Using partial least square discriminate analysis (PLSDA), we studied the spectroscopic differences between the commonly used filler‐binder microcrystalline cellulose (MCC) from five manufactures. These samples had subtle differences in the chemical and physical properties, which are often the cause of differences in excipient performance. Studying these differences allowed us to build and validate a model to classify five manufacturers of MCC using near-infrared (NIR) spectra. More
Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims. More