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ISPE Glossary of Pharmaceutical and Biotechnology Terminology
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Impurity
Any component present in the intermediate or API that is not the desired entity. It may be either process or product related.
Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
Impurity
A foreign agent or material either introduced as part of processing (such as buffers or salts added during chromatography) or intrinsic to the nature of bioprocessing (such as product variants and cellular debris).
Impurity
Any entity of the drug substance (API) or drug product (final container product) that is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product.
Publication Source: ISPE Good Practice Guide: Technology Transfer
Publication Date: 2003
Impurity
(ICH Q7) Any component present in the intermediate or API that is not the desired entity.
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Impurity
(ICH Q3A (R2)) Any component of the new drug substance that is not the chemical entity defined as the new drug substance.
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Impurity
(ICH Q3B (R2)) Any component of the new drug product that is not the drug substance or an excipient in the drug product.
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Impurity
(ICH Q5C) Any component of the drug substance (bulk material) or drug product (final container product) which is not the chemical entity defined as the drug substance, an excipient, or other additives to the drug product.
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Impurity
(ICH Q6A) Any component of the new drug substance which is not the chemical entity defined as the new drug substance. (2) Any component of the drug product which is not the chemical entity defined as the drug substance or an excipient in the drug product.
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