Welcome to the frequently asked questions page of the BP website.
Did you know?.....
Requirements in monographs have been framed to provide appropriate limitation of potential impurities rather than to provide against all possible impurities.
(General Notices, Volume I, page 4)
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Frequently Asked Questions:
- If my product uses a brand name and does not claim compliance with the BP, does the product have to comply with the monograph?
- How does a manufacturer of a drug substance, excipient or drug product get a new monograph into the British Pharmacopoeia?
- We have developed a test which is superior to the current BP method. Would the BP consider publishing this test?
- We believe that there is an error in a test in a monograph and we have supplied data to verify this. What happens next?
- My company only manufactures a few products, can I buy a single monograph of the BP?
- When I compare methods in the current edition of the BP with the Ph. Eur. method in the latest supplement, it seems as if the Ph. Eur. has been amended and the version in the BP has not?
- I am having difficulty in meeting the system suitability criteria in a monograph. What changes can I make to the chromatographic conditions?
- Can you supply details of the suppliers of reagents specified in the BP? Can you recommend a contract laboratory who can perform BP monograph methods?
- We are manufacturing an unlicensed medicine. Do we have to comply with any BP requirements?
- I am in the process of comparing the acceptance of Essential Oil as "medicinal products" and "complementary medicines" in different countries and to ascertain the specific restrictions concerning the use of essential oils. Do Essential Oils have to be registered to be sold in the UK? If yes, in which institution or department? Is the internal use of Essential Oils permitted? Are there any restrictions on use (dosages, form, kind of essential oils)? Are Aromatherapists allowed to prescribe or to give advice on essential oils?
- In the sucrose monograph it states that a kit for sulphite determination should be used. Where can I obtain the kit?
- The monograph indicates that the BPCRS should be used in the standard preparation, can I use a different grade of material?
- We performed the TLC procedure as specified in the monograph and the spots were not visible, can you revise the method?
- The monograph for "Active substance XXX" has been revised to include an HPLC method for related substances. Why has the same method not been included in the corresponding formulation monographs?
- We are manufacturing "XXX Tablets". Can we claim the assay limit as 95.0 to 105.0% of the labelled content or do we have to apply the fiducial limits of error as the limits?
- If we manufacture and label a product as BPC 1973 and it is licensed as such, would you expect the product to be tested to the latest BP monograph?
- In the BP what do the numbers in brackets, such as (2.6.12) indicate?
- Under "Volumetric reagents and solutions" (Appendix I B - A129), it states “In assays and other quantitative tests, solutions are to be standardised before use; including the letters VS after then name of reagent”. If we have validated the concentration of the volumetric solution for a fixed period of time can we use it without standardising before every use over this time period?
- We would like to request for a clarification regarding the interpretation of the “test for related substances" in the "dry powder for injection" monographs of the BP.
- Assay Method in the monograph for Indoramin Hydrochloride
- Amikacin impurity A CRS use in the Amikacin, Amikacin Sulphate and Amikacin Injection monographs