Quality Control Guide¶
1. RPL Peptide Quality System¶
RPL Peptide maintains a comprehensive quality control system aligned with ICH Q7 (Good Manufacturing Practice for Active Pharmaceutical Ingredients).
Quality Framework:
| Element | Description |
|---|---|
| Raw Material Control | All starting materials tested to specification before use |
| Process Control | In-process monitoring of critical quality attributes |
| Final Product Testing | Comprehensive multi-method analysis per batch |
| Stability Monitoring | Real-time and accelerated stability studies |
| Quality Review | Periodic quality review of batch data and trends |
2. Analytical Methods¶
| Method | Application | Instrumentation |
|---|---|---|
| RP-HPLC | Purity, impurity profile | C18 column, UV detection at 214/254 nm |
| LC-MS | Identity confirmation, MW determination | ESI or MALDI-TOF mass spectrometry |
| Karl Fischer | Water content | Coulometric titration |
| LAL Assay | Endotoxin testing | Chromogenic or turbidimetric |
| Amino Acid Analysis | Composition, content | Post-column derivatization |
| UV Spectroscopy | Concentration, content | UV-Vis spectrophotometer |
3. Specifications¶
| Parameter | Standard Specification |
|---|---|
| HPLC Purity (214 nm) | ≥98% |
| Peptide Content | ≥70% (variable by sequence) |
| Water Content | ≤5% |
| Endotoxin | ≤1 EU/mg (research grade) |
| Appearance | White to off-white lyophilized cake |
| Molecular Weight | Confirmed within ±1 Da by MS |
4. Release Process¶
- Sampling: Representative sample drawn per batch
- Testing: Full panel of analytical tests performed
- Review: Results reviewed against specifications
- Release: QC manager authorizes batch release
- Documentation: COA generated and archived
5. Non-Conformance Handling¶
If any parameter falls outside specification: 1. Initiate deviation investigation (CAPA) 2. Identify root cause 3. Implement corrective action 4. Re-test after corrective action 5. Document investigation findings
For quality inquiries: [email protected]