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Chemical grade

BP Grade (British Pharmacopoeia) chemicals

Material that complies with its British Pharmacopoeia monograph, the UK standard that incorporates Ph. Eur. texts.

What the grade means

BP grade material complies with its monograph in the British Pharmacopoeia, prepared by the British Pharmacopoeia Commission and published for the Medicines and Healthcare products Regulatory Agency. A new edition is normally issued every year. The BP reproduces all European Pharmacopoeia monographs and adds national texts, mainly for finished formulations.

What a monograph controls

  • Definition, content limits, appearance and solubility.
  • Identification tests.
  • Related substances, residual solvents, elemental impurities, water and sulfated ash.
  • Assay, storage and labelling, often with a list of specified impurities.

Citric acid monohydrate BP, as an example, requires 99.5 to 100.5 percent content on the anhydrous basis, water of 7.5 to 9.0 percent and sulfated ash of 0.1 percent at most.

When to choose it

Choose BP grade for products registered in the UK and in Commonwealth markets that reference the BP. Where Ph. Eur. and BP texts are identical, one test set can support both claims.

Documentation

Each lot carries a COA naming the BP edition and a GHS SDS. See Ph. Eur. grade for the European equivalent.

BP Grade (British Pharmacopoeia) products

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Questions

About BP Grade (British Pharmacopoeia)

Why does the BP change every year?
The British Pharmacopoeia is republished annually to include new and revised monographs and updated European texts. A COA should state which edition the lot was tested against, since limits can change between editions.
Which countries reference the BP?
Besides the UK, a number of Commonwealth and other markets accept or reference the BP in their regulations. Check with your local authority, as many also accept Ph. Eur. or USP.
Is BP grade material suitable for veterinary products?
The BP has a separate veterinary volume. Substances used in veterinary medicines must meet that monograph where it exists, and the manufacturer remains responsible for regulatory approval.

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