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High Quality USP/EP/BP GMP DMF FDA Domperidone Tablets CAS NO 57808-66-9Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ126
  • Dideu
  • 57808-66-9
  • C22H24ClN5O2
  • 260-968-7
  • China
  • Domperidone 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

Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

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Domperidone Tablets

Action and use

Peripheral dopamine receptor antagonist; antiemetic.

Definition

Domperidone Tablets contain Domperidone Maleate.

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

Content of domperidone, C22H24ClN5O2

95.0  to 105.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using a precoated silica gel F254 plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 5  volumes of a solution prepared by dissolving 1.36  g of sodium acetate in 50  ml of water, adjusting the pH to 4.7 with dilute acetic acid and adding sufficient water to produce 100  ml, 18  volumes of methanol, 23  volumes of dichloromethane and 54  volumes of ethyl acetate as the mobile phase. Apply separately to the plate 10 µl of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing the equivalent of 10  mg of domperidone with 10  ml of a mixture of equal volumes of dichloromethane and methanol and filter through a glass microfibre filter (Whatman GF/C is suitable). Solution (2) contains 0.127% w/v of domperidone maleate BPCRS in a mixture of equal volumes of dichloromethane and methanol. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). Spray the plate with potassium iodobismuthate solution and examine again. Using each method of visualisation the principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


B.  In the Assay, the principal peak in the chromatogram obtained with solution (1) has 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. Measure the absorbance of the filtrate, Appendix II B, diluted with the dissolution medium if necessary, at 286  nm using dissolution medium in the reference cell. Measure the absorbance of a 0.001% w/v solution of domperidone maleate BPCRS in the dissolution medium and calculate the total content of domperidone, C22H24ClN5O2, in the medium using the declared content of C22H24ClN5O2 in domperidone maleate BPCRS.


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use. For solution (1) to a quantity of the powdered tablets containing the equivalent of 50  mg of domperidone add 10  ml of a mixture of equal volumes of 0.01m hydrochloric acid and methanol, mix with the aid of ultrasound for 20  minutes and filter through a glass microfibre filter (Whatman GF/C is suitable). For solution (2) dilute 1  volume of solution (1) to 200  volumes with a mixture of equal volumes of 0.01m hydrochloric acid and methanol. Dilute 1  volume of the resulting solution to 2  volumes with a mixture of equal volumes of 0.01m hydrochloric acid and methanol. Solution (3) contains 0.01% w/v of domperidone maleate BPCRS and 0.015% w/v of droperidol EPCRS in a mixture of equal volumes of 0.01m hydrochloric acid and methanol.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with base-deactivated, end-capped octadecylsilyl silica gel for chromatography (3 µm) (Hypersil BDS is suitable). Carry out a linear gradient elution with a flow rate of 1.5  ml per minute using the following conditions.


Mobile phase A  Methanol.


Mobile phase B  A 0.5% w/v solution of ammonium acetate.

1105


Use a detection wavelength of 280  nm. Equilibrate the column for at least 30  minutes with methanol and equilibrate with the initial mobile phase for at least 5  minutes. Adjust the sensitivity of the system so that the height of the principal peak in the chromatogram obtained with 10 µl of solution (2) is at least 50% of the full scale of the recorder.


Inject separately 10 µl of a mixture of equal volumes of 0.01m hydrochloric acid and methanol as a blank and 10 µl of each of solutions (1), (2) and (3). The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2. If necessary adjust the concentration of methanol in the mobile phase or adjust the time programme for the linear gradient.


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) (0.25%) and the sum of the areas of any secondary peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (0.5%). Disregard any peak in the chromatogram obtained with the blank solution and any peak with an area less than 0.2  times the area of the 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. For solution (1) add sufficient methanol to 10 whole tablets to produce a solution containing 0.02% w/v of domperidone, mix with the aid of ultrasound for 20  minutes and filter through a glass microfibre filter (Whatman GF/C is suitable). To 50  ml of the filtrate add 1  ml of 0.1m hydrochloric acid and sufficient water to produce 100  ml. Solution (2) contains 0.0127% w/v of domperidone maleate BPCRS in a mixture of equal volumes of 0.002m hydrochloric acid and methanol.


The chromatographic procedure described under Related substances may be used.


Calculate the content of C22H24ClN5O2 in the tablets using the declared content of C22H24ClN5O2 in domperidone maleate BPCRS.

Storage

Domperidone Tablets should be stored in an airtight container.

Labelling

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




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.

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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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