High Quality USP/EP/BP GMP DMF FDA Calcium Folinate Tablets CAS NO 1492-18-8 Producer

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Model: AZ038
Brand: Dideu
CAS No.: 1492-18-8
MF: C20H21CaN7O7
EINECS No.: 216-082-8
Place of Origin: China
Type: Calcium Folinate Tablets
Grade Standard: High quality
Purity: 99.0% Min
Assay: 99%-101%
Appearance: Tablet
Solubility: Solubility in water
Water: 1.0% max
Sulfated Ash: 0.5% Max
Heavy Metals: 10 ppm Max
Test Method: H-NMR
Total Impurity: 0.5% Max
Application: Medicine

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Calcium Folinate Tablets
Action and use	Vitamin B component.
Definition	Calcium Folinate Tablets contain Calcium Folinate. The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of folinic acid, C20H23N7O7	90.0 to 110.0% of the stated amount.
Identification	A. Shake a quantity of the powdered tablets containing the equivalent of 15 mg of folinic acid with 150 ml of 0.1m sodium hydroxide and dilute to 200 ml with the same solvent. Filter and dilute 10 ml of the clear filtrate to 50 ml with 0.1m sodium hydroxide. The light absorption of the resulting solution, Appendix II B, in the range 220 to 350 nm exhibits a maximum at about 282 nm. B. In the test for Related substances, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (4).
Tests Related substances	Protect the solutions from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) Add 20 ml of water to a quantity of the powdered tablets containing the equivalent of 25 mg of folinic acid, shake for 15 minutes and dilute to 25 ml with water. Filter through a glass fibre filter (Whatman GF/C is suitable). (2) Dilute 1 volume of solution (1) to 100 volumes with water. (3) 0.001% w/v of formylfolic acid EPCRS in the mobile phase. (4) 0.001% w/v of calcium folinate EPCRS in water. (5) 0.0001% w/v of calcium folinate EPCRS in water. (6) Mix 10 volumes of solution (3) with 5 volumes of solution (4). chromatographic conditions (a) Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable). (b) Use isocratic elution and the mobile phase described below. (c) Use a flow rate of 1 ml per minute. (d) Use a column temperature of 40°. (e) Use a detection wavelength of 280 nm. (f) Inject 20 µl of each solution. mobile phase A mixture of 220 ml of methanol and 780 ml of a solution containing 2.0 ml of tetrabutylammonium hydroxide solution and 2.2 g of disodium hydrogen orthophosphate and previously adjusted to pH 7.5 with 10% v/v orthophosphoric acid. system suitability The test is not valid unless, in the chromatogram obtained with solution (6), the resolution factor between the peaks corresponding to calcium folinate and formylfolic acid is at least 2.2. If necessary, adjust the methanol content in the mobile phase. limits In the chromatogram obtained with solution (1): the area of any peak corresponding to formylfolic acid is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (1%); the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%); the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%). Disregard any peak with an area less than that of the principal peak in the chromatogram obtained with solution (5) (0.1%).
Assay	Protect the solutions from light. Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) Add 200 ml of water to a quantity of the powdered tablets containing the equivalent of 25 mg of folinic acid, shake for 15 minutes and dilute to 250 ml with water. Filter through a glass fibre filter (Whatman GF/C is suitable). (2) 0.011% w/v of calcium folinate EPCRS in water. (3) 5 volumes of a 0.001% w/v solution of formylfolic acid EPCRS in the mobile phase and 10 volumes of a 0.001% w/v solution of calcium folinate EPCRS in water. chromatographic conditions The chromatographic conditions described under Related substances may be used. system suitability The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to calcium folinate and formylfolic acid is at least 2.2. If necessary, adjust the methanol content in the mobile phase. determination of content Calculate the content of folinic acid, C20H23N7O7 using the declared content of C20H21CaN7O7, in calcium folinate EPCRS. Each mg of C20H21CaN7O7 is equivalent to 0.926 mg of C20H23N7O7.
Storage	Calcium Folinate Tablets should be stored at a temperature not exceeding 30°.
Labelling	The quantity of active ingredient is stated in terms of the equivalent amount of folinic acid.

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.