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|Action and use||Vitamin K epoxide reductase inhibitor; oral anticoagulant.|
Acenocoumarol Tablets contain Acenocoumarol.
The tablets comply with the requirements stated under Tablets and with the following requirements.
|Content of acenocoumarol, C19H15NO6|
92.5 to 107.5% of the stated amount.
A. Heat a quantity of the powdered tablets containing 50 mg of Acenocoumarol with 30 ml of acetone under a reflux condenser for 5 minutes, filter and wash the residue with two 10 ml quantities of acetone. Evaporate the combined filtrate and washings to 5 ml, add water drop wise until the solution becomes turbid, heat on a water bath until the solution is clear and allow to stand. Filter, wash the crystals with a mixture of equal volumes of acetone and water and dry at 100° at a pressure of 2 kPa for 30 minutes. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of acenocoumarol (RS 001).
B. The light absorption, Appendix II B, of the final solution obtained in the Assay exhibits maxima at 283 nm and 306 nm.
C. Heat 25 mg of the residue obtained in test A with 2.5 ml of glacial acetic acid, 0.5 ml of hydrochloric acid and 0.2 g of zinc powder on a water bath for 5 minutes, cool and filter. To the filtrate add 0.05 ml of sodium nitrite solution and add the mixture to 10 ml of a 1% w/v solution of 2-naphthol containing 3 ml of 5m sodium hydroxide. A bright red precipitate is produced.
Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 20 volumes of glacial acetic acid, 50 volumes of chloroform and 50 volumes of cyclohexane 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 20 mg of Acenocoumarol with 5 ml of acetone, centrifuge and use the supernatant liquid. For solution (2) dilute 1 volume of solution (1) to 200 volumes with acetone. After removal of the plate, allow it to dry in air and immediately examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%).
Uniformity of content
Tablets containing 4 mg or less of Acenocoumarol comply with the requirements stated under Tablets using the following method of analysis. Finely crush one tablet, add 30 ml of methanol, stir the mixture for 30 minutes and filter through sintered glass, washing the residue with three 15 ml quantities of methanol. To the combined filtrate and washings add 10 ml of 1m hydrochloric acid and sufficient methanol to produce 100 ml. If necessary dilute further with a solvent prepared by diluting 1 volume of 1m hydrochloric acid to 10 volumes with methanol to produce a solution containing about 0.001% w/v of Acenocoumarol. Measure the absorbance of the resulting solution at the maximum at 306 nm, Appendix II B. Calculate the content of C19H15NO6 taking 521 as the value of A (1%, 1 cm) at the maximum at 306 nm.
Weigh and powder 20 tablets. To a quantity of the powder containing 1 mg of Acenocoumarol add 30 ml of methanol, stir the mixture for 30 minutes and filter through sintered glass, washing the residue with three 15 ml quantities of methanol. To the combined filtrate and washings add 10 ml of 1m hydrochloric acid and sufficient methanol to produce 100 ml and measure the absorbance of the resulting solution at the maximum at 306 nm, Appendix II B. Calculate the content of C19H15NO6 taking 521 as the value of A (1%, 1 cm) at the maximum at 306 nm.
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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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.