?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.