Analytical Testing

Analytical Testing

  • Extractables/Leachable Testing
    Elemental Impurities
    Non-volatile organic compounds
  • Hemodialysis Water Testing
    Chemical and microbial components that may be found in drinking water meeting US EPA regulations may have the potential to produce significant negative effects in patients undergoing hemodialysis.

    A comprehensive validation testing of the system producing water for hemodialysis should be performed initially and periodically thereafter to ensure that the water treatment equipment and system sanitization processes are functioning properly.

    TOC -USP<643> Microbial Enumeration Tests USP<61>
    Tests for Specified Microorganisms USP<62>
    Conductivity USP<645>/ pH
    Bacterial Endotoxins USP <85>
    Chemicals USP<1820>
    • Aluminum
    • Antimony
    • Arsenic
    • Barium
    • Beryllium
    • Cadmium
    • Calcium
    • Chromium
    • Copper
    • Fluoride
    • Iron
    • Lead
    • Magnesium
    • Mercury
    • Nickel
    • Nitrate
    • Phosphorus
    • Potassium
    • Selenium
    • Silver
    • Sodium
    • Sulfate
    • Thallium
    • Zinc
  • Identity
    USP <191> General, <193> Tetracyclines (method II) and USP <201> Thin-layer chromotographic 
  • Potency
    USP <301> Acid-Neutralizing Capacity
    USP <411> Folic Acid Assay
    USP <425> Iodometric Assay – Antibiotics
    USP <441> Niacin or Niacinamide Assay (chromatographic methods)
    USP <466> Ordinary Impurities
    USP <503> Acetic Acid in Peptides
    USP <551> Vitamin E Assay
    USP <571> Vitamin A Assay
    USP <581> Vitamin D Assay
  • Process/Utility Testing and Validation
    Test Includes:
    Water Systems
    Environmental Monitoring 
    Autoclave Qualifications and Biological Indicator Analysis
    Media Fill 
    Cleaning Validation/Verification
    Calibration Services
    Qualification Services
    Compressed Air
  • Stability Testing/Shelf Life/Accelerated Stability Testing

    The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.
    Stability studies should include testing of those attributes of the drug product that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system).

    • Potency of API and degradation products
    • pH
    • Dissolution
    • Water loss


    Appearance, physical attributes, and functionality test (e.g., color, phase separation, resuspendability, caking, hardness, dose delivery per actuation) etc.
     

  • Total Organic Carbon Testing (TOC)
    Total Organic Carbon (TOC) is an indirect measure of organic molecules in pharmaceutical waters measured as carbon. Individual monographs for water require TOC testing according to USP <643>.
  • Trace Elements and Impurities
    USP <221> Chloride and Sulfate 
    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
  • Veterinary Hospital Water System Testing
    Lead 
    Copper 
    Microbiology 
    Other chemical contaminates available
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