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High Quality USP/EP/BP GMP DMF FDA Beclometasone Cream CAS NO 4419-39-0 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
  • AZ465
  • Dideu
  • 4419-39-0
  • C22H29ClO5
  • 224-585-9
  • China
  • Beclometasone 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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Beclometasone Cream 

Action and use

Glucocorticoid.

Definition

Beclometasone Cream contains Anhydrous Beclometasone Dipropionate in a suitable basis.


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

Content of beclometasone dipropionate, C28H37ClO7

90.0  to 110.0% of the stated amount.
Identification

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


(1)  Disperse a quantity of the preparation being examined containing 0.5  mg of Anhydrous Beclometasone Dipropionate in 20  ml of methanol (80%) by heating on a water bath until the methanol begins to boil. Shake vigorously, cool in ice for 30  minutes and centrifuge. Mix 10  ml of the supernatant liquid with 3  ml of water and 5  ml of chloroform, shake vigorously, allow the layers to separate, evaporate the chloroform layer to dryness in a current of nitrogen with gentle heating and dissolve the residue in 1  ml of chloroform.

(2)  0.025% w/v of beclometasone dipropionate BPCRS in chloroform.

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


chromatographic conditions

(a)  Use as the coating silica gel G.

(b)  Use the mobile phase as described below. 

(c)  Apply 10 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  After removal of the plate, allow it to dry in air until the solvent has evaporated, heat at 105° for 5  minutes and, while hot, spray with alkaline tetrazolium blue solution.


mobile phase

100  volumes of chloroform, 10  volumes of acetone and 5  volumes of absolute ethanol.


confirmation

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, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to beclometasone dipropionate in the chromatogram obtained with solution (1).

Assay

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


For creams containing 0.025% w/w of Anhydrous Beclometasone Dipropionate.


(1)  Mix 10  ml of methanol (80%) containing 0.01% w/v of beclometasone dipropionate BPCRS and 0.0005% w/v of beclometasone 17-propionate BPCRS with 2  ml of a 0.05% w/v solution of testosterone propionate (internal standard) in methanol (80%) and dilute to 50  ml with the same solvent.

(2)  Disperse a quantity of the preparation being examined containing 1  mg of Anhydrous Beclometasone Dipropionate in 20  ml of hot methanol (90%), add 25  ml of 2,2,4-trimethylpentane, cool, shake the mixture and filter the lower layer through a small plug of absorbent cotton previously washed with methanol (80%). Repeat the extraction of the trimethylpentane solution with two further 10  ml quantities of methanol (80%), filtering the extracts through the absorbent cotton. Combine the extracts and add sufficient methanol (80%) to produce 50  ml. If the resulting solution is more than slightly cloudy, filter.

(3)  Prepare in the same manner as solution (2) but add 2  ml of a 0.05% w/v solution of the internal standard in methanol (80%) before diluting to 50  ml.


For creams containing 0.5% w/w of Anhydrous Beclometasone Dipropionate.


(1)  Mix 25  ml of methanol (80%) containing 0.04% w/v of beclometasone dipropionate BPCRS and 0.002% w/v of beclometasone 17-propionate BPCRS with 20  ml of a 0.05% w/v solution of testosterone propionate (internal standard) in methanol (80%) and dilute to 200  ml with the same solvent.

(2)  Add 100  ml of methanol (80%) to a quantity of the preparation being examined containing 10  mg of Anhydrous Beclometasone Dipropionate and heat on a water bath, with swirling, until the preparation has dispersed. Cool, dilute to 200  ml with methanol (80%) and filter.

(3)  Prepare in the same manner as solution (2) but add 20  ml of a 0.05% w/v solution of the internal standard in methanol (80%) before diluting to 200  ml.


chromatographic conditions 

(a)  Use a stainless steel column (10  cm × 5  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable).

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

(c)  Use a flow rate of 2 ml per minute.

(d)  Use a column temperature of 60°.

(e)  Use a detection wavelength of 238 nm.

(f)  Inject 20 µl of each solution.


mobile phase

A mixture of methanol and water such that the resolution factor between the peaks due to beclometasone 17-propionate (retention time about 1.5  minutes) and beclometasone dipropionate (retention time about 2  minutes) is greater than 2.0 (a mixture of 70  volumes of methanol and 30  volumes of water is usually suitable).


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (1), the resolution factor between the peaks due to beclometasone 17-propionate (retention time about 1.5  minutes) and beclometasone dipropionate (retention time about 2  minutes) is greater than 2.0.


determination of content 

Calculate the content of C28H37ClO7 in the preparation being examined using the declared content of C28H37ClO7 in beclometasone dipropionate BPCRS.

Storage

Beclometasone Cream 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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