Excipient Quality
Excipients are either natural / naturally derived or synthetic / semi-synthetic. In all cases they are obtained through chemical processing of a raw material source that usually has an animal, vegetable or mineral origin.
Besides differences in process technology, conditions and parameters, these raw materials required to produce the excipient are an important source of variability in the composition of excipients. For example, one of the most important components of cellulose ethers is the cellulose raw material itself. No two trees are alike, so there will be inherent variability from batch to batch of cellulose raw material.
Excipia offers fast and flexible hands-on solutions and troubleshooting services to reveal and compare hidden excipient properties like the presence of potential reactive impurities or functional groups, degradation products and related substances, just like molecular weight distributions, degree of substitution, substituent distribution, monomer ratio and many other featured characteristics.
With this in-depth knowledge we can guide excipient manufacturers to select and control their feedstock, production processes and optimize product reliability and consistency.
In addition, we can help users of excipients to pick the most appropriate excipient manufacturer, select the most suitable grade for their finished dosage form, or define customized specifications to control product performance, quality and safety.
