Supporting pharmaceutical, personal care products, medical device, biopharmaceuticals, cosmetics and other life science companies with exceptional analytical services is our business. Quantex provides GMP compliant analytical chemistry services for the qualitative and quantitative assessment of raw materials, Active Pharmaceutical Ingredients (API), In-Process Materials and Finished Products. Our analytical services support product manufacturing, formulation development, release testing, analytical chemistry, analytical development, drug and biopharmaceutical development, CMC support, stability storage, and drug delivery device testing, as well as regulatory support for e-liquids. Our laboratory develops assays for identity, strength and purity of products and raw materials, as well as, developing stability indicating assays. Our cGMP compliant FDA registered and inspected, and ISO/IEC 17025 compliant facility is equipped with state of the art instrumentation to ensure rapid and accurate product characterization and method development. Over the years, our analytical team has successfully developed-validated-transferred in excess of 2,000 chromatography (HPLC/GC/MS), spectroscopy (AAS/ICP/ICP-MS) or other chemistry analytical procedures, including several now in the USP.
Our laboratory employs compendial (USP, EP, JP) methods, client-supported methods or methods that we have developed and validated for our clients. Methods developed or supplied by Clients are typically transferred following a specific method transfer protocol. Compendial methods are verified in compliance with specific regulatory requirements. Analytical methods are validated following specific validation protocols in compliance with FDA, ICH, USP, Ph. Eur, and GMP guidelines and requirements.