Methyl 3-(benzyloxy)-1-((tert-butoxycarbonyl)amino)-4-oxo-1,4-dihydropyridine-2-carboxylate

‌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.