FOI release

Information regarding the British Pharmacopoeia monograph for Ramipril tablets

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00978

Received 1 September 2026

Published 13 October 2026

Request

We would like to request information regarding the British Pharmacopoeia monograph for Ramipril tablets (strengths 1.25 mg, 2.5 mg, 5 mg and 10 mg). Specifically, we seek clarification on the scientific and regulatory basis used by the British Pharmacopoeia Commission to establish the impurity limits for Ramipril Impurity D + Impurity E (per strength), any other impurity, and total impurities (per strength) in the monograph. In this context, we would appreciate confirmation as to whether relevant international guidelines (e.g. ICH Q3A(R2), ICH Q3B(R2), ICH M7, EMA impurity guidance, including EMA/CHMP/4299/2026) were considered in setting these limits, and whether any toxicological evaluation formed part of the assessment. Furthermore, a summary of the approach used in establishing these limits, including any non-confidential information on the supporting data, scientific justification, or expert advisory group considerations involved in the decision-making process, would be highly appreciated. We understand that commercially confidential or proprietary data may be redacted and confirm that we are not requesting access to such information.

Response

See attached

Documents

• 2003-10_draft BP Ramipril Tablets monograph.pdf (347.4 KB)
• EAG minutes_Ramipril Tablets.pdf (666.0 KB)
• FOI2026_00978 (redacted).pdf (953.1 KB)

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