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High Quality USP/EP/BP GMP DMF FDA Betamethasone and Clioquinol Cream CAS NO Producer

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  • AZ468
  • Dideu
  • China
  • Betamethasone and Clioquinol 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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Mobile:+86-15129568250; Whatsapp: +8615129568250

Betamethasone and Clioquinol Cream 

Action and use

Glucocorticoid.

Definition

Betamethasone and Clioquinol Cream contains Betamethasone Valerate and Clioquinol, the latter in very fine powder, in a suitable basis.


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

Content of betamethasone, C22H29FO5

90.0  to 110.0% of the stated amount.
Content of clioquinol, C9H5ClINO90.0  to 110.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 5  volumes of absolute ethanol, 10  volumes of acetone and 100  volumes of chloroform as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) disperse a quantity of the preparation being examined containing the equivalent of 0.5  mg of betamethasone in 20  ml of methanol (80%) by heating on a water bath until the methanol begins to boil. Shake vigorously, cool in ice and centrifuge. Transfer 10  ml of the supernatant liquid to a separating funnel, add 3  ml of water and 5  ml of chloroform, shake vigorously, allow the layers to separate and evaporate the chloroform layer to dryness in a current of nitrogen with gentle heating. Dissolve the residue in 1  ml of chloroform. Solution (2) contains 0.03% w/v of betamethasone valerate BPCRS in chloroform. After removal of the plate, allow it to dry in air, heat at 105° for 5  minutes and spray while hot with alkaline tetrazolium blue solution. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


B.  In the Assay for betamethasone the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to betamethasone valerate in the chromatogram obtained with solution (1).


C.  In the Assay for clioquinol the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to clioquinol in the chromatogram obtained with solution (1).

Assay

For betamethasone

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix 10  ml of a solution containing 0.024% w/v of betamethasone valerate BPCRS and 0.0012% w/v of betamethasone 21-valerate BPCRS in ethanol (80%) with 5  ml of a 0.072% w/v solution of beclometasone dipropionate BPCRS (internal standard) in ethanol (80%) and dilute to 50  ml with the same solvent. For solution (2) shake a quantity of the cream containing the equivalent of 2  mg of betamethasone with 100  ml of hot hexane for 2  minutes, cool, extract the mixture with 20  ml of ethanol (96%) and filter the lower, ethanolic layer through absorbent cotton previously washed with ethanol (75%). Repeat the extraction of the hexane mixture with two 10  ml quantities of ethanol (75%), filtering each extract in turn through the absorbent cotton and dilute the combined filtrates to 50  ml with ethanol (75%). Prepare solution (3) in the same manner as solution (2) but add 5  ml of a 0.072% w/v solution of the internal standard in ethanol (80%) before diluting to 50  ml.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 5  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable) and maintained at 60°, (b) as the mobile phase with a flow rate of 2  ml per minute a mixture of absolute ethanol and water adjusted so that the resolution factor between the peaks due to betamethasone valerate (retention time about 5  minutes) and betamethasone 21-valerate (retention time about 7  minutes) is more than 1.0 (a mixture of 42  volumes of absolute ethanol and 58  volumes of water is usually suitable) and (c) a detection wavelength of 238  nm.


Calculate the content of C22H29FO5 in the cream using the declared content of C22H29FO5 in betamethasone valerate BPCRS and using peak areas.


For clioquinol

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix 5  ml of a solution containing 0.024% w/v of clioquinol BPCRS in an 80% v/v solution of 2-methoxyethanol and 1  ml of a solution containing 1% w/v of nickel(ii) chloride hexahydrate in water and dilute to 50  ml with the mobile phase. For solution (2) add 80  ml of a hot 80% v/v solution of 2-methoxyethanol to a quantity of the cream containing 30  mg of Clioquinol and heat on a water bath for 5  minutes, swirling vigorously. Cool to room temperature, dilute to 100  ml with the same solvent, mix and filter. To 5  ml of the filtrate add 1  ml of a solution containing 1% w/v of nickel(ii) chloride hexahydrate and dilute to 50  ml with the mobile phase.


The chromatographic procedure may be carried out using (a) a column (25  cm × 4.6  mm) packed with particles of silica the surface of which has been modified with chemically bonded phenyl groups (5 µm) (Spherisorb Phenyl is suitable), (b) a solution containing 0.024% w/v of nickel(ii) chloride hexahydrate in a mixture of 2  volumes of methanol, 3  volumes of acetonitrile and 5  volumes of water as the mobile phase with a flow rate of 1.5  ml per minute and (c) a detection wavelength of 273  nm.


Calculate the content of C9H5ClINO in the cream using the declared content of C9H5ClINO in clioquinol BPCRS.

Storage

Betamethasone and Clioquinol Cream should be protected from light.

Labelling

The quantity of active ingredient with respect to Betamethasone Valerate is stated in terms of the equivalent amount of betamethasone.




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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