Foothill Ranch, CA
ACTA tests APIs, excipients, and raw materials against their USP, EP, BP, CP, or JP monograph for identity, strength, quality, and purity. Send us the material and the monograph, and a chemist and/or microbiologist scopes the panel. The same lab tests the finished product it becomes.
| Identification | IR <197> | Conforms |
| Assay | HPLC <621> | Meets |
| Related substances | <621> | Meets |
| Loss on drying | <731> | Meets |
| Residue on ignition | <281> | Meets |
| Elemental impurities | <232> / <233> | Meets |
| Residual solvents | <467> | Meets |
ACTA performs compendial monograph testing on incoming raw materials, active pharmaceutical ingredients (APIs), and excipients. For a named article, ACTA follows the USP and NF, EP, BP, CP, or JP monograph, a method you have already validated, or a method ACTA develops and validates in house.
A typical panel covers identity by infrared <197> and the general and chemical identification tests <191>, <193>, <201>, and <202>; assay by HPLC or titration per <621>; related substances and organic impurities by HPLC; loss on drying <731> and water by Karl Fischer <921>; residue on ignition <281>; elemental impurities <232> and <233> by ICP-MS, with the older <231> heavy metals test where a monograph still cites it; and residual solvents <467> by headspace GC.
You receive a cGMP Certificate of Analysis (COA) that states each attribute, its result, the specification, and the pharmacopeia and edition applied. Because ACTA also tests finished products, one lab can carry a material from the incoming raw lot through the product it becomes.
A monograph gives you the method, but a method still has to be shown to work in the lab that runs it, if FDA GMP compliance is needed. USP <1226> Verification of Compendial Procedures confirms that a compendial method performs for your specific article, on ACTA's instruments and analysts. It is a targeted check, not a full revalidation. It looks at the attributes that matter for the material, such as specificity, accuracy, precision, and a system suitability check.
When a method is non-compendial, when you use an alternative to the monograph procedure, or when you change the compendial method, that method needs full validation to USP <1225> and ICH Q2, and it has to be shown equivalent to the compendial method.
ACTA develops, validates, verifies, and transfers methods in house when requested by our clients. The same lab that tests your raw material owns the method behind every number on the COA.
From the named article to the COA: fit the method, confirm identity, run the purity and assay panel, and report against the monograph. Hover any stage to see what it does.
The large labs route a single raw material into a queue that can take a month to start. ACTA takes the one material, scopes the monograph panel with a chemist, and follows up. Many of our largest accounts started as one small test. And because ACTA also runs the finished product, one lab can carry your material from the incoming raw lot through the product it becomes.
Assay, uniformity, dissolution, and QC on the finished dosage form.
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Assay and related substances by HPLC per <621>.
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USP <232> and <233> elemental impurities by ICP-MS.
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Residual solvents (USP <467>) and volatiles by GC.
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Verify, validate, and transfer compendial and custom methods.
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cGMP storage with scheduled, monitored pull testing.
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