- Full lifecycle QMS from raw material to final release
- Annual surveillance audits by Bureau Veritas
- Document control and CAPA management system
- Supplier qualification and incoming QC program
Quality Assurance
At PEPLYRA Research, quality is the foundation of everything we do, supported by rigorous review and clear documentation.
Our Regulatory Certifications
& Compliance Standards
Click any certification to view full details, scope, and highlights. Certificates are available upon request for qualified customers.
- Electronic batch records with full audit trail
- Validated computerised manufacturing systems
- Environmental monitoring and cleanroom certification
- Validated cleaning and sterilisation procedures
- Registered API manufacturer for U.S. IND/NDA supply
- Pre-approval inspection (PAI) readiness maintained
- Drug Master File (DMF) support available
- 21 CFR Part 211 compliance documentation
- Full ICH Q7 chapter compliance mapping
- Third-party gap analysis completed 2023
- Change control and deviation management
- Stability program per ICH Q1A guidelines
- All substances registered with ECHA
- Safety Data Sheets (SDS) available for all products
- Substance of Very High Concern (SVHC) screening
- Supply chain communication compliance
- HPLC methods validated per USP <621>
- Endotoxin testing per USP <85> LAL method
- Reference standards traceable to NIST
- Residual solvents per ICH Q3C / USP <467>
Verify a Batch Report
Enter the complete PB-prefixed Document Verification code from a PEPLYRA Certificate of Analysis, or scan its QR code for an immediate batch-level lookup.
Verify a report code or scan the QR code printed in the Document Verification section.
Certificate of Analysis
Batch Reports
Every batch ships with a full CoA. Select a product, then switch between historical batches to review our analytical records.
Semaglutide
CAS No. 910463-68-2- Batch No.
- PB-2026-SEM-0163
- Grade
- GMP
- Release Date
- Jun 23, 2026
- Appearance
- White lyophilized powder
Analytical Test Results
8 tests- Result
- 99.3%
- Spec
- ≥99.0%
- Result
- 4113.6 Da
- Spec
- 4113.58 ± 0.5 Da
- Result
- Conforms
- Spec
- Conforms to sequence
- Result
- 0.51 EU/mg
- Spec
- < 1.0 EU/mg
- Result
- < ICH Q3C limits
- Spec
- ICH Q3C Class 2
- Result
- 5.8%
- Spec
- ≤ 8.0%
- Result
- -32.0°
- Spec
- -25° to -32°
- Result
- 95.2%
- Spec
- ≥95.0%
| Test | Result | Specification | Status |
|---|---|---|---|
| HPLC Purity | 99.3% | ≥99.0% | PASS |
| Molecular Weight (MS) | 4113.6 Da | 4113.58 ± 0.5 Da | PASS |
| Amino Acid Analysis | Conforms | Conforms to sequence | PASS |
| Endotoxin (LAL) | 0.51 EU/mg | < 1.0 EU/mg | PASS |
| Residual Solvents | < ICH Q3C limits | ICH Q3C Class 2 | PASS |
| Water Content (KF) | 5.8% | ≤ 8.0% | PASS |
| Optical Rotation | -32.0° | -25° to -32° | PASS |
| Peptide Content (AAA) | 95.2% | ≥95.0% | PASS |
How We Guarantee
Quality at Every Stage
Our ISO 9001 and GMP-compliant Quality Management System covers every step of the manufacturing process — from supplier qualification to final product release.
- 01Raw Material Receipt
- 02Incoming QC Testing
- 03Material Release
- 04Synthesis & Production
- 05In-Process Controls
- 06Final QC Testing
- 07QP Batch Review
- 08CoA Issuance & Shipment
Document Control
Every procedure, specification, and record is controlled, version-tracked, and accessible through our validated EDMS — ensuring full traceability from raw material to final release.
- SOPs for all manufacturing and QC operations
- Electronic document management system (EDMS)
- Version-controlled batch manufacturing records
- Change control with impact assessment
- Deviation and CAPA management workflow
Our Quality Process
Raw Material Control
Careful supplier selection and incoming material review before the testing process.
Testing & Analysis
Identity and purity review through appropriate analytical methods.
Batch Documentation
Complete records for each batch including COA and analytical results.
Quality Verification
Final review and release only after standards and records are confirmed.
Testing & Documentation
Every material has a consistent place for identity, purity, batch, and handling information.
HPLC Analysis
Chromatographic purity review.
Mass Spectrometry
Molecular identity information.
Certificate of Analysis
Batch-specific release documentation.
Batch Records
Lot and manufacture information.
Storage Guidance
Handling and storage requirements.
Controlled Review
Quality Standards
Full Documentation
Batch Traceability
Research Focused

Quality Built Into Every Step
From material review through batch release, the PEPLYRA quality framework keeps information consistent, traceable, and ready for qualified review.
- Consistent product specifications
- Batch-specific documentation
- Analytical information fields
- Clear storage and handling guidance
Quality You Can Research With
Browse the catalog or contact our team about documentation requirements.