 mg/mL
in chloroform
Mobile phase: Butyl chloride / Water-saturated
butyl chloride / Tetrahydrofuran / Methanol /
Glacial acetic acid (95:95:14:7:6)
Injection: 10 L
2H07000 - Hydrocortisone acetate - USP Method
0758
USP Tailing Factor > 2.0
Column Performance:
Resolution = NA
10m Silica(2)
44
USP/NF 23 page:
USP Methods
APP. ID No 3271
Standard prep: Hydrocortisone-50g/mL in methanol
Mobile phase: Water / Acetronitrile (75 : 25)
Injection: 15 L
- Hydrocortisone cream - USP Method 2H06300
0754
None stated
Column Performance:
Efficiency(N) =13,569
USP Tailing Factor =1.02
Resolution = NA
5m C18(2)
45
USP/NF 23 page:
APP. ID No 8714
USP Methods
Standard prep: Hydrocortisone-50g/mL in methanol
Mobile phase: Water / Acetronitrile (75 : 25)
Flow rate: 1.5 mL/min (was 2mL/min USP)
Injection: 15 L
- Hydrocortisone cream - USP Acceptable Modified Method
0754
None started
Column Performance:
Resolution = NA
3m C18(2)
46
USP/NF 23 page:
USP Methods
APP. ID No 3278
Standard prep: Ibuprofen 12mg/mL and valerophenone 0.35mg/mL in mobile phase
Mobile phase: Acetonitrile / Water (600:400) with 20mM Chloroacetic acid, pH3.0
Injection: 5 L
Sample: 1. Ibuprofen
2. Valerophenone
- Ibuprofen - USP Method 2I00100
0785
Resolution > 2.5
Column Performance:
Resolution = 8.08
5m C18(2)
47
USP/NF 23 page:
APP. ID No 3277
USP Methods
Standard prep: Ibuprofen 12mg/mL andvalerophenone 0.35mg/mL in mobile phase
Mobile phase: Acetonitrile / Water (600:400) with 20mM Chloroacetic acid, pH3.0
Injection: 5 L
2. Valerophenone
2I00100 - Ibuprofen - USP Acceptable Modified Method
0786
Resolution > 2.5
Column Performance:
Resolution = 5.77
5m C18(2)
48
USP/NF 23 page:
USP Methods
APP. ID No 3263
Standard prep: Ibuprofen - 0.4 mg/mL
Benzophenone - 0.3 mg/mL in mobile phase
Mobile phase: 0.01M phosphoric acid / Acetonitrile (55 : 45)
(USP method states 63 : 37)
Injection: 5 L
Sample: 1. Benzophenone
2. Ibuprofen
- Ibuprofen Oral Suspension - USP Acceptable Modified Method 2I00150
0551
Resolution > 1.5
Peak tailing < 2.0 (was 1.03)
Column Performance:
Resolution = 7.93
5m C8(2)
49
USP/NF 23 page:
APP. ID No 3272
USP Methods
Standard prep: Imipenem 0.4 mg/mL in mobile phase
Mobile phase: 7mM potassium phosphate pH 6.8
Injection: 10 L
2I00770 - Sterile Imipenem - USP Method
0792
Efficiency(N) > 600
Column Performance:
Resolution = NA
Column used: 150 x 4.6mm AQUA
5m C18
50
USP/NF 23 page:
USP Methods
APP. ID No 3255
Standard prep: Imipramine and desipramine 0.3mg/mL
in mobile phase
Mobile phase: 0.06M Sodium perchlorate / Acetonitrile /
Triethlamine (625 : 375 : 1), adjusted with
Perchloric acid to a pH of 2.0
Injection: 20 L
Sample: 1. Imipramine
2. Desipramine
- Imipramine - USP Method 2I00800
0794
Resolution > 1.3
Column Performance:
Resolution = 2.76
5m C18(2)
51
USP/NF 23 page:
APP. ID No 3248
USP Methods
- Imipramine - USP Acceptable Modified Method
0794
Resolution > 1.3
Column Performance:
Resolution = 2.12
5m C18(2)
Standard prep: Imipramine and desipramine 0.3mg/mL
