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|Action and use|
Co-danthrusate Capsules contain Dantron and Docusate Sodium in the proportions, by weight, 5 parts to 6 parts.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of dantron, C14H8O4
|90.0 to 110.0% of the stated amount.|
|Content of docusate sodium, C20H37NaO7S||90.0 to 110.0% of the stated amount.|
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Shake a quantity of the contents of the capsules containing 50 mg of Dantron with 10 ml of dichloromethane, filter and dilute 2 ml of the filtrate to 20 ml with dichloromethane.
(2) 0.06% w/v of docusate sodium BPCRS in dichloromethane.
(3) 0.05% w/v of dantron BPCRS in dichloromethane.
(a) Use as the coating silica gel GF254 (Merck silica gel 60 F254 plates are suitable).
(b) Use the mobile phase described below.
(c) Apply 10 µl of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, allow it to dry in air, spray with ethanolic sulphuric acid (10%) and heat at 120° for 15 minutes.
15 volumes of methanol and 85 volumes of ethyl acetate.
The two principal spots in the chromatogram obtained with solution (1) correspond to the principal spots in the chromatograms obtained with solutions (2) and (3).
B. Shake a quantity of the contents of the capsules containing 60 mg of Docusate Sodium with 50 ml of water. To 5 ml of this mixture add 1 ml of 2m sulphuric acid, 10 ml of dichloromethane and 0.2 ml of dimethyl yellow solution and mix; a red colour is produced in the dichloromethane layer. Add 50 mg of cetrimide and mix; the dichloromethane layer is yellow.
C. To a quantity of the contents of the capsules containing 50 mg of Dantron add 10 ml of dichloromethane and 5 ml of 1m ammonia and mix. A red colour is produced in the aqueous layer.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Shake a quantity of the mixed contents of 20 capsules containing 50 mg of Dantron with 20 ml of tetrahydrofuran for 5 minutes and dilute to 100 ml with the mobile phase.
(2) Dilute 1 volume of solution (1) to 50 volumes with the mobile phase.
(3) Dissolve 50 mg of dantron impurity standard BPCRS in 20 ml of tetrahydrofuran and dilute to 100 ml with the mobile phase.
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 ml per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 254 nm.
(f) Inject 20 µl of each solution.
(g) For solution (2) allow the chromatography to proceed for 1.5 times the retention time of the principal peak.
2.5 volumes of glacial acetic acid, 40 volumes of tetrahydrofuran and 60 volumes of water.
The test is not valid unless, in the chromatogram obtained with solution (3):
a peak due to 1-hydroxyanthraquinone appears immediately before the principal peak, as indicated in the reference chromatogram supplied with dantron impurity standard BPCRS;
the height of the trough separating the two peaks is not greater than one third of the height of the peak due to 1-hydroxyanthraquinone.
In the chromatogram obtained with solution (1):
the area of any peak corresponding to 1-hydroxyanthraquinone is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (3.3% taking into account the correction factor for the impurity);
the sum of the areas of any other secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (2%).
Disregard any peak with a retention time less than one third of that of the principal peak.
To a quantity of the mixed contents of 20 capsules containing 35 mg of Dantron add 50 ml of absolute ethanol, heat on a water bath for 30 minutes and cool. Add sufficient absolute ethanol to produce 100 ml and filter through glass-fibre paper (Whatman GF/C is suitable). Dilute 5 ml of the filtrate to 100 ml with absolute ethanol and measure the absorbance of the resulting solution at the maximum at 430 nm, Appendix II B. Calculate the content of C14H8O4 taking 458 as the value of A(1%, 1 cm) at the maximum at 430 nm.
For docusate sodium
To a quantity of the mixed contents of 20 capsules containing 0.3 g of Docusate Sodium add 25 ml of absolute ethanol, heat to 60° for 5 minutes and cool. Add sufficient water to produce 200 ml and filter through glass-fibre paper (Whatman GF/C is suitable). To 25 ml of the filtrate add 10 ml of water and 15 ml of chloroform and titrate with 0.004m benzethonium chloride VS, using dimidium bromide-sulphan blue mixed solution as indicator, to the first appearance of a green colour in the chloroform layer and shaking vigorously towards the end point. Each ml of 0.004m benzethonium chloride VS is equivalent to 1.778 mg of C20H37NaO7S.
The label states the quantities of Dantron and of Docusate Sodium in each capsule.
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.
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:
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.