Peptide Quality Control
Peptide Quality Control
Section titled “Peptide Quality Control”ICH Guidelines
Section titled “ICH Guidelines”| Guideline | Scope | Key Requirements |
|---|---|---|
| ICH Q6A | Specifications | Test procedures, acceptance criteria |
| ICH Q1A(R2) | Stability | Long-term, accelerated, stress testing |
| ICH Q1B | Photostability | Light exposure testing |
| ICH Q3A(R2) | Impurities (drug substance) | Characterization, qualification |
| ICH Q5C | Biotech products | Stability of peptides/proteins |
QC Testing Panel
Section titled “QC Testing Panel”| Test | Method | Acceptance Criteria |
|---|---|---|
| Identity | MS (ESI/MALDI) | MW ±0.1 Da |
| Purity | RP-HPLC | ≥95% (research), ≥98% (GMP) |
| Sequence | MS/MS or Edman | Confirmed |
| Water content | Karl Fischer | <10% (research), <5% (GMP) |
| Endotoxin | LAL | <10 EU/mg (research) |
| Residual solvents | GC-MS | Per ICH Q3C |
| Peptide content | Amino acid analysis | 90-110% of label |