What is in the British Pharmacopoeia

& How do I Find it?

Scott Colbourne
Business Manager NSW – ALS Food & Pharmaceutical

R IG H T S O L U T I O N S | R I G H T PA RT N E R
Contents

• What is in the British Pharmacopoeia

• Tips for finding stuff

• Tips for sending samples to a contract lab

• How much is it?

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British Pharmacopoeia (BP) Overview

• Been around for 150 years

Volume I Volume II
Introduction, General Notices and Monographs for Pharmaceutical Substances

Volume III Volume IV

Formulated Preparations More Formulated Preparations

Volume V
Infrared Reference Spectra, Appendices, Veterinary
Supplementary Chapters

• New edition released every year (Official as of 01-Jan)

• Most of the monographs are from the European Pharmacopoeia

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Volumes I and II

• Introduction and other generic information about the BP

• General Notices

• Monographs: Medicinal and Pharmaceutical Substances

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Volumes I and II

• Introduction and other generic information about the BP

• General Notices

• Monographs: Medicinal and Pharmaceutical Substances

Anything Interesting?
• Lists the BP Commision’s purpose and people
• Does the same with the BP’s advisory groups,
experts and working parties
• International collaborations listed – TGA, World
Health Organization and Chinese, Kazakhstan &
United States Pharmacopoeias
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Volumes I and II – General Notices

Some “interesting points” are…

• Clear definitions of:

– Constant Weight

– ppm

– Freshly prepared

– Recently Prepared

• Excipients – if a monograph exists, you must comply

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Volumes I and II – General Notices

• Not official requirements on a monograph:

– Characteristics

– Solubility

Descriptive Term mL /g of solute

very soluble less than 1
freely soluble from 1 to 10
soluble from 10 to 30 However they are
sparingly soluble from 30 to 100
slightly soluble from 100 to 1000 well defined
very slightly soluble from 1000 to 10 000
practically insoluble more than 10 000

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Volumes I and II:
General Notices of the European Pharmacopoeia

• Alternative Methods can be used – but they need to be

agreed with the competent authority (e.g TGA)

• Pharmacopoeial methods:
– Validation: not required

– Implementation: user to assess based on the situation

• ‘Should’ is defined as informative or advisory

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Volumes I and II:
General Notices of the European Pharmacopoeia

• Test quantity stated for examination is approximate:

allowed 10% deviation

• Volumetric Glassware – class A

• Analytical procedures between 15ºC and 25ºC

• Solvent not stated? Then ‘solution’ implies in water

• Water specified or implied? Then use Purified Water

• ‘Ethanol’ defaults to anhydrous.

• ‘Alcohol’ defaults to ethanol (96 %)

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Volumes I and II: Monographs:
Medicinal and Pharmaceutical Substances

There are 1768 in

the current BP

They are listed in

alphabetical order

Most of them are

from the European
Pharmacopoeia

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Volumes I and II: Monographs:
Medicinal and Pharmaceutical Substances

Monographs
have a
consistent
structure

European
Pharmacopoeia
references are
clearly shown
Chris Byrne will be covering monographs in more detail later
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Volume III
Formulated Preparations: General Monographs
39 of these are in the current BP

Of these 25 are from the Ph. Eur.

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Volume III
Formulated Preparations: Specific Monographs

• There are 1324 of these in the current BP

• They are listed in alphabetical order

• They follow the same structure as the other monographs

• As a contract laboratory, ALS barely ever use these

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Volume IV:
Formulated Preparations: General Monographs
• List of other monographs. The majority from the Ph. Eur.

# of Monographs
Herbal Drugs, Herbal Drug Preparations
355
and Herbal Medicinal Products
Materials for the Use in the Manufacture of
41
Homoeopathic Preparations
Blood-Related Products 31
77
Immunosera,
Immunological Products vaccines and
diagnostic
preparations
Radiopharmaceuticals 72
Surgical Materials 7

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Volume V: Infrared Reference Spectra

421 reference spectra listed to be used in conjunction with

monographs

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Volume V: Appendices

• These are grouped from I to XXV

• Most containing multiple appendices
• These cover theory, calibrations and tests referenced in monographs
Appendix Details
I Reagents and solutions
Analytical techniques
II, III
e.g. IR, UV/Vis, Chromatography,
Physical and chemical properties, Limit tests,
IV - XI
Titrations, ‘Values’ and Contaminants
Disintegration, Dissolution and
XII
Consistency of Formulated Preparations
XIII Particulates
XIV - XVI Biological, Vaccine and Microbiological parameters
XVII Tests on powders and solids
XVIII Methods of Sterilisation
XIX - XXV AND THE LIST GOES ON…

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Volume V: Appendices cont…

Something interesting in ‘Appendix III – Chromatographic

Separation Techniques’ are the allowable changes that do
not require revalidation of the method.