in mobile phase
Mobile phase: 0.06M Sodium perchlorate / Acetonitrile /
Triethlamine (625 : 375 :1),
adjusted with Perchloric acid to a pH of 2.0
Flow rate: 2 mL/min (was 1.5 in USP)
Injection: 20 L
Sample: 1. Imipramine
2. Desipramine
52
USP/NF 23 page:
USP Methods
APP. ID No 3254
Standard prep: Lidocaine-1.7mg/mL in mobile phase
Methyl paraben-220g/mL in mobile phase
Mobile phase: Acetonitrile / Water with 5% Acetic acid, pH 3.4 (20:80)
Injection: 5 L (was 20 L in USP method)
Sample: 1. Lidocaine
2. Methyl paraben
0887
Resolution Lidocaine/methyl paraben > 3.0
Column Performance:
Resolution = 22.57
5m C18(2)
- Lidocaine HCl - USP Acceptable Modified Method 2L02900
53
USP/NF 23 page:
APP. ID No 3253
USP Methods
min 1.0 2.0 3.0 4.0 5.0
2L05856 - Lorazepam Tablets - USP Method
0905
Column Performance:
Resolution = NA
5m C18(2)
Standard prep: Lorazepam 0.1mg/mL in mobile phase
Mobile phase: Water / Methanol / Acetic acid (55 : 45 : 2)
Injection: 20 L
54
USP/NF 23 page:
USP Methods
APP. ID No 3266
Standard prep: Minoxidil 0.2 mg/mL and Medroxyprogesterone acetate 0.25 mg/
mL in mobile phase
Mobile phase: Methanol / Water / Acetic acid (700 : 300 : 10) with
7mM Docusate sodium and pH 3.0 with perchloric acid
Detection: UV@254nm
Injection: 10 L
Sample: 1. Minoxidil
2. Medroxyprogesterone acetate
- Minoxidil - USP Method 2M23430
1032
Resolution > 2.0
Column Performance:
Resolution = 15.50
5m C18(2)
55
USP/NF 23 page:
APP. ID No 3265
USP Methods
- Minoxidil - USP Acceptable Modified Method
1032
Resolution > 2.0
Column Performance:
Resolution = 2.12
5m C18(2)
Standard prep: Minoxidil 0.2 mg/mL and Medroxyprogesterone acetate 0.25 mg/mL
in mobile phase
Mobile phase: Methanol / Water / Acetic acid (700 : 300 : 10) with
3.0g docusate sodium pH 3.0 with perchloric acid
Flow rate: 1.5 mL/min (was 1 mL/min in USP)
Injection: 10 L
Sample: 1. Minoxidil
2. Medroxyprogesterone acetate
56
USP/NF 23 page:
USP Methods
APP. ID No 3282
- Naproxen Tablets - USP Method 2N01900
1054
Resolution > 11.0
Column Performance:
Resolution = 14.46
5m C18(2)
Standard prep: Naproxen 25 g/mL and butyrophenone
0.001L/mL
Mobile phase: Acetonitrile / Water / Glacial Acetic acid
(50 : 49 : 1)
Injection: 20 L
Sample: 1. Naproxen
2. Butyrophenone
57
USP/NF 23 page:
APP. ID No 3283
USP Methods
2N01950 - Naproxen Oral Suspension - USP Acceptable Modified Method
1053
Resolution > 3.0
Column Performance:
USP Tailing Factor = 1.15 for naproxen
Resolution = 8.91
5m C18(2)
Standard prep: Naproxen - 50 g/mL
Ethylparaben - 4.4 g/mL
Mobile phase: Methanol / Water (50 : 50) with 30mM Sodium acetate pH 5.8
Injection: 20 L
Sample: 1. Naproxen
2. Ethylparaben
58
USP/NF 23 page:
USP Methods
APP. ID No 9296
- Nortriptyline HCl Capsules - USP Method 2N12400
1107
Efficiency(N) > 500
Column Performance:
Resolution = NA
5m CN
Standard prep: Nortriptyline 0.38mg/mL in methanol
Mobile phase: Acetonitrile / Methanol / 12mM Potassium
phosphate pH 6.7 (40 : 43 : 17)
