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High Quality USP/EP/BP GMP DMF FDA Miconazole Cream CAS NO 22916-47-8 Producer

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Price: $ 0.08 / pcs
Quantity:
min order: 1 pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ498
  • Dideu
  • 22916-47-8
  • C18H14Cl4N2O
  • 245-324-5
  • China
  • Miconazole 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

Miconazole Cream 

Action and useAntifungal azole.

Definition

Miconazole Cream contains Miconazole Nitrate 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.
Identification

A.  Mix a quantity containing 40  mg of Miconazole Nitrate with 20  ml of a mixture of 1  volume of 1m sulphuric acid and 4  volumes of methanol and shake with two 50  ml quantities of hexane, discarding the organic layers. Make the aqueous phase alkaline with 2m ammonia and extract with two 40  ml quantities of chloroform. Combine the chloroform extracts, shake with 5  g of anhydrous sodium sulphate, filter and dilute the filtrate to 100  ml with chloroform. Evaporate 50  ml to dryness and dissolve the residue in 50  ml of a mixture of 1  volume of 0.1m hydrochloric acid and 9  volumes of methanol. The light absorption of the resulting solution, Appendix II B, in the range 230  to 350  nm exhibits maxima at 264, 272 and 280  nm.


B.  In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as the peak due to miconazole in the chromatogram obtained with solution (2).

Tests

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 50  mg of Miconazole Nitrate with 30  ml of a mixture of equal volumes of methanol and tetrahydrofuran for 30  minutes, add sufficient of the same solvent mixture to produce 50  ml and filter through a glass microfibre filter (Whatman GF/C is suitable). For solution (2) dilute 5  volumes of solution (1) to 100  volumes with a mixture of equal volumes of methanol and tetrahydrofuran and 5  volumes of the resulting solution to 100  volumes with the same solvent mixture. Solution (3) contains 0.0025% w/v of miconazole nitrate BPCRS and 0.0025% w/v of econazole nitrate BPCRS in a mixture of equal volumes of methanol and tetrahydrofuran.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (3 µm) (Hypersil 3 ODS is suitable), (b) as the mobile phase with a flow rate of 2  ml per minute a 0.6% w/v solution of ammonium acetate in a mixture of 300  volumes of acetonitrile, 320  volumes of methanol and 380  volumes of water and (c) a detection wavelength of 235  nm.


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to miconazole and econazole is at least 10. If necessary adjust the composition of the mobile phase.


In the chromatogram obtained with solution (1) the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.25%) and the sum of the areas of any secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).

Assay

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 30  ml of a mixture of equal volumes of methanol and tetrahydrofuran for 30  minutes, add sufficient of the same solvent mixture to produce 50  ml and filter through a glass microfibre filter (Whatman GF/C is suitable). Solution (2) contains 0.1% w/v of miconazole nitrate BPCRS in a mixture of equal volumes of methanol and tetrahydrofuran. Solution (3) contains 0.0025% w/v of miconazole nitrate BPCRS and 0.0025% w/v of econazole nitrate BPCRS in a mixture of equal volumes of methanol and tetrahydrofuran.


The chromatographic procedure 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 peaks due to miconazole and econazole is at least 10. If necessary adjust the composition of the mobile phase.


Calculate the content of C18H14Cl4N2O,HNO3 in the cream using the declared content of C18H14Cl4N2O,HNO3 in miconazole nitrate BPCRS.

Storage

If Miconazole Cream is kept in aluminium tubes, their inner surfaces should be coated with a suitable lacquer.




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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