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Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99.5% up by HPLC, DML, WC, DMF Crisaborole 906673-24-3
CAS No.:906673-24-3
Standard:ChP
Price(USD):Negotiable
Company:Sinoway Industrial Co. Ltd
Grade: Pharmaceutical Grade
Factory Location: Xiamen
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Monthly Production Capacity: 10tons/year
Contract Manufacturing: CRO,CMO
Packaging Information: 25kg/bag
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/C
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Product Information |
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Product name |
Crisaborole； 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole |
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CAS No. |
906673-24-3 |
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Molecular Formula |
C14H10BNO3 |
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Molecular Weight |
251.049 |
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Quality Standard |
98.0-102.0% by HPLC |
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Appearance |
White to pale yellow powder |
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COA |
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Test Items |
Specifications |
Results |
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Appearance |
White to pale yellow powder |
Conforms |
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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 |
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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 |
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IR Identification |
The infrared absorption spectrum of the sample shall be consistent with that of the reference substance. |
Conforms |
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Chloride |
≤ 0.01% |
Conforms |
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Organic impurities: |
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Impurity A |
≤ 0.01% |
Not detected |
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Impurity B |
≤ 0.08% |
Not detected |
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Other individual impurity |
≤ 0.08% |
0.007% |
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Total impurities |
≤ 1.0% |
0.022% |
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Residual solvents |
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Methanol |
≤ 0.3% |
Not detected |
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Isopropanol |
≤ 0.5% |
0.03% |
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Dichloromethane |
≤ 0.06% |
Not detected |
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Ethyl acetate |
≤ 0.5% |
Not detected |
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Tetrahydrofuran |
≤ 0.072% |
Not detected |
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Triethylamine |
≤ 0.5% |
0.0002% |
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Heptane |
≤ 0.5% |
Not detected |
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Toluene |
≤ 0.089% |
Not detected |
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Analysis |
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Benzene |
≤ 0.0002% |
Not detected |
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N,N-Dimethylformamide |
≤ 0.088% |
Not detected |
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Acetic acid |
≤ 0.5% |
Not detected |
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Loss on drying |
≤ 0.5% |
0.02% |
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Heavy metals |
≤ 10ppm |
Conforms |
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Total yeast&mold |
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Conforms |
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E.Coli |
Not detected |
Conforms |
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Microbial limit |
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TAMC |
≤ 100cfu/g |
<25cfu/g |
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TYMC |
≤ 10cfu/g |
<5cfu/g |
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Staphylococcus aureus must not be detected/g |
Not detected |
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Pseudomonas aeruginosa must not be detected/g |
Not detected |
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Assay |
98.0% - 102.0% |
100.5% |
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Conclusion |
The product complies with the specification |
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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.
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Pharma Sources Insight January 2025
