Analytical Methods
Lab Testing
Every batch of every product is submitted to an independent, ISO 17025-accredited laboratory for comprehensive analytical testing. Testing is performed blind — the lab receives coded samples without identifying information.
Laboratory Accreditation
ISO/IEC 17025:2017
Primary Method
HPLC + LC-MS/MS
Purity Standard
≥99.0% by HPLC
Testing Process
Sample Preparation
A representative sample is pulled from each production batch following a statistical sampling plan. Samples are weighed, dissolved in appropriate solvent, and filtered prior to analysis.
HPLC Analysis
High-performance liquid chromatography separates and quantifies the active compound against a certified reference standard. Peak area comparison determines purity percentage.
Mass Spectrometry Confirmation
LC-MS/MS confirms molecular identity by exact mass matching. Eliminates the possibility of isobaric impurities passing as the target compound.
Heavy Metal Screening
ICP-MS screening for arsenic, cadmium, lead, and mercury. Results must comply with USP <232> limits for oral and parenteral products as applicable.
Microbiological Testing
Total aerobic microbial count, total yeast and mold count, and absence testing for specified organisms per USP <61> and <62> methods.
COA Issuance
Upon passing all tests, the accredited laboratory issues a Certificate of Analysis documenting all results with instrument data. This COA is the release document for the batch.