Pregabalin

Pregabalin Impurities

The qualification and application of Pregabalin Impurities Standards are essential for maintaining drug quality and ensuring compliance with global regulatory standards. These impurity materials—once properly identified, characterized, and qualified—can be used as working standards or secondary reference standards. Internal validation is recommended under FDA and international pharmacopeial guidelines.

Pregabalin EP Impurities

We offer a validated selection of Pregabalin EP impurities. These impurities are structurally confirmed and analytically validated to meet European Pharmacopoeia (EP) specifications. They support impurity profiling, method development, and batch release testing. Internal qualification ensures their suitability for regulated workflows.

Pregabalin Related Compounds

Our catalog includes Pregabalin related compounds such as degradation products, synthetic intermediates, and structural analogs. These compounds are essential for forced degradation studies, impurity identification, and analytical method optimization. Each material must be qualified and documented to meet pharmacopeial and regulatory expectations.

Pregabalin Impurity Reference Standards

Pregabalin impurity reference standards are supplied with full structural characterization and validated analytical documentation. These standards ensure reproducibility across research, formulation development, and quality control environments. They are suitable for product development, ANDA and DMF filing, method validation, and genotoxicity assessment. Internal validation confirms their ongoing reliability in regulated pharmaceutical applications.