Crisaborole 906673-24-3

99.5% up by HPLC, DML, WC, DMF

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Product Details

Product Information

Product name	Crisaborole； 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole
CAS No.	906673-24-3
Molecular Formula	C14H10BNO3
Molecular Weight	251.049
Quality Standard	98.0-102.0% by HPLC
Appearance	White to pale yellow powder

COA

Test Items	Specifications	Results
Appearance	White to pale yellow powder	Conforms
Solubility	Very soluble in N,N-Dimethylformamide, Freely soluble in isopropanol and propanediol; Soluble in Ethanol, acetonitrile and dichloromethane; Sparingly soluble in methanol; Insoluble in water.	Conforms
Identification (by HPLC)	The retention time of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay.	Conforms
IR Identification	The infrared absorption spectrum of the sample shall be consistent with that of the reference substance.	Conforms
Chloride	≤ 0.01%	Conforms
Organic impurities:
Impurity A	≤ 0.01%	Not detected
Impurity B	≤ 0.08%	Not detected
Other individual impurity	≤ 0.08%	0.007%
Total impurities	≤ 1.0%	0.022%
Residual solvents
Methanol	≤ 0.3%	Not detected
Isopropanol	≤ 0.5%	0.03%
Dichloromethane	≤ 0.06%	Not detected
Ethyl acetate	≤ 0.5%	Not detected
Tetrahydrofuran	≤ 0.072%	Not detected
Triethylamine	≤ 0.5%	0.0002%
Heptane	≤ 0.5%	Not detected
Toluene	≤ 0.089%	Not detected
Analysis
Benzene	≤ 0.0002%	Not detected
N,N-Dimethylformamide	≤ 0.088%	Not detected
Acetic acid	≤ 0.5%	Not detected
Loss on drying	≤ 0.5%	0.02%
Heavy metals	≤ 10ppm	Conforms
Total yeast&mold		Conforms
E.Coli	Not detected	Conforms
Microbial limit
TAMC	≤ 100cfu/g	<25cfu/g
TYMC	≤ 10cfu/g	<5cfu/g
Staphylococcus aureus must not be detected/g		Not detected
Pseudomonas aeruginosa must not be detected/g		Not detected
Assay	98.0% - 102.0%	100.5%
Conclusion	The product complies with the specification

Usage

Core Functions of Crisaborole

Crisaborole is a non-steroidal topical ointment primarily indicated for the treatment of mild-to-moderate atopic dermatitis (eczema) in patients aged 2 years and older. Its therapeutic effect is mediated through selective inhibition of phosphodiesterase-4 (PDE-4), an enzyme responsible for promoting inflammatory responses. By suppressing PDE-4 activity, Crisaborole reduces the release of pro-inflammatory cytokines, thereby alleviating skin inflammation, pruritus, and erythema. Notably, it avoids the adverse effects associated with corticosteroids, such as skin atrophy, making it a safer long-term option for pediatric and adult populations.

The advantage of Sinoway’s Crisaborole

1. Cost and Production Efficiency:

China’s globally competitive active pharmaceutical ingredient (API) supply chain and economies of scale enable significant cost reductions, enhancing affordability and accessibility.Besides, robust pharmaceutical and chemical infrastructure accelerates localized production of generic versions, streamlining time-to-market.

2. Technological and Quality Standards

Chinese manufacturers adhere to stringent bioequivalence assessments and international certifications, ensuring parity with originator drugs in quality and efficacy. Meanwhile, adoption of sustainable synthesis technologies optimizes Crisaborole production while minimizing environmental impact.

3. Market Potential and Patient Base

The world’s vast eczema patient population (over 30 million) and growing parental preference for non-steroidal therapies position Crisaborole as a high-growth segment in dermatology.