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High Quality USP/EP/BP GMP DMF FDA Aluminium Hydroxide Oral Suspension CAS NO 21645-51-2 Producer

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  • AZ559
  • Dideu
  • 21645-51-2
  • AlH3O3
  • 244-492-7
  • China
  • Oral Suspension
  • High quality
  • 99.0% Min
  • 99%-101%
  • Oral Suspension
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Aluminium Hydroxide Oral Suspension 

Definition

Aluminium Hydroxide Oral Suspension is an aqueous suspension of hydrated aluminium oxide together with varying quantities of basic aluminium carbonate. It contains the equivalent of 4% w/w of aluminium oxide and has a peppermint flavour.

The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.

Content of aluminium oxide, Al2O3

The equivalent of 3.5  to 4.4% w/w.

Identification

A solution in 2m hydrochloric acid yields the reaction characteristic of aluminium salts, Appendix VI.

Tests

Related substances

Alkalinity

pH, when diluted with an equal volume of carbon dioxide-free water, not more than 7.5, Appendix V L.

Neutralising capacity

Disperse 5  g in 100  ml of water, heat to 37°, add 100  ml of 0.1m hydrochloric acid VS previously heated to 37° and stir continuously, maintaining the temperature at 37°. The pH of the solution, at 37°, after 10, 15 and 20  minutes, is not less than 1.8, 2.3 and 3.0 respectively and at no time during this period is it more than 4.0. Add 10  ml of 0.5m hydrochloric acid VS previously heated to 37°, stir continuously for 1  hour maintaining the temperature at 37° and titrate the solution with 0.1m sodium hydroxide VS to pH 3.5. Not more than 50  ml of 0.1m sodium hydroxide VS is required.

Ammonium salts

To 25  g in an ammonia-distillation apparatus add 25  ml of 5m sodium hydroxide and 250  ml of water, distil about 100  ml, collecting the distillate in 25  ml of 0.1m hydrochloric acid VS, and titrate the excess of acid with 0.1m sodium hydroxide VS using methyl red solution as indicator. Not less than 20.0  ml of 0.1m sodium hydroxide VS is required.

Arsenic

Dissolve 2.0  g in 18  ml of brominated hydrochloric acid and 32  ml of water. 25  ml of the resulting solution complies with the limit test for arsenic, Appendix VII (1  ppm).

Heavy metals

Dissolve 2.0  g in 20  ml of 1m hydrochloric acid and 10  ml of water, add 0.5  ml of nitric acid and boil for about 30  seconds. Cool, add 2  g of ammonium chloride and 2  g of ammonium thiocyanate and extract with two 10  ml quantities of a mixture of equal volumes of isoamyl alcohol and ether. To the aqueous layer add 2  g of citric acid and dilute to 40  ml with water. 12  ml of the resulting solution complies with limit test A for heavy metals, Appendix VII. Use lead standard solution (1  ppm Pb) to prepare the standard (20  ppm).

Chloride

Dissolve 0.30  g in 2  ml of 2m nitric acid, boil, cool, dilute to 250  ml with water and filter. 15  ml of the filtrate complies with the limit test for chlorides, Appendix VII (0.3%).

Sulphate

Dissolve 0.50  g in 5  ml of 2m hydrochloric acid, boil, cool, dilute to 200  ml with water and filter. 12.5  ml of the filtrate, diluted to 15  ml with 2m hydrochloric acid, complies with the limit test for sulphates, Appendix VII (0.5%).

Microbial contamination

Carry out a quantitative evaluation for Enterobacteria and certain other Gram-negative bacteria, Appendix XVI B1. 0.01  ml of the preparation gives a negative result, Table I (most probable number of bacteria per gram fewer than 102).

Assay

Dissolve 5  g in 3  ml of hydrochloric acid by warming on a water bath, cool to below 20° and dilute to 100  ml with water. To 20  ml of this solution add 40  ml of 0.05m disodium edetate VS, 80  ml of water and 0.15  ml of methyl red solution and neutralise by the drop wise addition of 1m sodium hydroxide. Heat on a water bath for 30  minutes, add 3  g of hexamine and titrate with 0.05m lead nitrate VS using 0.5  ml of xylenol orange solution as indicator. Each ml of 0.05m disodium edetate VS is equivalent to 2.549  mg of Al2O3.

Storage

Aluminium Hydroxide Oral Suspension should be kept at a temperature not exceeding 30°. It should not be allowed to freeze.




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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

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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.


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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