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High Quality USP/EP/BP GMP DMF FDA Prolonged-release Metoprolol Tartrate Tablets CAS NO 56392-17-7 Producer

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  • AZ311
  • Dideu
  • 56392-17-7
  • 2C15H25NO3.C4H6O6
  • 260-148-9
  • China
  • Prolonged-release Metoprolol Tartrate 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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Prolonged-release Metoprolol Tartrate Tablets 

Action and use

Beta-adrenoceptor antagonist.

Prolonged-release Metoprolol Tartrate Tablets from different manufacturers, whilst complying with the requirements of the monograph, are not interchangeable unless otherwise justified and authorised.


Prolonged-release Metoprolol Tartrate Tablets contain Metoprolol Tartrate. They are formulated so that the medicament is released over a period of several hours.


A suitable dissolution test is carried out to demonstrate the appropriate release of Metoprolol Tartrate. The dissolution profile reflects the in vivo performance which in turn is compatible with the dosage schedule recommended by the manufacturer.

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

Content of metoprolol tartrate, (C15H25NO3)2,C4H6O6

95.0  to 105.0% of the stated amount.


A.  Mix a quantity of the powdered tablets containing 50  mg of Metoprolol Tartrate with 25  ml of water, add 2  ml of 5m ammonia, extract with 20  ml of dichloromethane, filter the dichloromethane layer through anhydrous sodium sulphate, wash the filter with 10  ml of dichloromethane and evaporate the combined filtrate and washings to dryness using a rotary evaporator, using gentle heat if necessary. Cool the residue to –18° for 30  minutes and allow to warm to room temperature. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of metoprolol (RS 228).

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

(1)  Shake a quantity of the powdered tablets containing 0.5  g of Metoprolol Tartrate with 15  ml of methanol for 1  hour, add sufficient methanol to produce 25  ml and mix. Filter through a glass microfibre filter (Whatman GF/F is suitable) and use the filtrate.

(2)  2.0% w/v of metoprolol tartrate BPCRS in methanol.

(3)  0.5% w/v of (+)-tartaric acid in methanol.

(4)  Mix 1  volume of solution (1) with 1  volume of solution (3).

chromatographic conditions

(a)  Use as the coating a silica gel H precoated plate (Analtech Uniplate plates are suitable).

(b)  Use the mobile phase as described below.

(c)  Apply 10 µl of each solution.

(d)  Develop the plate to 5 cm.

(e)  After removal of the plate, dry in air for about 10  minutes, dry in an oven at 100° for 20  minutes and spray the plate with a solution prepared in the following manner. Dissolve 75  mg of bromocresol green and 25  mg of bromophenol blue in 100  ml of absolute ethanol (solution A); dissolve 0.25  g of potassium permanganate and 0.5  g of sodium carbonate in 100  ml of water (solution B); mix 9  volumes of solution A and 1  volume of solution B and use immediately.

mobile phase

40  volumes of anhydrous formic acid and 140  volumes of ether.

system suitability

The chromatogram obtained with solution (1) closely resembles the chromatogram obtained with solution (2). The test is not valid unless the chromatogram obtained with solution (4) shows two clearly separated principal spots; the spot of low Rf value is purple and the spot of high Rf value, which is a single, compact spot, is yellow.


In the chromatogram obtained with solution (1) the spot with the higher Rf value corresponds to the spot in the chromatogram obtained with solution (3).

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 0.5  g of Metoprolol Tartrate with 20  ml of chloroform for 10  minutes, centrifuge, remove and retain the supernatant layer. Extract the residue with a further 20  ml quantity of chloroform, centrifuge and remove the supernatant layer. Evaporate the combined chloroform extracts to dryness at ambient temperature, add sufficient mobile phase to produce 25  ml, mix and filter.

(2)  Dilute 1 volume of solution (1) to 20 volumes with mobile phase and dilute 3 volumes of this solution to 50 volumes with mobile phase.

(3)  0.005% w/v of metoprolol tartrate BPCRS and 0.003% w/v of metoprolol impurity A EPCRS in mobile phase.

(4)  Prepare the solution in a fume cupboard in the following manner if necessary (see limits below). Place an evaporating dish 10  cm in diameter containing 10  ml of a 0.1% w/v solution of metoprolol tartrate BPCRS in 0.1m hydrochloric acid so that the surface of the solution is 5  cm from a lamp emitting ultraviolet light at (254  nm) for 6  hours. Dilute 1  volume of this solution to 50  volumes with the mobile phase.

chromatographic conditions 

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Waters Symmetry C18 is suitable).

(b)  Use isocratic elution and 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 20 µl of each solution.

(g)  Allow the chromatography to proceed for three times the retention time of metoprolol (the retention time of metoprolol is about 7 minutes, the relative retention of metoprolol impurity C is 0.3 and the relative retention of metoprolol impurity A is 0.7).

mobile phase 

10 volumes of glacial acetic acid, 146 volumes of acetonitrile and 810 volumes of 0.48% w/v of ammonium acetate.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to metoprolol and metoprolol impurity A is at least 6.0.


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) (0.3%);

the sum of the areas of any other secondary peaks is not greater than 1.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).

If any of the above limits are exceeded, and if a secondary peak occurs with a retention time of about 2  minutes (metoprolol impurity C), then in the chromatogram obtained with solution (1): divide the area of the peak corresponding to the principal peak in the chromatogram obtained with solution (4) (metoprolol impurity C) by 10: this divided area is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.3%); the sum of this divided area and the areas of any other secondary peaks is not greater than 1.7 times the area of the principal peak in the chromatogram obtained with solution (2) (0.5%).

Disregard any peak with an area less than 0.17 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).


Weigh and powder 20  tablets. Add to a quantity of the powdered tablets containing 75  mg of Metoprolol Tartrate 150  ml of absolute ethanol, shake with the aid of ultrasound for 15  minutes, allow to cool, add sufficient absolute ethanol to produce 200  ml and filter (Whatman GF/C paper is suitable). To 20  ml of the filtrate add sufficient absolute ethanol to produce 50  ml and measure the absorbance of the resulting solution at the maximum at 274  nm, Appendix II B. Calculate the content of (C15H25NO3)2,C4H6O6 from the absorbance obtained with a 0.015% w/v solution of metoprolol tartrate BPCRS in absolute ethanol and from the declared content of (C15H25NO3)2,C4H6O6 in metoprolol tartrate BPCRS.


The impurities limited by the requirements of this monograph include those impurities listed under Metoprolol Tartrate.

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.


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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