Analytical testing structure
Osmora Testing Standard
Osmora’s analytical testing is organised into a Core Release Standard of 9 checks and an Extended Analytical Framework of 7 additional checks — 16 total analytical checks. The 9 Core checks are the release standard; the Extended checks extend the analytical framework. Each check below links to an Academy explanation of what it measures and what it can and cannot establish. This page explains the structure; it does not report results for any lot — those live in Osmora’s Quality system and verification records.
Core Release Standard
9 checks — the release standard
- 01Identity ConfirmationUnderstand this test →
Confirms which molecule is present, distinct from how pure it is.
- 02HPLC / UPLC PurityUnderstand this test →
The proportion of detected material attributable to the main component under the method.
- 03Vial Content / QuantityUnderstand this test →
How much of the intended substance is present, as an absolute amount.
- 04Bacterial EndotoxinUnderstand this test →
Detects and estimates bacterial endotoxin, a specific contamination category.
- 05PCR Microbial ScreeningUnderstand this test →
Uses nucleic-acid amplification to screen for microbial genetic material.
- 06Heavy Metals / Elemental ImpuritiesUnderstand this test →
Measures trace chemical elements such as certain metals.
- 07Fentanyl ScreeningUnderstand this test →
A targeted screen for the presence of fentanyl as a specific contaminant of concern.
- 08pH AnalysisUnderstand this test →
Measures the acidity or alkalinity of a solution.
- 09Documented AppearanceUnderstand this test →
A recorded description of the material's observable physical characteristics.
Extended Analytical Framework
7 additional checks
These extend the analytical framework beyond the Core Release Standard. They are not part of the 9-check release standard.
- 10Potency AssayUnderstand this test →
Characterises activity — distinct from purity (proportion) and quantity (amount).
- 11USP SterilityUnderstand this test →
Whether viable microorganisms are detectable under the test's conditions.
- 12BioburdenUnderstand this test →
An estimate of the viable microbial load present.
- 13Residual SolventsUnderstand this test →
Volatile solvents that may remain from processing.
- 14TFA ContentUnderstand this test →
Trifluoroacetic acid associated with the material as counter-ion or residue.
- 15Moisture / Water ContentUnderstand this test →
The amount of water associated with a material.
- 16Same-Lot ConformityUnderstand this test →
Whether documentation and testing consistently correspond to one specific lot.