Pharmaceutical Grade Clotrimazole Medical Grade Clotrimazole API for Preparation with CDE Filing No. A and Full Qualifications

Clotrimazole is a commonly used imidazole antifungal drug, widely employed in the treatment of skin, mucosal, and some systemic fungal infections. As an important pharmaceutical raw material, its quality standards directly impact the safety and efficacy of the preparations. As a high-quality supplier of active pharmaceutical ingredients (APIs) and pharmaceutical excipients in China, our company provides high-quality clotrimazole products and related services, offering comprehensive support to pharmaceutical enterprises.

Pharmacopoeia Quality Standards for Pharmaceutical Grade Clotrimazole

Clotrimazole API is included in multiple pharmacopoeias (such as the Chinese Pharmacopoeia, European Pharmacopoeia, and United States Pharmacopoeia). Its quality requirements cover physical, chemical, and microbiological controls, with specific standards as follows:

1. Appearance

Clotrimazole should be a white or almost white crystalline powder, free from visible impurities, with a faint characteristic odor.

2. Purity and Content

- Content: Calculated on the dried basis, the content of clotrimazole should not be less than the pharmacopoeial requirement (typically ≥98.0%).

- Impurity Limits: Single impurities should generally not exceed 0.5%, and total impurities should not exceed 1.0%.

3. Melting Range

- The melting point of clotrimazole typically ranges between 147°C and 150°C, which is an important indicator of physical purity.

4. Solubility

- Clotrimazole is slightly soluble in water and readily soluble in organic solvents such as ethanol and dichloromethane, meeting the needs of formulation development.

5. Specific Rotation

- As per pharmacopoeial requirements, specific rotation is tested to confirm the stereochemical properties of the molecule.

6. Moisture Content

- Generally required to be ≤0.5% to ensure the physical stability of the product.

7. Residual Solvents

- Solvent residues must comply with international ICH guidelines, with common solvents such as ethanol and dichloromethane controlled within safe limits.

8. Microbial Limits

- As an API for topical preparations, rigorous microbiological testing is required to ensure sterility or compliance with limit standards.

Pharmaceutical Grade Clotrimazole Medical Grade Clotrimazole API for Preparation with CDE Filing No. A and Full Qualifications

Main products include:
Common excipients for topical preparations: Glycerin/Propylene Glycol, Vaseline/Lanolin, Laurocapram, Stearic Acid, Triethanolamine, Poloxamer 188/407, Polysorbate 80, Polyethylene Glycol Series, Solid Paraffin, Liquid Paraffin (Light/Heavy), Mixed Fatty Acid Glycerides, and other varieties.
Excipients for oral preparations: Honey/Sucrose, Lactose/Aspartame, Hydroxypropyl Beta-Cyclodextrin, Hypromellose, Methylcellulose, Ethylcellulose, Microcrystalline Cellulose, Povidone K30, Magnesium Stearate, Maltose/Saccharin Sodium/Sucralose/Tranexamic Acid/Stevioside, Gelatin, Color Lakes, Flavors, and other varieties.
Excipients for injections: (Endotoxin & Microbial Limits required)
Cholesterol, Trehalose (Anhydrous/Dihydrate), Lecithin/Soybean Phospholipid, Polysorbate (for injection), Citric Acid/Sodium Citrate, Sodium Dihydrogen Phosphate/Dipotassium Hydrogen Phosphate, Lactose (for injection), Disodium Edetate (for injection)
Raw materials for topical disinfection and bacteriostasis:
Chlorhexidine Acetate, Chlorhexidine Gluconate Solution, Benzalkonium Bromide/Benzalkonium Chloride, Menthol/Peppermint Oil, Salicylic Acid/Sodium Benzoate, Vitamin E Oil, Dimethicone, Span 80/85, Methylparaben/Ethylparaben/Propylparaben/Sodium Methylparaben/Sodium Propylparaben, Dibutyl Hydroxytoluene, Tromethamine, Chlorobutanol, Dihydroxyaluminum Aminoacetate, etc.

Sterile Water for Injection, Silver Sulfadiazine, Vitamin A, Camphor, Borneol, Sodium Bicarbonate, Berberine, Pentoxyverine Citrate, Metformin, Artificial Cow Bezoar, Paracetamol, Simple Syrup, Dexamethasone, Glycerin, Potassium Citrate, Chitosan, Calamine, Roxithromycin, Procaine
Also available for consultation: Food-grade products, extracts, reagents, intermediates, cosmetic raw materials, and export products.