[2-bromo-5-(4-cyanophenoxy)phenyl]methyl acetate

‌Crisaborole Impurity (CAS 2227126-09-0)‌
Google Keywords: Crisaborole Impurity, CAS 2227126-09-0, Eczema Drug Analysis, Topical PDE4 Inhibitors, Pharmaceutical Impurity Standards, GMP QC Testing

🌟 ‌Product Overview‌

‌Crisaborole Impurity‌ (CAS 2227126-09-0) is a high-purity reference standard essential for quality control in the synthesis of ‌Crisaborole‌, a topical phosphodiesterase-4 (PDE4) inhibitor approved for treating mild-to-moderate atopic dermatitis (eczema). This impurity ensures accurate identification, quantification, and control during drug development and manufacturing.

1. ‌Primary Function‌: Supports impurity profiling, stability studies, and regulatory compliance for Crisaborole API.

2. ‌Applications‌: Atopic dermatitis drug development, analytical method validation, and batch release testing.

✅ ‌Key Advantages‌

🔹 ‌Exceptional Purity‌ | ≥99.0% (HPLC/LC-MS verified) | Meets ICH Q3A/B impurity thresholds.
🔹 ‌Regulatory Alignment‌ | Fully characterized (NMR, HRMS) for FDA/EMA submissions.
🔹 ‌Stability Assurance‌ | Tested under ICH-recommended storage conditions for long-term reliability.

🧪 ‌Applications‌

• ‌Topical Drug Development‌: Critical for QC in Crisaborole API and formulation production.

• ‌Analytical Method Validation‌: Used in HPLC, LC-MS, and GC testing protocols.

• ‌Regulatory Compliance‌: Ensures adherence to ICH guidelines for impurity reporting.

📜 ‌Quality Assurance‌

• ‌Testing Methods‌: HPLC, GC, NMR, HRMS, and FTIR for structural confirmation and purity analysis.

• ‌Standards‌: Complies with USP <1086>, EP 10.0, and ISO 17025:2017 certified processes.

📈 ‌Market Trends‌

The global ‌atopic dermatitis treatment market‌ is expected to surpass ‌$23.7 billion by 2030‌ (CAGR 13.5%), driven by rising prevalence of eczema and demand for non-steroidal therapies like Crisaborole. High-quality impurities are vital for accelerating generic drug development post-patent expiry.

Empower your eczema drug QC with Crisaborole Impurity – precision, compliance, and reliability for superior pharmaceutical manufacturing.