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High Quality USP/EP/BP GMP DMF FDA Gastro-resistant Omeprazole Capsules CAS NO Producer

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  • AZ424
  • Dideu
  • C17H19N3O3S
  • China
  • Gastro-resistant Omeprazole 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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Gastro-resistant Omeprazole Capsules 

Action and use

Proton pump inhibitor; treatment of peptic ulcer disease.

Definition

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


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

Content of omeprazole, C17H19N3O3S

95.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the finely powdered contents of the capsules containing 20  mg of Omeprazole with 50 ml of 0.1M sodium hydroxide, dilute to 100 ml, filter and further dilute 10 ml to 100  ml. The light absorption, Appendix II B, in the range 230 to 350  nm exhibits two maxima, at 276  nm and 305  nm.


B.  In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is similar to that of the principal peak in the chromatogram obtained with solution (2).

Tests

Related substances

Dissolution

Carry out 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).


Mix 5.2 volumes of 1m anhydrous sodium dihydrogen orthophosphate and 63.2 volumes of 0.5m anhydrous disodium hydrogen orthophosphate, dilute to 1000 volumes with water and adjust the pH, if necessary, to 7.6 with orthophosphoric acid or 10m sodium hydroxide, as appropriate (solution C).


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 0.05m phosphate buffer solution pH 4.5. After 45 minutes, withdraw 5 ml of the medium, filter the aliquot, 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 100 revolutions per minute and continue to operate the apparatus for 45 minutes. Withdraw 5 ml of the medium, filter the aliquot, 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)  Use the sample solutions taken above.

(2)  Dissolve a sufficient quantity of omeprazole 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 

(a)  Use a stainless steel column (15  cm × 2  mm) packed with octadecylsilyl silica gel for chromatography R (5 µm) (Nucleosil C18 is suitable). Use a suitable guard column.

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

(c)  Use a flow rate of 0.25 ml per minute.

(d)  Use a column temperature of 30°.

(e)  Use a detection wavelength of 302 nm.

(f)  Inject 10 µl of each solution.

(g)  Allow the chromatography to proceed for 8 times the retention time of omeprazole.


mobile phase 

25 volumes of solution C, 35 volumes of water and 40 volumes of acetonitrile. Adjust the pH, if necessary, to 7.6 with orthophosphoric acid or 10m sodium hydroxide, as appropriate.


system suitability 

Inject solution (2) six times. The test is not valid unless the relative standard deviation of the areas of the peak due to omeprazole is not more than 2.0% and the symmetry factor of the peak due to omeprazole is not more than 2.0.


determination of content

Calculate the total content of C17H19N3O3S in the medium using the declared content of C17H19N3O3S in omeprazole BPCRS.


limits

The amount of omeprazole released after the first stage is not more than 10% of the stated amount. The amount of omeprazole released after the final stage is not less than 65% (Q) of the stated amount.


Impurity C

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


Prepare a mixture of equal volumes of methanol and dichloromethane (solvent A).


(1)  Weigh the contents of 20 capsules and grind to a fine powder. Disperse a quantity of the powder containing 50  mg of Omeprazole in 15  ml of solvent A, mix with the aid of ultrasound for 30 minutes, dilute with solvent A to produce 20 ml, mix and filter. Evaporate the filtrate to dryness and dissolve the residue in 1 ml of the same solvent.

(2)  Dilute 1 volume of solution (1) to 100 volumes with solvent A. Dilute 1 volume of this solution to 10 volumes with solvent A.


chromatographic conditions 

(a)  Use silica gel F254 as the coating substance.

(b)  Use the mobile phase as described below.

(c)  Apply 10 µl for each solution.

(d)  Develop the plate to 15 cm.

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


mobile phase

20 volumes of propan-2-ol, 40 volumes of dichloromethane that has been previously shaken with concentrated ammonia (shake 100 ml of dichloromethane with 30 ml of concentrated ammonia in a separating funnel; allow the layers to separate and use the lower layer) and 40 volumes of dichloromethane.


limits

Any spot in the chromatogram obtained with solution (1) with a higher Rf value than that of the spot due to omeprazole is not more intense than the spot in the chromatogram obtained with solution (2) (0.1%).


Related substances

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


(1)  Weigh the contents of 20 capsules and grind to a fine powder. Disperse a quantity of the powder containing 24  mg of Omeprazole in 150  ml of mobile phase, mix with the aid of ultrasound for 30 minutes, dilute with sufficient mobile phase to produce 200  ml, mix and filter.

(2)  Dilute 5 volumes of solution (1) to 100 volumes with the mobile phase. Dilute 1  volume of this solution to 10 volumes with the mobile phase.

(3)  Mix 10 mg each of omeprazole BPCRS and omeprazole impurity D EPCRS in mobile phase and dilute to 100 ml with the same solvent.


chromatographic conditions 

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with octylsilyl silica gel for chromatography (5 µm) (Nucleosil RP8 is suitable).

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

(c)  Use a flow rate of 1  ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 280  nm.

(f)  Inject 40 µl of each solution.

(g)  Allow the chromatography to proceed for 3 times the retention time of omeprazole.


mobile phase 

27 volumes of acetonitrile and 73 volumes of a 0.14% w/v solution of disodium hydrogen orthophosphate that has been previously adjusted to pH 7.6 with orthophosphoric acid.


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurity D and omeprazole is greater than 3.0 and the retention time of omeprazole is about 9 minutes. 


limits 

In the chromatogram obtained with solution (1):


the area of any peak due to impurity D or any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);


the sum of the areas of any secondary peaks is not greater than four times the area of the principal peak in the chromatogram obtained with solution (2) (2.0%).

Assay

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


(1)  Weigh the contents of 20 capsules and grind to a fine powder. Disperse a quantity of the powder containing 24  mg of Omeprazole in 150  ml of mobile phase, mix with the aid of ultrasound for 30 minutes, dilute with sufficient mobile phase to produce 200 ml, mix and filter and further dilute 10  volumes to 100  volumes with the mobile phase.

(2)  0.0012%  w/v of omeprazole BPCRS in the mobile phase.

(3)  Mix 10 mg each of omeprazole BPCRS and omeprazole impurity D EPCRS in mobile phase and dilute to 100 ml with the same solvent.


chromatographic conditions

The chromatographic conditions described under Related substances may be used but with a detection wavelength of 305 nm.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to impurity D and omeprazole is greater than 3.0.


determination of content

Calculate the content of C17H19N3O3S in the capsules from the chromatograms obtained and using the declared content of C17H19N3O3S in omeprazole BPCRS. 

Impurities

The impurities limited by this monograph include those listed under Omeprazole.




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

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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

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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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