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High Quality USP/EP/BP GMP DMF FDA Prolonged-release Ibuprofen Capsules CAS NO 15687-27-1 Producer

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Price: $ 0.08 / pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ452
  • Dideu
  • 15687-27-1
  • C13H18O2
  • 239-784-6
  • China
  • Prolonged-release Ibuprofen 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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Prolonged-release Ibuprofen Capsules 

Definition

Prolonged-release Ibuprofen Capsules contain Ibuprofen. They are formulated so that the medicament is released over a period of several hours.

Production

A suitable dissolution test is carried out to demonstrate the appropriate release of Ibuprofen. The dissolution profile reflects the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.


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

Content of ibuprofen, C13H18O2 

95.0  to 105.0% of the stated amount.
Identification

Extract a quantity of the capsule contents containing 0.5  g of Ibuprofen with 20  ml of acetone , filter and evaporate the filtrate to dryness in a current of air without heating. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ibuprofen (RS 186) .

Tests

Related substances

Carry out the method for liquid chromatography , Appendix III D, using the following solutions.


(1)  Dissolve a quantity of the capsule contents containing 20  mg of Ibuprofen in 2 ml of acetonitrile for chromatography and add sufficient mobile phase A to produce 10  ml.

(2)  Dilute 1 volume of solution (1) to 100 volumes with mobile phase A.

(3)  Dissolve 20 mg of ibuprofen BPCRS in 2 ml of acetonitrile for chromatography , add 1 ml of a 0.006% w/v solution of ibuprofen impurity B EPCRS in acetonitrile for chromatography , then add sufficient mobile phase A to produce 10 ml.


chromatographic conditions

(a)  Use stainless steel column (15 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 2 is suitable).

(b)  Use gradient elution and the mobile phases described below.

(c)  Use a flow rate of 2 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 214 nm.

(f)  Inject 20 µl of each solution.

(g)  Equilibrate the column with mobile phase A for about 45 minutes.


mobile phase 

Mobile phase A   0.5 volume of orthophosphoric acid , 340 volumes of acetonitrile for chromatography and 600 volumes of water. Allow to equilibrate and add sufficient water to produce 1000 ml. 


Mobile phase B   acetonitrile. 


1104-0925

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the peak-to-valley ratio between the peaks due to ibuprofen and ibuprofen impurity B is not less than 1.5.


limits

In the chromatogram obtained with solution (1):


the area of the peak corresponding to ibuprofen impurity B is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.3%);


the area of any other secondary peak is not greater than 0.3 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);


the sum of the area of any secondary peaks , other than the peak due to impurity B, is not greater than 0.7 time the area of the principal peak in the chromatogram obtained with solution (2) (0.7%).


Disregard any peak with an area less than 0.05 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).

Assay

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 0.2 g of Ibuprofen in 30 ml of mobile phase for 30 minutes. Add sufficient mobile phase to produce 100 ml and mix. Centrifuge an aliquot of the suspension at 2500 g for 5 minutes and use the supernatant liquid.

(2)  0.2% w/v of ibuprofen BPCRS in mobile phase.


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Nucleosil C18 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1.5 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 264 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

3  volumes of orthophosphoric acid , 247  volumes of water and 750  volumes of methanol. 


determination of content

Calculate the content of C13H18O2 in the capsules using the declared content of C13H18O2 in ibuprofen BPCRS .

Impurities

The impurities limited by the requirements of this monograph include:


1. (2RS)-2-(4-butylphenyl)propanoic acid (Ibuprofen Impurity B).




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

IV)Environmental Friendly Chemical And Chemurgy Industries

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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