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Ferrous Fumarate and Folic Acid Tablets
|Action and use|
Vitamin B component.
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, C4H2FeO4||90.0 to 105.0% of the stated amount.|
Content of folic acid, C19H19N7O6
|90.0 to 115.0% of the stated amount.|
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.
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.
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.
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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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.
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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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.