cGMP HPLC assay and impurities testing on pharmaceutical APIs and drug products, to USP, BP, JP, and EP methods or a method ACTA develops for you. Send a specific test on a specific material and a chemist scopes it directly.
ACTA Laboratories is a cGMP, FDA-registered testing laboratory that performs HPLC analyses on pharmaceutical APIs (active pharmaceutical ingredients) and finished drug products. Typical work includes assay (potency) and related substances / impurities testing.
We follow USP, BP, JP, CP, and EP compendial methods, or develop a method for your material, with method validation and verification to meet FDA requirements. You receive a cGMP Certificate of Analysis (COA) for submission or release.
HPLC (high-performance liquid chromatography) separates a mixture using a solid stationary phase packed in a column and a liquid mobile phase pumped through it. Different compounds are retained to different degrees, so they exit the column at different times. A detector measures each compound as it elutes, and its response is compared against a known standard to determine concentration.
Sample is injected into the mobile-phase stream, separated on the column, and measured by the detector. Hover any stage to see what it does.
As the big labs consolidate, they have stopped taking projects that are not large enough, and just getting into their queue can take a month. ACTA is FDA-registered, DEA-licensed, and cGMP, and small enough to actually respond and follow up. Many of our largest accounts started as one small test.


The chemists who develop and validate your method are the same people at the instrument who run it. No handoff to a faceless queue, no method that changes hands three times before a result reaches you. Every result is reviewed and approved by Quality before it is released.
You reach the scientist leading the work, not a queue.
Compendial and custom methods across instruments.
View →Separation of volatile compounds by GC (FID, TCD, MS).
View →USP <232> / <233> elemental impurities by ICP-MS.
View →TOC, conductivity, and endotoxin for water systems.
View →cGMP storage with scheduled, monitored pull testing.
View →Method development and validation to USP and ICH.
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