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High Quality USP/EP/BP GMP DMF FDA Sodium Valproate Tablets CAS NO 1069-66-5 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
  • AZ340
  • Dideu
  • 1069-66-5
  • C8H15NaO2
  • 213-961-8
  • China
  • Sodium Valproate 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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Sodium Valproate Tablets 

Action and use

Antiepileptic.

Definition

Sodium Valproate Tablets contain Sodium Valproate.

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

Content of sodium valproate, C8H15NaO2

95.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the powdered tablets containing 0.5  g of Sodium Valproate with 10  ml of water and centrifuge. Acidify 5  ml of the supernatant liquid with 2m sulphuric acid, shake with 25  ml of dichloromethane and wash the dichloromethane layer with 5  ml of water. Dry by shaking with anhydrous sodium sulphate, filter and evaporate the dichloromethane. The infrared absorption spectrum of a thin film of the residue, Appendix II A, is concordant with the reference spectrum of valproic acid (RS 431).


B.  Shake a quantity of the powdered tablets containing 0.25  g of Sodium Valproate with 3  ml of water and centrifuge. To 2  ml of the supernatant liquid add 0.5  ml of a 10% w/v solution of cobalt(ii) nitrate. A purple precipitate is produced which is soluble in dichloromethane.

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 900 ml of phosphate buffer pH 6.8, at a temperature of 37°, as the medium.


procedure 

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


(1)  After 45 minutes withdraw a 20 ml sample of the medium and filter. Use the filtrate diluted, if necessary, to give a solution expected to contain 0.002% w/v of Sodium Valproate.

(2)  0.002% w/v of sodium valproate BPCRS in phosphate buffer pH 6.8.


chromatographic conditions 

(a)  Use a stainless steel column (30  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (µBondapak C18 is suitable).

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

(c)  Use a flow rate of 2 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 220 nm.

(f)  Inject 50 µl of each solution.


mobile phase 

45  volumes of a 0.32% w/v solution of potassium dihydrogen orthophosphate adjusted to pH 3.0 with orthophosphoric acid and 55  volumes of acetonitrile.


determination of content 

Calculate the total content of sodium valproate, C8H15NaO2, in the medium from the chromatogram obtained and using the declared content of C8H15NaO2 in sodium valproate BPCRS.


Related substances

Carry out the method for gas chromatography, Appendix III B, using the following solutions. 


(1)  0.020% w/v of octanoic acid (internal standard) in dichloromethane.


(2)  Shake a quantity of the powdered tablets containing 0.50  g of Sodium Valproate with 10  ml of water, acidify with 2m sulphuric acid and shake with three 20-ml quantities of dichloromethane. Wash the combined dichloromethane extracts with 10  ml of water, shake with anhydrous sodium sulphate, filter, evaporate the filtrate to a volume of about 8  ml at a temperature not exceeding 30°, using a rotary evaporator and dilute to 10  ml with dichloromethane.


(3)  Shake a quantity of the powdered tablets containing 0.50  g of Sodium Valproate with 10  ml of a 0.020% w/v solution of the internal standard in 0.1m sodium hydroxide, acidify with 2m sulphuric acid and shake with three 20-ml quantities of dichloromethane. Wash the combined dichloromethane extracts with 10  ml of water, shake with anhydrous sodium sulphate, filter, evaporate the filtrate to a volume of about 8  ml at a temperature not exceeding 30°, using a rotary evaporator and dilute to 10  ml with dichloromethane.


chromatographic conditions

(a)  Use a glass column (1.5 m × 4  mm) packed with acid-washed, silanised diatomaceous support (80  to 100  mesh) coated with 15% w/w of free fatty acid phase and 1% w/w of orthophosphoric acid.

(b)  Use helium as the carrier gas at 1.7 ml per minute.

(c)  Use an oven temperature of 170°. 

(d)  Use an injection temperature of 190°.

(e)  Use a flame ionisation detector at 250°.

(f)  Inject 1 µl of each solution.


limits

In the chromatogram obtained with solution (3):


the sum of the areas of any secondary peaks is not greater than the area of the peak due to the internal standard (0.4%).

Assay

Weigh and powder 20  tablets. To a quantity of the powder containing 0.3  g of Sodium Valproate add 70  ml of water, shake for 10  minutes, dilute to 100  ml with water and filter. To 50  ml of the filtrate add 10  ml of a 30% w/v solution of sodium chloride and 10  ml of 2m hydrochloric acid. Extract with 40  ml of a mixture of 2  volumes of ether and 1  volume of petroleum spirit (boiling range, 40° to 60°) and allow to separate. Shake the aqueous layer with a further 40  ml of the ether-petroleum spirit mixture. Shake each of the ether extracts with the same three 10-ml quantities of a saturated solution of sodium chloride, combine the ether extracts and evaporate to a volume of about 1  ml at a temperature not exceeding 30°. Add 50  ml of ethanol (96%), previously neutralised with 0.1m sodium hydroxide VS, using phenolphthalein solution R1 as indicator, and titrate with 0.1m sodium hydroxide VS. Each ml of 0.1m sodium hydroxide VS is equivalent to 16.62  mg of C8H15NaO2.




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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