Elemental Impurities in Pharmaceutical Excipients

Elemental Impurities in Pharmaceutical Excipients.

Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by ...

The safety of pharmaceutical excipients.

The most important part of a medicine as far as its weight is concerned, is constituted by its excipients, which have the important functions of guaranteeing the dosage, stability and bioavailability of the active principle. The components employed as excipients must present the characteristics required by their technological function but, as with any substance administered to man, they must al...

Analytix 3/2014 - Elemental Impurities and Heavy Metals Testing in Pharmaceutical Quality Control

Risk evaluation of impurities in topical excipients: The acetol case

Pharmaceutical excipients for topical use may contain impurities, which are often neglected from a toxicity qualification viewpoint. The possible impurities in the most frequently used topical excipients were evaluated in-silico for their toxicity hazard. Acetol, an impurity likely present in different topical pharmaceutical excipients such as propylene glycol and glycerol, was withheld for the...

Poloxamers: A pharmaceutical excipients with therapeutic behaviors

The effect of excipients for synergistic effect or any combinational therapy is became a one of the best alternative for the dosage form development in the current research. Here we have reviewed on the different category of poloxamers as novel polymer for the drug delivery. Apart from the very good excipient properties, poloxamers showed a clinical and therapeutic uses for cure and treatment o...