Accessed from 190.216.198.

50 by JNJconsumer on Mon May 06 11:48:03 EDT 2013

USP 36
glacial acetic acid, and 1.0 mL of triethylamine. Pass through a filter of 0.5-m or finer pore size. Solution B: 2.2 g of sodium 1-octanesulfonate in 500 mL of water. Add 500 mL of methanol, 20 mL of glacial acetic acid, and 1.0 mL of triethylamine. Pass through a filter of 0.5-m or finer pore size. Mobile phase: See Table 1.
Table 1 Time (min) 0 30 50 55 Solution A (%) 90 80 0 0 Solution B (%) 10 20 100 100

Official Monographs / Oxygen 4649

Acceptance criteria Individual impurities: NMT 1.0% Total impurities: NMT 2.0% SPECIFIC TESTS CONTENT OF TEREPHTHALIC ACID Sample solution: Transfer 1 g into a 50-mL beaker. Add 25 mL of 0.2 N hydrochloric acid, and heat to boiling with continuous stirring. Cover the beaker with a watch glass, and allow to cool to room temperature. Pass the suspension through a tared, medium-porosity filtering crucible. Transfer any material remaining in the beaker to the crucible with the aid of small portions of cold 0.2 N hydrochloric acid. Wash the material in the crucible with several portions of cold 0.2 N hydrochloric acid. [NOTEReserve the combined filtrates for use in Identification test A.] Analysis: Dry the material in the crucible at 105 for 1 h, allow to cool, and reweigh. The material in the crucible is terephthalic acid. Determine the weight of terephthalic acid, and calculate the percentage of terephthalic acid. Acceptance criteria: Between 20.2% and 21.5% of terephthalic acid (C8H6O4) in Oxycodone Terephthalate on the dried basis LOSS ON DRYING 731: Dry a sample at 105 for 4 h: it loses NMT 1.5% of its weight. ADDITIONAL REQUIREMENTS PACKAGING AND STORAGE: Preserve in tight containers. USP REFERENCE STANDARDS 11 USP Oxycodone RS

Diluent: 0.1 N hydrochloric acid Standard stock solution: 0.9 mg/mL of USP Oxycodone RS in Diluent Standard solution: 0.09 mg/mL of USP Oxycodone RS from the Standard stock solution, prepared by adding to 20% of the flask volume of methanol, and diluting with Diluent to volume System suitability stock solution: 0.05 mg/mL of 4-hydroxybenzoic acid isopropyl ester in methanol System suitability solution: 0.01 mg/mL of 4-hydroxybenzoic acid isopropyl ester and 0.09 mg/mL of USP Oxycodone RS in Diluent from the System suitability stock solution and Standard stock solution, respectively Sample solution: 11 mg/mL of Oxycodone Terephthalate in methanol prepared as follows. Transfer the required amount of sample to a suitable volumetric flask. Add 80% of the flask volume of methanol, and shake by mechanical means for about 20 min to dissolve. Dilute with methanol to volume. Chromatographic system (See Chromatography 621, System Suitability.) Mode: LC Detector: UV 280 nm Column: 3.9-mm 15-cm; packing L1 Column temperature: 45 1 Flow rate: 1.5 mL/min Injection size: 25 L System suitability Samples: Standard solution and System suitability solution Suitability requirements Resolution: NLT 8 between the oxycodone and 4-hydroxybenzoic acid isopropyl ester peaks, System suitability solution Relative standard deviation: NMT 5.0%, Standard solution Analysis Samples: Standard solution and Sample solution Calculate the percentage of each impurity in the portion of the sample taken: Result = (rU/rS) (CS/CU) (Mr1/Mr2) 100 rU = peak area of an individual impurity from the Sample solution rS = peak area of oxycodone from the Standard solution CS = concentration of USP Oxycodone RS in the Standard solution (mg/mL) CU = concentration of Oxycodone Terephthalate in the Sample solution (mg/mL) Mr1 = one-half of the molecular weight of oxycodone terephthalate, 398.43 Mr2 = molecular weight of oxycodone, 315.37 [NOTEIf any impurity is found having a retention time of about 2 in relation to that of the oxycodone peak, divide its apparent percentage by 4.8.]

