Baloxavir Impurity (CAS 1228258-40-9)
Google Keywords: Baloxavir Impurity, CAS 1228258-40-9, Antiviral Drug Impurity, Influenza Treatment, GMP Reference Standard
🌟 Product Overview
Baloxavir Impurity (CAS 1228258-40-9) is a high-purity reference standard used in the quality control and analytical profiling of Baloxavir Marboxil, a novel antiviral drug targeting influenza. This impurity is critical for ensuring compliance with regulatory requirements during API manufacturing and formulation studies.
Primary Function: Serves as a certified impurity marker for method validation and batch release.
Applications: Pharmaceutical QC/QA, stability studies, and regulatory submissions.
✅ Key Advantages
🔹 Ultra-High Purity | ≥98% (HPLC/GC-MS verified) | Traceable to USP/EP standards.
🔹 Regulatory Compliance | Meets ICH Q3A/B guidelines for impurities in APIs.
🔹 Stability | Certified stability data under ICH storage conditions (-20°C, 24 months).
🧪 Applications
Antiviral Drug Development: Essential for impurity profiling in Baloxavir Marboxil production.
Quality Control Labs: Used in HPLC/LC-MS method development and validation.
Regulatory Compliance: Supports EMA/FDA filings for influenza drug approvals.
📜 Quality Assurance
Testing Methods: HPLC, GC-MS, NMR, and FTIR for structural confirmation.
Standards: Complies with USP <1086>, EP 10.0, and GMP requirements.
📈 Market Trends
The global influenza treatment market is projected to reach $1.8 billion by 2027 (CAGR 5.2%), driven by rising demand for targeted antivirals like Baloxavir. As regulatory scrutiny on impurity control intensifies, this reference standard addresses critical needs in drug safety and efficacy.
Ensure precision in your antiviral drug development with Baloxavir Impurity – certified quality, compliance, and traceability for global regulatory success.
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