PEARLITOL® mannitol
Since the 1970's, Roquette has been continuously working on improving the remarkable intrinsic properties by providing mannitol with DC properties, self disintegration, low endotoxin level, leading to the creation of the largest mannitol range for the pharmaceutical industry.
Continuous commitment to Mannitol development to Support the growth of the Pharmaceutical Market Segments
Mannitol has a share of the most desirable qualities that formulators seek in mineral, sugar or even polymeric excipients: notably a characteristic low chemical reactivity, an extraordinarily low level of hygroscopicity making it one of the "driest" products for moisture sensitive formulation, coupled with a pleasant taste and mouthfeel.
Since the 1970’s, Roquette has been continuously working on improving the remarkable intrinsic properties by providing mannitol with DC properties, self disintegration, low endotoxin level, leading to the creation of the largest mannitol range for the pharmaceutical industry: PEARLITOL® C, SD, DC, FLASH and PF.
Company name: ROQUETTE
Website: www.roquettepharma.com
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
