Crisaborole Impurity (CAS 906673-45-8) | Certified Reference Standard for Dermatological Drug QC
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🔬 Product Overview
Crisaborole Impurity (CAS 906673-45-8) is a pharmaceutically significant impurity associated with the synthesis or degradation of Crisaborole, a non-steroidal PDE4 inhibitor used to treat mild-to-moderate atopic dermatitis. This impurity serves as a critical reference material for ensuring quality control (QC) and regulatory compliance in Crisaborole API and topical formulation production.
Primary Function: Enables precise identification, quantification, and control of impurities in Crisaborole batches.
Applications: Pharmaceutical QC/QA, analytical method validation, stability studies.
✅ Key Advantages
⭐ High Purity & Reliability
📊 Regulatory Alignment
🔬 Batch-to-Batch Consistency
🌡️ Stability Compliance
📋 Applications
API Manufacturing: Critical for impurity monitoring during Crisaborole synthesis.
Topical Formulation QC: Ensures safety and efficacy of dermatological drug products.
Method Development: Calibration standard for HPLC/UPLC quantification in R&D.
Regulatory Submissions: Supports impurity data packages for FDA/EMA approvals.
🏅 Quality Certifications
Fully characterized via HPLC, LC-MS, NMR, and FTIR (aligned with ICH/USP/EP protocols).
Detailed Certificate of Analysis (CoA) with chromatograms, spectral data, and impurity specifications.
🌐 Market Trends
The global atopic dermatitis treatment market is projected to grow at 7.1% CAGR (2024-2030), driven by rising prevalence of skin disorders and demand for non-steroidal therapies like Crisaborole. With stringent regulatory requirements for impurity limits, certified reference standards are essential for generic drug approvals, particularly in North America and Europe.
🔍 Why Choose Us?
Custom Purity Grades: Available from 95% to 98%+ for research or commercial needs.
Fast Delivery: ISO 17025-accredited testing with expedited global shipping.
Technical Expertise: Comprehensive support for impurity characterization and regulatory compliance.
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