ANALYTICAL METHOD DEVELOPMENT AND VALIDATION

Develop and Validate methods for use in the testing of APIs and drug products

Develop and validate analytical methods to analyze in process, finished product and stability samples, as well as swabs to verify the cleanliness of manufacturing equipment

Methods for in-process, content, uniformity of dosage units, disintegration and dissolution sample analysis are developed and validated using UV, HPLC, or GC procedures

Methods to perform identification, chemical assay, related substances/impurities or chiral purity testing on API and finished drug product are developed and validated using HPLC or GC

Methods for stability sample analysis are validated to ensure they are stability indicating

Analytical method development and validation performed according to FDA-ICH guidelines, client-approved protocols, and standard operating procedures

Extensive experience performing pharmaceutical stability studies on APIs, early prototype formulations and finished dosage forms