Qualified Reference Standards: Setting the Standard for Product Quality

Case study
Reference standards

Drug producers face increasing stringency from regulatory authorities to substantiate the purity of drug products and to demonstrate control of impurities. Qualified reference standards play a critical role in providing validated benchmarks to satisfy regulatory requirements pertaining to purity. An experienced CDMO can connect the value of investing in qualified reference standards to the impact on final product quality.

In this example, our client required a reference standard for a newly observed impurity in order to perform quantitative analysis during the development process.

Download the full case study to learn how our integrated team of experts quickly identified the impurity, synthesized the reference standard, and developed a custom analytical method to characterize the impurity.