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Tranexamic Acid Tablets
|Action and use|
Tranexamic Acid Tablets contain Tranexamic Acid.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of tranexamic acid, C8H15NO2
|95.0 to 105.0% of the stated amount.|
Shake a quantity of the powdered tablets containing 0.5 g of Tranexamic Acid with 5 ml of water for 15 minutes, filter and add 2 ml of ether to the filtrate. Stir, add 10 ml of methanol, stir again and allow to crystallise. The crystals, after drying, comply with the following tests.
A. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of tranexamic acid (RS 344).
B. To 1 ml of a 1% w/v solution add 1 ml of a 0.2% w/v solution of ninhydrin in ethanol (96%) and heat on a water bath for 2 minutes. A dark bluish violet colour is produced.
C. Dissolve 0.2 g in 10 ml of 5m sodium hydroxide, add 0.2 ml of benzoyl chloride and shake vigorously for 10 minutes. Acidify to pH 4 with 2m hydrochloric acid, filter, wash the residue with 5 ml of ether and dry at 50° at a pressure of 2 kPa. The melting point of the residue is about 186°, Appendix V A.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Shake a quantity of the powdered tablets containing 1 g of Tranexamic Acid with 100 ml of water for 10 minutes, filter and use the filtrate.
(2) 0.01% w/v of tranexamic acid EPCRS in water.
(3) 0.001% w/v of tranexamic acid impurity C EPCRS in water.
(4) 0.001% w/v of 4-aminomethylbenzoic acid in water.
(5) 1% w/v of tranexamic acid impurity standard BPCRS in water.
(a) Stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography R (5 µm) (Hypersil is suitable).
(b) Isocratic elution using the mobile phase described below.
(c) Flow rate of 0.9 ml per minute.
(d) Ambient column temperature.
(e) Detection wavelength of 220 nm.
(f) Injection volume of 20 µl.
Dissolve 11.0 g of anhydrous sodium dihydrogen orthophosphate in 500 ml of water, add 5 ml of triethylamine and 1.4 g of sodium dodecyl sulphate, adjust the pH to 2.5 with 2m orthophosphoric acid and add sufficient water to produce 600 ml. Add 400 ml of methanol and mix
Inject solution (1) and allow the chromatography to proceed for 3 times the retention time of tranexamic acid (about 13 minutes). Identify the impurities from the chromatogram obtained with solution (5) and from the reference chromatogram supplied with tranexamic acid impurity standard BPCRS.
The test is not valid unless the chromatogram obtained with solution (5) closely resembles the reference chromatogram supplied with tranexamic acid impurity standard BPCRS and the resolution factor between the peaks corresponding to tranexamic acid and impurity C is at least 2.0.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%);
the area of any peak corresponding to impurity B is not greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);
the area of any peak corresponding to impurity C is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.1%);
the area of any peak corresponding to impurity D is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.1%);
the area of any other secondary peak is not greater than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).
Weigh and powder 20 tablets. Dissolve a quantity of the powdered tablets containing 0.25 g of Tranexamic Acid in 50 ml of anhydrous acetic acid 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 15.72 mg of C8H15NO2.
The impurities limited by the requirements of this monograph include those listed in the monograph for Tranexamic Acid.
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.
a) Free sample can be supplied.
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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:
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.