Glossary
Impurity Profile
A description of the identified and unidentified impurities present in an API, and of their levels.
Source · ICH Q7, §20 Glossary, Impurity Profile; MFDS, 「알기 쉬운 GMP 용어집」 Korean original
Related sections
21 CFR 211.160–211.194EU GMP Part I Chapter 6
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Failure to establish an impurity profile for identified and unidentified impurities and failure to ensure all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.
FDA · FDA Warning Letter · 2026-03-17 -
Failure to establish an impurity profile for identified and unidentified impurities.
FDA · FDA Warning Letter · 2022-09-27 -
Established impurity profiles for US market APIs are inadequate.
FDA · FDA 483 · 2024-08-28
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7, §20 Glossary, Impurity Profile; MFDS, 「알기 쉬운 GMP 용어집」 Korean originalGRM Regulatory Glossary
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