Foothill Ranch, CA
ACTA runs quantitative ICP-MS for elemental impurities on pharmaceutical APIs and finished drug products, to USP <232> and <233> or your validated method. Send us a specific material and a chemist scopes the work.
ACTA performs quantitative ICP-MS for elemental impurities on pharmaceutical APIs (active pharmaceutical ingredients) and finished drug products, to USP <232> (Limits) and USP <233> (Procedures). ACTA follows USP, BP, JP, or EP methods, or develops and validates a method for your product.
For clients whose monographs still cite it, ACTA also runs the USP <231> Heavy Metals wet chemistry test for Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu, and Mo. You receive a cGMP Certificate of Analysis (COA) for submission or release.
ICH Q3D and USP <232> and <233> replaced the older <231> colorimetric heavy metals test. The old test was visual, was not specific, and did not give a number. ICP-MS measures each regulated element on its own, at trace levels.
The guidelines control 24 elemental impurities, grouped by toxicity and likelihood into Class 1 (As, Cd, Hg, Pb), Class 2A (Co, Ni, V), Class 2B, and Class 3. Limits depend on the route of administration. Oral, parenteral, and inhalation each have their own Permitted Daily Exposure, and parenteral and inhalation are the strictest.
In the analysis, the digested sample enters an argon plasma at roughly 6,000 to 10,000 K, which ionizes the elements. A mass spectrometer separates the ions by mass and counts them, which gives a quantitative concentration for each regulated element.
Your digested sample is ionized in the plasma, separated by mass, and counted for each regulated element. Hover any stage to see what it does.
The large labs route a single elemental impurities job 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.
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.
View →
