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|Action and use||Inhibition of ATP-dependent potassium channels (sulfonylurea); treatment of diabetes mellitus.|
Chlorpropamide Tablets contain Chlorpropamide.
The tablets comply with the requirements stated under Tablets and with the following requirements.
|Content of chlorpropamide, C10H13ClN2O3S||92.5 to 107.5% of the stated amount.|
Extract a quantity of the powdered tablets containing 1 g of Chlorpropamide with five 4-ml quantities of acetone, filter and evaporate the filtrate carefully to dryness on a water-bath. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of chlorpropamide (RS 057).
Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.
(a) Use Apparatus 1, rotating the basket at 100 revolutions per minute.
(b) Use 900 ml of a 0.68% w/v solution of potassium dihydrogen orthophosphate adjusted to pH 6.8 by the addition of 1m sodium hydroxide, at a temperature of 37°C, as the medium.
(1) After 45 minutes withdraw a 10 ml sample of the medium and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 230 nm, Appendix II B using the medium in the reference cell.
determination of content
Calculate the total content of chlorpropamide, C10H13ClN2O3S, in the medium taking 469 as the value of A(1%, 1 cm) at the maximum at 230 nm.
Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shake a quantity of the powdered tablets containing 0.5 g of Chlorpropamide with 10 ml of acetone for 10 minutes and filter (Whatman GF/C filter paper is suitable).
(2) 0.015% w/v of 4-chlorobenzenesulphonamide in acetone.
(3) 0.015% w/v of 1,3-dipropylurea in acetone.
(4) Dilute 0.3 volume of solution (1) to 100 volumes with acetone.
(5) Dilute 1 volume of solution (4) to 3 volumes with acetone.
(6) Dissolve 5 mg of 4-chlorobenzenesulphonamide and 5 mg of 1,3-dipropylurea in 2 ml of solution (1) and add sufficient acetone to produce 10 ml.
(a) Use as the coating silica gel 60.
(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 it in a current of cold air and heat at 110° for 10 minutes. Place the hot plate in a tank of chlorine gas prepared by the addition of hydrochloric acid to a 5% w/v solution of potassium permanganate contained in a beaker placed in the tank and allow to stand for 2 minutes. Dry it in a current of cold air until the excess of chlorine is removed and an area of the plate below the line of application gives at most a very faint blue colour with a 0.5% w/v solution of potassium iodide in starch mucilage; avoid prolonged exposure to cold air. Spray the plate with a 0.5% w/v solution of potassium iodide in starch mucilage.
11.5 volumes of 13.5m ammonia, 30 volumes of cyclohexane, 50 volumes of methanol and 100 volumes of dichloromethane.
The test is not valid unless the chromatogram obtained with solution (6) shows three clearly separated spots with Rf values of approximately 0.4, 0.6 and 0.9 corresponding to chlorpropamide, 4-chlorobenzenesulphonamide and 1,3-dipropylurea, respectively.
In the chromatogram obtained with solution (1):
any spot corresponding to 4-chlorobenzenesulphonamide is not more intense than the spot in the chromatogram obtained with solution (2) (0.3%);
any spot corresponding to 1,3-dipropylurea is not more intense than the spot in the chromatogram obtained with solution (3) (0.3%);
any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (4) (0.3%);
not more than two such spots are more intense than the spot in the chromatogram obtained with solution (5) (0.1%).
Weigh and powder 20 tablets. Shake a quantity of the powder containing 0.25 g of Chlorpropamide with 40 ml of methanol for 20 minutes, add sufficient methanol to produce 50 ml, mix, filter and dilute 5 ml of the filtrate to 100 ml with 0.1m hydrochloric acid. Dilute 10 ml of this solution to 250 ml with 0.1m hydrochloric acid and measure the absorbance of the resulting solution at the maximum at 232 nm, Appendix II B. Calculate the content of C10H13ClN2O3S taking 598 as the value of A(1 cm, 1%) at the maximum at 232 nm.
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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.
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.