Pharmaceutical Impurity Reference Standards: All You Need To Know

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The Pharmaceutical Impurity Reference Standards is a set of reference materials used to calibrate and validate analytical methods to determine impurities in pharmaceuticals.

What should I know about this?

They are often used to support regulatory compliance, manufacturing quality assurance, research and development, customer product testing, or vendor qualification. Pharmaceutical Standards are also available in the form of certified reference material sets that have been manufactured by an approved supplier using well-defined procedures under strict quality control.

They provide traceability through their identification with a unique batch number, which can be traced back to specific manufacturer lot numbers. This ensures that samples come from identical production batches to those being tested in laboratories. These Standards are also available in the form of certified reference material sets that have been manufactured by an approved supplier using well-defined procedures under strict quality control.
We hope this information has been helpful to you.