4-(4-broMo-3-(hydroxyMethyl)phenoxy)benzonitrile

‌Crisaborole Impurity (CAS 906673-45-8) | Certified Reference Standard for Dermatological Drug QC‌
‌Google Search Keywords‌: Crisaborole Impurity, CAS 906673-45-8, Crisaborole Related Compound, Atopic Dermatitis Drug Impurity, Pharmaceutical QC Standard

🔬 ‌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

• Purity ≥98% (HPLC/LC-MS validated), supported by NMR and FTIR data for structural confirmation.

📊 ‌Regulatory Alignment‌

• Complies with ‌ICH Q3A/B‌ guidelines and USP/EP standards for impurity profiling.

🔬 ‌Batch-to-Batch Consistency‌

• ≤1.0% variability across batches, ensuring reproducible analytical results.

🌡️ ‌Stability Compliance‌

• Stable under recommended storage (-20°C, desiccated), ideal for long-term QC use.

📋 ‌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.