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|Action and use|
Naftidrofuryl Capsules contain Naftidrofuryl Oxalate.
The capsules comply with the requirements stated under Capsules and with the following requirements.
Content of naftidrofuryl oxalate, C26H35NO7
|95.0 to 105.0% of the stated amount.|
A. Shake, with the aid of ultrasound, a quantity of the powdered contents of the capsules containing 0.1 g of Naftidrofuryl Oxalate with 5 ml of water and filter (Whatman GF/C filter paper is suitable). Add 5 ml of 2m sodium hydroxide to the filtrate, extract with two 10 ml quantities of chloroform, wash the combined chloroform extracts with two 10 ml quantities of water, evaporate to dryness using a rotary evaporator and dry the oily residue over phosphorus pentoxide at a pressure of 2 kPa for 18 hours. The infrared absorption spectrum of the oily residue, Appendix II A, is concordant with the reference spectrum of naftidrofuryl (RS 240).
B. Mix a quantity of the powdered contents of the capsules containing 0.25 g of Naftidrofuryl Oxalate with 5 ml of water, shake for 10 minutes and filter. Add calcium chloride solution to the filtrate; a white precipitate is produced. The residue dissolves in mineral acids but is practically insoluble in 2m acetic acid and in 6m ammonia.
Carry out the method for liquid chromatography, Appendix III D, using 20 µl of the following solutions. For solution (1) mix with the aid of ultrasound a quantity of the powdered contents of the capsules with sufficient of the mobile phase to produce a solution containing 0.1% w/v of Naftidrofuryl Oxalate and filter (Whatman GF/C filter paper is suitable). Solution (2) contains 0.001% w/v of 3-(1-naphthyl)-2-tetrahydrofurfurylpropionic acid BPCRS in the mobile phase. Solution (3) contains 0.0002% w/v of 2-diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)propionate oxalate BPCRS in the mobile phase. Solution (4) contains 0.01% w/v of naftidrofuryl oxalate BPCRS and 0.005% w/v of 2-diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)-propionate oxalate BPCRS in the mobile phase.
The chromatographic conditions described under Assay may be used.
The test is not valid unless in the chromatogram obtained with solution (4) the resolution factor between the two principal peaks is at least 4.
Inject solution (1) and record the chromatography for twice the retention time of the principal peak. In the chromatogram obtained with solution (1) the area of any peak corresponding to 3-(1-naphthyl)-2-tetrahydrofurfurylpropionic acid is not greater than the area of the peak in the chromatogram obtained with solution (2) (1%), the area of any peak corresponding to 2-diethylaminoethyl-3-(1-naphthyl)-2-(1-naphthylmethyl)-propionate oxalate is not greater than the area of the peak in the chromatogram obtained with solution (3) (0.2%), the area of any other secondary peak is not greater than half the area of the peak in the chromatogram obtained with solution (3) (0.1%) and the sum of the areas of all the secondary peaks other than those corresponding to the named impurities is not greater than 1.5 times the area of the peak in the chromatogram obtained with solution (3) (0.3%).
Carry out the method for liquid chromatography, Appendix III D, using 20 µl of the following solutions. For solution (1) finely powder the contents of 10 capsules, mix with the aid of a spatula, dissolve with the aid of ultrasound in sufficient of the mobile phase to produce a solution containing 1% w/v of Naftidrofuryl Oxalate, filter (Whatman GF/C filter paper is suitable) and dilute 1 volume of the filtrate to 10 volumes with the mobile phase. Solution (2) contains 0.1% w/v of naftidrofuryl oxalate BPCRS in the mobile phase.
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with particles of silica the surface of which has been modified by chemicallybonded phenyl groups (5 µm) (Spherisorb Phenyl is suitable), (b) a mixture of 40 volumes of 0.05m sodium acetate, adjusted to pH 4.0 with an 85% v/v solution of orthophosphoric acid, and 60 volumes of acetonitrile as the mobile phase with a flow rate of 1 ml per minute and (c) a detection wavelength of 283 nm.
Calculate the content of C26H35NO7 in the capsules using the declared content of C26H35NO7 in naftidrofuryl oxalate BPCRS.
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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.
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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.