Foothill Ranch, CA
Gas chromatography mass spectrometry at a cGMP, FDA-registered, DEA-licensed laboratory. Identification and quantitation of trace-level volatile impurities, confirmation of residual solvent results from USP <467> analyses, and compound identification on pharmaceutical APIs, drug products, and medical devices. Send a specific material and a chemist scopes it directly.
A gas chromatograph separates the volatile compounds in your sample. What you learn depends on the detector at the end of the column. ACTA runs both a flame ionization detector and a mass spectrometer, so we can quantify a known compound, and help investigate one you cannot yet name.
A flame ionization or thermal conductivity detector measures a peak and returns a retention time and an area. It is the workhorse for routine quantitation, but it cannot tell you what an unexpected peak actually is. For quantitation by GC, see GC analysis and testing.
The mass spectrometer records a mass spectrum for every peak, a structural fingerprint matched against reference libraries. GC-MS both quantifies and supports identification, which is what you need for low-level impurities and for investigating an unexpected peak.
Residual solvents are volatile organic chemicals used or produced in the manufacture of a drug substance, excipient, or product. USP General Chapter <467> and ICH Q3C classify them by toxicity and set limits. The primary technique is static headspace GC with flame ionization detection, and ACTA uses the mass spectrometer to support identification.
One nuance worth knowing: ICH Q3C applies to new drug products, while USP <467> applies the same limits to new and existing products. ACTA follows USP, BP, JP, and EP methods, or develops and validates a method for your material.
Solvents with unacceptable toxicity, such as benzene and carbon tetrachloride. Known or suspected human carcinogens and environmental hazards.
Solvents to be limited, such as methanol, acetonitrile, and methylene chloride, controlled to a permitted daily exposure and concentration limit.
Solvents with low toxic potential, permitted up to 50 mg per day (5000 ppm), and often included in the same headspace run.
Headspace GC on a USP G43 column identifies Class 1 and Class 2 solvents and screens them against their limits.
A USP G16 column confirms any solvent that appears to exceed its limit in Procedure A, using a different separation.
A quantitative determination on a USP G43 or G16 column for any solvent that does not meet the limit under Procedures A and B.
Not every volatile in a sample is on a compendial list. GC-MS screens for organic volatile impurities, process related volatiles, and volatile degradants, and helps identify what they are rather than just flagging a peak.
When a chromatogram shows a peak you did not expect, the mass spectrum is the answer. ACTA matches the spectrum against reference libraries to support identification of the compound, the consultative work that starts with a specific question about a specific material.
Headspace sampling seals your sample in a heated vial and injects only the volatile gas above it, which keeps non volatile matrix out of the instrument. It is the right choice for residual solvents and low boiling volatiles in a drug matrix.
Direct liquid injection introduces the solution itself, used for higher boiling and polar compounds. ACTA also runs a gas sampling valve for gas samples in a cylinder or sampling bag, so the introduction method fits the material rather than the other way around.
This is the GC-MS in our Foothill Ranch laboratory, for volatile impurities. The chemists who develop and validate your method run the analysis.
That is what a lab your size gives you. You reach the scientist leading the work, not a queue.
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.
Separation of volatile compounds by GC with FID, TCD, and MS.
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USP <232> and <233> elemental impurities by ICP-MS.
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Method development and validation to USP and ICH.
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Compendial and custom methods across instruments.
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