Oxygen
.

O2 32.00 Oxygen. Oxygen [7782-44-7].

Oxygen contains not less than 99.0 percent, by volume, of O2. [NOTEOxygen that is produced by the air-liquefaction process is exempt from the requirements of the tests for Carbon dioxide and Carbon monoxide.]
Packaging and storagePreserve in cylinders or in a pressurized storage tank. Containers used for Oxygen must not be treated with any toxic, sleep-inducing, or narcosisproducing compounds, and must not be treated with any compound that will be irritating to the respiratory tract when the Oxygen is used. NOTEReduce the container pressure by means of a regulator. Measure the gases with a gas volume meter downstream from the detector tube in order to minimize contamination or change of the specimens. LabelingLabel it to indicate whether or not it has been produced by the air-liquefaction process. Where it is piped directly from the cylinder or storage tank to the point of use, label each outlet Oxygen. [NOTEThe various detector tubes called for in the respective tests are listed under Reagents in the section Reagents, Indicators, and Solutions.] Identification A: When tested as directed in the Assay, not more than 1.0 mL of gas remains. B: Pass 100 5 mL released from the vapor phase of the contents of the Oxygen container through a carbon dioxide detector tube at the rate specified for the tube: no color change is observed (distinction from carbon dioxide).

Official from May 1, 2013 Copyright (c) 2013 The United States Pharmacopeial Convention. All rights reserved.

Accessed from 190.216.198.50 by JNJconsumer on Mon May 06 11:48:03 EDT 2013

4650 Oxygen / Official Monographs

OdorCarefully open the container valve to produce a moderate flow of gas. Do not direct the gas stream toward the face, but deflect a portion of the stream toward the nose: no appreciable odor is discernible. Carbon dioxidePass 1000 50 mL through a carbon dioxide detector tube at the rate specified for the tube: the indicator change corresponds to not more than 0.03%. Carbon monoxidePass 1000 50 mL through a carbon monoxide detector tube at the rate specified for the tube: the indicator change corresponds to not more than 0.001%. AssayPlace a sufficient quantity of ammonium chlorideammonium hydroxide solution, prepared by mixing equal volumes of water and ammonium hydroxide and saturating with ammonium chloride at room temperature, in a test apparatus composed of a calibrated 100-mL buret, provided with a two-way stopcock, a gas absorption pipet, and a leveling bulb, both of suitable capacity and all suitably interconnected. Fill the gas absorption pipet with metallic copper in the form of wire coils, wire mesh, or other suitable configuration. Eliminate all gas bubbles from the liquid in the test apparatus. Activate the test solution by performing two or three tests that are not for record purposes. Fill the calibrated buret, all interconnecting tubing, both stopcock openings, and the intake tube with liquid. Draw 100.0 mL of Oxygen into the buret by lowering the leveling bulb. Open the stopcock to the absorption pipet, and force the Oxygen into the absorption pipet by raising the leveling bulb. Agitate the pipet to provide frequent and intimate contact of the liquid, gas, and copper. Continue agitation until no further diminution in volume occurs. Draw the residual gas back into the calibrated buret, and measure its volume: not more than 1.0 mL of gas remains.

