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USP Monograph Testing

The USP establishes primary standards for ensuring quality in pharmaceutical development & manufacturing.

USP Reference Standards are rigorously tested and evaluated by multiple independent commercial, regulatory, and academic laboratories to confirm accuracy and reproducibility.

USP Tests

Below are the most common general chapter tests we perform. We also perform many analyses by partial or full monographs in the official USP.

<61><62>Suitability Testing • Suitability of the Counting Methods in the Presence of Product. • Suitability of the Test Methods in the Presence of Product.
<2021><2022>Preparatory Testing
<51>Antimicrobial Effectiveness Testing
<60>Burkholderia cepacia complex (Bcc)
<61>Microbial Enumeration Testing • Total Aerobic Microbial Count • Total Yeasts and Molds Count
<62>Bile Tolerant Gram Negative Bacteria
<62>Escherichia coli (E.coli)
<62>Pseudomonas aeruginosa Staphylococcus aureus
<62>Candida albicans
<197>Spectrophotometric Identification Test
<201>Thin-Layer Chromatography Identification Test
<221>Chloride and Sulfate
<228>Ethylene Oxide and Dioxane
<232>Elemental Impurities – Limits
<233>Elemental Impurities – Procedures
<281>Residue On Ignition
<311>Alginates Assay
<401>Fats and Fixed Oils
Acid Value, Sap Value, Hydroxyl value, Iodine value (method I & II), Unsap value, Fatty Acid Composition. Omega-3 Fatty Acids Determination and Profile, Peroxide value
<467>Organic Volatile Impurities
<469>Ethylene Glycol, Diethylene Glycol, and Triethylene Glycol in Ethoxylated Substances
<471>Oxygen Flask Combustion
<525>Sulfur Dioxide
<616>Bulk Density And Tapped Density Of Powder
<621>Chromatography (GC. HPLC and HPTLC)
<643>Total Organic Carbon
<645>Water Conductivity
<651>Congealing Temperature
<721>Distilling Range
<731>Loss On Drying
<733>Loss On Ignition
<741>Melting Range or Temperature
<781>Optical Rotation
<781>Particle Size Distribution Estimation by Analytical Sieving
<831>Refractive Index
<841>Specific Gravity
<851>Spectrophotometry and Light-Scattering
<905>Uniformity of Dosage Units
<911>Viscosity-Capillary Viscometer
<912>Viscosity-Rotational Rheometer Methods
<921>Water Determination by KF (Karl Fischer)
<2021>Bile Tolerant Gram Negative Bacteria
<2022>Escherichia coli (E.coli)
<2022>Staphylococcus aureus
<2040>Disintegration and Dissolution of Dietary Supplements
<2091>Weight Variation of Dietary Supplements