primary reference standard
- Guideline or reference source
- NSF363 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients
- Definition
- A substance that has been shown by an extensive set of analytical tests to be authentic material that is of high purity. This standard may be: (1) obtained from an officially recognized 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
- secondary reference standard
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