Quality control ensures peptide identity, purity, potency, and stability. This reference covers ICH guidelines, testing methods, and acceptance criteria for research-grade and GMP-grade peptides.
| 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 |
| 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 |
| Category | Origin | Control Strategy |
|---|
| Process-related | Solvents, reagents | Removal during purification |
| Product-related | Deletion, oxidation | Stability testing |
| Genotoxic | Alkylating agents | ICH M7 assessment |
| Elemental | Catalysts, equipment | ICH Q3D guidelines |
| Condition | Temperature | Humidity | Duration | Testing Intervals |
|---|
| Long-term | 25°C ± 2°C | 60% ± 5% RH | 12–36 months | 0, 3, 6, 9, 12, 18, 24, 36 months |
| Accelerated | 40°C ± 2°C | 75% ± 5% RH | 6 months | 0, 3, 6 months |
| Intermediate | 30°C ± 2°C | 65% ± 5% RH | 12 months | 0, 3, 6, 9, 12 months |
| Photostability | 1.2M lux·hours | — | Per ICH Q1B | Before and after exposure |
| Document | GMP Required | Research Grade |
|---|
| Certificate of Analysis | Yes | Optional |
| Batch record | Yes | No |
| Stability data | Yes | No |
| Impurity profile | Yes | Summary |
| Mass spectrum | Yes | Yes |
| HPLC chromatogram | Yes | Yes |
QC testing supplies available from Kingston Peptides
