Escitalopram: Impurity Profiling and Reference Standards - aquigenbio/blog GitHub Wiki

Escitalopram, a widely prescribed antidepressant, is a selective serotonin reuptake inhibitor (SSRI) used in the treatment of major depressive disorder and generalized anxiety disorder. As with any pharmaceutical active ingredient, ensuring the safety, efficacy, and quality of escitalopram relies heavily on the identification, characterization, and control of its impurities. Aquigen Bio offers a comprehensive range of Escitalopram impurity standards to support analytical research and regulatory compliance. Explore Escitalopram Impurity Standards:  https://aquigenbio.com/products/impurity-standards/escitalopram/ Why Are Impurity Standards Important in Escitalopram? Impurities in active pharmaceutical ingredients (APIs) can arise from synthetic processes, degradation, or external contamination. These trace components, though present in small amounts, must be meticulously identified and quantified to meet ICH and pharmacopoeial requirements. In the case of Escitalopram, the European Pharmacopoeia (EP) defines several specified impurities that must be controlled to ensure product safety. Aquigen Bio supports this need with high-purity, well-characterized impurity reference materials. Key Escitalopram Impurity Reference Materials Available

1. Escitalopram EP Impurity A Escitalopram EP Impurity A is a known process-related impurity in the synthesis of escitalopram. Its controlled measurement helps ensure manufacturing consistency and product quality.
2. Escitalopram EP Impurity B This impurity often arises due to side reactions or incomplete synthesis. Aquigen Bio provides this impurity standard with precise characterization, aiding in method development and validation studies.
3. Escitalopram EP Impurity C Impurity C is another structurally related compound detected in the escitalopram production process. Monitoring this impurity is crucial for regulatory submissions and stability testing.
4. N-Nitroso Escitalopram EP Impurity D N-nitroso impurities, including Impurity D, have gained significant attention due to their potential carcinogenicity. Aquigen Bio provides this nitrosamine impurity with thorough analytical data to support nitrosamine risk assessments and regulatory expectations. Why Choose Aquigen Bio for Escitalopram Impurities? High-Purity Standards COA, Mass, NMR, HPLC Data Provided Quick Global Delivery Regulatory-Compliant Materials

Whether you are engaged in drug development, quality control, or regulatory submission, Aquigen Bio offers the right set of impurity standards for Escitalopram that meet stringent industry norms. Partner with Aquigen Bio for all your impurity profiling needs:  Escitalopram Impurity Standards - View Full Product Range