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High Quality USP/EP/BP GMP DMF FDA Gastro-resistant Lansoprazole Tablets CAS NO 103577-45-3 Producer

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  • AZ170
  • Dideu
  • 103577-45-3
  • C16H14F3N3O2S
  • 2017-001-1
  • China
  • Gastro-resistant Lansoprazole 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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Gastro-resistant Lansoprazole Tablets

Action and use

Proton pump inhibitor; treatment of peptic ulcer disease.

Definition

Gastro-resistant Lansoprazole Tablets contain Lansoprazole. They are covered with a gastro-resistant coating or prepared from granules or particles covered with a gastro-resistant coating.

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

Content of lansoprazole, C16H14F3N3O2S

95.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the powdered tablets containing 30  mg of Lansoprazole with 50  ml of methanol , filter and dilute 1 volume to 50 volumes. The light absorption, Appendix II B, in the range 220 nm to 350nm exhibits a maximum at 285 nm.


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

Related substances

Dissolution

Comply with the dissolution test for tablets and capsules , Appendix XII B1.


Mix 11 volumes of 0.25m trisodium orthophosphate and 22 volumes of 0.5m anhydrous disodium hydrogen orthophosphate , dilute to 100 volumes with water and adjust the pH, if necessary, to 11.0 with orthophosphoric acid or 10m sodium hydroxide , as appropriate (solution A).


Mix 1 volume of 10m sodium hydroxide with 99 volumes of 0.05m phosphate buffer solution pH 4.5 (solution B).


test conditions

(a)  Use Apparatus 2, rotating the paddle at 150 revolutions per minute.

(b)  Use as the media the solutions described sequentially below.


First stage (pH 4.5)

Use as the medium 700 ml of 0.05 m phosphate buffer solution pH 4.5 . After 45 minutes, withdraw 5 ml of the medium, filter, dilute to 25  ml with solution A and retain the samples for analysis as described below. Proceed immediately to the final stage.


Final stage (pH 6.8)

Within 5 minutes, add 200 ml of solution B at 37° to the vessel. Maintain the rotation speed at 150 revolutions per minute and continue to operate the apparatus for 45 minutes. Withdraw 5 ml of the medium, filter, dilute to 25 ml with solution A and retain the samples for analysis as described below.


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

(1)  The sample solutions taken above.

(2)  Dissolve a sufficient quantity of lansoprazole BPCRS in solution A and dilute with water; the concentration of the final solution should be the same as that expected for solution (1).


chromatographic conditions 

The chromatographic conditions described under Related substances may be used.


determination of content

Calculate the total content of C16H14F3N3O2S, in the medium using the declared content of C16H14F3N3O2S in lansoprazole BPCRS. 


limits

The amount of lansoprazole released after the first stage is not more than 10% of the stated amount. The amount of lansoprazole released after the final stage is not less than 75% (Q) of the stated amount. 


Related substances

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


solvent a

Mix 1 volume of triethylamine with 60 volumes of water, adjust the pH to 10.5 using orthophosphoric acid and mix the solution with 40 volumes of acetonitrile. 


(1)  Shake a quantity of the powdered tablets containing 50  mg of Lansoprazole with 50 ml of solvent A and filter. 

(2)  Dilute 1 volume of solution (1) to 100  volumes with solvent A and dilute a further 1 volume to 5 volumes with solvent A. 

(3)  0.01%  w/v of lansoprazole impurity standard BPCRS in solvent A. 

(4)  0.0003% w/v of 2-mercaptobenzimidazole (impurity E) in solvent A. 


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 3.0  mm) packed with amidohexadecylsilyl silica gel for chromatography (5 µm) (Supelcosil LC-ABZ is suitable). 

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

(c)  Use a flow rate of 1.2  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 285  nm.

(f)  Inject 10 µl of each solution.

(g)  Identify any peaks in the chromatogram obtained with solution (1) corresponding to lansoprazole impurities A and B using solution (3).


mobile phase 

1 volume of triethylamine, 60 volumes of water, adjusted to pH 6.2 using orthophosphoric acid and mix the solution with 40 volumes of acetonitrile. 


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to lansoprazole and impurity B is at least 3.0.


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity A is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);


the area of any peak corresponding to impurity B is not greater than 2 times the area of the principal peak in the chromatogram obtained with solution (2) (0.4%);


the area of any peak corresponding to impurity E 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%); 


the sum of the areas of all the secondary peaks is not more than 2.0%. 


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 in solvent A, and protect from light.


solvent a

Mix 1 volume of triethylamine with 60 volumes of water, adjust the pH to 10.5 using orthophosphoric acid and mix the solution with 40 volumes of acetonitrile. 


(1)  Weigh and powder 20 tablets. To a quantity of the powdered tablets containing 50 mg of Lansoprazole add 50  ml of solvent  A, shake for 30 minutes and filter. Dilute 1 volume to 5 volumes with solvent A.

(2)  0.02%  w/v of lansoprazole BPCRS. 

(3)  0.01% w/v of lansoprazole impurity standard BPCRS. 


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 lansoprazole and impurity B is at least 3.


determination of content

Calculate the total content of lansoprazole, C16H14F3N3O2S, in the tablets using the declared content of C16H14F3N3O2S in lansoprazole BPCRS . 




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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