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High Quality USP/EP/BP GMP DMF FDA Fenbufen Capsules CAS NO 36330-85-5 Producer

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  • AZ417
  • Dideu
  • 36330-85-5
  • C16H14O3
  • 252-979-0
  • China
  • Fenbufen Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Fenbufen Capsules 

Action and use

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.

Definition

Fenbufen Capsules contain Fenbufen.


The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of fenbufen, C16H14O3

95.0  to 105.0% of the stated amount.
Identification

A.  To a quantity of the contents of the capsules containing 0.9  g of fenbufen add 10  ml of acetone, triturate using a glass pestle, filter through filter paper wetted with acetone into 100  ml of petroleum spirit (boiling point, 40° to 60°), stir rapidly with a glass rod to induce crystallisation and allow to stand for 15  minutes. Filter through a fine porosity sintered-glass funnel, rinse the crystals with 25  ml of petroleum spirit (boiling point, 40° to 60°), remove the solvent under reduced pressure and dry the crystals at 105° for 15  minutes. The infrared absorption spectrum of the dried crystals, Appendix II A, is concordant with the reference spectrum of fenbufen (RS 140).


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

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900  ml of a phosphate buffer prepared by dissolving 6.69  g of potassium dihydrogen orthophosphate and 1.63  g of sodium hydroxide in sufficient water to produce 1000  ml, adjusting the pH to 7.5 with 5m sodium hydroxide if necessary, and rotate the paddle at 100 revolutions per minute. Withdraw a sample of 10  ml of the medium, filter (Whatman 541 paper is suitable) and dilute 1  ml of the filtrate to 50  ml with the dissolution medium. Measure the absorbance of this solution, Appendix II B, at 285  nm using dissolution medium in the reference cell. Measure the absorbance of a suitable solution of fenbufen BPCRS prepared by dissolving 50  mg in 50  ml of methanol and diluting to a suitable volume with the dissolution medium and using dissolution medium in the reference cell. Calculate the total content of fenbufen, C16H14O3 in the medium from the absorbances obtained and from the declared content of C16H14O3 in fenbufen BPCRS.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add to a quantity of the contents of the capsules containing 0.25  g of fenbufen 20  ml of dimethylformamide, mix with the aid of ultrasound for 20  minutes, dilute to 50  ml with the initial mobile phase and filter (Whatman GF/F paper is suitable). For solution (2) dilute 1  volume of solution (1) to 100  volumes with the initial mobile phase and further dilute 1  volume of this solution to 10  volumes with the initial mobile phase. Solution (3) contains 0.0025% w/v of fenbufen BPCRS and 0.0006% w/v of 3-(4-chlorobenzoyl)propionic acid.


The chromatographic procedure may be carried out using a stainless steel column (10  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 2 is suitable). Use as the initial mobile phase a mixture of 32  volumes of acetonitrile and 68  volumes of a solution consisting of 1  volume of glacial acetic acid and 55  volumes of water and as the final mobile phase a mixture of 45  volumes of acetonitrile and 55  volumes of a solution consisting of 1  volume of glacial acetic acid and 55  volumes of water. Maintain the initial mobile phase for 15  minutes, carry out a linear gradient elution with a flow rate of 2  ml per minute for 5  minutes and maintain the final mobile phase for 15  minutes with the same flow rate. Use a detection wavelength of 254  nm.


The test is not valid unless in the chromatogram obtained with solution (3) the resolution factor between the two principal peaks is at least 10.


In the chromatogram obtained with solution (1) the area of any secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.1%) and the sum of the areas of any such peaks is not greater than five times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add to a quantity of the mixed contents of 20 capsules containing 0.1  g of fenbufen 30  ml of methanol, mix with the aid of ultrasound for 15  minutes, add sufficient of the mobile phase to produce 100  ml and dilute 1  volume of this solution to 10  volumes with the mobile phase. For solution (2) dissolve fenbufen BPCRS in methanol, add sufficient of the mobile phase to produce a 0.1% w/v solution and dilute 1  volume of this solution to 10  volumes with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (30  cm × 3.9  mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (µBondapak C18 is suitable), maintained about 40°, (b) a mixture of 1  volume of glacial acetic acid, 44  volumes of acetonitrile and 55  volumes of water as the mobile phase with a flow rate of 1.5  ml per minute and (c) a detection wavelength of 280  nm.


Calculate the content of C16H14O3 in the capsules using the declared content of C16H14O3 in fenbufen BPCRS.




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.

Capsules 1CapsulesCapsules 106

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:


I)Pharmaceutical Industries

II)Nutrition Additive Industries

III)Daily-Use Chemical Products Industries & Agrochemicals

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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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