Peptide Industry advanced
Peptide Quality Control
Analytical testing and quality control requirements for therapeutic peptide products.
By Encyclopeptide Editorial | 1 min read
quality-control analytics testing gmp
Overview
Quality control for therapeutic peptides requires comprehensive analytical testing to ensure identity, purity, potency, and safety.
Key Tests
- Identity: Mass spectrometry, amino acid analysis
- Purity: HPLC, capillary electrophoresis
- Potency: Bioassays, receptor binding assays
- Safety: Endotoxin, sterility, residual solvents
Specifications
- Purity typically >95% for API
- Related substances controlled individually
- Counterion content specified
- Water content by Karl Fischer
Stability Testing
ICH guidelines require long-term, accelerated, and stress stability studies to establish shelf life and storage conditions.
References
- Source: ENCP Peptide Database
- Category: Peptide Industry
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