The British Pharmacopoeia Laboratory is responsible for the procurement, establishment and maintenance of British Pharmacopoeia Chemical Reference Substances (BPCRS) to support the monographs of the BP.
British Pharmacopoeia Chemical Reference Substances (BPCRS) are produced to support the monographs of the British Pharmacopoeia (BP). They are supplied solely for use in the tests and assays of the BP or BP (Veterinary) in which a BPCRS is required. They are issued only for chemical analysis and may not be suitable for any other purposes. They are not intended for administration to humans or animals. BPCRS are supplied in unit packs containing sufficient material to carry out the prescribed procedures.
The specificity of pharmacopoeial reference standards is recognised by the International Standards Organisation (ISO Guide 35 Certification of Reference materials - General and statistical principles, “Pharmacopoeial reference standards are established by pharmacopoeial authorities following the general principles of the ISO guides but a different approach is used when giving the user information usually provided by the certificate of analysis and expiration date; the uncertainty of any assigned value is not given since allowance is made for this in the limits and tolerances in the official test requirements for which they are used”).
BPCRS are established following laboratory characterisation in accordance with defined procedures and are approved and adopted for use by the relevant Expert Advisory Groups of the BP Commission. Pharmacopoeial standards are recognised as Primary Standards in accordance with the World Health Organisation definition (WHO Technical Report Series 885, Annex 3, “A reference substance that is widely acknowledged as having appropriate qualities within a specified context, and whose value is accepted without reliance on comparison to another substance”).
For more information concerning the availability, purchase and use of BPCRS please choose from the menu on the left.
BPCRS Prices 2013
The prices of BPCRS are as follows:
- Quantitative (Assay) standards, currently £111 per vial
- Non-quantitative (Impurity) standards, currently £97 per vial