Quality Control¶
Analytical methods and testing protocols for peptide characterization and release.
QC Tests¶
- HPLC Analysis — Purity determination by reversed-phase HPLC
- LC-MS Testing — Identity confirmation by mass spectrometry
- Purity Analysis — HPLC purity calculation and impurity profiling
- Peptide Content — Net peptide content determination
- Water Content — Karl Fischer moisture analysis
- Residual Solvents — GC analysis of organic solvents
- Mass Confirmation — Molecular weight verification
- Amino Acid Analysis — Composition verification
- Endotoxin Testing — See quality specs at RPL Peptide FAQ
- COA Understanding — How to read a Certificate of Analysis
- Method Validation — ICH Q2(R1) method validation for peptide testing
- Stability Testing — Shelf life and degradation studies
- Impurity Profiling — Identification and quantification of peptide impurities
Typical QC Specification¶
| Test | Research Grade | GMP Grade |
|---|---|---|
| Purity (HPLC) | ≥95% | ≥98% |
| LC-MS | Confirm MW | Confirm MW |
| Peptide Content | ≥80% | ≥85% |
| Water | ≤5% | ≤5% |
| Residual Solvents | — | ≤0.5% |
| Endotoxin | — | ≤10 EU/mg |
| Appearance | White powder | White powder |