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High Quality USP/EP/BP GMP DMF FDA Hydrocortisone and Clioquinol Ointment CAS NO Producer

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  • AZ533
  • Dideu
  • China
  • Hydrocortisone and Clioquinol Ointment
  • 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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Hydrocortisone and Clioquinol Ointment 

Action and use

Corticosteroid.

Definition

Hydrocortisone and Clioquinol Ointment contains Hydrocortisone and Clioquinol, the latter in very fine powder , in a suitable basis.


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

Content of hydrocortisone, C21H30O5 

92.5  to 107.5% 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 77  volumes of dichloromethane , 15  volumes of ether , 8  volumes of methanol and 1.2  volumes of water as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) disperse, by warming and shaking, a quantity of the ointment containing 2.5  g of Hydrocortisone in 10  ml of ethanol (96%) , cool, allow to stand at 0° for 30  minutes, filter and use the filtrate. Solution (2) contains 0.25% w/v of hydrocortisone BPCRS in ethanol (96%) . For solution (3) dissolve 12.5  mg of hydrocortisone BPCRS in 5  ml of solution (1). After removal of the plate, allow it to dry in air and spray 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). The principal spot in the chromatogram obtained with solution (3) appears as a single, compact spot.


B.  In the Assay for hydrocortisone the chromatogram obtained with solution (3) shows a peak with the same retention time as the peak due to hydrocortisone in the chromatogram obtained with solution (1).


C.  Fuse a quantity of the ointment containing 0.1  g of Clioquinol with anhydrous sodium carbonate , dissolve the fused mass in water and acidify with 2m nitric acid . Add silver nitrate solution ; a pale yellow precipitate is produced which is insoluble in 5m ammonia . Add 5m ammonia until the solution becomes alkaline, boil gently, filter and acidify the filtrate with 2m nitric acid ; a white precipitate is produced which darkens on exposure to light.

Assay

For hydrocortisone

Carry out the method for liquid chromatography , Appendix III D, using the following solutions. For solution (1) dissolve 5  mg of hydrocortisone BPCRS in 5  ml of a 4% v/v solution of bromobenzene (internal standard) in methanol and dilute to 50  ml with methanol (80%). For solution (2) add 30  ml of 2,2,4-trimethylpentane to a quantity of the ointment containing 10  mg of Hydrocortisone and warm on a water bath until the preparation has melted. Extract the warm mixture with successive quantities of 30, 20 and 20  ml of methanol (80%), combine the aqueous methanolic layers, cool to about 20° and dilute to 100  ml with the same solvent. Prepare solution (3) in the same manner as solution (2) but adding 10  ml of a 4% v/v solution of bromobenzene in methanol to the cooled methanolic extract.


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 5  mm) packed with octadecylsilyl silica gel for chromatography (Spherisorb ODS 1 is suitable), (b) methanol (65%) as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 242  nm.


Calculate the content of C21H30O5 in the ointment using the declared content of C21H30O5 in hydrocortisone BPCRS .


For clioquinol

To a quantity containing 25  mg of Clioquinol add 80  ml of a hot mixture of 24  volumes of 2-methoxy-ethanol and 6  volumes of water and heat on a water bath for 5  minutes. Cool in ice for 10  minutes, allow to warm to room temperature, dilute to 100  ml with the aqueous methoxyethanol, mix and filter. To 10  ml of the filtrate add 10  ml of 2-methoxyethanol and 2  ml of a solution prepared by dissolving 0.5  g of iron(III) chloride hexahydrate in 80  ml of 2-methoxyethanol and adding 0.1  ml of hydrochloric acid and sufficient 2-methoxyethanol to produce 100  ml. Dilute the solution to 25  ml with 2-methoxyethanol and measure the absorbance of the resulting solution at the maximum at 650  nm, Appendix II B, using in the reference cell a solution prepared by treating 10  ml of the aqueous methoxyethanol in the same manner beginning at the words 'add 10  ml of 2-methoxyethanol …'.


Repeat the operation beginning at the words 'add 10  ml of 2-methoxyethanol …' using 10  ml of a solution prepared in the following manner. Dissolve 0.125  g of clioquinol BPCRS in sufficient 2-methoxyethanol to produce 50  ml, warming to effect solution; add 1  ml of water to 5  ml of the solution and add sufficient of a mixture of 6  volumes of water and 24  volumes of 2-methoxyethanol to produce 50  ml. Calculate the content of C9H5ClINO from the absorbances obtained using the declared content of C9H5ClINO in clioquinol BPCRS .

Storage

Hydrocortisone and Clioquinol Ointment should be protected from light.




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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