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High Quality USP/EP/BP GMP DMF FDA Warfarin Tablets CAS NO 81-81-2 Producer

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  • AZ377
  • Dideu
  • 81-81-2
  • C19H16O4
  • 201-377-6
  • China
  • Warfarin 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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Warfarin Tablets 

Action and use

Vitamin K epoxide reductase inhibitor; oral anticoagulant (coumarin).

Definition

Warfarin Tablets contain Warfarin Sodium or Warfarin Sodium Clathrate.

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

Content of warfarin sodium, C19H15NaO4

95.0 to 105.0% of the stated amount.
Identification

A.  Extract a quantity of the powdered tablets containing the equivalent of 0.1  g of warfarin sodium with 30  ml of water, add 0.1  ml of 2m hydrochloric acid, filter, wash the precipitate with water and dry. Warm the residue gently with 3  ml of ethanol (96%), filter and add the filtrate to 25  ml of water containing 0.1  ml of 2m hydrochloric acid. Filter, wash the precipitate with water and dry it at 105°. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of warfarin (RS 361).


B.  The melting point of the residue obtained in test A is about 159°, Appendix V A.

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 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. For tablets containing 2  mg or less of warfarin sodium, place three tablets in the basket for each test; for tablets containing more than 2  mg of warfarin sodium, place a single tablet in the basket for each test. Withdraw a sample of 10  ml of the medium. Measure the absorbance of a layer of suitable thickness of the filtered sample, suitably diluted if necessary, at the maxima at 307  nm and 360  nm, Appendix II B, and calculate the difference between the two readings (ΔA). Calculate the total content of warfarin sodium, C19H15NaO4, in the medium taking 428 as the value of ΔA(1%, 1  cm).


Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 50  volumes of dichloromethane, 50  volumes of cyclohexane and 20  volumes of glacial acetic acid as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing the equivalent of 40  mg of warfarin sodium with 30  ml of water for 15  minutes, add 0.1  ml of hydrochloric acid and extract with three 10  ml quantities of chloroform, drying each extract with anhydrous sodium sulphate; evaporate the combined extracts using a rotary evaporator at a temperature not exceeding 40° and dissolve the residue in 2  ml of acetone. Solution (2) contains 0.0020% w/v of (E)-4-phenylbut-3-en-2-one in acetone. Solution (3) contains 0.0020% w/v of 4-hydroxycoumarin in acetone. For solution (4) dilute 1  volume of solution (1) to 200  volumes with acetone. After removal of the plate, allow it to dry in air, examine immediately in visible light noting the position of any coloured spots and then examine under ultraviolet light (254  nm), disregarding any spot that was noted in visible light. Any spots corresponding to (E)-4-phenylbut-3-en-2-one and 4-hydroxycoumarin in the chromatogram obtained with solution (1) are not more intense than the spots in the chromatograms obtained with solutions (2) and (3) respectively and any other secondary spot is not more intense than the spot in the chromatogram obtained with solution (4).


Uniformity of content

Tablets containing less than 2  mg of warfarin sodium comply with the requirements stated under Tablets but using in place of the content of active ingredient the individual peak areas obtained by the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solution. Shake one tablet with 10  ml of 0.01m sodium hydroxide for 15  minutes, add 10  ml of a 2% v/v solution of glacial acetic acid in acetonitrile, centrifuge for 10  minutes and use the clear supernatant liquid.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable), (b) a mixture of 55  volumes of acetonitrile, 45  volumes of water and 1  volume of glacial acetic acid as the mobile phase with a flow rate of 2  ml per minute and (c) a detection wavelength of 283  nm.

Assay

Weigh and powder 20  tablets. 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 the equivalent of 5  mg of warfarin sodium with 50  ml of 0.01m sodium hydroxide for 15  minutes, add 50  ml of a 2% v/v solution of glacial acetic acid in acetonitrile, centrifuge for 10  minutes and use the clear supernatant liquid. For solution (2) dilute 5  ml of a 0.010% w/v solution of warfarin BPCRS in 0.01m sodium hydroxide to 10  ml with the mobile phase.


The chromatographic procedure may be carried out using the conditions described under Uniformity of content.


Calculate the content of C19H15NaO4 in the tablets from the chromatogram obtained and using the declared content of C19H16O4 in warfarin BPCRS. Each mg of C19H16O4 is equivalent to 1.071  mg of C19H15NaO4.

Storage

Warfarin Tablets should be protected from light.

Labelling

When the active ingredient is Warfarin Sodium Clathrate the quantity is stated in terms of the equivalent amount of warfarin sodium.




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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