Bulk Clotrimazole Powder CAS 23593-75-1 | API Grade Raw Material Supplier
Product Introduction of Clotrimazole
Chemical Properties and Physical Parameters
Detailed physical and chemical parameters are essential for formulation scientists establishing manufacturing process controls and compatibility profiles:
Chemical Name: 1-[(2-chlorophenyl)diphenylmethyl]-1H-imidazole
CAS Number: 23593-75-1
Molecular Formula: C22H17ClN2
Molecular Weight: 344.84 g/mol
Appearance: White to light yellow crystalline powder
Assay (Purity): 98.0% – 102.0% (Calculated on dried basis, HPLC)
Melting Point: 141°C to 145°C
Loss on Drying: <= 0.5%
Residue on Ignition / Sulfated Ash: <= 0.1%
Heavy Metals: <= 20 ppm
Solubilization: Practically insoluble in water; freely soluble in dichloromethane and ethanol; soluble in ether.
Product Packaging
Application of Clotrimazole
Clotrimazole (CAS: 23593-75-1) is supplied as a raw material for diverse processing and research activities:
Topical Formulation Manufacturing: Functions as the primary active ingredient in topical emulsion creams, powders, sprays, and liquid liniments. Formulators utilize its specific hydrophobic profile to create stable oil-in-water (O/W) and water-in-oil (W/O) emulsion matrices.
Pharmaceutical Research & Synthesis: Used as a target active molecule or intermediate in bio-analytical testing, stability chamber degradation studies, and comparative assay validations.
Veterinary & Specialized Formulations: Incorporated into veterinary topical ear drops, soothing ointments, and animal care formulations requiring controlled active constituent loading.
Related Questions:
Q1: Does your Clotrimazole (CAS: 23593-75-1) comply with USP or EP pharmacopeial standards?
Q2: Can you supply micronized Clotrimazole powder for specific suspension formulations?
Yes. We can offer custom particle size control (including micronized grades) to meet specific suspension stability and dissolution requirements in topical semi-solid formulations.
Q3: What is the typical lead time for commercial bulk shipments?
Q4: What documentation is provided for regulatory filings?
We supply standard technical packages including COA, SDS, BSE/TSE statements, process flow charts, and regulatory documentation to support customer quality audits and registration filings.
Manufacturing Excellence & Quality Control
Our quality management framework ensures that every lot of Clotrimazole meets stringent analytical benchmarks aligned with pharmacopeial standards (such as EP, USP, and BP guidelines).
Chromatographic Assay Verification: Purity and related substance limits (Impurities A through F) are evaluated via High-Performance Liquid Chromatography (HPLC-UV).
Structural Identity Testing: Fourier-Transform Infrared Spectroscopy (FTIR) identification matched against official reference spectra, complemented by Melting Range determination.
Residual Solvent Control: Gas Chromatography with Headspace Sampling (GC-HS) verification ensuring volatile organic impurities comply with ICH Q3C guidelines.
Microbial Limit Testing: Routine testing ensures low bioburden counts appropriate for non-sterile topical manufacturing processes.
Solvent Selection: Due to its lipophilic nature, complete dissolution prior to emulsification is best achieved using organic phases, ethanol, or specialized glycol co-solvents.
Thermal Handling: Clotrimazole exhibits good thermal stability up to its melting point. However, localized overheating during bulk liquid mixing should be avoided to prevent thermal discoloration.
Light & Moisture Sensitivity: Keep containers tightly closed. Although structurally stable, extended exposure to intense ultraviolet light can induce minor photolytic degradation over time.
Clotrimazole (CAS: 23593-75-1) provided by Organic Intermediate is distributed exclusively as a raw material for industrial manufacturing, commercial formulation, and laboratory research.
Documentation Package: Every order is accompanied by a batch-specific Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), Residual Solvent Statement, and BSE/TSE-Free Declaration.
Regulatory Responsibility: Finished product manufacturers are responsible for securing appropriate market authorizations, ensuring GMP compliance of final dosage forms, and fulfilling local health authority regulatory requirements (such as US FDA, EMA, or regional drug agencies).
Standard Packaging: Packed in double-lined PE bags within tamper-evident aluminum foil barrier sacks, housed in 25 kg heavy-duty fiber drums. Custom packaging options (1 kg, 5 kg sample drums) available upon request.
Storage Conditions: Store in a cool, dry, well-ventilated area away from direct sunlight, heat, and strong oxidizing agents. Recommended storage temperature: 15°C to 25°C.
Manufacturer of Clotrimazole
API, usually referring to chemical raw materials, is the active ingredient in chemical drug formulations.
Clotrimazole Safety Information
| Hazard Codes | Xn |
| Risk Statements | 22-36/38 |
| Safety Statements | 26-36 |
| WGK Germany | 3 |
| RTECS | NI4377000 |
| HS Code | 29332900 |
| Storage Class | 11 – Combustible Solids |
OrganicIntermediate is a professional foreign trade enterprise specializing in chemical raw materials. Upholding people-oriented values and cooperating with reliable manufacturers, we aim to become the world’s most trusted chemical supplier. Our production plant is located 50 meters south of the intersection of North Ring Road and 13th Road, Chenwang Street, Juancheng County, Heze City, Shandong Province. Our R&D laboratory is situated at R&D Base : F5, Yinfeng Biomedical City, Free Trade Zone, Jinan, Shandong. Integrating R&D and production, we strictly control product quality. With stable supply and sincere service, we welcome global customers for consultation and procurement.
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This article was written by William, the chief chemist of Shandong Zhishang New Materials Co., Ltd.
Pubchem-Clotrimazole