reference standard, primary
- Guideline or reference source
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognised source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.
- Broader Term
- reference standard
- Related Term
- reference standard, secondary
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