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High Quality USP/EP/BP GMP DMF FDA Fluoxetine Capsules CAS NO 54910-89-3 Producer

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  • AZ420
  • Dideu
  • 54910-89-3
  • C17H18F3NO
  • 611-209-7
  • China
  • Fluoxetine 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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Fluoxetine Capsules 

Action and use

Selective serotonin reuptake inhibitor; antidepressant.

Definition

Fluoxetine Capsules contain Fluoxetine Hydrochloride.


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

Content of fluoxetine, C17H18F3NO

95.0  to 105.0% of the stated amount.
Identification

A.  Extract a quantity of the contents of the capsules containing the equivalent of 20  mg of fluoxetine with 10  ml of methanol, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of fluoxetine hydrochloride (RS 385).


B.  In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal 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 0.1m hydrochloric acid and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 20  ml of the medium and filter, discarding the first 5  ml of filtrate. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare a mixture of 250  volumes of acetonitrile and 1  volume of diethylamine, mix well and adjust the apparent pH to 3.5 with orthophosphoric acid (solution A); a white precipitate may form, keep the mixture well stirred. For solution (1) add to 5  ml of filtered medium 2  ml of solution A and mix well. For solution (2) add to 5  ml of a 0.0022% w/v solution of fluoxetine hydrochloride BPCRS 2  ml of solution A and mix well.


The chromatographic procedure may be carried out using (a) a stainless steel column (15  cm × 4.6  mm) packed with particles of silica the surface of which has been modified with chemically-bonded cyano groups (5 µm) (Zorbax CN is suitable), (b) as the mobile phase at a flow rate of 2  ml per minute a mixture of 4  volumes of diethylamine, 400  volumes of acetonitrile and 600  volumes of water, the mixture adjusted to pH 3.5 with orthophosphoric acid and (c) a detection wavelength of 226  nm.


Inject 50 µl of each solution. Calculate the content of C17H18F3NO in the medium from the chromatograms obtained using the declared content of C17H18F3NO,HCl in fluoxetine hydrochloride BPCRS and taking each mg of C17H18F3NO,HCl to be equivalent to 0.8944  mg of C17H18F3NO.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dissolve a quantity of the contents of the capsules containing the equivalent of 20  mg of fluoxetine in sufficient of the mobile phase to produce 10  ml, filter and use the filtrate, discarding the first 2  ml. Solution (2) contains 0.001% w/v of fluoxetine hydrochloride 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 cyanosilyl silica gel for chromatography (5 µm) (DuPont Zorbax SB-CN is suitable), (b) as the mobile phase with a flow rate of 1  ml per minute a mixture of 35  volumes of acetonitrile and 65  volumes of a solution containing 1  volume of triethylamine and 99  volumes of water, and adjusting the pH to 6.0 with orthophosphoric acid and (c) a detection wavelength of 215  nm. If necessary, adjust the composition of the mobile phase so that, in the chromatogram obtained with solution (2), the retention time of the peak due to fluoxetine is between 10 and 20  minutes.


Inject 10 µl of each solution and for solution (1) allow the chromatography to proceed for twice the retention time of the peak due to fluoxetine hydrochloride.


In the chromatogram obtained with solution (1), the area of any secondary peak is not greater than half the area of the peak in the chromatogram obtained with solution (2) (0.25%), the area of not more than two such peaks is greater than 0.2  times the area of the peak in the chromatogram obtained with solution (2) (0.1%) and the sum of the areas of all the secondary peaks is not greater than 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) dissolve a quantity of the mixed contents of 20 capsules containing the equivalent of 20  mg of fluoxetine in sufficient of the mobile phase to produce 200  ml, filter and use the filtrate, discarding the first 2  ml. Solution (2) contains 0.011% w/v of fluoxetine hydrochloride BPCRS in the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (7.5  cm × 4.6  mm) packed with end-capped octylsilyl silica gel for chromatography (3.5 µm) (DuPont Zorbax RX-C8 is suitable), (b) as the mobile phase with a flow rate of 1  ml per minute a mixture of 33  volumes of a solution containing 0.3% w/v of glacial acetic acid and 0.64% w/v of sodium pentanesulphonate, adjusted to pH 5.0 with 5m sodium hydroxide, and 67  volumes of methanol and (c) a detection wavelength of 227  nm.


Inject solution (2) six times. The assay is not valid unless the relative standard deviation of the area of the principal peak is at most 2.0%.


Inject solutions (1) and (2). Calculate the content of C17H18F3NO in the capsules from the chromatograms obtained using the declared content of C17H18F3NO,HCl in fluoxetine hydrochloride BPCRS and taking each mg of C17H18F3NO,HCl to be equivalent to 0.8944  mg of C17H18F3NO.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of fluoxetine.

Impurities

The impurities limited by the requirements of this monograph include impurities A and B listed under Fluoxetine Hydrochloride.




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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