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High Quality USP/EP/BP GMP DMF FDA Miconazole and Hydrocortisone Acetate Cream CAS NO Producer

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  • AZ496
  • Dideu
  • China
  • Miconazole and Hydrocortisone Acetate 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

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Miconazole and Hydrocortisone Acetate Cream 

Action and use Antifungal azole.

Definition

Miconazole and Hydrocortisone Acetate Cream contains Miconazole Nitrate and Hydrocortisone Acetate in a suitable basis.


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

Content of miconazole nitrate, C18H14Cl4N2O,HNO3 

95.0 to 105.0% of the stated amount.
Content of hydrocortisone acetate, C23H32O6  95.0 to 105.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III  A, using a precoated silica gel F254 plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 20  volumes of ammonium acetate, 40  volumes of dioxan and 40  volumes of methanol 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 cream containing 0.15  g of Miconazole Nitrate by shaking with 25  ml of methanol for about 30 minutes, dilute to 50  ml with methanol, filter and use the filtrate. Solution (2) contains 0.3% w/v of miconazole nitrate BPCRS in methanol. Solution (3) contains 0.15%  w/v of hydrocortisone acetate BPCRS in methanol. Solution (4) contains 0.15%  w/v of hydrocortisone BPCRS and 0.15%  w/v of hydrocortisone acetate BPCRS in methanol. After removal of the plate, allow it to dry in air, expose to iodine vapour until spots appear and examine in daylight. The principal spots in the chromatogram obtained with solution (1) are similar in position, colour and size to those in the chromatograms obtained with solutions (2) and (3). The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated spots.


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


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

Tests

Related substances

Acidity

pH of a 10% w/v dispersion in carbon dioxide-free water, 3.5 to 4.5, Appendix V L.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the cream containing 25 mg of Miconazole Nitrate with 30 ml of methanol for 30 minutes, add sufficient methanol to produce 50 ml and filter (Whatman GF/F is suitable). For solution (2) dilute 1 volume of solution (1) to 200 volumes with methanol. Solution (3) contains 0.02% w/v each of miconazole impurity A EPCRS and 2,4-dichlorobenzenemethanol in methanol.


The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm × 4.6 mm) packed with base-deactivated, end-capped octadecylsilyl silica gel for chromatography (3 µm) (Hypersil BDS is suitable), (b) as the mobile phase with a flow rate of 1.5 ml per minute the changing proportions of mobile phases A and B described below and (c) a detection wavelength of 235 nm. 


Inject 20 µl of each solution.


Mobile phase A  A solution containing 0.01m ammonium dihydrogen orthophosphate adjusted to pH 6.0 with dilute ammonia R1.


Mobile phase B  A mixture of 10 volumes of tetrahydrofuran and 90 volumes of acetonitrile.


1109-0955

When the chromatograms are recorded under the prescribed conditions the retention times are: hydrocortisone acetate, about 8 minutes; miconazole, about 18 minutes.


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is greater than 5.0.


In the chromatogram obtained with solution (1), the area of any peak other than those of Hydrocortisone acetate and Miconazole is not greater than the area of the miconazole peak in the chromatogram obtained with solution (2) (0.5%) and the sum of the areas of any such peaks is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%). Disregard any peak due to nitrate ion and any peak with an area less than 0.2 times the area of the peak in the chromatogram obtained with solution (2) (0.1%).

Assay

For miconazole nitrate 

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the cream containing 50 mg of Miconazole Nitrate with 50 ml of methanol for 15 minutes, add sufficient methanol to produce 100 ml and filter if necessary. Solution (2) contains 0.050% w/v of miconazole nitrate BPCRS in methanol. Solution (3) contains 0.02% w/v each of miconazole impurity A EPCRS and 2,4-dichlorobenzenemethanol.


The chromatographic conditions described under Related substances may be used. 


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is greater than 5.0. 


Calculate the content of C18H14Cl4N2O in the preparation being examined using the declared content of C18H14Cl4N2O.HNO3 in miconazole nitrate BPCRS.


For hydrocortisone acetate

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the cream containing 25 mg of Hydrocortisone Acetate with 50 ml of methanol for 15 minutes, add sufficient methanol to produce 100 ml and filter if necessary. Solution (2) contains 0.025% w/v of hydrocortisone acetate BPCRS in methanol. Solution (3) contains 0.02% w/v each of miconazole impurity A EPCRS and 2,4-dichlorobenzenemethanol.


The chromatographic conditions described under Related substances may be used. 


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is greater than 5.0.


Calculate the content of C23H32O6 in the preparation being examined using the declared content of C23H32O6 in hydrocortisone acetate BPCRS.

Impurities

The impurities limited by the requirements of this monograph include impurity A listed under Miconazole Nitrate and the following:


2,4-dichlorobenzenemethanol,


2,4-dichloro-β-[2,4-dichlorophenyl)-methoxy]benzene ethanamine,


N-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)-methoxy]ethyl]formamide.




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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