Quality and compliance
QuantVera results are produced with referenced methods, tracked from receipt to release, and published in a certificate whose authenticity can be checked by anyone holding it.
Analytical methods
Where a United States Pharmacopeia chapter or ICH guideline applies, the analysis follows it and the certificate cites it. Other analyses are described on the certificate by technique and conditions.
- USP <71>Sterility. Membrane filtration, 14-day incubation
- USP <85>Bacterial endotoxins. Kinetic chromogenic LAL
- USP <790>Visible particulates. Visual inspection against black and white backgrounds
- USP <467>Residual solvents. Headspace GC-MS
- USP <232> and <233>, ICH Q3DElemental impurities and catalyst residues. ICP-MS
- ICH M7, USP <1469>Mutagenic and nitrosamine risk. Risk assessment with confirmatory LC-MS/MS
- ICH Q3 reporting thresholdsPurity and related substances. RP-UPLC, UV 214 nm, with MS
- USP <631>Color. Visual comparison against color standards
- Ph. Eur. 2.2.1Clarity and degree of opalescence. Visual comparison against reference suspensions
- USP <791>pH. Potentiometric
- USP <785>Osmolality. Freezing point depression
- USP <697>Extractable volume. Volumetric withdrawal
- USP <921>Water content. Karl Fischer titration
- ICH Q1A, Q1BDegradation pathways and forced degradation. Stress conditions with UPLC-MS
- ICH Q1AStability program. Timepoint testing at controlled conditions
- USP <1207>Container closure integrity. Vacuum decay
- USP <1663> and <1664>Extractables and leachables. LC-MS, GC-MS and ICP-MS screening
Chain of custody
Identification at submission
Each lot is assigned a sample ID when the submission is placed. The ID is printed on the packet and marked on every vial before shipment.
Reconciliation on receipt
Vials are reconciled against the packet on arrival and receipt is confirmed to the client. Analysis begins once every lot in the submission has been received.
Recorded milestones
Receipt, start of analysis and certificate release are recorded against the submission and stated on the certificate.
Certificate integrity
Unique certificate ID
Every certificate carries an ID tied to one lot and one submission, with a QR code that opens the verification record.
Document fingerprint
A SHA-256 hash of each certificate is recorded at release and shown on the verification page, so any altered copy can be identified.
Issued copy on record
The certificate as released is retained by the laboratory and can be retrieved from the verification page at any time.
Reporting policy
Results are reported exactly as measured, with the specification beside each one. A lot that does not meet specification receives a certificate in the same format as a conforming lot, with the conclusion stated on the first page.
The fee for an analysis is independent of its outcome. A certificate reports analytical results for the lot tested; it is not a regulatory approval and does not state that a product is suitable for any use.
Verify a certificate
Check a QuantVera certificate ID against the laboratory record.