Entecavir hydrate CAS 142217-80-9 research use NT

6-(Benzyloxy)-9-((1S,3R,4S)-4-(benzyloxy)-3-((benzyloxy)methyl)-2-methylenecyclopentyl)-N-((4-methoxyphenyl)diphenylmethyl)-9H-purin-2-amine (CAS 142217-80-9) is an impurity of Entecavir, a potent reverse transcriptase inhibitor used for the treatment of chronic hepatitis B virus (HBV) infection. As a key quality control marker, this impurity serves as an essential reference standard in the pharmaceutical analysis of Entecavir and its related formulations. It is also known as Entecavir Impurity 3 or Entecavir Impurity 10.

Role in Pharmaceutical Quality Control:

• Impurity Profiling: This compound is a specified impurity in the synthesis of Entecavir, used to monitor the quality and purity of the final API during production.

• Regulatory Compliance: Serves as a critical reference standard for analytical method validation and quality control (QC) in accordance with ANDA and DMF regulatory requirements.

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Chemical Characteristics:

• Contains a complex chiral cyclopentyl structure with multiple benzyloxy protecting groups.

• Features a purine core with an N-trityl protection group bearing a methoxyphenyl substituent.

• Serves as a protected intermediate and impurity marker in the Entecavir synthetic pathway.

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Applications:

• Pharmaceutical R&D: As a high-quality reference standard for Entecavir impurity profiling in drug development.

• Quality Control: For analytical method development, method validation (AMV), and routine QC testing in Entecavir API and formulation manufacturing.

• Regulatory Submissions: Used as a qualified reference standard for impurity identification and quantification in ANDA and DMF filings.

• Analytical Method Development: Suitable for HPLC and LC-MS method validation, forced degradation studies, and stability indicating method development.

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Packaging: ___ (e.g.: 10mg, 50mg, 100mg per package, as per customer's request)

Storage: Store in a cool, dry, well-ventilated area, away from direct sunlight and moisture. Recommended storage temperature: -20°C (Freezer) for long-term storage.

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