Product Overview & China Production Capacity
Crotamiton (CAS 483-63-6, molecular formula C₁₃H₁₇NO, MW 203.28) is a topical pharmaceutical agent with dual antipruritic and scabicidal activity. It is the active ingredient in prescription and OTC creams and lotions used to treat scabies (Sarcoptes scabiei infestation) and to relieve itching associated with various dermatological conditions. As an excipient, crotamiton also serves as a penetration enhancer in transdermal drug delivery formulations, improving the percutaneous absorption of co-administered active ingredients.
China is a key global manufacturing base for crotamiton with combined capacity exceeding 3,000 MT annually. Our quality-certified synthesis facility in Zhejiang Province produces 800 MT/year of pharmaceutical-grade crotamiton using a highly optimized N-crotonylation route, achieving consistently high chemical and isomeric purity suitable for finished dosage form manufacturing.
Manufacturing Standards & Quality Assurance
Manufacturing is conducted under controlled pharmaceutical conditions with ISO 9001:2015 certification. The product meets USP/NF, EP, BP, and ChP specifications for Crotamiton. Our synthesis process incorporates green chemistry principles with solvent recycling and waste stream minimization. Full ICH stability data is available for Zone I–IV climatic conditions.
Quality control includes HPLC assay and related substances testing, GC residual solvents analysis, refractive index, specific gravity, color and clarity assessment, heavy metals, and microbial limits. Isomeric purity (trans/cis ratio) is monitored by GC to ensure compliance with pharmacopeial requirements. Each batch is released with a complete COA and retained for 5 years.
Technical Specifications
| Parameter | Specification |
|---|---|
| Appearance | Colorless to pale yellow oily liquid |
| Assay (HPLC) | 97.0–103.0% |
| Refractive Index (20°C) | 1.540–1.546 |
| Specific Gravity (25°C) | 0.982–0.992 |
| Related Substances (total) | ≤2.0% |
| Residual Solvents | Meets ICH Q3C |
| Heavy Metals (as Pb) | ≤10 ppm |
| Water Content | ≤0.5% |
| Color (Gardner) | ≤3 |
Packaging & Export Logistics
Supplied in 25 kg or 50 kg HDPE drums with tamper-evident closure and PE inner liner. Aluminum drums available for extended stability. Store in a cool, dark place at 15–25°C, protected from light. Shelf life is 24 months from manufacture. The product is classified as non-hazardous for transport but should be handled with standard chemical safety precautions.
We ship from Shanghai and Ningbo ports with temperature-controlled options for summer transit. Air freight available for urgent or sample orders. Documentation includes COA, MSDS, and regulatory support for finished product registration in destination markets.
China Supply Advantage
Sourcing crotamiton from our China facility provides 35–50% cost reduction versus European API manufacturers. Our optimized synthesis route and economies of scale in crotonyl chloride production deliver inherent cost advantages that we pass to our pharmaceutical customers globally.
MOQ is 100 kg with standard production lead times of 14–21 business days. We maintain ready stock of 20+ MT for rapid dispatch. Our regulatory affairs team can support ANDA/generic product filings with DMF reference, impurity profiles, and validation data. Contact us for a competitive API quotation and regulatory documentation package.