In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
Mandated by regulatory requirements such as USP <797> Pharmaceutical Compounding – Sterile Preparations and Current Good Manufacturing Practices (CGMP), sterility testing is a quality control measure ...
Monoclonal antibody (mAb) therapies require comprehensive characterization of their physicochemical and functional critical quality attributes (CQAs) to ensure product stability, efficacy, safety, and ...
Natural cyclodextrins (CDs) and their synthetically modified forms, hydroxypropyl-β-cyclodextrin (HP-β-CD) and sulfobutyl-β-cyclodextrin (SB-β-CD), are critical components in pharmaceutical ...
Salt Lake City, UT — Nelson Laboratories, LLC, a business unit of Sotera Health Company and a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the ...
Specifications ensure drug substances/products meet acceptance criteria, forming a foundation for robust control strategies. Validated methods must be fit for purpose, with MODRs providing flexibility ...
Challenging method conditions can impact autosampler performance on High-Performance Liquid Chromatography (HPLC) systems. Methods with highly organic sample diluents, coupled with low injection ...
Method conditions and instrument characteristics can affect the autosampler performance of High-Performance Liquid Chromatography (HPLC) systems. Challenging method conditions, such as low injection ...
The 1.0 version of the Hypertext Transfer Protocol, issued way back in 1996, only defined three HTTP verbs: GET, POST and HEAD. The most commonly used HTTP method is GET. The purpose of the GET method ...
DNA-Based Heat Resistant Mold Test Delivers Deeper Diagnostics in a Fraction of the Time, On-Site Solution is Now Available for Implementation Developed in partnership with historic brand Ocean Spray ...
With increasingly complex pharmaceutical products, biologics, and cell and gene therapies, there is greater demand for more advanced and efficient testing solutions. Sterility testing plays a crucial ...
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