ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English
Deutsch
Francais

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.

Publication Source:

Impurity

(ICH Q3A (R2)) Any component of the new drug substance that is not the chemical entity defined as the new drug substance.

Publication Source:

Impurity

(ICH Q3B (R2)) Any component of the new drug product that is not the drug substance or an excipient in the drug product.

Publication Source:

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.

Publication Source:

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.

Publication Source:

Do you have a term that should be included in the glossary?
Submit a term for review

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift