cGMP Compendial/Raw Materials Testing
Quantum performs comprehensive analytical testing of raw materials, active pharmaceutical ingredients, excipients and finished pharmaceutical products. Our services can assist you in the qualification of your vendors or in the release of raw materials for production and manufacturing purposes. Compendial testing is performed in accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies and monographs, as well as with client-supplied or vendor-specified methods.
Quantum’s highly trained scientists, in conjunction with our considerable investment in laboratory resources, can handle the analysis of significant quantities of samples. We maintain a well equipped state-of-the-art laboratory that routinely support the analysis of raw materials including actives, fillers, binders, colors, and other excipients. All our laboratory operations and procedures are based on written, detailed SOPs and stringent quality assurance practices in compliance with cGMP regulations.
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USP Chemical Tests & Assays
|<181> Identification – Organic Nitrogenous Bases||<191> Identification Tests - General||<193> Identification - Tetracyclines||<197> Spectrophotometric Identification Tests||<201> TLC Identification Test||<206> Aluminum||<211> Arsenic||<216> Calcium, Potassium, and Sodium||<221> Chloride and Sulfate||<231> Heavy Metals||<241> Iron||<251> Lead||<261> Mercury||<271> Readily Carbonizable Substances||<281> Residue on Ignition||<281> Residue on Ignition||<341> Antimicrobial Agents Content
Methylparaben and Propylparabe
|<401> Fats and Fixed Oils
Fatty Acid Composition
|<461> Nitrogen Determination||<466> Ordinary Impurities||<467> Residual Solvents||<591> Zinc|
USP Physical Tests & Determinations
|<611> Alcohol Determination||<631> Color and Achromicity||<641> Completeness of Solution||<643> Total Organic carbon||<645> Water Conductivity||<651> Congealing Temperature||<698> Deliverable Volume||<731> Loss on Drying||<741> Melting Range or Temperature||<781> Optical Rotation||<785> Osmolarity||<786> Particle Size Distribution||<788> Particulate Matter in Injections||<791> pH||<831> Refractive Index||<841> Specific Gravity||<911> Viscosity||<921> Water Determination||