Description

Baloxavir Marboxil Impurity 19 is a designated process-related impurity or degradation product of the antiviral pharmaceutical Baloxavir Marboxil. This high-purity reference standard is critical for analytical method development, validation, and quality control during the drug substance manufacturing process. It is essential for pharmaceutical R&D and quality assurance laboratories to ensure the safety, efficacy, and regulatory compliance of the final active pharmaceutical ingredient (API).

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for qualitative and quantitative analysis in HPLC, UPLC, and LC-MS methods.
• Method Development & Validation: Used to establish and validate analytical procedures for impurity profiling of Baloxavir Marboxil API.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a marker to track the formation of specific degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing the synthetic pathway to minimize the formation of this impurity.

Basic Information

Product Name	Baloxavir Marboxil Impurity 19
CAS No.	2374735-31-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Baloxavir Marboxil Related Compound 19; Baloxavir Impurity 19; S-033447 Impurity 19; (12aR)-12-[(11S)-7,8-Difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl]-N-(methoxycarbonyl)-6-oxo-3,4,6,12-tetrahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazine-9-carboxamide; Xofluza Impurity 19
EINECS	Contact for details

Quality Control

Our Baloxavir Marboxil Impurity 19 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled under inert conditions if specified.

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)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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