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|Action and use|
Coal tar extract; treatment of psoriasis.
Dithranol Cream contains Dithranol in a suitable oil-in-water emulsified basis.
The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.
Content of dithranol, C14H10O3
|85.0 to 110.0% of the stated amount.|
A. In the Assay the principal peak in the chromatogram obtained with solution (2) has the same retention time as that in the chromatogram obtained with solution (1).
B. Suspend a quantity containing 0.5 mg of dithranol in 5 ml of 1m sodium hydroxide and heat on a water bath for 1 minute while stirring. A pink colour is produced.
Dihydroxyanthraquinone and dithranol dimer
Not more than 10.0% of the stated amount of dithranol, calculated as the sum of the amounts of dihydroxyanthraquinone and dithranol dimer when determined by the method for liquid chromatography, Appendix III D, using the following solutions. For creams containing more than 0.5% w/v of Dithranol, use as solution (1) solution A obtained in the Assay. For solution (2) add 4 ml of glacial acetic acid to 20 ml of a solution containing 0.005% w/v of 1,8-dihydro-xyanthraquinone and 0.005% w/v of dithranol dimer BPCRS in dichloromethane and add sufficient n-hexane to produce 100 ml. For creams containing 0.5% w/v or less of Dithranol, use as solution (1) solution B obtained in the Assay. For solution (2) add 20 ml of glacial acetic acid to 10 ml of a solution containing 0.005% w/v of 1,8-dihydroxyanthraquinone and 0.005% w/v of dithranol dimer BPCRS in dichloromethane and add sufficient dichloromethane to produce 100 ml.
The chromatographic procedure described under Assay may be used but using a detection wavelength of 380 nm.
In the chromatogram obtained with solution (2) the peaks, other than the solvent peak, are, in order of emergence, due to dihydroxyanthraquinone and dithranol dimer. Calculate the amounts of dihydroxyanthraquinone and dithranol dimer in the cream with reference to the corresponding peaks in the chromatogram obtained with solution (2).
Carry out the method for liquid chromatography, Appendix III D, in subdued light using the following freshly prepared solutions. For solution (1) disperse a quantity of the cream containing 10 mg of Dithranol in 30 ml of water at about 50°, add 30 ml of a warm, saturated solution of sodium chloride, cool and extract with three 40 ml quantities of chloroform. Filter the extract successively through anhydrous sodium sulphate on a suitable filter (Whatman GF/C is suitable). Evaporate the filtrate under reduced pressure to a volume of about 2 ml, add 25 ml of warm methanol, shake, cool in ice for 15 minutes and filter (Whatman GF/C paper is suitable). Evaporate the filtrate to dryness under reduced pressure and dissolve the residue in 10 ml of a mixture of 5 volumes of glacial acetic acid and 95 volumes of acetonitrile; filter if necessary. For solution (2) dissolve 25 mg of dithranol impurity D EPCRS (1-hydroxy-9-anthrone) in 0.5 ml of glacial acetic acid and add sufficient acetonitrile to produce 50 ml (solution A); dilute 1 ml of solution A to 20 ml with acetonitrile. For solution (3) dilute 1 volume of solution (1) to 40 ml with a mixture of 5 volumes of glacial acetic acid and 95 volumes of acetonitrile. For solution (4) dissolve 50 mg of dithranol BPCRS in 0.5 ml of glacial acetic acid, add 2 ml of solution A and sufficient acetonitrile to produce 50 ml.
The chromatographic procedure may be carried out using (a) a stainless steel column (20 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 and Spherisorb ODS 2 are suitable), (b) a mixture of 2.5 volumes of glacial acetic acid, 40 volumes of tetrahydrofuran and 60 volumes of water as the mobile phase with a flow rate of 1.5 ml per minute and (c) a detection wavelength of 254 nm.
The test is not valid unless the chromatogram obtained with solution (4) closely resembles the chromatogram supplied with dithranol BPCRS.
In the chromatogram obtained with solution (1) the area of any peak corresponding to the principal peak in the chromatogram obtained with solution (2) (1-hydroxy-9-anthrone) is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (2.5%).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For creams containing more than 0.5% w/w of Dithranol prepare solution (1) in the following manner, protected from light. Disperse by shaking a quantity of the cream containing 50 mg of Dithranol in 10 ml of glacial acetic acid and 20 ml of dichloromethane, filter through a glass microfibre filter paper (Whatman GF/C is suitable) into a 100 ml graduated flask, wash the filter with dichloromethane and add sufficient dichloromethane to produce 100 ml. Shake the flask vigorously and allow to stand until two layers are obtained, add dichloromethane until the dichloromethane and water interface is level with the calibration mark, shake vigorously and again allow to stand until two layers are obtained. Dilute 20 volumes of the lower layer to 50 volumes with n-hexane (solution A). Dilute a suitable volume of solution A with n-hexane to contain 0.002% w/v of Dithranol. For creams containing 0.5% w/w or less of Dithranol prepare solution (1) in the following manner, protected from light. Disperse, by shaking, a quantity of the cream containing 5 mg of Dithranol in 10 ml of glacial acetic acid and 20 ml of dichloromethane, filter through a glass microfibre filter paper (Whatman GF/C is suitable) into a 50 ml graduated flask, wash the filter with dichloromethane and add sufficient dichloromethane to produce 50 ml. Shake the flask vigorously and allow to stand until two layers are obtained, add dichloromethane until the dichloromethane and water interface is level with the calibration mark, shake vigorously and again allow to stand until two layers are obtained (solution B). Dilute a suitable volume of solution B with n-hexane to contain 0.002% w/v of Dithranol. For solution (2) add 1 ml of glacial acetic acid to 10 ml of a 0.02% w/v solution of dithranol BPCRS in dichloromethane and add sufficient of the mobile phase to produce 100 ml.
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with silica gel for chromatography (5 µm) (Lichrosorb Si 60 is suitable), (b) a mixture of 1 volume of glacial acetic acid, 5 volumes of dichloromethane and 82 volumes of n-hexane as the mobile phase with a flow rate of 2 ml per minute and (c) a detection wavelength of 354 nm.
Calculate the content of C14H10O3 in the cream using the declared content of C14H10O3 in dithranol BPCRS.
Dithranol Cream should be protected from light.
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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.
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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.