USP 36
Carbon dioxidePass 1000 50 mL through a carbon dioxide detector tube at the rate specified for the tube: the indicator change corresponds to not more than 0.03%. Carbon monoxidePass 1000 50 mL through a carbon monoxide detector tube at the rate specified for the tube: the indicator change corresponds to not more than 0.001%. AssayPlace a sufficient quantity of ammonium chlorideammonium hydroxide solution, prepared by mixing equal volumes of water and ammonium hydroxide and saturating with ammonium chloride at room temperature, in a test apparatus composed of a calibrated 100-mL buret, provided with a two-way stopcock, a gas absorption pipet, and a leveling bulb, both of suitable capacity and all suitably interconnected. Fill the gas absorption pipet with metallic copper in the form of wire coils, wire mesh, or other suitable configuration. Eliminate all gas bubbles from the liquid in the test apparatus. Activate the test solution by performing two or three tests that are not for record purposes. Fill the calibrated buret, all interconnecting tubing, both stopcock openings, and the intake tube with liquid. Draw 100.0 mL of Oxygen 93 Percent into the buret by lowering the leveling bulb. Open the stopcock to the absorption pipet, and force the Oxygen 93 Percent into the absorption pipet by raising the leveling bulb. Agitate the pipet to provide frequent and intimate contact of the liquid, gas, and copper. Continue agitation until no further diminution in volume occurs. Draw the residual gas back into the calibrated buret, and measure its volume: not more than 10.0 mL and not less than 4.0 mL of gas remains.

Water O 15 Injection*
.

Oxygen 93 Percent
.

Oxygen 93 Percent is Oxygen produced from air by the molecular sieve process. It contains not less than 90.0 percent and not more than 96.0 percent, by volume, of O2, the remainder consisting mostly of argon and nitrogen.
Packaging and storagePreserve in cylinders or in a low pressure collecting tank. Containers used for Oxygen 93 Percent must not be treated with any toxic, sleep-inducing, or narcosis-producing compounds, and must not be treated with any compound that will be irritating to the respiratory tract when the Oxygen 93 Percent is used. LabelingWhere it is piped directly from the collecting tank to the point of use, label each outlet Oxygen 93 Percent. NOTEThe various detector tubes called for in the respective tests are listed under Reagents in the section Reagents, Indicators, and Solutions. Where it is preserved in cylinders, reduce the pressure by means of a regulator. Measure the gases with a gas volume meter downstream from the detector tube in order to minimize contamination or change of the specimens. Identification A: When tested as directed in the Assay, not more than 10.0 mL and not less than 4.0 mL of gas remains. B: Pass 100 5 mL released from the vapor phase of the contents of the Oxygen 93 Percent container or from the outlet at the point of use through a carbon dioxide detector tube at the rate specified for the tube: no color change is observed (distinction from carbon dioxide). OdorCarefully open the container valve or system outlet to produce a moderate flow of gas. Do not direct the gas stream toward the face, but deflect a portion of the stream toward the nose: no appreciable odor is discernible.

Water O 15 Injection is a sterile solution of H215O in Sodium Chloride Injection suitable for intravenous injection, in which a portion of the molecules are labeled with radioactive 15O (see Positron Emission Tomography Drugs for Compounding, Investigational, and Research Uses 823). It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of 15O expressed in MBq (or mCi) per mL at the time indicated in the labeling.
Packaging and storagePreserve in a single-dose container that is adequately shielded. LabelingLabel it to include the following, in addition to the information specified for Labeling under Injections 1: the time and date of calibration; the amount of 15O as water expressed as MBq (mCi) per mL, at time of calibration; total activity at time of calibration; the expiration time and date; and the statement CautionRadioactive Material. The labeling indicates that in making dosage calculations, correction is to be made for radioactive decay and also indicates that the radioactive half-life of 15O is 2.03 minutes. The label also includes the statement, Do not use if cloudy or if it contains particulate matter. USP Reference standards 11 USP Endotoxin RS Identification A: Radionuclidic identityIts half-life, determined using a suitable detector system (see Radioactivity 821), is between 1.83 and 2.08 minutes. B: Radiochemical identityThe retention time of the major peak in the chromatogram of the Test solution corresponds to that of the water contained within the product formulation, as obtained in the test for Radiochemical purity.
* Assignment of an official United States Adopted Name (USAN) is pending.

Official from May 1, 2013 Copyright (c) 2013 The United States Pharmacopeial Convention. All rights reserved.