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Introduction
Product Name: | Crotamiton |
Synonyms: | (2E)-N-Ethyl-N-(2-methylphenyl)-2-butenamide;2-Butenamide, N-ethyl-N-(2-methylphenyl)-;component of Eurax;Crotalgin;Crotamitex;Crotamitone;Eurasil;Eurax |
CAS: | 483-63-6 |
MF: | C13H17NO |
MW: | 203.28 |
EINECS: | 207-596-3 |
Product Categories: | APIs;API's;EURAX |
Mol File: | 483-63-6.mol |
Function
Crotamiton is available as a 10% cream for the treatment of scabies, although it is less effective than pyrethrins or permethrin. Because crotamiton may need to be applied a second time for successful treatment of scabies but the pyrethrins or permethrin require a single application, poor patient compliance with crotamiton may reduce its effectiveness. The advantage of crotamiton over lindanes comes from the fact that lindanes has potential neurotoxicity if absorbed especially in infants and children, whereas crotamiton has less systemic neurotoxicity.
Chemical PropertiesN-Ethyl-o-crotonotoluidide is colourless or pale yellow, oily liquid
Usesantipruritic, scabicide
UsesFungicide, insecticide.
Specification
Batch No. | HF161118 | Quantity | 1110kgs |
Mfg. Date | Nov.18, 2016 | Package | As required |
Rep. Date | Nov.25, 2016 | Exp. Date | Nov.17, 2018 |
Items | Standards | Results | |
Appearance | White or off-white amorphous,odorless,hygroscopic powder | Complies | |
Identification | By IR | Complies | |
By UV | Complies | ||
By TLC | Complies | ||
By Masculine reaction | Complies | ||
Specific Rotation | -0.5°~+0.5° | 0° | |
Water Content | ≤3.00% | 1.50% | |
Heavy Metal | ≤10ppm | Complies | |
Free Aromatic Amine | ≤0.05% | 0.01% | |
Free Iodine | Complies with standard | Complies | |
Free Iodide | ≤0.001% | ND | |
Ionic Compounds | ≤0.01% | ND | |
Residual Solvent | Isopropyl alcohol ≤50ppm | 1ppm | |
Methanol ≤50ppm | 1ppm | ||
Methoxyethanol ≤20ppm | 2ppm | ||
N-Butanol ≤50ppm | 1ppm | ||
3-Chloro-1,2-propanedio ≤25ppm | ND | ||
Color Of Solution | 400nm:≤0.180 | 0.137 | |
420nm≤0.030 | 0.006 | ||
450nm≤0.015 | 0.000 | ||
Related Substance | Impurity A: ≤0.30% | 0.14% | |
O-alkylated compounds:≤0.50% | 0.48% | ||
Any individual impurity:≤0.10% | 0.04% | ||
The total impurities:≤0.30% | 0.13% | ||
Assay (HPLC,basis on drying) | 98.5%~102.0% | 99.10% | |
Reference Standard | USP36 and TCS09-602-09 Standard | ||
Conclusion | The product complied to USP36 and TCS09-602-09 Standard. | ||
Storage | The product is hygroscopic and odorless,preserve in tight,sealed and light-resistant containers in a cool place |