Injection: 5 L
59
USP/NF 23 page:
APP. ID No 9297
USP Methods
- Nortriptyline HCl Capsules - USP Acceptable Modified Method
1107
Efficiency(N) > 500
Column Performance:
Resolution = NA
3m CN
Standard prep: 0.38mg/mL in methanol
Mobile phase: Acetonitrile / Methanol / 12mM Potassium
phosphate pH 6.7 (40 : 43 : 17)
Injection: 5 L
60
USP/NF 23 page:
USP Methods
APP. ID No 3246
- Phenylephrine Hydrochloride Injection - USP Method 2P13200
1212
Resolution > 1.0
Column Performance:
USP Tailing Factor = 1.32 for epipnephrine, 0.78 for phenylephrine
Resolution = 7.32
5m C18(2)
Standard prep: Phenylephrine HCl and Epinephrine bitartrate,
both 0.4mg/mL in mobile phase
Mobile phase: Water / Methanol (50 : 50) with 0.1%
1-octanesulfonic acid adjust to pH3.0
with phosphoric acid
Injection: 5 L (USP was 20L)
Sample: 1. Epinephrine bitartrate
2. Phenylephrine HCl
61
USP/NF 23 page:
APP. ID No 8275
USP Methods
1214
Resolution > 5.0
Column Performance:
Resolution = 13.24
5m C18(2)
Standard prep: Phenylpropanolamine HCl and Dextroamphetamine sulfate, each
5g/mL in mobile phase
Mobile phase: THF / Methanol / Water with 0.2% TMAH and 0.5% Phosphoric acid
(4 : 40 : 956)
Flow rate: 1.5 mL/min (USP was 1.0mL/min)
Injection: 10 L (was 5 L in USP)
Sample: 1. Phenylpropanolamine
2. Dextroamphetamine
- Phenylpropanolamine HCl-Limit of Amphetamine
- USP Acceptable Modified Method
62
USP/NF 23 page:
USP Methods
APP. ID No 3268
- Prednisone oral solution - USP Acceptable Modified Method 2N12400
1285
USP Tailing Factor< 2.0
Column Performance:
Resolution = NA
5m C18(2)
Standard prep: Prednisone at 40g/mL in methanol / water
(25 : 75)
Mobile phase: 17mM Monobasic potassium phosphate /
Acetonitrile (60 : 40)
Injection: 10 L
63
USP/NF 23 page:
APP. ID No 11202
USP Methods
2P23800 - Prednisolone - USP Method
1277
Resolution > 3.5
Column Performance:
Resolution = 10.30
5m Silica(2)
Standard prep: Presnisolone and Betamethasone, 0.1mg/mL
in chloroform
Mobile phase: Butyl chloride / Water-saturated butyl chloride /
Tetrahydrofuran / Methanol / Glacial acetic acid
(95 : 95 : 14 : 7 : 6)
Injection: 10 L
Sample: 1. Betamethasone
2. Presnisolone
64
USP/NF 23 page:
USP Methods
APP. ID No 3269
- Prednisolone - USP Acceptable Modified Method
1230
Resolution > 3.5
Column Performance:
Resolution = 6.64
5m Silica(2)
Standard prep: Presnisolone and betamethasone, 0.1mg/mL
in chloroform
Mobile phase: Butyl chloride / Water-saturated butyl chloride /
Tetrahydrofuran / Methanol / Glacial acetic acid
(95 : 95 : 14 : 7 : 6)
Injection: 10 L
2. Presnisolone
65
USP/NF 23 page:
APP. ID No 3261
USP Methods
2P28300 - Procainamide HCl - USP Method
1294
Resolution > 5.0
Column Performance:
Resolution = 5.99
10m C18(2)
Standard prep: Procainamide HCl - 0.05mg/mL in mobile phase
p-Aminobenzoic acid - 0.01mg/mL in mobile
phase
Mobile phase: Water / Methanol / TEA (140 : 60 : 1) adjusted to
pH 7.5 with phosphoric acid
Injection: 20 L
Sample: 1. p-Aminobenzoic acid
2. Procainamide HCl
