?Baloxavir Impurity (CAS 2136287-59-5)?
Google Keywords: Baloxavir Impurity, CAS 2136287-59-5, Antiviral Drug Analysis, Influenza API QC, GMP Reference Standards

?? ?Product Overview?

?Baloxavir Impurity? (CAS 2136287-59-5) is a high-purity reference standard critical for quality control during the synthesis of ?Baloxavir Marboxil?, a revolutionary antiviral API targeting influenza A and B. This impurity ensures rigorous monitoring of synthesis pathways, enabling compliance with regulatory requirements for drug safety and efficacy.

• ?Primary Function?: Facilitates impurity profiling, stability studies, and batch release testing for Baloxavir Marboxil.

• ?Applications?: Antiviral API manufacturing, analytical method validation, and regulatory submissions.

? ?Key Advantages?

?? ?Ultra-High Purity? | ≥98.5% (HPLC/LC-MS verified) | Complies with ICH Q3A/B guidelines.
?? ?Structural Confirmation? | Fully characterized by NMR, HRMS, and FTIR for traceability.
?? ?Regulatory Readiness? | Supports FDA/EMA filings with comprehensive CoA (Certificate of Analysis).

?? ?Applications?

1. ?Influenza Drug QC?: Essential for impurity identification in Baloxavir Marboxil production.

2. ?Stability Testing?: Monitors degradation pathways under ICH-recommended storage conditions.

3. ?Method Development?: Validates HPLC, LC-MS, and GC protocols for API quality assurance.

?? ?Quality Assurance?

• ?Testing Methods?: HPLC, LC-MS, NMR, and FTIR for identity, purity, and impurity quantification.

• ?Standards?: Meets USP <1086>, EP 10.0, and ISO/IEC 17025:2017 accredited protocols.

?? ?Market Trends?

The global ?antiviral therapeutics market? is projected to reach ?$78.5 billion by 2030? (CAGR 4.3%), fueled by increasing influenza outbreaks and demand for precision medicine. Baloxavir impurities play a vital role in accelerating the development of next-generation antiviral APIs.

Elevate your influenza drug quality control with Baloxavir Impurity – precision, compliance, and reliability for world-class pharmaceutical standards.