STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced API Impurity Identification services for clients in the medical device, ...

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs. Detection and quantitation of ...

We describe the identification of novel rapamycin derivatives present as low-level impurities in active pharmaceutical ingredients using an integrated, multidisciplinary approach. Rapamycin, a ...

All aspects of a drug’s lifecycle should be considered when evaluating risk assessment for elemental impurities. The safety of a drug product is as important as its effectiveness. Testing a drug for ...