66
USP/NF 23 page:
USP Methods
APP. ID No 3269
- Propoxyphene HCl Capsules - USP Acceptable Modified Method 2P30900
1319
Column Performance:
Resolution = NA
3m C18(2)
Part No.:00B-4251-E0
Standard prep: Propoxyphene 6.5g/mL in mobile phase
Mobile phase: 50mM Monobasic potassium phosphate pH 3.0
with 20mM Triethylamine / Acetonitrile
(70 : 30, was 3 : 2 in USP)
Injection: 5 L (10L in USP)
Sample: 1. Propoxyphene
67
USP/NF 23 page:
APP. ID No 3291
USP Methods
2P31700 - Propranolol - USP Method
1327
Resolution > 2.0
USP Tailing Factor for propranolol < 3.0
Column Performance:
Resolution = 15.88
5m C8(2)
Standard prep: Propranolol (0.04mg/mL) and Procainamide
Mobile phase: Water / Acetonitrile / Methanol (70 : 70 : 90)
with 7mM Sodium Lauryl sulfate
and 11mM Phosphoric acid
Injection: 20 L
Sample: 1. Procainamide
2. Propranolol
68
USP/NF 23 page:
- Reserpine - USP Method 2R01000
1369
Column Performance:
Resolution = NA
5m C18(2)
Standard prep: Reserpine at 10g/mL in mobile phase
Mobile phase: Acetonitrile / 1% Ammonium chloride,
pH5.6 (50 : 50)
Injection: 20 L
USP Methods
APP. ID No 3292
69
USP/NF 23 page:
2T05300 - Tetracaine HCl opthalmic solution - USP Method
1506
Efficiency(N) > 500
Column Performance:
Resolution = NA
5m CN
Standard prep: 0.1mg/mL in water
Mobile phase: 10mM Ammonium phosphate pH3.0 / Acetonitrile
(70 : 30)
Injection: 5 L
APP. ID No 3293
USP Methods
70
ALTERNATIVE METHODS
USP Alternative Methods
The following Alternative Methods are based
on USP methods but have been changed to
optimize runtime, peak shape and/or provide
more rugged mobile phase conditions.
Because the methods are "changed" and not
"modified" within the proposed guidelines of
Pharmacopeial Forum vol. 25(2) and vol. 26(2),
the following methods are not USP accepted
modified methods.
These methods warrant additional validation by
the USP.
71
Standard prep: Alprazolam and Triazolam each 0.025mg/mL
in mobile phase
Mobile phase: Hexane / Methylene choride / Methanol (75 : 20 : 5)
Injection: 20 L
2. Alprazolam
3m CN
- Alprazolam - Alternative Method
Resolution > 2.0
Column Performance:
Resolution = 2.74
APP. ID No 3309
72 USP Alternative Methods
- Amoxicillin - Alternative Method
k between 1.1 -2.8
Column Performance:
Resolution = NA
5m C8(2)
Standard prep: Amoxicillin - 1.2mg/mL in phosphate buffer
Mobile phase: 20mM Ammonium acetate pH4.9 / Methanol
(95 : 5)
Injection: 5 L
APP. ID No 3294
73
APP. ID No 3301
- Aspirin tablets - Alternative Method
Column Performance:
Resolution = 7.34
5m C18(2)
Standard prep: Aspirin 2mg/mL and Salicylic acid 1.6mg/mL
Mobile phase: 20mM Ammonium formate pH3.0 / Acetonitrile
(75 : 25)
Injection: 2 L
Sample: 1. Aspirin
2. Salicylic acid
APP. ID No 3308
- Cephalexin - Alternative Method
Resolution > 5.0
Column Performance:
Resolution = 9.61
5m Phenyl-Hexyl
Standard prep: Cephalexin(0.2mg/mL) and 1-Hydroxybenzotriazole
Mobile phase: Water with 0.05%formic acid / Methanol with 0.05% formic acid (70 : 30)
