Pharmaceutical Testing Services
Areas of Expertise
- Raw materials (USP, Ph. Eur., JP, FCC, ACS, BP)
- Quality control tests on raw materials, finished products, in-process testing, stability management & storage and environmental monitoring for ISO areas.
- Dosage Forms: Parenterals, Oral Solutions, Powders, Tablets/Capsules, Creams/Ointments
- Stability Storage: 25°C/60% RH, 40°C/75% RH, 30°C/65% RH, 5°C, -20°C, -80°C, Photostability, Cycling Studies, Custom Conditions
USP General Chapters Supported
- USP <1> Injections and Implanted Drug Products (Parenterals) Product Quality Tests
- USP <2> Oral Drug Products-Product Quality Tests
- USP <3> Topical and Transdermal Drug Products-Product Quality Tests
- USP <4> Mucosal Drug Products-Product Quality Tests
- USP <51> Antimicrobial Effectiveness Testing
- USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP <85> Bacterial Endotoxins Test
- USP <181> Identification-Organic Nitrogenous Bases
- USP <191> Identification Tests-General
- USP <197> Spectrophotometric Identification Tests
- USP <201> Thin Layer Chromatographic Identification Tests
- USP <211> Arsenic
- USP <221> Chloride and Sulfate
- USP <228> Ethylene Oxide and Dioxane
- USP <231> Heavy Metals
- USP <232> Elemental Impurities – Limits
- USP <233> Elemental Impurities – Procedures
- USP <241> Iron
- USP <251> Lead
- USP <271> Readily Carbonizable Substances Test
- USP <281> Residue on Ignition
- USP <311> Alginates
- USP <401> Fats and Fixed Oils
- USP <461> Nitrogen Determination
- USP <466> Ordinary Impurities
- USP <467> Residual Solvents
- USP <541> Titrimetry
- USP <621> Chromatography
- USP <641> Color and Completeness of Solution
- USP <643> Total Organic Carbon
- USP <645> Water Conductivity
- USP <651> Congealing Temperature
- USP <697> Container Content for Injections
- USP <698> Deliverable Volume
- USP <701> Disintegration
- USP <711> Dissolution
- USP <721> Distilling Range
- USP <730> Plasma Spectroscopy
- USP <731> Loss on Drying
- USP <733> Loss on Ignition
- USP <736> Mass Spectroscopy
- USP <741> Melting Range or Temperature
- USP <755> Minimum Fill
- USP <785> Osmolarity and Osmolality
- USP <791> pH
- USP <831> Refractive Index
- USP <841> Specific Gravity
- USP <852> Atomic Absorption Spectroscopy
- USP <857> Ultraviolet – Visible Spectroscopy
- USP <905> Uniformity of Dosage
- USP <911> Viscosity – Capillary Methods
- USP <912> Viscosity – Rotational Methods
- USP <921> Water Determination