TESTING & QUALITY ASSURANCE
How every batch is tested.
Every Zenovate batch is tested for identity, purity, potency, safety and stability by an independent accredited laboratory before it is listed. Below is the testing framework we apply, and the standards behind it.
[ testing methods ]
Identity · purity · safety · stability
OUR TESTING FRAMEWORK
Identity, purity, safety and stability, verified by method.
01IdentityConfirms the compound matches the label, by intact-mass analysis (LC-MS) and sequence confirmation (LC-MS/MS).
02PurityThe share of the sample that is the target compound, measured by UPLC / HPLC against a written specification.
03CompositionCounterions, residual solvents and water content, checked by ion chromatography, GC headspace and Karl Fischer titration.
04LaboratoryWho ran it. Independent and accredited means no stake in the result.
05StabilityReal-time and accelerated stability testing establishes shelf-life before a batch is ever listed.
TESTING METHODS
METHODCATEGORYWHAT IT VERIFIESSTANDARD
UPLC / HPLC (PDA)Identity & PurityPurity, assay (potency), related substancesICH
UPLC / HPLC (PDA)ICH
Identity & PurityPurity, assay (potency), related substancesLC-MS (ESI)Identity & PurityIntact mass & molecular-weight confirmationICH
LC-MS (ESI)ICH
Identity & PurityIntact mass & molecular-weight confirmationLC-MS/MSIdentity & PuritySequence & fragment confirmationICH
LC-MS/MSICH
Identity & PuritySequence & fragment confirmationICP-MSSafetyElemental impurities / heavy metalsUSP
ICP-MSUSP
SafetyElemental impurities / heavy metalsKarl FischerSafetyWater content determinationUSP
Karl FischerUSP
SafetyWater content determinationStability chambersStabilityReal-time & accelerated shelf-lifeICH
Stability chambersICH
StabilityReal-time & accelerated shelf-life