Compendial Testing

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The following is a list of compendial tests that Apertus conducts per USP-NF guidelines. High priority sample services available with next-day turn around. Volume pricing available for multiple samples.

Other compendial tests such as PhEur/PharmEuropa, JP/JPE, AOAC, DAB, and ACS methods are available on request.

Please use the Contact Us form on the left to request more information.

Instrument-based Testing
Test ID Description
[621] HPLC Procedures as described in a monograph using designated columns, stationary phases, mobile phases and gradients to assay samples and ascertain impurity profiles.
[621] GC Procedures as described in a monograph using the designated capillary or packed column, temperature gradient and detector to ascertain sample assay and impurity profile.
[401] FAME Fatty acid methyl ester composition.  Sample derivatization and analysis by GC-FID or GC-MS to determine the fatty acid molecular weight distribution in fats or oils.
[467] Residual Solvents Testing of drug substances, excipients and drug product for residual Class 1,2 or 3 solvents as defined in the Q3C ICH guidelines. Procedures A,B, and C can be run individually or  in sequence as required by the customer.
[733] Mass Spectrometry Analysis by direct infusion, LCMS or GCMS.  Analyte ID by mass and fragmentation.  Complete fragmentation studies available using our ion trap mass spectrometer.
[741] Melting Range or Temp. Melting point or range procedure under Class I conditions using an instrument type "Apparatus II" as defined in the USP.
[761] NMR Spectrometry Quantitative or qualitative analysis available.  We can provide structure elucidation via 1D, 2D and multinuclear experiments.
Chemistry Bench Tests
Test ID Description
[191] Identification Tests – General Tests frequently referred to in the US Pharmacopeia for the identification of official articles.  These tests are typically simple wet chemistry bench tests.
[921] Water Determination Karl Fischer titration of liquid or solid samples by the coulometric method.  The standard methanol-based titration conditions and ketone specific conditions are both available.
[541] Titrations Direct, residual, complexometric and redox titrations as described in individual monographs are available.
[221] Chloride and Sulfate Wet chemistry limit test for the presence of chloride or sulfate.
[731] Loss on Drying Determination of the mass of volatile matter in a solid sample as described in a given monograph.
[733] Loss on Ignition Determination of the loss of mass on ignition in a muffle furnace at high temperature as described in individual monographs.
[791] pH Potentiometric determination of solution pH.