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High Quality USP/EP/BP GMP DMF FDA Ondansetron Tablets CAS NO 99614-02-5 Producer

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  • AZ256
  • Dideu
  • 99614-02-5
  • C18H20ClN3O
  • 619-449-4
  • China
  • Ondansetron Tablets
  • High quality
  • 99.0% Min
  • 99%-101%
  • Tablet
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Ondansetron Tablets 

Action and use

Serotonin 5HT3 antagonist; treatment of nausea and vomiting.

Definition

Ondansetron Tablets contain Ondansetron Hydrochloride Dihydrate. They are coated.

The tablets comply with the requirements stated under Tablets and with the following requirements. 

Content of ondansetron, C18H19N3O

95.0 to 105.0% of the stated amount.
Identification

Shake a quantity of the powdered tablets containing the equivalent of 30  mg of ondansetron with 20 ml of acetonitrile, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ondansetron hydrochloride (RS 419).

Tests

Related substances

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 500 ml of water, at a temperature of 37 º, as the medium.


procedure

(1)  After 45 minutes, withdraw a 10 ml sample of the medium, and measure the absorbance of the filtered sample, suitably diluted with the dissolution medium if necessary, at the maximum at 310 nm, Appendix II B, using water in the reference cell.

(2)  Measure the absorbance of a 0.01% w/v solution of ondansetron hydrochloride dihydrate BPCRS using water in the reference cell.


determination of content

Calculate the total content of ondansetron, C18H19N3O, in the medium from the absorbances obtained and using the declared content of C18H19N3O, in ondansetron hydrochloride dihydrate BPCRS. Each mg of C18H19N3O is equivalent to 1.25  mg C18H19N3O,HCl,2H2O.


Impurity B

Carry out the method for thin-layer chromatography, Appendix III  A, using the following solutions in solvent A.


solvent a

0.5 volumes of 13.5m ammonia, 100 volumes of ethanol (96%) and 100 volumes of methanol.


(1)  Shake a quantity of the powdered tablets containing the equivalent of 20  mg of ondansetron with 25  ml acetonitrile, filter and evaporate the filtrate to dryness using a rotary evaporator. Dissolve the residue in 2  ml of solvent A.

(2)  Dilute 1  volume of solution (1) to 50 volumes and dilute 4 volumes of the resulting solution to 20 volumes.

(3)  0.25% w/v solution of ondansetron for TLC system suitability BPCRS.


chromatographic conditions

(a)  Use as the coating silica gel GF254.

(b)  Use the mobile phase described below.

(c)  Apply 10 µl of each solution.

(d)  Develop the plate to 15 cm.

(e)  Remove the plate, dry in air and examine under ultraviolet light (254  nm).


mobile phase

2  volumes of 13.5m ammonia, 40 volumes of methanol, 50 volumes of ethyl acetate and 90 volumes of dichloromethane.


system suitability

The test is not valid unless the chromatogram obtained with solution (3) shows 3 clearly separated spots.


limit

In the chromatogram obtained with solution (1):


any secondary spot corresponding to impurity B is not more intense than the spot obtained in the chromatogram obtained with solution (2) (0.4%).


Related substances

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


(1)  Shake a quantity of the powdered tablets containing the equivalent of 20  mg of ondansetron with 25  ml of acetonitrile, filter and evaporate the filtrate to dryness. Dissolve the residue in 20  ml of mobile phase.

(2)  Dilute 1  volume of solution (1) to 50 volumes with the mobile phase and further dilute 1 volume of the resulting solution to 10 volumes with the mobile phase.

(3)  0.0001%  w/v of imidazole (impurity E) and 0.0001%  w/v of 2-methylimidazole (impurity F) in the mobile phase.

(4)  0.05%  w/v of ondansetron impurity standard BPCRS in the mobile phase.


chromatographic conditions

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with nitrile silica gel for chromatography (5µm) (Spherisorb CN 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 216 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

20 volumes of acetonitrile and 80 volumes of 0.02m sodium dihydrogen orthophosphate dihydrate, previously adjusted to pH 5.4 with 1m sodium hydroxide.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurity E and impurity F is at least 1.3 and in solution (4) the resolution factor between the peaks due to impurity C and impurity D is at least 2.5.


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity D (the second eluting peak in solution (4) is not greater than 0.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%);


the area of any peak corresponding to impurity C (the first eluting peak in solution (4)) is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);


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%);


the sum of the areas of any other secondary peaks is not greater than 2.5 times the principal peak in the chromatogram obtained with solution (2) (0.5%).


Disregard any peak with an area less than 0.25 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 powdered tablets containing the equivalent of 20  mg of ondansetron with 25  ml of acetonitrile, filter and evaporate the filtrate to dryness. Dissolve the residue in 200  ml of mobile phase and dilute 1 volume to 10 volumes with mobile phase.

(2)  0.0125%  w/v of ondansetron hydrochloride dihydrate BPCRS in the mobile phase.

(3)  0.05%  w/v of ondansetron impurity standard BPCRS in the mobile phase.


chromatographic conditions

The chromatographic conditions described under Related substances may be used. 


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurity C and impurity D is at least 2.5.


determination of content

Calculate the content of C18H19N3O in the tablets using the declared content of C18H19N3O, in ondansetron hydrochloride dihydrate BPCRS.

Labelling

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

Impurities

The impurities limited by the requirements of this monograph include those listed under Ondansetron Hydrochloride Dihydrate.




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.

2316

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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