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High Quality USP/EP/BP GMP DMF FDA Ergocalciferol Tablets CAS NO 50-14-6 Producer

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Price: $ 0.08 / Tablet
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  • AZ136
  • Dideu
  • 50-14-6
  • C28H44O
  • 200-014-9
  • China
  • Ergocalciferol 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

Ergocalciferol Tablets

Action and use

Vitamin D analogue (Vitamin D2).

Definition

Ergocalciferol Tablets contain Ergocalciferol.

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

Content of ergocalciferol, C28H44O

90.0  to 125.0% of the stated amount.

Identification

A.  In the test for Uniformity of content, 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.  Extract one tablet, in powder, with 5  ml of dichloromethane, filter and to 1  ml of the filtrate add 9  ml of antimony trichloride solution. A brownish red colour is produced.

Tests

Related substances

Uniformity of content

Tablets containing less than 2  mg of Ergocalciferol comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure protected from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.


(1)  0.001% w/v of ergocalciferol BPCRS in hexane

(2)  For tablets containing more than 0.25  mg of ergocalciferol prepare the solution in the following manner. Add 4  ml of water to one tablet in an amber flask and disperse with the aid of ultrasound. Add 12  ml of dimethyl sulphoxide, mix, extract with 100  ml of hexane by shaking for 30  minutes, centrifuge the hexane layer and use the clear supernatant liquid.

For tablets containing 0.25  mg or less carry out the same procedure but using 2  ml of water, 6  ml of dimethyl sulphoxide and 25  ml of hexane.

(3)  Dissolve 0.5  g of cholecalciferol for performance test EPCRS in 2  ml of toluene and dilute to 10  ml with the mobile phase; heat under a reflux condenser in a water bath at 90° for 45  minutes and cool.


chromatographic conditions

(a)  Use a stainless steel column (20  cm × 4.6  mm) packed with silica gel for chromatography (5 µm) (Partisil 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 254  nm.

(f)  Inject 20 µl of each solution.


Inject a suitable volume of solution (1) and record the chromatogram using a sensitivity such that the height of the peak due to ergocalciferol is more than 50% of full-scale deflection. Repeat the operation using solution (2) and injecting the same volume.


mobile phase

8  volumes of pentan-1-ol and 992  volumes of hexane.


system suitability

Inject 20 µl of solution (3) and record the chromatogram using a sensitivity such that the height of the peak due to colecalciferol is more than 50% of full-scale deflection. When the chromatogram is recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol. The test is not valid unless the resolution factor between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0. If necessary, adjust the proportions of the constituents and the flow rate of the mobile phase to obtain this resolution.


determination of content 

Calculate the content of ergocalciferol, C28H44O, in each tablet using the declared content of C28H44O in ergocalciferol BPCRS and using peak heights.

Assay

For tablets containing 2 mg or more of ergocalciferol

Carry out the following procedure in subdued light. Weigh and powder 25  tablets, or more if necessary. To a quantity of the powdered tablets containing 6  mg of Ergocalciferol add 50  ml of ethanol (96%), 14  ml of glycerol and 20  ml of a 50% w/v solution of potassium hydroxide. Boil under a reflux condenser for 30  minutes, swirling occasionally, add 110  ml of water and allow to stand for 10  minutes with occasional stirring. Cool and add sufficient ethanol (96%) to produce 250  ml. Shake 5  ml with 25  ml of petroleum spirit (boiling range, 40° to 60°) for 3  minutes and evaporate duplicate 5  ml portions of the extract to dryness in a current of oxygen-free nitrogen. Dissolve each residue in 1  ml of ethanol-free chloroform, add rapidly 9  ml of antimony trichloride solution and measure the absorbance of each solution at 500  nm and at 550  nm, 90  to 120  seconds after adding the reagent, Appendix II B. Repeat the operations using duplicate 1  ml portions of a solution containing a known amount of ergocalciferol BPCRS in ethanol-free chloroform and beginning at the words 'add rapidly 9  ml of antimony trichloride solution…'. Subtract the absorbance at 550  nm from that at 500  nm and calculate the content of ergocalciferol in mg from the average value so obtained and from the amount of ergocalciferol in the reference solution using the declared content of C28H44O in ergocalciferol BPCRS.


For tablets containing less than 2 mg of ergocalciferol

Use the average of the 10 individual results obtained in the test for Uniformity of content. 

Labelling

The label states the equivalent number of IU (units) of antirachitic activity (vitamin D) per tablet.


Each μg of ergocalciferol is equivalent to 40  IU of antirachitic activity (vitamin D).


When calciferol tablets are prescribed or demanded, Colecalciferol Tablets or Ergocalciferol Tablets shall be dispensed or supplied.




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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