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High Quality USP/EP/BP GMP DMF FDA Pravastatin Tablets CAS NO 81093-37-0 Producer

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Price: $ 0.08 / Tablet
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  • AZ291
  • Dideu
  • 81093-37-0
  • C23H36O7
  • China
  • Pravastatin 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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Mobile:+86-15129568250; Whatsapp: +8615129568250

Pravastatin Tablets 

Action and use

HMG Co-A reductase inhibitor; lipid-regulating drug.

Definition

Pravastatin Tablets contain Pravastatin Sodium.

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

Content of pravastatin sodium, C23H35NaO7

92.5  to 107.5% of the stated amount.
Identification

A.  Shake a quantity of the powdered tablets containing 10 mg of Pravastatin Sodium with 80 ml of water for 10 minutes, dilute to 100 ml with water, filter and dilute 1 ml to 10 ml with water. The light absorption of the resulting solution, Appendix II B, in the range 220 to 350 nm, exhibits a maximum only at 238 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

Dissolve 4.10 g of anhydrous sodium acetate in 400 ml of water, adjust the pH to 5.6 with glacial acetic acid and add sufficient water to produce 500 ml (solution A). Mix 20 volumes of methanol with 80 volumes of solution A (solution B). Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 20 ml of solution A to a quantity of the powdered tablets containing 10 mg of Pravastatin Sodium, mix using a vortex mixer and then with the aid of ultrasound for 15 minutes. Centrifuge and dilute 1 volume of the clear supernatant liquid to 5 volumes with solution B. For solution (2) dilute 1 volume of solution (1) to 100 volumes with solution B. For solution (3) dilute 1 volume of solution (2) to 5 volumes with solution B. For solution (4) dilute 1 volume of solution (3) to 4 volumes with solution B. For solution (5) dissolve 2 mg of pravastatin impurity A EPCRS in the minimum volume of methanol and dilute to 20 ml with solution (1). Inject 20 µl of each solution.


The chromatographic procedure may be carried out using (a) a stainless steel column (15 cm × 4.6 mm) packed with octadecylsilyl silica gel for chromatography (5µm) (Ultrasphere ODS is suitable) maintained at 25°, (b) as the mobile phase with a flow rate of 1.3 ml per minute a mixture of 1 volume of glacial acetic acid, 1 volume of triethylamine, 450 volumes of methanol and 550 volumes of water and (c) a detection wavelength of 238 nm.


The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks corresponding to pravastatin impurity A and pravastatin is at least 7.0.


In the chromatogram obtained with solution  (1) the area of any secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution  (2)  (2%), not more than one such peak has an area greater than the area of the principal peak in the chromatogram obtained with solution  (2)  (1%), not more than a further one such peak has an area greater than the area of the principal peak in the chromatogram obtained with solution  (3)  (0.2%) and the sum of the areas of all such peaks is not greater than three times the area of the principal peak in the chromatogram obtained with solution  (2)  (3%). Disregard any peak with an area less than the area of the principal peak in the chromatogram obtained with solution  (4)  (0.05%).

Assay

Weigh and powder 20 tablets. Dissolve 4.10  g of anhydrous sodium acetate in 400 ml of water, adjust the pH to 5.6 with glacial acetic acid and add sufficient water to produce 500 ml (solution A). Mix 20 volumes of methanol with 80 volumes of solution  A (solution B). Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) add 20 ml of solution A to a quantity of the powdered tablets containing 10  mg of Pravastatin Sodium, mix using a vortex mixer and then with the aid of ultrasound for 15 minutes. Centrifuge and dilute 1 volume of the clear supernatant liquid to 5 volumes with solution B. For solution (2) dissolve 12.4  mg of pravastatin 1,1,3,3,-tetramethylbutylamine EPCRS in 20  ml of solution A and dilute 1 volume to 5 volumes with solution B. For solution (3) dissolve 2  mg of pravastatin impurity A EPCRS in the minimum volume of methanol and dilute to 20  ml with solution (1).


The chromatographic conditions described under Related substances may be used.


The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to pravastatin impurity A and pravastatin is at least 7.0.


Calculate the content of C23H35NaO7 in the tablets using the declared content of C23H36O7 in pravastatin 1,1,3,3,-tetramethylbutylamine EPCRS. Each mg of C23H36O7 is equivalent to 1.052 mg of C23H35NaO7.

Storage

Pravastatin Tablets should be protected from light and moisture.

Impurities

The impurities limited by the requirements of this monograph include those listed under Pravastatin Sodium.




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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