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High Quality USP/EP/BP GMP DMF FDA Metformin Tablets CAS NO 657-24-9 Producer

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Price: $ 0.08 / Tablet
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  • AZ221
  • Dideu
  • 657-24-9
  • C4H11N5
  • 211-517-8
  • China
  • Metformin 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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Metformin Tablets 

Action and use

Biguanide; treatment of diabetes mellitus.

Definition

Metformin Tablets contain Metformin Hydrochloride. They are coated.

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

Content of metformin hydrochloride, C4H11N5,HCl

95.0  to 105.0% of the stated amount.
Identification

Shake a quantity of the powdered tablets containing 20 mg of Metformin Hydrochloride with 20 ml of absolute ethanol , filter, evaporate the filtrate to dryness on a water bath and dry the residue at 105° for 1 hour. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of metformin hydrochloride (RS 217).

Tests

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 0.68% w/v solution of potassium dihydrogen orthophosphate adjusted to pH 6.8 by the addition of 1m sodium hydroxide and rotating the basket at 100 revolutions per minute. Withdraw a sample of 10  ml of the medium. Filter, dilute 10  ml of the filtrate to 100  ml with water and dilute 10  ml of the resulting solution to 100  ml with water. Measure the absorbance of a layer of suitable thickness of the filtered sample, suitably diluted if necessary, at the maximum at 233  nm, Appendix II B. Calculate the total content of metformin hydrochloride, C4H11N5,HCl, in the medium taking 806 as the value of A (1%, 1  cm) at the maximum at 233  nm.


1-Cyanoguanidine

Carry out the method for liquid chromatography , Appendix III D, using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 0.50 g of Metformin Hydrochloride with 100 ml of the mobile phase, filter and use the filtrate. For solution (2) dissolve 20 mg of 1-cyanoguanidine in water, dilute to 100 ml with water and dilute 1 ml of the resulting solution to 200 ml with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5 cm × 4.6 mm) packed with a regular, porous silica gel to which benzene sulphonic acid groups have been chemically bonded (5 µm) (Partisphere 5 µ SCX is suitable), (b) a 1.7% w/v solution of ammonium dihydrogen orthophosphate adjusted to pH 3.0 with orthophosphoric acid as the mobile phase with a flow rate of 1 ml per minute and (c) a detection wavelength of 218 nm.


Inject 20 µl of solution (2). Adjust the sensitivity of the system so that the height of the principal peak in the chromatogram obtained is not less 50% of the full scale of the recorder.


Inject separately 20 µl of solutions (1) and (2). In the chromatogram obtained with solution (1) the area of any peak corresponding to 1-cyanoguanidine is not greater than the area of the peak in the chromatogram obtained with solution (2) (0.02%).

Assay

Weigh and powder 20  tablets. Shake a quantity of the powder containing 0.1  g of Metformin Hydrochloride with 70  ml of water for 15  minutes, dilute to 100  ml with water and filter, discarding the first 20  ml. Dilute 10  ml of the filtrate to 100  ml with water and dilute 10  ml of the resulting solution to 100  ml with water. Measure the absorbance of the resulting solution at the maximum at 232  nm, Appendix II B. Calculate the content of the C4H11N5,HCl taking 798 as the value of A(1%, 1  cm) at the maximum at 232  nm.




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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