drug substance
- Guideline or reference source
- ICHQ6B Test procedures and acceptance criteria for biotechnological/biological products
- Definition
- The material which is subsequently formulated with excipients to produce the drug product. It can be composed of the desired product, product-related substances, and product- and process-related impurities. It may also contain excipients including other components such as buffers.
- Narrower Term
- new drug substance
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