Pharmaceutical Sciences: Analytical Chemistry

SRI Biosciences offers state-of-the-art technology and experienced scientists for the development and validation of a broad range of analytical chemistry methods, and for quality control analyses of small molecules and biologics. Researchers work closely with drug development experts in medicinal chemistry, formulations, pharmacokinetics, toxicology, and manufacturing to perform analytical chemistry method validation, and to identify, quantify, and characterize materials to meet R&D needs and fully comply with the Food and Drug Administration's Good Laboratory Practice (GLP) and Current Good Manufacturing Practices (cGMP) requirements.

SRI's analytical chemistry team offers the following:

Pharmaceutical Analyses

• Reference standard characterization and Certificates of Analysis

• Bulk pharmaceutical ingredients

• Excipient testing according to official monographs

• Structure elucidation of intermediates, impurities, and degradants

Analytical Chemistry Methods Development and Validation

• In-house use

• Method transfer in and out

• Validation levels tailored to the phase of development

Analytical Support for Preformulation and Formulation Development

• Efficient, immediate feedback to formulators

• Short-term stability studies

• Planning for final product methods

Dose Verification for in Vivo and in Vitro GLP Studies

• Dose concentrations and homogeneity in vehicle media or devices

• Short-term dose stability under conditions of use

• Test article characterization and stability analyses

Chemistry Quality Control Activities and cGMP Clinical Trial Materials

• Quarantine, testing, and release or rejection of materials and products

• In-process testing

• Cleaning validation

• Stability studies according to International Conference on Harmonization (ICH) guidelines for drug substances and products