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Fluocinolone Ointment contains Fluocinolone Acetonide or Fluocinolone Acetonide Dihydrate in a suitable basis.
The ointment 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.|
A. Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 60 volumes of n-hexane, 40 volumes of chloroform, 10 volumes of methanol and 1 volume of triethylamine as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (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. Solution (2) contains 0.025% w/v solution of fluocinolone acetonide BPCRS in chloroform. After removal of the plate, allow it to dry in air until the solvent has evaporated, heat at 105° for 5 minutes and spray whilst hot 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).
B. In the Assay the chromatogram obtained with solution (3) shows a peak with the same retention time as the peak due to fluocinolone acetonide in the chromatogram obtained with solution (1).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.0050% w/v of fluocinolone acetonide BPCRS and 0.40% v/v of toluene (internal standard) in methanol (80%).
For ointments containing 0.01% w/w or less of fluocinolone acetonide prepare solution (2) in the following manner. To a quantity of the ointment containing 0.5 mg of fluocinolone acetonide add 50 ml of 2,2,4-trimethylpentane and 8 ml of methanol (80%), warm gently on a water bath until the preparation is dispersed and shake vigorously for 2 minutes. Separate the lower, aqueous methanolic layer and wash the upper layer with 1 ml of methanol (80%), adding the washing to the previous extract. To the combined extracts add sufficient methanol (80%) to produce 10 ml. Prepare solution (3) in the same manner as solution (2) but adding 1 ml of a 4% v/v solution of the internal standard in methanol to the combined extracts before dilution to 10 ml.
For ointments containing 0.025% w/w of fluocinolone acetonide, prepare solution (2) in the following manner. To a quantity of the ointment containing 1.25 mg of fluocinolone acetonide add 50 ml of 2,2,4-trimethylpentane and 20 ml of methanol (80%), warm gently on a water bath until the preparation is dispersed and shake vigorously for 2 minutes. Separate the lower, aqueous methanolic layer and wash the upper layer with 2 ml of methanol (80%), adding the washing to the previous extract. To the combined extracts add sufficient methanol (80%) to produce 25 ml. Prepare solution (3) in the same manner as solution (2) but adding 1 ml of a 10% v/v solution of the internal standard in methanol to the combined extracts before dilution to 25 ml.
The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm × 5 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 55 volumes of water, 45 volumes of acetonitrile and 0.1 volume of glacial acetic acid as the mobile phase with a flow rate of 1 ml per minute and (c) a detection wavelength of 238 nm.
Calculate the content of C24H30F2O6 in the ointment using the declared content of C24H30F2O6 in fluocinolone acetonide BPCRS.
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.
a) Free sample can be supplied.
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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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.