Foothill Ranch, CA
ACTA runs gas chromatography on pharmaceutical APIs and finished drug products, to USP, BP, JP, and EP methods or a method we develop for you. Common work includes residual solvents, volatile impurities, quantitation of volatile ingredients, and identification / quantitation by GC-MS.
ACTA performs GC analyses on pharmaceutical APIs (active pharmaceutical ingredients), finished drug products, and medical devices. ACTA follows USP, BP, JP, or EP methods, or develops and can validate a method for your product.
ACTA issues a cGMP Certificate of Analysis (COA) for release or submission.
In gas chromatography, the sample is vaporized and carried by an inert gas, usually nitrogen or helium, through a column. Compounds separate by their volatility and by how strongly they interact with the column coating, so they reach the detector at different times.
The detector signal is proportional to how much of each compound is present, and results are compared against a known standard. Headspace injection lets ACTA measure volatile residual solvents without injecting the sample matrix itself.
ACTA runs both packed and capillary columns, with FID, TCD, and mass spectrometry detection. GC-MS adds a mass spectrum for identifying and confirming compounds.
The sample is injected into the flowing carrier gas, separated on the temperature-programmed column, and measured by the detector. Hover any stage to see what it does.
The large labs route a single GC method into a queue that can take a month to start. ACTA takes the one material, scopes it with a chemist, and follows up. Many of our largest accounts started as one small test.
A chemist reviews your material and what you need measured.
Follow USP, BP, JP, or EP, or develop and validate a method for your material.
GC with the right injection and detector, under cGMP.
A cGMP Certificate of Analysis (COA), and we follow up on your results.
Inside the lab / Foothill Ranch
A gas chromatograph on our Foothill Ranch bench measures volatiles and residual solvents by headspace and direct injection. The chemists who develop and validate your method are the ones who run it.
What we measure
Volatiles and residual solvents
How we run it
Headspace and direct injection
Who signs it
A scientist in Quality or Management
Compendial and custom methods across instruments.
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Separation of volatile compounds by GC (FID, TCD, MS).
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USP <232> / <233> elemental impurities by ICP-MS.
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TOC, conductivity, and endotoxin for water systems.
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cGMP storage with scheduled, monitored pull testing.
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Method development and validation to USP and ICH.
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