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High Quality USP/EP/BP GMP DMF FDA Glibenclamide Tablets CAS NO Producer

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Price: $ 0.08 / Tablet
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min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ177
  • Dideu
  • China
  • Glibenclamide 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

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Glibenclamide Tablets

Action and use

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

DefinitionGlibenclamide Tablets contain Glibenclamide.

Production

The dissolution test below is carried out to demonstrate the appropriate release of Glibenclamide subject to approval from the competent authority.


Prepare a mixture containing 0.8134% w/v of anhydrous disodium hydrogen phosphate and 0.1350% w/v of potassium dihydrogen orthophosphate (solution A).


Carry out the dissolution test for tablets and capsules, Appendix XII B1. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.


test conditions

(a)  Use Apparatus 2 rotating the paddle at 100 revolutions per minute.

(b)  Use 900 ml of solution A at a temperature of 37° as the medium.


procedure

(1)  Withdraw 10  ml of the medium, filter (Minisart GS 25mm filters are suitable) and use the filtrate, discarding the first 5 ml of the filtrate.

(2)  Dissolve glibenclamide BPCRS in the minimum quantity of methanol and dilute to an appropriate concentration with solution A. 


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS is suitable).

(b)  Use isocratic elution using the mobile phase described below.

(c)  Use a flow rate of 1.0 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 225 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

40 volumes of 0.1m potassium dihydrogen orthophosphate previously adjusted to pH 3.0 with orthophosphoric acid and 60 volumes of acetonitrile. 


determination of content

Calculate the total content of glibenclamide, C23H28ClN3O5S, in the medium from the chromatograms obtained and using the declared content of C23H28ClN3O5S in glibenclamide BPCRS. 


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

Content of glibenclamide, C23H28ClN3O5S

95.0 to 105.0% of the stated amount.

Identification

A.  In the Assay, the principal peak in the chromatogram obtained with solution (1) has the same retention time as that of the principal peak in the chromatogram obtained with solution (2).


B.  In the test for Related substances, the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (4).

Tests

Related substances

Carry out the method for thin-layer chromatography , Appendix III A, using the following solutions.


(1)  Extract a quantity of the powdered tablets containing 20  mg of Glibenclamide with four 5-ml quantities of a mixture of 10  volumes of acetone and 20  volumes of dichloromethane , evaporate the combined extracts to dryness at a temperature not exceeding 40° at a pressure of 2  kPa and dissolve the residue in 4  ml of a mixture of equal volumes of chloroform and methanol .

(2)  0.012% w/v of 4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonamide BPCRS in a mixture of equal volumes of chloroform and methanol .

(3)  0.0020% w/v of methyl N-4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonylcarbamate BPCRS in a mixture of equal volumes of chloroform and methanol .

(4)  0.5% w/v of glibenclamide BPCRS in a mixture of equal volumes of chloroform and methanol .


chromatographic conditions

(a)  Use as the coating substance silica gel GF 254 .

(b)  Use the mobile phase described below.

(c)  Apply 10 µl of each solution.

(d)  Develop the plate to 15  cm.

(e)  After removal the plate, dry in air and examine under ultraviolet light (254  nm) .


mobile phase 

5  volumes of ethanol (96%) , 5  volumes of glacial acetic acid , 45  volumes of chloroform and 45  volumes of cyclohexane .


limits

In the chromatogram obtained with solution (1);


any spots corresponding to 4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonamide and methyl N-4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzenesulphonylcarbamate are not more intense than the spots in the chromatograms obtained with solutions (2)(2.4%) and (3)(0.4%) respectively.


Uniformity of content 

Tablets containing 5  mg or less of Glibenclamide comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography , Appendix III D, using the following solutions.


(1)  Powder one tablet, add a mixture of 2  ml of water and 20  ml of methanol , mix with the aid of ultrasound until fully dispersed and filter through a 0.2-µm membrane filter (Anatop LC is suitable).


(2)  Add 2  ml of water to 20  ml of a 0.025% w/v solution of glibenclamide BPCRS in methanol , mix with the aid of ultrasound until fully dispersed and filter (0.2-µm Anatop LC is suitable).


chromatographic conditions

The chromatographic conditions described under Assay may be used.


determination of content

Calculate the content of C23H28ClN3O5S in each tablet using the declared content of C23H28ClN3O5S in glibenclamide BPCRS .

Assay

Weigh and powder 20  tablets. Carry out the method for liquid chromatography , Appendix III D, using the following solutions.


(1)  Mix, with the aid of ultrasound, a quantity of the powdered tablets containing 5  mg of Glibenclamide with a mixture of 2  ml of water and 20  ml of methanol until fully dispersed and filter through a 0.2-µm membrane filter (Anatop LC is suitable).

(2)  Dissolve 50  mg of glibenclamide BPCRS in 10  ml of methanol with the aid of ultrasound for 20  minutes, add sufficient methanol to produce 50  ml and dilute 1  volume of this solution to 4  volumes with methanol . To 20  ml of this solution add 2  ml of water and mix.


chromatographic conditions

(a)  Use a stainless steel column (10  cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS is suitable).

(b)  Use isocratic elution using the mobile phase below.

(c)  Use a flow rate of 1.5 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 300 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

47  volumes of acetonitrile and 53  volumes of a 1.36% w/v solution of potassium dihydrogen orthophosphate previously adjusted to pH 3.0 with orthophosphoric acid .


determination of content

Calculate the content of C23H28ClN3O5S in the tablets using the declared content of C23H28ClN3O5S in glibenclamide BPCRS .




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

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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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