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High Quality USP/EP/BP GMP DMF FDA Calcium and Colecalciferol Tablets CAS NO Producer

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  • AZ036
  • Dideu
  • China
  • Calcium and Colecalciferol 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:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

                                                                                 Calcium and Colecalciferol Tablets 

Definition

Calcium and Colecalciferol Tablets contain Calcium Carbonate and Colecalciferol.

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

Content of calcium85.0  to 115.0% of the stated amount.
Content of colecalciferol, C27H44O


90.0  to 120.0% of the stated amount.

Identification


A.  Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 20 µg of colecalciferol with 20  ml of the mobile phase with the aid of ultrasound for 15  minutes, cool to room temperature, centrifuge and use the supernatant liquid. Solution (2) contains 0.0001% w/v each of colecalciferol BPCRS and ergocalciferol BPCRS in the mobile phase. Solution (3) contains 0.0001% w/v of colecalciferol BPCRS in the mobile phase.


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 10  volumes of water and 90  volumes of methanol and (c) a detection wavelength of 265  nm.


Inject 50 µl of each solution. The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the two principal peaks is at least 1.4. If necessary, adjust the composition of the mobile phase to obtain the required resolution.


A peak in the chromatogram obtained with solution (1) has the same retention time as the peak due to colecalciferol in the chromatogram obtained with solution (3).


B.  Shake a quantity of the powdered tablets containing the equivalent of 10  mg of calcium with 50  ml of water and filter. The solution yields reaction A characteristic of calcium salts, Appendix VI.

Tests

Related substances

Disintegration

The requirement for Disintegration does not apply to Calcium and Colecalciferol Tablets intended to be chewed. Tablets intended to be swallowed whole comply with the test for disintegration of uncoated tablets or of coated tablets, as appropriate.


Uniformity of content

Tablets containing less than 2  mg or 2% of Colecalciferol comply with the requirements stated under Tablets, with respect to the content of Colecalciferol, 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. For solution (1) add 15  ml of methanol (90%), mix with the aid of ultrasound until the tablet is dispersed and then for a further 5  minutes, dilute to 20  ml with methanol (90%), mix, centrifuge and filter through a glass-fibre filter (Whatman GF/C is suitable). Solution (2) contains 0.00005% w/v of colecalciferol BPCRS in methanol (90%).


The chromatographic procedure described under Assay may be used.


Calculate the content of C27H44O in each tablet using the declared content of C27H44O in colecalciferol BPCRS.


Assay

For calcium

Weigh and powder 20  tablets. To a quantity of the powder containing the equivalent of 50  mg of calcium add 50  ml of water and 5  ml of hydrochloric acid. Heat the dispersion gently to boiling and continue to boil for about 2  minutes. Allow to cool and add 50  ml of 0.05m disodium edetate VS. Neutralise the solution using 2m sodium hydroxide, add 10  ml of ammonia buffer pH 10.9 and 50  ml of water. Titrate the excess of disodium edetate with 0.05m zinc chloride VS using mordant black II solution as indicator. Each ml of 0.05m disodium edetate VS is equivalent to 2.004  mg of Ca.


For colecalciferol

Carry out the following procedure protected from light. Weigh and powder 20  tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) shake a quantity of the powdered tablets containing 0.1  mg of Colecalciferol with about 170  ml of methanol (90%) for 5  minutes and then mix with ultrasound for 5  minutes, dilute to 200  ml with methanol (90%), mix, centrifuge and filter through a glass-fibre filter (Whatman GF/C is suitable). Solution (2) contains 0.00005% w/v of colecalciferol BPCRS in methanol.


The chromatographic procedure may be carried out using (a) a stainless steel column (10  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable), (b) a mixture of 3  volumes of water and 97  volumes of methanol as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 264  nm. Inject 50 µl of each solution.


Calculate the content of C27H44O in the tablets using the declared content of C27H44O in colecalciferol BPCRS.

Labelling

The label states (1) where appropriate, that the tablets should be chewed before swallowing; (2) the equivalent number of IU (Units) of antirachitic activity (vitamin D); (3) the equivalent amount of calcium.

Each microgram of Colecalciferol is equivalent to 40  IU of antirachitic activity (vitamin D).




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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