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The qualification and use of Escitalopram Impurities are vital for pharmaceutical quality assurance and regulatory compliance. These impurity materials—once characterized, identified, and qualified—can serve as secondary reference standards or working standards. Internal validation may be necessary under FDA and international guidance frameworks.
We offer an extensive array of Escitalopram EP impurities that are structurally confirmed and analytically validated to comply with European Pharmacopoeia (EP) specifications. These impurities play a key role in method validation, impurity profiling, and routine analysis. Proper internal validation ensures fitness for use and regulatory alignment.
Our range of Escitalopram related compounds includes degradation products, structural analogs, and synthetic intermediates. These are crucial for developing accurate analytical methods, conducting forced degradation studies, and profiling impurities in finished formulations. For compliant application, each material must be properly qualified and documented.
Escitalopram impurity reference standards are delivered with complete structural characterization and validated analytical documentation. They offer reliable performance across laboratory testing, stability studies, and regulatory submissions. Internal validation supports consistent use in quality control environments.
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