Quantum provides GMP compliant analytical chemistry services for the qualitative and quantitative assessment of raw materials, Active Pharmaceutical Ingredients (API), In-Process Materials and Finished Products. Our analytical services support product manufacturing, formulation development, release testing, analytical chemistry, analytical development, drug and biopharmaceutical development, CMC support, stability testing, and drug delivery device testing.
Our laboratory develops assays for identity, strength and purity of products and raw materials, as well as, developing stability indicating assays. Our cGMP compliant FDA registered and inspected, laboratory is equipped with state of the art instrumentation to ensure rapid and accurate product characterization and method development.
Common USP tests performed by Quantum Analytics Group
- <191> Identification Tests - General
- <197> Spectrophotometric Identification Tests
- <201> Thin Layer Chromatography Identification Test
- <206> Aluminum
- <211> Arsenic
- <216> Calcium, Potassium, and Sodium
- <221> Chloride and Sulfate
- <228> Ethylene Oxide and Dioxane
- <231> Heavy Metals
- <232> Elemental Impurities - Limits
- <233> Elemental Impurities - Procedures
- <241> Iron
- <251> Lead
- <261> Mercury
- <281> Residue of Ignition (Ash)
- <291> Selenium <341> Antimicrobial Agents Content
- Benzyl Alcohol
- Chlorobutanol
- Phenol
- Methylparaben and Propylparaben
- <401> Fats and Fixed Oils
- Specific Gravity
- Melting Temperature
- Acid Value
- Ester Value
- Hydroxyl Value
- Iodine Value
- Peroxide Value
- Saponification Value
- Fatty Acid Composition
- <466> Ordinary Impurities
- <467> Residual Solvents
- <469> Ethylene Glycol, Diethylene Glycol and Triethylene Glycol in Ethoxylated Substances
- <525> Sulfur Dioxide
- <541> Titrimetry
- <591> Zinc
- <611> Alcohol Determination
- <621> Chromatography – HPLC, GC
- <731> Loss on Drying
- <733> Loss on Ignition
- <741> Melting Range or Temperature
- <781> Optical Rotation
- <791> pH
- <831> Refractive Index
- <841> Specific Gravity
- <851> Spectrophotometry and Light Scattering
- <911> Viscosity - Capillary Viscometer
- <912> Viscosity - Rotational Rheometer Methods
- <921> Water Determination by Karl Fischer
- <1225> Validation of Compendial Procedures
- <1226> Verification of Compendial procedures