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High Quality USP/EP/BP GMP DMF FDA Ketoprofen Capsules CAS NO 22071-15-4 Producer

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  • AZ432
  • Dideu
  • 22071-15-4
  • C16H14O3
  • 244-759-8
  • China
  • Ketoprofen 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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Ketoprofen Capsules 

Action and use

Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.


Ketoprofen Capsules contain Ketoprofen.

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

Content of ketoprofen, C16H14O3 

92.5  to 107.5% of the stated amount.

Shake a quantity of the contents of the capsules containing 0.5  g of Ketoprofen with 50  ml of chloroform for 5  minutes, filter, evaporate to dryness using a rotary evaporator and induce crystallisation by prolonged scratching of the side of the container with a glass rod. The infrared absorption spectrum of the crystals, Appendix II A, is concordant with the reference spectrum of ketoprofen (RS 198) .



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 1.46  g of potassium dihydrogen orthophosphate and 20.06  g of disodium hydrogen orthophosphate in sufficient water to produce 1000  ml, adjusting the pH to 7.5 if necessary with orthophosphoric acid , and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10  ml of the medium, filter and dilute the filtrate with sufficient of the dissolution medium to give a solution expected to contain about 0.001% w/v of Ketoprofen. Measure the absorbance of this solution, Appendix II B, at the maximum at 260  nm using dissolution medium in the reference cell. Calculate the total content of ketoprofen, C16H14O3, in the medium taking 662 as the value of A(1%, 1  cm) at the maximum at 260  nm.

Related substances

Protect the solutions from light. Carry out the method for liquid chromatography , Appendix III D, using the following freshly prepared solutions. For solution (1) shake a quantity of the contents of the capsules containing 0.1  g of Ketoprofen with 100  ml of a mixture of 40  volumes of acetonitrile and 60  volumes of water (solvent A), filter and use the filtrate. For solution (2) dilute 1  volume of solution (1) to 50  volumes with solvent A and further dilute 1  volume to 10  volumes with solvent A. Solution (3) contains 0.0002% w/v of impurity C EPCRS (2-(3-carboxyphenyl)propionic acid) in solvent A. Solution (4) contains 0.0003% w/v of impurity A EPCRS (3-acetyl-benzophenone) in solvent A. For solution (5) dilute 1  volume of solution (1) to 100  volumes with solvent A; to 1  ml add 1  ml of solution (4).

The chromatographic procedure may be carried out using (a) a stainless steel column (15  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable), (b) a mixture of 2  volumes of freshly prepared phosphate buffer pH 3.5 , 43  volumes of acetonitrile and 55  volumes of water as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 233  nm.

Inject 20 µl of solution (5). The test is not valid unless the resolution factor between the peaks due to ketoprofen and 3-acetylbenzophenone is at least 7.

Inject separately 20 µl of solutions (1) to (4). Allow the chromatography to proceed for seven times the retention time of ketoprofen. In the chromatogram obtained with solution (1) the area of any peak corresponding to 2-(3-carboxyphenyl)propionic acid is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.2%), the area of any peak corresponding to 3-acetylbenzophenone is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (0.3%), the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%) and the sum of the areas of all the secondary peaks other than those due to the two named impurities is not greater than 2.5  times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%). Disregard any peak with an area less than 0.1  times the area of the principal peak in the chromatogram obtained with solution (2) (0.02%).


Shake a quantity of the mixed contents of 20 capsules containing 50  mg of Ketoprofen for 10  minutes with 300  ml of methanol (75%), mix and dilute to 500  ml with methanol (75%). Allow to stand, dilute 5  ml of the supernatant liquid to 100  ml with methanol (75%) and measure the absorbance of the resulting solution at the maximum at 258  nm, Appendix II B. Calculate the content of C16H14O3  taking 662 as the value of A(1%, 1  cm) at the maximum at 258  nm.

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

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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.

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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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