Scientists performing analytical testing use reference standards to determine quantitative and qualitative data, performance standards, and calibrators. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results.
What are Pharmaceutical Analytical Standards?
The FDA defines a reference-standard material as a "highly purified compound that is well characterized." USP defines reference-standard materials as "highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators."
Types of reference-standard materials include:
- Assays—used to determine potency for active pharmaceutical ingredients (APIs) and salts
- Degradation products—used to identify and possibly to quantitate degradation products
- Process impurities—used to identify and possibly quantitate process-related compounds
- Resolution—used to determine assay performance or impurity method
- Metabolites—used to identify and possibly to quantitate substances generated through a metabolic process.
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