ARL Bio Pharma qualifies drug substances, excipients, and drug products to meet pharmacopeia specifications.
USP / NF (United States Pharmacopeia) testing
EP (European Pharmacopeia) testing
JP (Japanese Pharmacopeia) testing
Identification by IR USP <197>
This test provides conclusive evidence of the identity of a substance using infrared absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
Identification by UV USP <197>
This test provides the identity of a substance using ultraviolet absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
This test measures the ratio of the density of a substance to the density of a standard, usually water.
Water - Methods 1a, 1b, 2 and 3 USP <921>
The determination of water content is important in demonstrating compliance with Pharmacopeial standards.
Residual Solvents USP <467>
Residual Solvents are organic volatile chemicals that are used or produced in the manufacture of a drug substance or excipient, or in the preparation of drug products. Residual solvents should be removed, to the extent possible, to meet ingredient and product specifications, good manufacturing practices or other quality-based requirements. This test calculates the levels of residual solvents present in the product.
Melting Point / Melting Range USP <741>
This test determines the temperature or temperature range at which a solid melts. This is often related to the purity of the substance.
Loss on Drying USP <731>
This test determines the amount of volatile matter driven off the sample under the conditions specified.
Residue on Ignition USP <281>
This test measures amount of residual substance not volatilized when the sample is ignited with sulfuric acid. Residue on Ignition is used for determining the content of inorganic impurities in an organic substance.
Assay – HPLC, UV, Titration
This test measures the analyte present in a given sample utilizing High Performance Liquid Chromatography, Ultra Violet Chromatography, or Titration.
Heavy Metals USP <231>
This test is a visual determination of metallic impurities. Substances that typically respond to this test are lead, mercury, bismuth, arsenic, antimony, tin, cadmium, silver, copper, and molybdenum.
pH USP <791>
A pH test measures the amount of acidity or basicity of a solution.
This test measures the extent to which a fluid resists a tendency to flow.
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