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If we are testing to a BP monograph for a pharmaceutical dosage form, can we use a different reference standard and treat as equivalent to the BPCRS?

April 26, 2017BP different dosage form monograph pharmaceutical Reference standard Testing treat

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If we are testing to a BP monograph for a pharmaceutical dosage form, can we use a different reference standard and treat as equivalent to the BPCRS?

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A. To evaluate any product against a BP monograph, the reference standard specified in the monograph should be used. If the monograph specifies BPCRS, the BPCRS should be used. If the monograph specifies EPCRS, the EPCRS should be used. It is only acceptable to use a different reference material from the one specified in the monograph if the alternative has been validated against the prescribed standard. Substituting without supporting data is not acceptable.