Pharmaceutical, Biopharmaceutical, & Animal Health

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