Description

Baloxavir Impurity 74 CAS NO 2136287-69-7 is a high-purity chemical reference standard specifically identified as a process-related impurity of the antiviral drug Baloxavir Marboxil. This compound is critical for pharmaceutical research and development, enabling the accurate identification, quantification, and control of impurities during drug substance manufacturing. It is an essential tool for quality assurance and regulatory compliance teams within the pharmaceutical and analytical chemistry industries, ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of Baloxavir Marboxil impurities in active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine QC testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used to track the formation and behavior of this specific impurity under various stress and long-term storage conditions.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Baloxavir Impurity 74
CAS No.	2136287-69-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Baloxavir Related Compound 74; Baloxavir Marboxil Impurity 74; S-033447 Impurity 74; (1S,2S,3S)-4-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-2,3-bis(hydroxymethyl)-N-methyl-1-cyclopentanecarboxamide Impurity; Baloxavir EP Impurity H; Baloxavir USP Impurity; Process Impurity of Baloxavir
EINECS	Contact for details

Quality Control

Every batch of Baloxavir Impurity 74 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, LC-MS, NMR) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis/label. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.