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High Quality USP/EP/BP GMP DMF FDA Ramipril Tablets CAS NO 87333-19-5 Producer

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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
  • AZ331
  • Dideu
  • 87333-19-5
  • C23H32N2O5
  • 642-904-3
  • China
  • Ramipril 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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Ramipril Tablets 

Action and use

Angiotensin converting enzyme inhibitor.

Definition

Ramipril Tablets contain Ramipril.

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

Content of ramipril, C23H32N2O5

90.0  to 105.0% of the stated amount.
Identification

Shake a quantity of the powdered tablets containing 25  mg of Ramipril with 50 ml of acetone, centrifuge for 10 minutes, filter the supernatant liquid through a 0.45-µl filter, evaporate the filtrate to dryness on a water bath and dry the residue for 3 hours at 60°. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of ramipril (RS 417).

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, using Apparatus 2. Use as the medium 500 ml of 0.1m hydrochloric acid and rotate the paddle at 75 revolutions per minute. Withdraw a sample of the medium and filter immediately through a 0.45-µm glass-fibre filter (Whatman GD/X is suitable), discarding the first 5 ml of filtrate. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) use the filtered dissolution medium diluted, if necessary, with 0.1m hydrochloric acid to produce a solution expected to contain 0.0025 mg of Ramipril per ml. Solution (2) contains 0.00025% w/v of ramipril BPCRS in 0.1m hydrochloric acid.


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil 100-C18 is suitable), (b) as the mobile phase with a flow rate of 1.0 ml per minute a mixture, adjusted to pH 2.1 with orthophosphoric acid, of 420 volumes of acetonitrile R1 and 580 volumes of a solution containing 1.4% w/v of sodium perchlorate and 0.58% w/v of orthophosphoric acid adjusted to pH 2.5 with triethylamine and (c) a detection wavelength of 210 nm.


Inject 40 µl of each solution.


Calculate the total content of ramipril, C23H32N2O5, in the medium using the declared content of C23H32N2O5 in ramipril BPCRS.


Related substances

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


(1)  Mix with the aid of ultrasound for 10 minutes, a quantity of the contents of the powdered tablets containing 25 mg of Ramipril with 50 ml of the mobile phase, centrifuge and use the clear supernatant liquid. 

(2)  Dilute 1 volume of solution (1) to 20 volumes with the mobile phase. 

(3)  Dilute 1 volume of solution (1) to 100 volumes with the mobile phase. 

(4)  0.05% w/v of ramipril BPCRS and 0.0005% w/v of each of ramipril impurity A EPCRS, ramipril impurity D EPCRS and ramipril impurity K BPCRS in the mobile phase.


CHROMATOGRAPHIC CONDITIONS

(a)  Stainless steel column (12.5 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil 100-C18 is suitable).

(b)  Isocratic elution using the mobile phase described below.

(c)  Flow rate of 1.0 ml per minute.

(d)  Ambient column temperature.

(e)  Detection wavelength of 210 nm.

(f)  Injection volume of 15 µl for each solution.


When the chromatograms are recorded under the prescribed conditions, the retention time of ramipril is about 10 minutes and retention times relative to ramipril are about 0.6 for ramipril impurity K (diketopiperazine acid impurity), about 0.7 for ramipril impurity A (methyl ester impurity) and about 2.6 for ramipril impurity D (diketopiperazine impurity).


mobile phase

A mixture, adjusted to pH 2.6 with orthophosphoric acid, of 350 volumes of acetonitrile R1 and 680 volumes of a solution adjusted to pH 3.9 with triethylamine, containing 1.4% w/v of sodium perchlorate and 0.58% w/v of orthophosphoric acid.


SYSTEM SUITABILITY

The test is not valid unless, in the chromatogram obtained with solution (4), the resolution factor between the peaks corresponding to ramipril impurity K and ramipril impurity A is at least 1.0.


LIMITS

For tablets containing more than 1.25 mg of Ramipril 

In the chromatogram obtained with solution (1) the combined area of peaks corresponding to ramipril impurity D and ramipril impurity E is not greater than 1.2 times the area of the principal peak in the chromatogram obtained with solution  (2)  (6.0%); the area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution  (3)  (0.5%). The sum of the areas of all the secondary peaks is not greater than 1.2 times the area of the principal peak in the chromatogram obtained with solution  (2)  (6.0%).


For capsules containing 1.25 mg or less of Ramipril 

In the chromatogram obtained with solution (1) the combined areas of peak corresponding to ramipril impurity D and ramipril impurity E is not greater than 1.6 times the area of the principal peak in the chromatogram obtained with solution  (2)  (8.0%); the area of any other secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution  (3)  (0.5%). The sum of the areas of all the secondary peaks is not greater than 1.6 times the area of the principal peak in the chromatogram obtained with solution  (2)  (8.0%).


Uniformity of content

Tablets containing less than 2  mg of Ramipril comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 5 ml of 0.1m hydrochloric acid to one tablet, mix with the aid of ultrasound for 10 minutes, dilute, if necessary, with sufficient 0.1m hydrochloric acid to produce a solution containing 0.025% w/v of Ramipril, centrifuge and use the supernatant liquid. Solution (2) contains 0.025% w/v of ramipril BPCRS in 0.1m hydrochloric acid.


The chromatographic procedure described under Dissolution may be used.


Calculate the content of C23H32N2O5 in each tablet using the declared content of C23H32N2O5 in ramipril BPCRS.

Assay

For tablets containing 2  mg or more of Ramipril 

Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.


(1)  Add 100 ml of 0.1m hydrochloric acid to a quantity of powdered tablets containing 25 mg of Ramipril, mix with the aid of ultrasound for 10 minutes and centrifuge, use the supernatant. 

(2)  0.025% w/v of ramipril BPCRS in 0.1m hydrochloric acid.


CHROMATOGRAPHIC CONDITIONS

The chromatographic procedure described under Dissolution may be used.


DETERMINATION OF CONTENT

Calculate the content of C23H32N2O5 in the tablets using the declared content of C23H32N2O5 in ramipril BPCRS.


For tablets containing less than 2  mg of Ramipril 

Use the average of the 10 individual results obtained in the test for Uniformity of content.

Impurities

The impurities limited by the requirements of this monograph include those listed in the monograph for Ramipril.




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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