Analytical Services

PharmaForm provides analytical services focused on accelerating product development assuring U.S. Food and Drug Administration (FDA) compliance in all areas. The Analytical Services group is composed of Quality Control and Analytical Research Development. Quality Control is responsible for raw material and finished product testing. Analytical Research and Development focuses on developing methods for standard analytical, refinement and validation processes and research and development testing.

State of the art methodologies are utilized from raw material and active ingredient testing to stability and USP monograph testing. Analytical chemists work closely with formulators and biopharmaceutical scientists to provide comprehensive analytical research that leads to development and validation of methods for the drug substance and drug product. The Analytical Services department is housed at the same location as the Formulation and Product Development laboratory and our Manufacturing Services groups allowing optimum interdisciplinary interaction as needed for the benefit of the project's completion.

Our expertise covers a wide array of solid, liquid, semi-solid drug products, delivery techniques and therapeutic areas. We have the scientific expertise and facilities to perform analytical testing for small or large molecules and controlled substances. Our stability services include protocol development, controlled storage facilities, analytical testing and report generation. Our analytical experts maintain thorough cGMP documentation in order to provide each client with the information necessary for regulatory filings. We monitor a drug's ongoing stability, and support the drug development process from its initiation through commercialization.

Points of Interest of Analytical Services
  • Skilled personnel and state-of-the-art laboratory facilities and equipment to conduct studies in abidance with the highest professional standards of the industry.

  • Routine audits by skilled personnel to maintain compliance.

  • Flexibility in facilities and protocol development to provide a broad range of customized services
Analytical Services Facilities

PharmaForm facilities are equipped with state-of-the-art instrumentation and chromatography data networks and are designed to allow for flexibility in configuring laboratory resources for urgent project completion or long-term specialized projects. Our laboratory facility located in Austin, Texas operates under Good Manufacturing Practices (cGMP) guidelines, and the stability testing facility is ICH compliant and conforms to DEA requirements for controlled substances. PharmaForm is registered with the FDA and registered and inspected by the Drug Enforcement Administration (DEA).

Analytical Services for Quality Control
  • Raw Material testing by USP/NF, including vendor and client-supplied methods
  • Vendor Qualification Testing

  • Stability Protocol Development

  • Identification of Degradation Products and Related Substances

  • Physical & chemical characterization of bulk materials & drug products

  • Containers and extractables testing per USP/NF

  • Stability storage and testing according to ICH guidelines

  • USP monograph testing

  • Harmonization of Monographs for Inactive Ingredient

  • Release testing of actives, excipients and drug products

  • Analytical testing of Total Organic Carbon

  • Process Validation Sample Testing

  • Cleaning Residuals Validation

  • ICH Compliant Method Validation

  • Validation for Drug Products and Comparative Studies
Analytical Services for Research and Development
  • Method Development and Validation

  • Cleaning Residuals Development

  • Support to Pre-Formulation Studies

  • Comprehensive Analytical Support for Formulation Development
Analytical Services Capabilities
  • High Performance Liquid Chromatography (HPLC)

  • Fixed or variable wavelength

  • Photodiode array

  • Automatic sampling

  • Solvent gradient

  • Variable temperature
    • Conductivity

    • Fluorescence

    • Ultra Violet

    • Refractive Index
  • Thin Layer Chromotography (TLC)

  • Atomic Absorption (AA)

  • UV and Visible Spectrophotometry

  • Fourier Transform Infrared Spectroscopy (FTIR)

  • Capillary Electrophoresis

  • Physical Characterization
    • Degradation Products and Related Substances Analysis

    • Dissolution Testing

    • Particle Size Analysis

    • Tablet Hardness and Disintegration Testing

    • Adhesion Testing

    • Viscosity

    • Aerodynamic Droplet Size Distribution by Laser Diffraction
  • Titrations

  • Total Organic Carbon (TOC)
In summary, you can rely on our highly skilled experts utilizing the most current methods to support your development project across the development continuum from pre-clinical testing, IND filing, manufacturing for Phase I-III clinical trials to NDA filings.

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