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

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  • AZ602
  • Dideu
  • 81-81-2
  • C19H16O4
  • 201-377-6
  • China
  • Oral Suspension
  • High quality
  • 99.0% Min
  • 99%-101%
  • Oral Suspension
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Warfarin Oral Suspension 

Action and use

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

Definition

Warfarin Oral Suspension is a suspension of Warfarin Sodium in a suitable flavoured vehicle.

The oral suspension complies with the requirements stated under Oral Liquids, the requirements stated under Unlicensed Medicines and with the following requirements.

Content of warfarin sodium, C19H15NaO4 

95.0 to 105.0% of the stated amount.

Identification

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

Tests

Related substances

Tests

Acidity

pH, 2.7 to 4.0, Appendix V L.

Dissolution 

Complies with the requirements stated under Unlicensed Medicines, Oral Suspensions, using 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 as the dissolution medium and rotating the paddle at 100 revolutions per minute. Use a volume of the oral suspension containing one dose.

Related substances 

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1)  To a quantity of the oral suspension containing 10 mg of Warfarin Sodium add 30 ml of acetonitrile and mix; add 50 ml of water, mix with the aid of ultrasound for 10 minutes and allow the solution to cool to room temperature. Add sufficient water to produce 100 ml, mix and filter through a 0.45-µm cellulose acetate filter (GD/X is suitable).

(2)  Dissolve 10 mg of 4-hydroxycoumarin (warfarin impurity B) in 50 ml of acetonitrile and add sufficient water to produce 100 ml. Dilute 1 volume of this solution to 10 volumes with a mixture containing 30 volumes of acetonitrile and 70 volumes of water and further dilute 1 volume to 10 volumes with the same mixture of solvents.

(3)  Dissolve 10 mg of benzalacetone (warfarin impurity C) in 50 ml of acetonitrile and add sufficient water to produce 100 ml. Dilute 1 volume of this solution to 10 volumes with a mixture containing 30 volumes of acetonitrile and 70 volumes of water and further dilute 1 volume to 10 volumes with the same mixture of solvents.

(4)  Dissolve 10 mg of (5RS)-3-(2-hydroxyphenyl)-5-phenylcyclohex-2-enone BPCRS (warfarin impurity A) in 50 ml of acetonitrile and add sufficient water to produce 100 ml. Dilute 1 volume of this solution to 10 volumes with a mixture containing 30 volumes of acetonitrile and 70 volumes of water and further dilute 1 volume to 10 volumes with the same mixture of solvents.

(5)  Dissolve 80 mg of benzoic acid in 50 ml of acetonitrile and add sufficient water to produce 100 ml. Dilute 1 volume of this solution to 10 volumes with a mixture containing 30 volumes of acetonitrile and 70 volumes of water and further dilute 1 volume to 10 volumes with the same mixture of solvents.

(6)  Mix equal volumes of solution (2) and solution (5).

chromatographic conditions

(a)  Use a stainless steel column (15 cm × 4.6 mm) packed with phenylhexylsilyl silica gel for chromatography (5 µm) (Phenomenex Luna Phenyl-Hexyl is suitable) fitted with a stainless steel guard column (4 mm × 3 mm) packed with octadecylsilyl silica gel for chromatography. 

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

(c)  Use a flow rate of 2 ml per minute.

(d)  Use a column temperature of 35°.

(e)  Use a detection wavelength of 283 nm.

(f)  Inject 50 µl of each solution.

When the chromatograms are recorded under the prescribed conditions the retention time of warfarin is about 19 minutes.

mobile phase

1 volume of acetic acid, 50 volumes of methanol and 50 volumes of water.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (6), the resolution factor between the peaks corresponding to 4-hydroxycoumarin and benzoic acid is at least 1.5. 

limits 

In the chromatogram obtained with solution (1):

the area of any peaks corresponding to 4-hydroxycoumarin, benzalacetone and (5RS)-3-(2-hydroxyphenyl)-5-phenylcyclohex-2-enone are not greater than half the area of the principal peaks in the chromatograms obtained with solutions (2), (3) and (4) respectively (0.5% of each);

the area of any other secondary peak is not greater than 0.2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);

Disregard any peak corresponding to the peak in the chromatogram obtained with solution (5).  

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1)  To a weighed quantity of the oral suspension containing 10 mg of Warfarin Sodium add 30 ml of acetonitrile and mix; add 50 ml of water, mix with the aid of ultrasound for 10 minutes and allow the solution to cool to room temperature. Add sufficient water to produce 100 ml, mix and filter through a 0.45-µm cellulose acetate filter (GD/X is suitable).

(2)  Dissolve 0.1 g of warfarin sodium BPCRS in 100 ml of a mixture of equal volumes of acetonitrile and water and then dilute 10 volumes of this solution to 100 volumes with a mixture containing 30 volumes of acetonitrile and 70 volumes of water.

chromatographic conditions

(a)  Use a stainless steel column (15 cm × 4.6 mm) packed with phenylhexylsilyl silica gel for chromatography (5 µm) (Phenomenex Luna Phenyl-Hexyl is suitable) fitted with a stainless steel guard column (4 mm × 3 mm) packed with octadecylsilyl silica gel for chromatography. 

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

(c)  Use a flow rate of 2 ml per minute.

(d)  Use a column temperature of 35°.

(e)  use a detection wavelength of 283 nm.

(f)  Inject 50 µl of each solution.

mobile phase

1 volume of acetic acid, 50 volumes of methanol and 50 volumes of water.

determination of content

Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of C19H15NaO4, weight in volume, using the declared content of C19H15NaO4 in warfarin sodium BPCRS.

StorageWarfarin Oral Suspension 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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

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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

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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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