Foothill Ranch, CA
Give ACTA the article and its monograph, and we run the entire required panel: identity, assay, related substances, water, and impurity tests the monograph names. Complete compendial testing applies whether the article is an incoming raw material or a finished drug product, using the applicable monograph and test panel for that article. FDA-registered, DEA-licensed, cGMP since 1990.
| Identification | IR <197> | Conforms |
| Assay | HPLC <621> | Meets |
| Related substances | <621> | Meets |
| Loss on drying | <731> | Meets |
| Water (Karl Fischer) | <921> | Meets |
| Residue on ignition | <281> | Meets |
| Elemental impurities | <232> / <233> | Meets |
| Residual solvents | <467> | Meets |
A USP monograph is the official specification for a named article. It lists every test the article has to pass, the method for each test, and the acceptance criterion. Complete monograph testing means ACTA runs that entire panel against the article, not a single test in isolation, and reports the article to its monograph on one Certificate of Analysis.
ACTA tests to the USP/NF monograph, and to the EP, BP, CP, or JP monograph where one applies, using the compendial procedure, a method you have already validated, or a method ACTA develops and validates in house. Send us the article and the monograph, and a chemist and/or microbiologist scopes the panel.
A typical monograph panel covers identity by infrared <197> and the general identification tests <191>; assay by HPLC or titration per <621>; related substances and organic impurities by HPLC; loss on drying <731> or water by Karl Fischer <921>; residue on ignition <281>; elemental impurities <232> and <233>; and residual solvents <467>, plus the article-specific tests the monograph names. The COA states each attribute, its result, the specification, and the pharmacopeia and edition applied.
This is why monograph testing stands on its own. A compendial monograph can govern an incoming active, excipient, or the finished dosage form it becomes. ACTA runs the named panel in either context, so one lab can carry the article from the raw lot through the product it ships in.
Confirm identity, assay, and purity of an incoming active or excipient against its monograph before it enters production. Identity by <197> and <191>, assay and related substances by <621>, water, and impurity tests the monograph names.
Raw material testing →Run the product monograph on a manufactured lot to support lot disposition, including the finished-dose tests a monograph adds, such as dissolution <711>, uniformity of dosage units <905>, and disintegration <701>, alongside identity, assay, and related substances.
Finished product testing →A monograph hands you the method, but the method still has to be shown to work in the lab that runs it for full cGMP compliance. ACTA offers USP <1226> Verification of Compendial Procedures to confirm that a compendial method performs for your specific article, on ACTA's instruments and analysts, to support full cGMP compliance. It is a targeted check of the attributes that matter, such as specificity, accuracy, precision, and a system suitability check, not a full revalidation.
When the monograph procedure is changed, or an alternative method is used in its place, that method needs full validation to USP <1225> and ICH Q2 and has to be shown equivalent to the compendial method. Methods moving between labs are handled by transfer under USP <1224>.
ACTA offers development, validation, verification, and transfer services in house. The same lab that runs your monograph can complete this cGMP requirement, if requested. See method development and validation.
From the named article to the COA: fit the method, confirm identity, run the monograph panel, and report against the monograph. Hover any stage to see what it does.
Identity and compendial testing of incoming actives and excipients against the monograph.
View →The product monograph on a manufactured lot, for lot disposition.
View →Assay and related substances by HPLC per <621>.
View →Residual solvents (USP <467>) and volatiles by GC.
View →USP <232> and <233> elemental impurities.
View →Verify, validate, and transfer compendial and custom methods.
View →
