Essential Release
For supplier qualification, routine lot verification, and any lot that needs a fast answer on identity, strength and microbial safety.
Safety
Control what can cause harm.
01SterilityAbsence of viable microorganisms over a 14-day incubation.
Samples are incubated in two media for fourteen days. This is the compendial method and sets the minimum turnaround for any program that includes it.
- Method
- Membrane filtration, 14-day incubation
- Reference
- USP <71>
02Bacterial endotoxinsEndotoxin in EU/mg against a product-specific limit.
Endotoxin is measured in EU per milligram and compared with a limit calculated for the product and dose.
- Method
- Kinetic chromogenic LAL
- Reference
- USP <85>
Holistic peptide quality
Is it what the label says, at labeled strength?
03Identity (intact mass)Confirms the molecular weight of the declared peptide.
High-resolution mass spectrometry measures the molecular weight to within a few parts per million and compares it with the theoretical mass of the declared peptide.
- Method
- LC-HRMS
04Purity and related substancesMain peak purity, with each impurity above the reporting threshold listed.
Reverse-phase chromatography separates the peptide from everything that resembles it. Purity is reported as main peak area percent, and each impurity at or above the reporting threshold is listed with its relative retention time and, where the mass allows, a tentative assignment.
- Method
- RP-UPLC, UV 214 nm, with MS
- Reference
- ICH Q3 reporting thresholds
05Net peptide contentPeptide content per vial against label claim.
The amount of peptide in the vial is quantified against a qualified reference standard and reported in milligrams and as a percentage of label claim, net of water and counterion.
- Method
- UPLC assay against reference standard
06Structural and conformational screenSolution conformation compared with a reference spectrum.
Chiroptical spectroscopy compares the solution structure of the sample with a reference. Two lots can match on mass and purity and still differ in how the peptide folds.
- Method
- Vibrational circular dichroism (VCD)
Submit samples for Essential Release
The online submission generates an itemised invoice and a shipping packet.