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High Quality USP/EP/BP GMP DMF FDA Potassium Hydroxyquinoline Sulphate and Benzoyl Peroxide Cream CAS NO Producer

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  • AZ501
  • Dideu
  • China
  • Potassium Hydroxyquinoline Sulphate and Benzoyl Peroxide Cream
  • High quality
  • 99.0% Min
  • 99%-101%
  • Cream
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Potassium Hydroxyquinoline Sulphate and Benzoyl Peroxide Cream 

Action and use

Definition

Potassium Hydroxyquinoline Sulphate and Benzoyl Peroxide Cream contains Potassium Hydroxyquinoline Sulphate and Hydrous Benzoyl Peroxide in a suitable astringent basis.


The cream complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.

Content of potassium hydroxyquinoline sulphate, (C9H7NO)2,H2SO4:K2SO4

90.0  to 110.0% of the stated amount.
Content of anhydrous benzoyl peroxide, C14H10O490.0  to 110.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and a mixture of 2  volumes of glacial acetic acid, 4  volumes of dichloromethane and 100  volumes of toluene as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) shake a quantity of the cream containing the equivalent of 50  mg of anhydrous benzoyl peroxide with 10  ml of chloroform and filter. Solution (2) contains 0.5% w/v of benzoyl peroxide in chloroform. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm). The principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).


B.  Add 20  ml of methanol to a quantity of the cream containing 10  mg of Potassium Hydroxyquinoline Sulphate, heat in a water bath, shaking occasionally, cool and filter through anhydrous sodium sulphate. To 10  ml of the filtrate add 5  ml of a 0.5% w/v solution of iron(ii) sulphate in methanol (70%). A dark blue or green colour is produced immediately.

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute 2  volumes of solution (2) to 100  volumes with the mobile phase. For solution (2) disperse a quantity of the cream containing the equivalent of 0.10  g of anhydrous benzoyl peroxide with 25  ml of acetonitrile by shaking vigorously, add sufficient water to produce 50  ml, mix and filter. Solution (3) contains 0.020% w/v of benzoic acid in the mobile phase. Solution (4) contains 0.0020% w/v of ethyl benzoate in the mobile phase. Solution (5) contains 0.0020% w/v of benzaldehyde in the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (20  cm × 4.6  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Spherisorb ODS 1 is suitable), (b) a mixture of 1  volume of glacial acetic acid, 500  volumes of acetonitrile and 500  volumes of water as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 235  nm.


In the chromatogram obtained with solution (2) the areas of any peaks corresponding to benzoic acid, ethyl benzoate and benzaldehyde are not greater than the areas of the principal peaks in the chromatograms obtained with solutions (3) (10%), (4) (1%) and (5) (1%) respectively. The area of any other secondary peak is not greater than half of the area of the principal peak in the chromatogram obtained with solution (1) (0.5%).

Assay

For potassium hydroxyquinoline sulphate

Shake vigorously a quantity of the cream containing 35  mg of Potassium Hydroxyquinoline Sulphate with 50  ml of chloroform and 10  ml of 13.5m ammonia for 5  minutes. Separate and reserve the chloroform layer and extract the aqueous layer with a further 50  ml of chloroform. Extract the combined chloroform layers with two 50  ml quantities of 3.5m hydrochloric acid, combine the extracts, wash gently with three 50  ml quantities of chloroform and discard the chloroform layers. Add 50  ml of 0.01m bromine VS, stopper the flask, shake for 20  minutes and allow to stand for 20  minutes. Add 10  ml of dilute potassium iodide solution and titrate with 0.02m sodium thiosulphate VS using starch solution, added towards the end of the titration, as indicator. Repeat the titration using 100  ml of 3.5m hydrochloric acid and beginning at the words 'Add 50  ml...'. The difference between the titrations represents the amount of bromine required. Each ml of 0.01m bromine VS is equivalent to 1.407  mg of (C9H7NO)2,H2SO4:K2SO4.


For benzoyl peroxide

Shake gently a quantity of the cream containing the equivalent of 0.4  g of anhydrous benzoyl peroxide with 50  ml of chloroform until the cream has dispersed and filter the lower layer excluding any solid matter that separates at the interface. Repeat the extraction with two further 50  ml quantities of chloroform, wash the filter with chloroform, combine the extracts and washings and dilute to 250  ml with chloroform. To 25  ml of the chloroform extract add 40  ml of a 0.0005% w/v solution of iron(iii) chloride hexahydrate in glacial acetic acid and 10  ml of dilute potassium iodide solution and shake for 20  minutes protected from light. Add 60  ml of water and titrate with 0.0125m sodium thiosulphate VS using starch solution, added towards the end of the titration, as indicator. Repeat the titration using 25  ml of chloroform in place of the chloroform extract. The difference between the titrations represents the amount of sodium thiosulphate required. Each ml of 0.0125m sodium thiosulphate VS is equivalent to 1.514  mg of C14H10O4.

Labelling

The content of Hydrous Benzoyl Peroxide is stated in terms of the equivalent amount of anhydrous benzoyl peroxide.




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.

Cream 9Cream 11Cream 86

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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