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High Quality USP/EP/BP GMP DMF FDA Crotamiton Cream CAS NO 483-63-6 Producer

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  • AZ475
  • Dideu
  • 483-63-6
  • C13H17NO
  • 207-596-3
  • China
  • Crotamiton Cream
  • High quality
  • 99.0% Min
  • 99%-101%
  • Cream
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

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Crotamiton Cream 

Action and use

Acaricide.

Definition

Crotamiton Cream contains Crotamiton in a suitable basis.


The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.

Content of crotamiton, C13H17NO

93.0  to 107.0% of the stated amount.
Identification

A.  Mix a quantity of the cream containing 0.5  g of Crotamiton with 50  ml of water and then slowly add 50  ml of 1m sodium hydroxide while stirring vigorously. Filter the mixture, adjust the filtrate to pH 7 with 5m hydrochloric acid and extract with 50  ml of ether. Wash the ether layer with 10  ml of a saturated solution of sodium chloride, dry the organic layer over anhydrous sodium sulphate, filter and evaporate to an oily residue. The light absorption, Appendix II B, in the range 220  to 350  nm of a 0.003% w/v solution of the residue in cyclohexane exhibits a maximum only at 242  nm. The A(1%, 1  cm) at the maximum is about 315.


B.  Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions in absolute ethanol.


(1)  0.25% w/v of the residue obtained in test A.

(2)  0.25% w/v of crotamiton BPCRS.

(3)  A mixture of equal volumes of solutions (1) and (2).


chromatographic conditions

(a)  Use as the coating silica gel GF254.

(b)  Use the mobile phase as described below. 

(c)  Apply 5 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, dry in air and examine under ultraviolet light (254  nm).


mobile phase

Shake 98  volumes of chloroform with 2  volumes of 18m ammonia, dry over anhydrous sodium sulphate, filter and mix 97  volumes of the filtrate with 3  volumes of propan-2-ol.


confirmation

The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2), but if not, the principal spot in the chromatogram obtained with solution (3) appears as a single compact spot.


C.  In the Assay, the principal peak in the chromatogram obtained with solution (2) has the same retention time as the principal peak in the chromatogram obtained with solution (3).

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using solutions (1), (4), (5), (6) and (7) as described under the Assay. For solution (1) allow the chromatography to proceed for 2.5  times the retention time of the principal peak.


chromatographic conditions

Use the chromatographic conditions described under Assay.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (6), the resolution factor between the peaks corresponding to the E-isomer and to crotamiton impurity A is at least 4.5.


limits 

In the chromatogram obtained with solution (1):


the area of any peak corresponding to crotamiton impurity A is not greater than the area of the corresponding peak in the chromatogram obtained with solution (4) (3%);


the sum of the areas of any secondary peaks apart from any peaks corresponding to the Z-isomer and to crotamiton impurity A is not greater than the sum of the areas of the peaks corresponding to the E- and Z-isomers in the chromatogram obtained with solution (5) (1%).


Disregard any peak with an area less than 0.02  times the area of the principal peak in the chromatogram obtained with solution (5) (0.02%) and any peak with the same retention time as the principal peak in the chromatogram obtained with solution (7).


Z-Isomer

Not more than 15% of the total content of E- and Z-isomers determined in the Assay.

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. 


(1)  Add 2  ml of water and 100  ml of cyclohexane to a quantity of the preparation being examined containing 0.1  g of Crotamiton, shake for 10  minutes and separate the lower, aqueous layer. Repeat the extraction using two 10  ml quantities of cyclohexane, filter the combined extracts and add sufficient cyclohexane to produce 200  ml.

(2)  Dilute 1  volume of solution (1) to 20  volumes with cyclohexane.

(3)  0.0025% w/v of crotamiton BPCRS in cyclohexane.

(4)  0.0015% w/v of crotamiton impurity A EPCRS in cyclohexane.

(5)  Dilute 1  volume of solution (1) to 100  volumes with cyclohexane.

(6)  Dilute 1  volume of a 0.015% w/v solution of crotamiton impurity A EPCRS to 10  volumes with solution (1).

(7)  0.001% w/v of methyl hydroxybenzoate in cyclohexane.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4  mm) packed with silica gel for chromatography (5 µm) (Lichrosorb Si60 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1 ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 242  nm.

(f)  Inject 20 µl of each solution.


mobile phase 

8  volumes of tetrahydrofuran and 92  volumes of cyclohexane.


system suitability 

For solutions (4) and (6), when the chromatograms are recorded under the prescribed conditions, the retention times relative to the principal peak (E-crotamiton) are: Z-isomer, about 0.5; N-ethyl-N-(2-methylphenyl)but-3-enamide (crotamiton impurity A), about 0.8. Adjust the sensitivity of the system so that the height of the principal peak in the chromatogram obtained with solution (4) is at least 70% of the full scale of the recorder.