Examples of allowable column changes

Column Parameters:
Liquid
Particle size: 50% reduction
Chromatography
Length: ± 70%
(Isocratic)
Internal diameter: ± 25%
Column Parameters:
Liquid
Particle size: No change allowed
Chromatography
Length: ± 70%
(Gradient Elution)
Internal diameter: ± 25%
Film Thickness: -50% to +100% (capillary)
Gas
Length: ± 70%
Chromatography
Internal Diamater: ± 50%

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Volume V: Supplementary Chapters

These are for information only to assist in using the

Pharmacopoeia. There are over 20 of them.

e.g. SC III A1. Contact Points:

Listing contact phone numbers including their extensions.

For example call +44 (0)20 3080 followed by:

Editor-in-Chief Mrs M Vallender 6562

Head of Analytical Science Mr S Young 6790

A total of 44 extensions are listed.

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British Pharmacopoeia: Veterinary

• Similar layout to the full BP

• Monographs are again listed similarly with:
– Medicinal and Pharmaceutical Substances
– Formulated Preparations: General Monographs
– Formulated Preparations: Specific Monographs
– Immunological Products
– Surgical materials (Sutures)

• Infrared Reference spectra

• Appendices – additional vet specific appendices (mainly
biological)

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BP – How do you find anything?

• Try and search on something not found in many monographs.

• The BP allows for searching within the

text and the title.

• If you look for sodium in the title. You

get 426 hits. These will be listed
according to their order in the BP.

• If you want to find Vitamin D3:

– Do not search for it;

– Or Cholecalciferol, but for

– Colecalciferol

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BP – Tips for your local Contract lab

Try and use the BP official name. e.g.

– Trade Name supplied - We look it up and try and match it to a
monograph. If there are various grades this is complicated and can
delay testing.
– An extreme case is…
Neo Heliopan® 303 Octocrylene
Neo Heliopan® 357 Butyl Methoxydibenzoylmethane or Avobenzone
Neo Heliopan® AP Disodium Phenyl Dibenzimidazole
Tetrasulfonate
Neo Heliopan® AV Ethylhexyl Methoxycinnamate
Neo Heliopan® BB Benzophenone-3 or Oxybenzone
Neo Heliopan® E1000 Isoamyl p-Methoxycinnamate
Neo Heliopan® HMS Homosalate
Neo Heliopan® Hydro Phenylbenzimidazole Sulfonic Acid
Neo Heliopan® MA Menthyl Anthranilate
Neo Heliopan® MBC 4-Methylbenzylidene Camphor
Neo Heliopan® OS Ethylhexyl Salicylate or Octisalate

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BP – Tips for your local Contract lab

If the request is inadvertently vague, then:

• more information is requested to clarify the exact requirements
• there may be delays
• the incorrect testing may be performed

Water is a good example…

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BP – Tips for your local Contract lab

BP Testing can be done in a few ways…

• A monographed material…
– using BP methods, with a result that complies (or not)
– using alternative methods, with a result that complies (or
not). Here the in-house method number is quoted

• A non-monographed material…
– Using BP methods from a ‘similar’ monograph, with a result
that complies (or not) to the supplied specification
– Using BP general methods (covered earlier), with a result
that complies (or not) to the supplied specification

Please supply your specification. It helps the laboratory define dilutions for the analysis
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BP – How much is it?

1. Hard Copy only: £875

2. Online single user access only: £875

3. USB download key: £875

4. Print Package: Hard copy, 1 USB, 1 online - £1000

Other multiple online user options available. Please note that

licences are user and IP address controlled.

Note the USP is not IP address controlled. Therefore can be used

on any workstation, up to the limit of licences purchased

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Any Questions?

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