Description

Baloxavir Impurity 2 CAS NO 2136287-60-8 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Baloxavir Marboxil, an antiviral medication. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Baloxavir Marboxil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing and validating chromatographic methods to monitor impurity profiles during the drug manufacturing process.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity under various stress conditions.
• Quality Control & Batch Release: A critical component in the quality control laboratory for routine analysis to ensure every batch of API meets stringent purity specifications.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity characterization, qualification, and control strategies.
• Research & Development: Used in R&D to understand the degradation pathways and chemical behavior of Baloxavir Marboxil, aiding in process optimization.

Basic Information

Product Name	Baloxavir Impurity 2
CAS No.	2136287-60-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Baloxavir Related Compound 2; Baloxavir Marboxil Impurity 2; S-033447 Impurity 2; (12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-N-(2,4-difluorophenyl)-6,8-dioxo-3,4,6,8,12,12a-hexahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazine-2-carboxamide Impurity; Baloxavir EP Impurity B; Baloxavir USP Impurity
EINECS	Contact for details

Quality Control

Our Baloxavir Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and conformity to client specifications or in-house reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment, supporting compliance with cGMP and ICH Q3A/B guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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