USP Pharmaceutical Analytical Impurities (PAI) are high-quality analytical reference materials that help pharmaceutical companies to detect impurities in active pharmaceutical ingredients and drugs early, to characterize them, and to develop analytical methods.

They complement the official USP reference standards by covering critical process and degradation products, as well as impurities, that are mentioned in USP monographs but not available as official standards. In this way, PAIs support robust quality control, accelerated analysis, and regulatory certainty in research, development, and production.

The use of the numerous Pharmaceutical Analytical Impurities (PAI) of the USP greatly facilitates the reliable identification of potential impurities in active pharmaceutical ingredients and drugs.

Application ranges:

✔ Research & Development (R&D): Early identification and characterization of impurities supports robust analytics from the outset.

✔ Method development: Optimization and validation of analytical methods such as stress, degradation and spiking studies.

✔ Manufacturing: Control of critical process and degradation products to ensure consistent product quality.

✔ Quality control: Support for precise impurity analyses and reliable release tests.

✔ Stability testing: Identification of impurities that form under ICH stability conditions.

✔ Post-market surveillance: Continuous monitoring of impurities to ensure long-term drug safety.

USP Biologics offers high-quality reference standards for the quality control of modern biotherapeutics – from mAbs to mRNA and oligonucleotides to cell and gene therapies.

✔ For identity, purity and potency testing

✔ Recognized worldwide by authorities and pharmacopoeias

✔ Ideal for development, QC and regulatory submissions

USP Analytical Reference Materials (ARMs) are high-quality, characterized substances specifically developed for pharmaceutical analysis and quality control. They are ideal for active pharmaceutical ingredients, formulations, or complex generics for which no USP monograph exists and provide reliable support for analytical testing.

ARM enables:

✔ Method development and validation

✔ Quality control of complex APIs and generics

✔ Identification and quantification of impurities

✔ Support for regulatory submissions

With extensive accompanying data and high analytical reliability, USP ARMs are an important complement to monographed USP reference standards – for precise results and maximum regulatory acceptance.