High-performance liquid chromatography (HPLC) is the typical method of choice for assessing the purity and impurities of new drug candidates in process development, running control and stability studies or evaluating new formulations for
A Reference standard is defined as a highly characterized material suitable to test the identity, strength, quality and purity of substances for pharmaceutical use and medicinal products.
At J-STAR Research, the preparation of high-quality reference standards
Method Validation & Verification are experimental processes of establishing that the performance characteristics of a method meet the requirements of the intended analytical application.
Methods can be developed in-house, adopted from the client, or transferred
ICH Stability Studies are a critical part of the drug development process. The results of these studies are used to determine the retest interval for an Active Pharmaceutical Ingredient (API) and dictate the shelf life
Since the FDA issued the ICH M7 (R1) guideline in March of 2018, expectations around the assessment and control of DNA reactive impurities (Genotoxic impurities, GTIs) in clinical development have become explicit. J-STAR works with
We currently have a Waters ZQ/2487 mass/UV triggered auto purification LC/PDA/MS system. This system can automatically collect chromatographic peaks via UV, mass or both signal detection. We have a variety of reverse
