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High Quality USP/EP/BP GMP DMF FDA Quinidine Sulphate Tablets CAS NO 50-54-4 Producer

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Price: $ 0.08 / Tablet
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  • AZ328
  • Dideu
  • 50-54-4
  • C40H50N4O8S
  • 200-046-3
  • China
  • Quinidine Sulphate 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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Quinidine Sulphate Tablets 

Action and use

Class I antiarrhythmic.

Definition

Quinidine Sulphate Tablets contain Quinidine Sulphate.

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

Content of quinidine sulphate, (C20H24N2O2)2,H2SO4,2H2O

95.0  to 105.0% of the stated amount.

Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel G as the coating substance and a mixture of 10  volumes of diethylamine, 20  volumes of acetone and 80  volumes of toluene as the mobile phase. Apply separately to the plate 2 µl of each of the following solutions. For solution (1) extract a quantity of the powdered tablets containing 0.1  g of Quinidine Sulphate with 10  ml of a mixture of 2  volumes of chloroform and 1  volume of ethanol (96%) and filter. Solution (2) contains 1.0% w/v of quinidine sulphate BPCRS in a mixture of 2  volumes of chloroform and 1  volume of ethanol (96%). Solution (3) contains 1.0% w/v each of quinidine sulphate BPCRS and quinine sulphate BPCRS. After removal of the plate, allow it to dry in air and spray with 0.05m ethanolic sulphuric acid and then with dilute potassium iodobismuthate solution. The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2). The test is not valid unless the chromatogram obtained with solution (3) shows two clearly separated spots.


B.  Shake a quantity of the powdered tablets containing 0.25  g of Quinidine Sulphate with 25  ml of a mixture of 2  volumes of chloroform and 1  volume of ethanol (96%) and filter. Evaporate the filtrate to dryness and wash the residue with 10  ml of ether. Filter, wash the residue with 10  ml of ether and dry the residue at 60° at a pressure not exceeding 15  Pa for 2  hours. The pH of a 1% w/v solution of the residue is 6.0  to 6.8, Appendix V L.


C.  Extract a quantity of the powdered tablets containing 0.1  g of Quinidine Sulphate with 20  ml of water and filter. The filtrate yields the reactions characteristic of sulphates, Appendix VI.


Other cinchona alkaloids

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) mix a quantity of the powdered tablets containing 50  mg of Quinidine Sulphate with 20  ml of the mobile phase. Heat gently to dissolve the powder as completely as possible, cool, dilute to 25  ml with the mobile phase and filter, discarding the first few ml of filtrate. For solution (2) dissolve 20  mg of quinine sulphate BPCRS, with gentle heating if necessary, in 5  ml of the mobile phase and dilute to 10  ml with the mobile phase. Prepare solution (3) in the same manner as solution (2) but using quinidine sulphate BPCRS in place of quinine sulphate BPCRS. Solution (4) is a mixture of equal volumes of solutions (2) and (3). For solution (5) dilute 1  volume of solution (2) to 10  volumes with the mobile phase and dilute 1  volume of the resulting solution to 50  volumes with the mobile phase. Solution (6) contains 0.10% w/v of thiourea in the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS 5 µm is suitable), (b) as the mobile phase with a flow rate of 1.5  ml per minute a solution prepared by dissolving 6.8  g of potassium dihydrogen orthophosphate and 3.0  g of hexylamine in 700  ml of water, adjusting the pH to 2.8 with 1m orthophosphoric acid, adding 60  ml of acetonitrile and diluting to 1000  ml with water and (c) a detection wavelength of 250  nm for recording the chromatogram obtained with solution (6) and 316  nm for the other solutions.


Inject separately 10 µl of each of solutions (3) and (6). If necessary, adjust the concentration of acetonitrile in the mobile phase so that in the chromatogram obtained with solution (3) the capacity factor of the peak due to quinidine is 3.5  to 4.5, V0 being calculated from the peak due to thiourea in the chromatogram obtained with solution (6). Inject 10 µl of each of solutions (2), (3), (4) and (5). The chromatogram obtained with solution (2) shows a principal peak due to quinine and a peak due to dihydroquinine with a retention time relative to quinine of about 1.4. The chromatogram obtained with solution (3) shows a principal peak due to quinidine and a peak due to dihydroquinidine, with a retention time relative to quinidine of about 1.2. The chromatogram obtained with solution (4) shows four peaks due to quinine, dihydroquinine, quinidine and dihydroquinidine which are identified by comparison of their retention times with those of the corresponding peaks in the chromatograms obtained with solutions (2) and (3).


The test is not valid unless (a) in the chromatogram obtained with solution (4) the resolution factor between the peaks due to quinine and quinidine is at least 1.5 and the resolution factor between the peaks due to dihydroquinidine and quinine is at least 1.0 and (b) the signal-to-noise ratio of the principal peak in the chromatogram obtained with solution (5) is at least 5.


Inject 10 µl of solution (1) and allow the chromatography to proceed for 2.5  times the retention time of the principal peak. Calculate the percentage content of related substances by normalisation, disregarding any peaks the areas of which are less than that of the peak in the chromatogram obtained with solution (5) (0.2%). The content of dihydroquinidine is not greater than 15%, the content of any related substance eluting before quinidine is not greater than 5% and the content of any other related substance is not greater than 2.5%.

Assay

Weigh and powder 20  tablets. Dissolve as completely as possible using heat a quantity of the powdered tablets containing 0.4  g of Quinidine Sulphate in 40  ml of acetic anhydride and carry out Method I for non-aqueous titration, Appendix VIII A, using crystal violet solution as indicator. Each ml of 0.1m perchloric acid VS is equivalent to 26.10  mg of (C20H24N2O2)2,H2SO4,2H2O.


Storage

Quinidine Sulphate Tablets should be protected from light.




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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