Quality control
Review the testing, storage and documentation requirements for each lot.
- Testing
- Independent laboratory, Texas
- Certificate
- Not yet published
- Status
- Launching end of 2026. Lot documentation pending.
Release testing
Purity
UHPLC
InstrumentAgilent 1290 Infinity II
HRMS identity
Orbitrap
InstrumentOrbitrap high resolution mass spectrometer
Sequence
LC-MS/MS
InstrumentTriple quadrupole LC-MS/MS system
Elemental impurities
ICP-MS
InstrumentICP mass spectrometer
Sterility
USP <71>
StandardUnited States Pharmacopeia <71>
Bacterial endotoxins
USP <85>
StandardUnited States Pharmacopeia <85>
Storage and packaging
Frozen storage from lyophilisation
-20 °C
Storagetemperature controlled until dispatch
USP Type I glass under nitrogen
Amber glass
Packagingvacuum sealed, light tight shipping
Laboratory and certificate
- Independent testing, Texas
- Every lot is tested by an independent laboratory in Texas before it is released. No lot has been released yet.
- Certificate of analysis
- Each lot's certificate of analysis will be published on its documentation record before shipment, identifying the laboratory, instruments and test results. No certificate has been issued yet.
Operated from Austin, Texas
Each released lot will have a documentation record identified by its lot number.
View lot documentation