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High Quality USP/EP/BP GMP DMF FDA Sodium Fusidate Ointment CAS NO 751-94-0 Producer

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Price: $ 0.08 / pcs
Quantity:
min order: 1 pcs
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ548
  • Dideu
  • 751-94-0
  • C31H47NaO6
  • 212-030-3
  • China
  • Sodium Fusidate Ointment
  • 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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Sodium Fusidate Ointment 

Definition

Sodium Fusidate Ointment contains Sodium Fusidate in a suitable basis.


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

Content of sodium fusidate, C31H47NaO6

92.5  to 107.5% of the stated amount.

Identification

A.  Disperse a quantity of the ointment containing 60  mg of Sodium Fusidate in 30  ml of n-hexane and shake with 6  ml of water. Allow to separate, remove the aqueous layer and add to it 5  ml of 0.2m orthophosphoric acid. Extract with two 10  ml quantities of chloroform, dry the combined chloroform extracts with anhydrous sodium sulphate, evaporate to dryness and dissolve the residue in 0.6  ml of chloroform IR. The infrared absorption spectrum of the resulting solution, Appendix II A, is concordant with the reference spectrum of fusidic acid (RS 166).


B.  In the Assay, the principal peak in the chromatogram obtained with solution (2) has the same retention time as the peak due to fusidic acid in the chromatogram obtained with solution (1).

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following three solutions. For solution (1) add 25  ml of n-hexane to a quantity of the ointment containing 50  mg of Sodium Fusidate, stir, extract with 10  ml of ethanol (70%) and allow the layers to separate. Use the ethanol layer and filter if necessary. For solution (2) mix 1  ml of a 0.10% w/v solution of 3-ketofusidic acid EPCRS in the mobile phase with 0.2  ml of solution (1) and dilute to 20  ml with the mobile phase. For solution (3) dilute 20 µl of solution (1) to 100  ml with the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (12.5  to 15  cm × 4  to 5  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Lichrospher 100 RP18 is suitable) (b) a mixture of 10  volumes of methanol, 20  volumes of a 1% w/v solution of orthophosphoric acid, 20  volumes of water and 50  volumes of acetonitrile as the mobile phase with a flow rate of 2  ml per minute and (c) a detection wavelength of 235  nm.


Inject separately 20 µl of each solution. Continue the chromatography for at least 3.5  times the retention time of the principal peak. The test is not valid unless the resolution factor between the peaks corresponding to 3-ketofusidic acid and sodium fusidate in the chromatogram obtained with solution (2) is at least 2.5 and unless the principal peak in the chromatogram obtained with solution (3) has a signal-to-noise ratio of at least 3.


In the chromatogram obtained with solution (1) the sum of the areas of any secondary peaks is not greater than 4  times the area of the peak corresponding to sodium fusidate in the chromatogram obtained with solution (2) (4%). Disregard any peak with an area less than that of the principal peak in the chromatogram obtained with solution (3) (0.02%).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.07% w/v of diethanolamine fusidate BPCRS in the mobile phase. For solution (2) add 10  ml of n-hexane and 25  ml of the mobile phase to a quantity of the ointment containing 30  mg of Sodium Fusidate, shake vigorously for 15  minutes and allow the layers to separate. Remove all of the lower layer, dilute to 50  ml with the mobile phase and filter through glass-fibre paper (Whatman GF/C is suitable).


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 (5 µm) (Lichrosorb RP-18 is suitable), (b) a mixture of 60  volumes of acetonitrile, 30  volumes of a 1% v/v solution of glacial acetic acid and 10  volumes of methanol as the mobile phase with a flow rate of 1.5  ml per minute and (c) a detection wavelength of 235  nm.


The column efficiency, determined using the principal peak in the chromatogram obtained with solution (1), should be not less than 14,000 theoretical plates per metre.


Calculate the content of C31H47NaO6 from the declared equivalent content of C31H47NaO6 in diethanolamine fusidate BPCRS.




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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