Pharmacopeial Impurities (EP / USP / BP)

Pharmacopoeial monographs name the impurities a method must detect, often by letter in the European Pharmacopoeia or as related compounds in the USP. This sub-category lists those named substances so laboratories can run monograph methods with confidence. Examples include Abacavir EP Impurity B and C, Abacavir USP Related Compound B and C, (R)-Atomoxetine EP Impurity A and (R)-Lansoprazole EP Impurity A.

These materials are used for peak identification, system suitability and method transfer. Where the monograph requires an official pharmacopoeial reference standard for a test, that requirement still applies. Our standards are secondary materials, well suited to development, routine identification and investigations. Each listing gives the pharmacopoeial name, chemical name, structure and CAS number where available.

Each vial is supplied with a COA showing HPLC purity and structural confirmation by NMR and MS. Quantities usually range from 10 mg to 100 mg. If a newer monograph adds an impurity not yet listed, send us the name and we will quote synthesis.