The test is not valid unless, in the chromatogram obtained with solution (6), the resolution factor between the peaks corresponding to the E-isomer and to crotamiton impurity A is at least 4.5.


determination of content 

Using chromatograms (2) and (3), calculate the contents of the E- and Z-isomers in the preparation being examined using the declared contents of E- and Z-crotamiton in crotamiton BPCRS and hence calculate the content of C13H17NO in the preparation being examined.




The packaging can be customized. the shipping term can be by sea, by air, and sample or small quantity can be shipped by DHL, FEDEX, EMS and TNT.

Cream 9Cream 11Cream 86

a) Free sample can be supplied.

b) Guide our clients by professional knowledge and teach them how to use our product after sales.

c) Accept SGS,BV any other third-party inspection before loading.

d) High quality best price Guaranteed.


Why do you choose Dideu Industries as your partner?


A) High quality can be guaranteed. Dideu Industries since 1975 are reputed chemical manufacturer and are Certified by ISO 9001;2015 and have GMP certification.Free sample can be arranged before shipment and SGS,BV and other third party inspection company are accepted before loading.For regular customers, we accept L/C 180 Days, D/P,D/A payment term. If there is any quality problem after goods arrive. Dideu Industries will do fully payment refund.


B) Best price can be guaranteed. As Dideu Industries are integrated pharmaceuticals and chemicals producer, the production cost can be controlled and price will be definitely more competitive than China trading companies.


C) Professional enginners from Dideu Industries will give professional usage guide and services after sales.


D)Dideu Industries work 7×24 hours and your request will be processed by our professional staff in different shift period.


Dideu Industries is one of the largest producer for general chemical, pharmaceutical, nutrition additive, natural extracts, agrochemical and Daily-Use Chemical in China and is headquartered in Shaanxi, China. The Dideu Group comprises subsidiaries and joint ventures in more than 10 countries and operates six integrated production sites and 21 other production sites in Europe, Asia, Australia, Americas and Africa.Its headquarters is located in Xi’An,China. Dideu has customers in over 200 countries and supplies products to a wide variety of industries.


At the end of 2014, the company employed more than 13000 people. In 2014, Group Dideu posted sales of 30 billion and income from operations before special items of about 7.5 billion. The company is currently expanding its international activities with a particular focus on Asia countries. Between 1990 and 2005, the company invested 5.2 billion in Asia, for example in sites near Guangxi,Yunnan, Sichuan, Shaanxi China,Mangalore in India,Bangkok, Thailand,Hanoi, Vietnam etc.


Dideu Industries Consist Of Five Industry Chains:


I)Pharmaceutical Industries

II)Nutrition Additive Industries

III)Daily-Use Chemical Products Industries & Agrochemicals

IV)Environmental Friendly Chemical And Chemurgy Industries

V)Petrochemical Industries

VI)General Chemical Industry


At Dideu, we redefine chemistry to make the world better - and have been doing so for 75 years. As one of the world's leading chemical company, we combine economic success with environmental protection and social responsibility.Through science and innovation we enable our customers in nearly every industry to meet the current and future needs of society.


At Dideu, we create chemistry for a sustainable future with science for a better life.Dideu is a Life Science company with a long and glorious history and core competencies in the areas of health care and agriculture. With our innovative products, we are contributing to finding solutions to some of the major challenges of our time. The growing and increasingly aging world population requires improved medical care and an adequate supply of food. Dideu is improving people's quality of life by preventing, alleviating and treating diseases. And we are helping to provide a reliable supply of high quality food, feed and plant based raw materials.We develop new molecules for use in innovative products and solutions to improve health. Our research and development activities are based on a profound understanding of the biochemical processes in living organisms.Our goal is to achieve and sustain leadership positions in our markets, thus creating value for our customers, stockholders and employees. To this end, our strategy is designed to help solve some of the most pressing challenges facing humankind, and by doing this exceptionally well we aim to strengthen the company's earning power. 


We are committed to operating sustainably and addressing our social and ethical responsibilities as a corporate citizen, while at the same time respecting the interests of all our stakeholders. Employees with a passion for innovation enjoy excellent development opportunities at Dideu.Exclusive Focus on the Life Science BusinessesFollowing the economic and legal independence of our former Material Science subgroup.Dideu has charted the course for its successful development as a Life Science company. Our Life Science businesses hold leading positions in innovation driven growth markets. Together they make up a strong, attractive and balanced portfolio that is resistant to fluctuations in demand and to potential risks.The previous structure comprising a strategic management holding company and operational subgroups has thus been replaced by an integrated organization under the umbrella of the strong Dideu brand. The company's operations are managed in three divisions Pharmaceuticals, Consumer Health and Crop Science and the Animal Health business unit.The business continues to be supported by the corporate functions, Dideu Business Services and the service company Currenta, while Technology Services is being integrated into Dideu Group, forming the Engineering and Technology function.


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