> For the complete documentation index, see [llms.txt](https://docs.rplpeptides.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://docs.rplpeptides.com/docs/guides/peptide-quality-control-guide.md).

# 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

1. **Sampling**: Representative sample drawn per batch
2. **Testing**: Full panel of analytical tests performed
3. **Review**: Results reviewed against specifications
4. **Release**: QC manager authorizes batch release
5. **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: <quality@rplpeptides.com>*


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