THE TEN-POINT TESTING FRAMEWORK
Know the method.
Understand the result.
Ten areas to understand.
Report-specific coverage. No assumed passes.
VERIFICATION AREA 01HPLC-UV/VIS
Purity
Measures relative chromatographic purity and helps reveal detectable impurities.
How to read the evidence
A chromatographic purity percentage describes the relative detected peak area under a stated method. It does not, by itself, establish molecular identity, vial content, sterility, or clinical safety.
Check the official record ↗VERIFICATION AREA 02HPLC Assay
Quantity
Measures the amount of the intended analyte against a reference standard.
How to read the evidence
Read the reported content, units, reference basis, and acceptance criteria. A high purity percentage does not automatically mean the vial contains its labeled quantity.
Check the official record ↗VERIFICATION AREA 03LC-MS
Identity
Uses liquid chromatography and mass spectrometry to help confirm the intended compound.
How to read the evidence
Compare the reported mass and identity findings with the expected analyte. Interpretation depends on the method, reference information, and any stated limitations.
Check the official record ↗VERIFICATION AREA 04LAL
Endotoxins
Screens for bacterial endotoxins in the tested sample.
How to read the evidence
Check the units, detection limit, sample preparation, and acceptance threshold. An endotoxin result is not interchangeable with a sterility result.
Check the official record ↗VERIFICATION AREA 05ICP-MS
Heavy metals
Measures elements such as arsenic, cadmium, lead, and mercury.
How to read the evidence
Review the individual elements, measured concentrations, reporting limits, and applicable specifications. “Not detected” means below the stated detection limit, not proof of absolute absence.
Check the official record ↗VERIFICATION AREA 06USP <71>
Sterility
Tests for viable microbial growth under specified test conditions.
How to read the evidence
Read the report for sampling, incubation conditions, method suitability, and findings. Results relate to the tested samples and do not establish suitability for human use.
Check the official record ↗VERIFICATION AREA 07LC-MS/MS
Fentanyl screening
Targets fentanyl and specified related compounds in the sample.
How to read the evidence
Confirm the exact analyte panel and detection limits. Screening for specified compounds should not be described as proving the absence of every possible contaminant.
Check the official record ↗VERIFICATION AREA 08Turbidimetric
Solubility
Assesses dissolution behavior or turbidity under defined laboratory conditions.
How to read the evidence
Solvent, concentration, temperature, and timing affect the result. Check the conditions stated in the record. This guide does not provide preparation or dosing instructions.
Check the official record ↗VERIFICATION AREA 09CCIT
Vial seal integrity
Evaluates container-closure integrity using a specified test method.
How to read the evidence
Check the method, sample population, and criteria. Integrity testing is distinct from chemical purity and cannot replace a review of storage and handling conditions.
Check the official record ↗VERIFICATION AREA 10Batch QC
Multi-vial conformity
Compares sampled units to assess consistency within a batch.
How to read the evidence
Review how many vials were sampled and which characteristics were compared. A sample-based assessment should not be overstated as individual testing of every vial.
Check the official record ↗