Quality Program
Reference-grade reagents require reference-grade documentation. Every batch of SR-17018 is fully characterized before release.
Overview
SR Biosciences maintains a rigorous analytical quality program designed to meet the evidentiary standards of peer-reviewed research. Every production batch undergoes multi-method characterization before release, including identity confirmation, purity determination, structural integrity verification, and physical assessment. Results are documented in a Certificate of Analysis issued by our ISO 17025-accredited partner laboratory, providing a traceable quality record for each batch supplied.
Batch Release Criteria
| Test | Method | Acceptance Criterion |
|---|---|---|
| Identity | LC-MS/MS | Matches reference spectrum |
| Purity | HPLC-UV | ≥99.0% |
| Structural Integrity | 1H-NMR | Consistent with reference standard |
| Moisture | Karl Fischer | ≤1.0% w/w |
| Appearance | Visual | White to off-white powder |
ISO 17025 Partner Laboratory
- All analytical testing is performed by an ISO/IEC 17025-accredited laboratory.
- Accreditation number: Partner lab name and accreditation number on file — contact support@srbio.com for details.
- Testing is performed on every production batch, not on a sampling basis.
Retention Samples
- Retention samples are maintained for a minimum of 24 months from batch date.
- Available upon request for dispute resolution or independent re-testing.
Stability Program
- Long-term stability: Monitored at −20 °C under inert atmosphere.
- Accelerated stability: 40 °C / 75% RH, assessed at 6-month intervals.
- Retest date: Assigned at batch release based on current stability data.
COA Archive
All batch Certificates of Analysis are publicly archived. View COA archive.