HIGH PRESSURE LIQUID CHROMATOGRAPHY (HPLC)

GAS CHROMATOGRAPHY (GC)

ATOMIC ABSORPTION

ICP-MS FOR HEAVY METALS

USP MONOGRAPH TESTING

PURIFIED WATER TESTING

  • Conductivity
  • Total Organic Carbon (TOC)

WET CHEMISTRY

2-4 Day Turn Around for our routine Analytical Procedures at NO EXTRA COST!

PRESERVATIVE EFFECTIVENESS TESTING

  • Per United States Pharmacopeia (USP)
  • Per CFTA Protocol
  • Per British and European Pharmacopeia
  • Modified procedures to satisfy client’s request

MICROBIAL LIMITS TEST

  • Total Aerobic Bacterial Count
  • Total Yeast and Mold Count
  • Escherichia coli
  • Salmonelia spp.
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Per USP/ISO

WATER TESTING

  • Total Microbial count by Membrane Filtration
  • Coliform count
  • Pseudomonas aeruginosa count

BIOBURDEN TESTING

ENVIRONMENTAL MONITORING

  • Air Sampling
  • Equipment and surface monitoring

MICROORGANISM IDENTIFICATION

CONSULTATION

  • Great knowledge and experience in the field of contamination control for manufacturing processes
  • Guidance for proper product preservation to reduce contamination incidence

Consultations free of charge!

STABILITY SERVICES

  • Temperature and humidity controlled chambers conforming to FDA & ICH guidelines
  • Testing may include:
    • HPLC/GC analysis of active ingredients
    • Color /Odor/Appearance
    • pH
    • Viscosity
    • Specific Gravity
    • Weight loss
    • Moisture/Solid
    • Freeze Thaw
    • Microbial limits
    • Preservatives Effectiveness Test

NO incubation fee!

VALIDATION OF WATER SYSTEM

  • Accuracy
  • ACCU Bio-Chem can lead and/or support validation of water systems
  • Multiple template protocols are available depending on the complexity of water system

METHOD VALIDATION

  • Precision
  • Specificity
  • Linearity &Range
  • Limits of Detection & Quantification
  • Robustness

METHOD VERIFICATION

  • Precision
  • Specificity
  • Linearity & Range

CLEANING VALIDATION