Foothill Ranch, CA
cGMP HPLC assay (percent label claim) and related substances and impurities testing on pharmaceutical APIs and finished drug products, to USP, BP, JP, and EP methods or a method ACTA develops and validates for you. Send a specific test on a specific material and a chemist scopes it directly.
Assay measures how much active is present. ACTA runs assay, or potency, by HPLC against a qualified reference standard and reports the result as a percent of label claim, with content uniformity by USP <905> when the dosage form calls for it.
Related substances are the organic impurities that travel with an active: starting materials, intermediates, process impurities, and degradation products. ACTA quantifies them as individual, total, and unspecified impurities against the method specification, and a related substances method can be developed to be stability-indicating so degradants are resolved from the active.
We follow USP, BP, JP, CP, and EP compendial methods, a customer-provided method, or a method ACTA develops and validates for your material. You receive a cGMP Certificate of Analysis (COA) for submission or release.
A single reverse-phase HPLC method can carry both results. The active and its impurities are separated on the column, each peak is measured by the detector, and the areas are compared against reference and impurity standards. The assay comes from the main peak. The related substances come from the smaller peaks, each judged against ICH reporting, identification, and qualification thresholds, with the run held to USP <621> system suitability before any result is reported.
The tall peak is the active, integrated for assay. The small peaks are related substances, each reported against threshold.
Thresholds rise as the maximum daily dose falls, per ICH Q3A(R2) for drug substances and Q3B(R2) for drug products.
Whether your product runs on a compendial monograph or needs a method built from scratch, ACTA carries it through the full lifecycle so the result stands up to an FDA review. Method development and validation is a service in its own right.
Design a selective, stability-indicating separation when no compendial method fits the material.
Specificity, accuracy, precision, linearity, range, LOD and LOQ, and robustness per ICH Q2 and USP <1225>.
Bring a validated method into ACTA per USP <1224> with documented, pre-agreed equivalence.
Confirm a compendial method performs under ACTA conditions and your matrix per USP <1226>.
Every assay begins with an accurate weight. Sample and standard preparation are recorded under our cGMP quality system before a single injection.
The core instrument behind assay and impurities work.
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USP <232> and <233> elemental impurities by ICP-MS.
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Develop, validate, transfer, and verify to USP and ICH.
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cGMP storage with scheduled, monitored pull testing.
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Separation of volatile compounds by GC (FID, TCD, MS).
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Compendial and custom methods across instruments.
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