4-Quinazolineacetic acid, 8-fluoro-1,2,3,4-tetrahydro-3-[2-Methoxy-5-(trifluoroMethyl)phenyl]-2-oxo-, Methyl ester

‌Crisaborole Impurity (CAS 917389-21-0) | Certified Reference Material for Pharmaceutical QC‌
‌Google Search Keywords‌: Crisaborole Impurity, CAS 917389-21-0, Crisaborole Related Compound, Atopic Dermatitis Impurity Standard, PDE4 Inhibitor QC

🔬 ‌Product Overview‌
Crisaborole Impurity (CAS 917389-21-0) is a ‌pharmaceutically relevant impurity‌ linked to the synthesis or degradation of ‌Crisaborole‌, a non-steroidal PDE4 inhibitor approved for treating mild-to-moderate atopic dermatitis. This certified reference standard is essential for quality control (QC) to ensure the safety and efficacy of Crisaborole API and topical formulations.
‌Primary Function‌: Facilitates accurate identification, quantification, and control of impurities in drug batches.
‌Applications‌: Pharmaceutical manufacturing, analytical testing, regulatory compliance.

✅ ‌Key Advantages‌
⭐ ‌High Purity & Precision‌

• Purity ≥98% (HPLC/LC-MS validated), with complete spectral data (NMR, IR) for structural verification.

📊 ‌Regulatory Compliance‌

• Aligns with ‌ICH Q3A/B‌ guidelines and ‌USP/EP‌ standards for impurity profiling in pharmaceuticals.

🔬 ‌Batch Consistency‌

• ≤1.0% inter-batch variability, ensuring reliable performance in analytical workflows.

🌡️ ‌Stability Guaranteed‌

• Stable under recommended storage conditions (-20°C, desiccated), maintaining integrity for long-term use.

📋 ‌Applications‌

• ‌API Quality Control‌: Critical for impurity monitoring during Crisaborole synthesis and purification.

• ‌Topical Formulation Testing‌: Ensures compliance with safety thresholds in dermatological products.

• ‌Analytical Method Validation‌: Reference standard for HPLC/UPLC quantification and method development.

• ‌Regulatory Submissions‌: Supports impurity documentation for FDA, EMA, and global regulatory approvals.

🏅 ‌Quality Certifications‌

• Rigorously characterized using ‌HPLC, LC-MS, NMR, and FTIR‌ (compliant with ICH, USP, and EP protocols).

• Comprehensive Certificate of Analysis (CoA) includes chromatographic purity, spectral analysis, and batch-specific data.

🌐 ‌Market Trends‌
The global atopic dermatitis treatment market, valued at ‌$7.5 billion in 2023‌, is expanding rapidly due to rising prevalence and demand for non-steroidal therapies like Crisaborole. Stringent regulatory oversight on impurity limits in topical drugs is driving growth in certified reference materials, with a projected ‌6.9% CAGR (2024-2030)‌ for QC standards in dermatological APIs.

🔍 ‌Why Choose Us?‌

• ‌Customizable Solutions‌: Available in purity grades from 95% to 99%+ (research to GMP-grade).

• ‌Fast Turnaround‌: Ready-to-ship batches with ISO 17025-accredited testing and global logistics support.

• ‌Expert Support‌: Dedicated technical assistance for impurity characterization and regulatory submissions.