Injection: 5 L
2. Cephalexin
75
APP. ID No 3295
- Cephradine capsules - Alternative Method
ResolutionResolution > 2.0
Column Performance:
Resolution = 5.0
5m C8(2)
Standard prep: Mix of Cephradine and Cephalexin, each 0.1mg/mL in mobile phase
Mobile phase: 20mM Ammonium acetete pH4.9 / Methanol (70 : 30)
Injection: 10 L
Sample: 1. Cephalexin
2. Cephradine
1
APP. ID No 3312
- Chloramphenicol - Alternative Method
Column Performance:
Resolution = NA
3m C18(2)
Standard prep: Chloramphenicol at 80g/mL in mobile phase
Mobile phase: Water with 0.05%formic acid / Methanol with
0.05% formic acid (70 : 30)
Injection: 4 L
77
APP. ID No 3303
- Hydrocortisone - Alternative Method
Resolution > 3.0
Column Performance:
Resolution = 2.91
USP column specified:
5m Phenyl-Hexyl
Standard prep: Hydrocortisone 0.1mg/mL in mobile phase and
Prednisone 0.06mg/mL in mobile phase
Mobile phase: Acetonitrile / Water (20 : 80)
Injection: 5 L
2. Prednisone
APP. ID No 3311
- Hydrocortisone Acetate - Alternative Method
Column Performance:
Resolution = NA
5m C8(2)
Standard prep: Hydrocortisone acetate 0.1mg/mL in mobile phase
Mobile phase: Methanol / Water (60 : 40)
Injection: 10 L
79
APP. ID No 3278
- Ibuprofen - Alternative Method
Resolution > 2.5
Column Performance:
Resolution = 7.71
5m C18(2)
Standard prep: Ibuprofen-12mg/mL in mobile phase
Valerophenone-0.35mg/mL in mobile phase
Mobile phase: 20mM Ammonium acetate pH4.0 / Acetonitrile
(60 : 40)
Injection: 5 L
2. Valerophenone
APP. ID No 3300
- Lidocaine HCl - Alternative Method
Resolution Lidocaine/methyl paraben > 3.0
Column Performance:
Efficiency(N) = 4136 plates/column for Lidocaine
Resolution = 11.16
5m C8(2)
Standard prep: Lidocaine-1.7mg/mL in mobile phase
Methyl paraben-220g/mL in mobile phase
Mobile phase: 20mM Ammonium acetate with 30mM TFA /
Acetonitrile / Methanol (70 : 10 : 20)
Injection: 5 L
Sample: 1. Lidocaine
2. Methyl paraben
81
APP. ID No 3296
- Oxacillin - Alternative Method
Column Performance:
Resolution = NA
5m Phenyl-Hexyl
Standard prep: Oxacillin 0.5mg/mL in mobile phase
Mobile phase: Water / Acetonitrile / Methanol,
all with 10mM Formic acid (40 : 30 : 30)
Injection: 2 L
APP. ID No 3302
- Prednisolone - Alternative Method
Resolution > 3.5
Column Performance:
Resolution = 4.05
3m Cyano
Standard prep: Prednisolone and Betamethasone,
0.1mg/mL in chloroform
Mobile phase: Hexane / Isopropanol (85 : 15)
Injection: 10 L
2. Prednisolone
83
APP. ID No 3297
- Thiamphenicol - Alternative Method
Column Performance:
Resolution = NA
3m C18(2)
Standard prep: Thiamphenicol at 0.5mg/mL in mobile phase
Mobile phase: Water with 0.05% formic acid / Methanol with
0.05% formic acid (85 : 15)
Injection: 20 L
84 Notes
85 Notes
86
87
88
USPmet hods
ADVANCED
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Torrance, CA
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USA
(310) 212-0555
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mail:
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