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High Quality USP/EP/BP GMP DMF FDA Ferrous Fumarate and Folic Acid Tablets CAS NO Producer

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Price: $ 0.08 / Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ151
  • Dideu
  • China
  • Ferrous Fumarate and Folic Acid 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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Ferrous Fumarate and Folic Acid Tablets

Action and use

Vitamin B component.

Definition

Ferrous Fumarate and Folic Acid Tablets contain Ferrous Fumarate and Folic Acid. They are coated.

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

Carry out the tests avoiding exposure to actinic light. 

Content of ferrous fumarate, C4H2FeO490.0  to 105.0% of the stated amount.

Content of folic acid, C19H19N7O6

90.0  to 115.0% of the stated amount.
Identification

A.  In the Assay for folic acid, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (1).

B.  Heat a quantity of the powdered tablets containing 0.77  g of Ferrous Fumarate with 25  ml of a mixture of equal volumes of hydrochloric acid and water on a water bath for 15  minutes, cool and filter. Retain the residue for test C. The filtrate yields reaction A characteristic of iron salts, Appendix VI.

C.  Wash the residue reserved in test B with a mixture of 1  volume of 2m hydrochloric acid and 9  volumes of water and dry at 105°. Suspend 0.1  g of the residue in 2  ml of sodium carbonate solution and add potassium permanganate solution dropwise. The permanganate is decolourised and a brownish solution is produced.

Tests

Related substances

Ferric iron

Dissolve a quantity of the powder prepared for the Assay for ferrous fumarate containing 1.5  g of Ferrous Fumarate in a mixture of 100  ml of water and 10  ml of hydrochloric acid by heating rapidly to the boiling point. Boil for 15  seconds, cool rapidly, add 3  g of potassium iodide, stopper, allow to stand in the dark for 15  minutes and titrate the liberated iodine with 0.1m sodium thiosulphate VS using starch mucilage as indicator. Repeat the operation without the substance being examined. The difference between the titrations is not more than 13.4  ml (5% ferric iron in Ferrous Fumarate).


Uniformity of Content

For folic acid

Tablets containing less than 2 mg of Folic Acid comply with the requirement stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.0007% w/v of folic acid EPCRS in a mixture containing 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate and 135 volumes of methanol. For solution (2) place one tablet in 40  ml of a mixture containing 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate and 135 volumes of methanol, shake for 5  minutes with the aid of ultrasound, shake for a further 15 minutes, dilute to 50 ml a mixture containing 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate and 135 volumes of methanol and filter (0.45 µm nylon filter is suitable).


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) as the mobile phase with a flow rate of 1  ml per minute a mixture of 135  volumes of methanol and 800  volumes of a solution containing 0.938% w/v of sodium perchlorate and 0.075% w/v of potassium dihydrogen orthophosphate adjusted to pH 7.2 with 0.1m potassium hydroxide and diluted to 1000  volumes with water and (c) a detection wavelength of 277  nm.


Calculate the content of C19H19N7O6 in each tablet using the declared content of C19H19N7O6 in folic acid EPCRS.

Assay

Weigh and powder 20  tablets.


For ferrous fumarate

Disperse a quantity of the powder containing 0.3  g of Ferrous Fumarate in 7.5  ml of 1m sulphuric acid with gentle heating. Cool, add 25  ml of water and titrate immediately with 0.1m ammonium cerium(iv) sulphate VS using ferroin solution as indicator. Each ml of 0.1m ammonium cerium(iv) sulphate VS is equivalent to 16.99  mg of C4H2FeO4.


For folic acid

For tablets containing 2 mg or more of folic acid

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.0007% w/v of folic acid EPCRS in a mixture containing 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate and 135 volumes of methanol. For solution (2) mix a quantity of the powdered tablets containing 0.35  mg of Folic Acid in 40  ml of a mixture containing 800 volumes of a 0.57% w/v solution of dipotassium hydrogen orthophosphate and 135 volumes of methanol, shake for 5  minutes with the aid of ultrasound, shake for a further 15 minutes and dilute to 50 ml with the same solvent and filter (0.45 µm nylon filter is suitable).


The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with octadecylsilyl silca gel for chromatography (5 µm) (Spherisorb ODS 1 is suitable), (b) as the mobile phase with a flow rate of 1  ml per minute a mixture of 135  volumes of methanol and 800  volumes of a solution containing 0.938% w/v of sodium perchlorate and 0.075% w/v of potassium dihydrogen orthophosphate adjusted to pH 7.2 with 0.1m potassium hydroxide and diluted to 1000  volumes with water and (c) a detection wavelength of 277  nm.


Calculate the content of C19H19N7O6 using the declared content of C19H19N7O6 in folic acid EPCRS.


For tablets containing less than 2 mg of folic acid

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

Storage

Ferrous Fumarate and Folic Acid Tablets should be protected from light.

304  mg of ferrous fumarate is equivalent to 100  mg of ferrous iron.




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.

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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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