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High Quality USP/EP/BP GMP DMF FDA Tolbutamide Tablets CAS NO 64-77-7 Producer

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  • AZ363
  • Dideu
  • 64-77-7
  • C12H18N2O3S
  • 200-594-3
  • China
  • Tolbutamide Tablets
  • High quality
  • 99.0% Min
  • 99%-101%
  • Tablet
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

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Tolbutamide Tablets 

Action and use

Inhibition of ATP-dependent potassium channels (sulphonylurea); treatment of diabetes mellitus.

Definition

Tolbutamide Tablets contain Tolbutamide.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of tolbutamide, C12H18N2O3S

95.0  to 105.0% of the stated amount.
Identification

Extract a quantity of the powdered tablets containing 1  g of Tolbutamide with 10  ml of chloroform, filter, evaporate the filtrate to dryness, scratching the side of the container, if necessary, to induce crystallisation, and dry the residue at 100° to 105° for 30  minutes. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of tolbutamide (RS 343).

Tests

Related substances

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using as the medium 900  ml of a solution containing 2.04% w/v of disodium hydrogen orthophosphate and 0.135% w/v of potassium dihydrogen orthophosphate and rotating the basket at 100 revolutions per minute. Withdraw a sample of 10  ml of the medium. Measure the absorbance of the filtered sample, suitably diluted if necessary, at the maximum at 228  nm, Appendix II B. Calculate the total content of tolbutamide, C12H18N2O3S, in the medium taking 417 as the value of A(1%, 1  cm) at the maximum at 228  nm.


Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 2  volumes of anhydrous formic acid, 8  volumes of methanol and 90  volumes of chloroform as the mobile phase. Apply separately to the plate 5 µl of each of solutions (1) and (2) and 10 µl of solution (3). For solution (1) shake a quantity of the powdered tablets containing 0.50  g of Tolbutamide with 10  ml of acetone and filter. Solution (2) contains 0.015% w/v of toluene-p-sulphonamide in acetone. Solution (3) is a mixture of equal volumes of solutions (1) and (2). After removal of the plate, dry it in a current of warm air and heat at 110° for 10  minutes. While still hot, place the plate in a chromatography tank with an evaporating dish containing a 5% w/v solution of potassium permanganate, add an equal volume of hydrochloric acid and close the tank. Leave the plate in the tank for 2  minutes, then place it in a current of cold air until the excess of chlorine is removed and an area of coating below the line of application gives at most a very faint blue colour with potassium iodide and starch solution; avoid prolonged exposure to cold air. Spray the plate with potassium iodide and starch solution and allow to stand for 5  minutes. Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.3%). The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.

Assay

Weigh and powder 20  tablets. To a quantity of the powder containing 0.5  g of Tolbutamide add 50  ml of ethanol (96%) previously neutralised to phenolphthalein solution R1, warm to dissolve, add 25  ml of water and titrate with 0.1m sodium hydroxide VS using phenolphthalein solution R1 as indicator. Each ml of 0.1m sodium hydroxide VS is equivalent to 27.03  mg of C12H18N2O3S.




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.

2316

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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