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High Quality USP/EP/BP GMP DMF FDA Fluocinolone Cream CAS NO 807-38-5 Producer

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  • AZ482
  • Dideu
  • 807-38-5
  • C21H26F2O6
  • 2123629
  • China
  • Fluocinolone 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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Fluocinolone Cream 

Action and useGlucocorticoid.

Definition

Fluocinolone Cream contains Fluocinolone Acetonide or Fluocinolone Acetonide Dihydrate in a suitable basis.


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

Content of fluocinolone acetonide, C24H30F2O6

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, by shaking, a quantity of the preparation being examined containing 0.25  mg of Fluocinolone Acetonide in 2  ml of chloroform, add 10  ml of methanol, shake vigorously, cool in ice for 15  minutes, centrifuge at 3000 revolutions per minute for 15  minutes, decant the clear, supernatant liquid, evaporate to dryness on a water bath in a current of nitrogen and dissolve the residue in 1  ml of chloroform.  

(2)  0.025% w/v solution of fluocinolone acetonide BPCRS in chloroform.


chromatographic conditions

(a)  Use as the coating silica gel G.

(b)  Use the mobile phase as described below. 

(c)  Apply 5 µl of each solution.

(d)  Develop the plate to 15 cm.

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


mobile phase

1  volume of triethylamine, 10  volumes of methanol, 40  volumes of chloroform and 60  volumes of n-hexane.


confirmation

The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


B.  In the Assay, the chromatogram obtained with solution (2) shows a peak with the same retention time as the peak due to fluocinolone acetonide 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% to 0.2% w/w of fluocinolone acetonide

(1)  0.025% w/v of fluocinolone acetonide BPCRS and 0.005% w/v of phenacetin (internal standard) in chloroform.

(2)  To a quantity of the cream containing 2.5  mg of Fluocinolone Acetonide add 60  ml of a solution prepared by adding 80  ml of methanol to 20  ml of a 25% w/v solution of lithium chloride and disperse by shaking vigorously. Add 100  ml of cyclohexane, shake gently for 2  minutes and separate the lower, aqueous methanolic layer, taking care to exclude any solid matter that separates at the interface. Repeat the extraction using a further 25  ml of the lithium chloride solution. To the combined extracts add a solution of 11  g of aluminium potassium sulphate in 214  ml of water followed by 50  ml of chloroform, shake vigorously for about 3  minutes, allow the layers to separate and filter the chloroform extract through filter paper (Whatman No. 1 is suitable), previously moistened with chloroform, again excluding any solid matter at the interface. Repeat the extraction with 50- and 10-ml quantities of chloroform, filtering the extracts as before. Evaporate the combined extracts to dryness on a water bath in a current of nitrogen, dissolve the residue in 5  ml of chloroform, transfer to a 10-ml graduated flask with the aid of chloroform and add sufficient chloroform to produce 10  ml.


(3)  Prepare in the same manner as solution (2) but add 1.0  ml of a 0.050% w/v solution of phenacetin to the chloroform solution before dilution to 10  ml.


For creams containing 0.01% w/w of fluocinolone acetonide

(1)  0.01% w/v of fluocinolone acetonide BPCRS and 0.002% w/v of phenacetin (internal standard) in chloroform.

(2)  Prepare as described above but using a quantity of the cream containing 1  mg of Fluocinolone Acetonide.

(3)  Prepare in the same manner as solution (2) but add 1  ml of a 0.02% w/v solution of phenacetin to the chloroform solution before diluting to 10  ml.


For creams containing 0.00625% w/w of fluocinolone acetonide

(1)  0.00625% w/v of fluocinolone acetonide BPCRS and 0.00125% w/v of phenacetin (internal standard) in chloroform.

(2)  Prepare as described above but using a quantity of the cream containing 0.62  mg of Fluocinolone Acetonide.

(3)  Prepare in the same manner as solution (2) but add 1  ml of a 0.0125% w/v solution of phenacetin to the chloroform solution before diluting to 10  ml.


For creams containing 0.0025% w/w of fluocinolone acetonide

(1)  0.0025% w/v of fluocinolone acetonide BPCRS and 0.0005% w/v of phenacetin (internal standard) in chloroform.

(2)  Prepare as described above but using a quantity of the cream containing 0.25  mg of Fluocinolone Acetonide.

(3)  Prepare in the same manner as solution (2) but add 1  ml of a 0.005% w/v solution of phenacetin to the chloroform solution before diluting to 10  ml.


chromatographic conditions

(a)  Use a stainless steel column (20  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 1.8  ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 243  nm.

(f)  Inject 20 µl of each solution.


mobile phase

58  volumes of hexane, 40  volumes of chloroform, 2  volumes of methanol and 0.1  volume of glacial acetic acid.


system suitability 

The assay is not valid unless the resolution factor (Rs) between the peaks due to fluocinolone acetonide and phenacetin is more than 2, and the capacity factors (k′) of fluocinolone acetonide and phenacetin are about 3 and 2, respectively. If these conditions are not achieved, adjust the concentration of methanol in the mobile phase, increasing its concentration to reduce the value of k′ and reducing its concentration to increase the value of k′. If the correct values cannot be obtained by this means, the column is faulty and must be repacked. If, when the correct k′ values have been obtained, the value of Rs is less than 2, reduce the concentration of chloroform in the mobile phase by 5% to obtain an increased retention time for both fluocinolone acetonide and phenacetin and re-adjust the k′ values to the specified values by increasing the concentration of methanol. Repeat the adjustment of chloroform and methanol concentrations until correct values for both Rs and k′ have been obtained.


determination of content 

Calculate the content of C24H30F2O6 in the cream using the declared content of C24H30F2O6 in fluocinolone acetonide BPCRS.

Labelling

When the active ingredient is Fluocinolone Acetonide Dihydrate, the quantity is stated in terms of the equivalent amount of fluocinolone acetonide.




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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