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|Action and use|
Clomethiazole Capsules contain a solution of Clomethiazole in a suitable fixed oil.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of clomethiazole, C6H8ClNS
|92.5 to 107.5% of the stated amount.|
A. Shake a quantity of the contents of the capsules containing 20 mg of Clomethiazole with 70 ml of 0.1m hydrochloric acid for 15 minutes and dilute to 100 ml with the same solvent. Filter and dilute 10 ml of the filtrate to 50 ml with 0.1m hydrochloric acid. The light absorption of the resulting solution, Appendix II B, in the range 230 to 350 nm exhibits a maximum only at 257 nm.
B. To a quantity of the contents of the capsules containing 0.3 g of Clomethiazole add 10 ml of 0.1m hydrochloric acid and shake. To the aqueous layer add 5 ml of 1m sodium hydroxide, mix and extract with 15 ml of chloroform. Dry the chloroform layer with anhydrous sodium sulphate, filter and evaporate to remove the solvent. The infrared absorption spectrum of a thin film of the residue, Appendix II A, is concordant with the reference spectrum of clomethiazole (RS 051).
C. Mix a quantity of the contents of the capsules containing 0.1 g of Clomethiazole with 0.2 g of powdered sodium hydroxide, heat to fusion and continue heating for a further few seconds. Cool, add 0.5 ml of water and a slight excess of 2m hydrochloric acid and warm. Any fumes evolved do not turn moistened starch iodate paper blue (distinction from clomethiazole edisilate).
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Add 100 ml of 1m sulphuric acid to whole capsules containing a total of 0.96 g of Clomethiazole, immerse in a water bath for 20 seconds, remove from the bath and shake vigorously. Repeat this treatment until the capsule shells have dissolved without exceeding a total heating time of 1 minute. Cool, centrifuge, filter the aqueous layer (Whatman GF/C paper is suitable) and dilute 5 ml of the filtrate to 50 ml with the mobile phase.
(2) Dilute 1 volume of solution (1) to 200 volumes with the mobile phase.
(3) Dilute 1 volume of a 0.030% w/v solution of 4-methyl-5-vinylthiazole edisilate BPCRS in methanol (solution A) to 50 volumes with the mobile phase.
(4) Dilute 1 volume of a 0.020% w/v solution of 5-(2-chloroethyl)-4-methyl-3-[2-(4-methylthiazol-5-yl)ethyl]thiazolium chloride BPCRS (quaternary dimer) in methanol (solution B) to 50 volumes with the mobile phase.
(5) Dilute 1 volume of a 0.020% w/v solution of 4-methyl-5-(2-hydroxyethyl)thiazole BPCRS in methanol (solution C) to 50 volumes with the mobile phase.
(6) Add 1 ml each of solutions A, B and C to 5 ml of the filtrate obtained in the preparation of solution (2) and dilute to 50 ml with the mobile phase.
(a) Use a stainless steel column (20 cm × 4 mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Lichrosorb RP18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 ml per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 257 nm.
(f) Inject 20 µl of each solution.
30 volumes of methanol and 70 volumes of a solution containing 0.13% w/v of sodium hexanesulphonate and 2.7% w/v of tetramethylammonium hydrogen sulphate, adjusted to pH 2.0 with 5m sodium hydroxide.
The test is not valid unless in the chromatogram obtained with solution (6) baseline separation is achieved between the peaks due to the three specified impurities and also between each of these peaks and the principal peak.
Calculate the content of each of the specified impurities with reference to the stated content of Clomethiazole in the capsules expressing the content of 4-methyl-5-vinyl-thiazole as the base (1 mg of 4-methyl-5-vinylthiazole edisilate is equivalent to 0.568 mg of its base). Calculate the content of each of any other impurities from the areas of their peaks in the chromatogram obtained with solution (1) using the principal peak in the chromatogram obtained with solution (2) as reference and assuming the same response as clomethiazole.
The content of each of the three specified impurities is not greater than 1.5% and the content of any other impurity is not greater than 0.5%. The total content of all the impurities is not greater than 3.0%.
Carry out Method I for non-aqueous titration, Appendix VIII A, using a quantity of the mixed contents of 20 capsules containing 0.4 g of Clomethiazole and crystal violet solution as indicator. Each ml of 0.1m perchloric acid VS is equivalent to 16.16 mg of C6H8ClNS.
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.
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:
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.