Quality
Quality & documentation
Every lot is released against a written specification and shipped with documentation that lets your laboratory reproduce our analytical result.
Release testing
Materials are characterised by orthogonal methods before release. Chromatographic purity is determined by HPLC-UV against an area-normalisation method; identity is confirmed by 1H-NMR and LC-MS; residual solvents are screened by headspace GC against ICH Q3C limits; water content is determined by Karl Fischer titration.
Standard release panel
- Appearance
- Visual inspection
- Identity
- 1H-NMR, LC-MS (ESI+)
- Chromatographic purity
- HPLC-UV, area normalisation
- Related substances
- HPLC-UV, single unspecified peak limit
- Residual solvents
- GC headspace, ICH Q3C
- Water content
- Karl Fischer titration
- Residue on ignition
- Gravimetric
Traceability & documentation
Each shipment carries a Certificate of Analysis referencing the exact lot number dispatched, with date of manufacture, retest date and the full analytical result table. Lot records are retained so a historical COA can be re-issued on request for audit purposes.
Included with every shipment
- Certificate of Analysis
- Lot-specific, signed release record
- Safety data sheet
- Current revision, GHS format
- Handling statement
- Storage, reconstitution and stability guidance
- Customs documentation
- Research-material declaration, HS classification
- Packaging
- Sealed amber glass vial, argon headspace, tamper-evident seal
- Retention
- Lot records retained for audit re-issue
Storage, stability and handling
Storage on receipt
Transfer to the storage condition stated on the vial label immediately on receipt. Most kinase inhibitor standards are held at −20 °C, desiccated and protected from light.
Stability
Retest dates are assigned from the date of manufacture based on the stability data for the material class. Do not use material beyond the stated retest date without re-qualification.
Laboratory handling
Handle fine powders in a ventilated enclosure with appropriate personal protective equipment, following your institution's standard operating procedures.