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High Quality USP/EP/BP GMP DMF FDA Fusidic Acid Oral Suspension CAS NO 6990-06-3 Producer

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  • AZ581
  • Dideu
  • 6990-06-3
  • C31H48O6
  • 230-256-0
  • 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

Our Reference Specification, for more details, pls contact us for COA,MSDS and certification:

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Fusidic Acid Oral Suspension

Action and use

Antibacterial.

Definition

Fusidic Acid Oral Suspension is a suspension of Fusidic Acid in powder of suitable fineness in a suitable flavoured vehicle.

Fusidic Acid Oral Suspension should not be diluted.

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

Content of anhydrous fusidic acid, C31H48O6 

92.5  to 107.5% of the stated amount.

Identification

A.  To a quantity containing the equivalent of 0.1  g of anhydrous fusidic acid add 5  ml of water and extract with three 10-ml quantities of chloroform. Wash the combined extracts with two 10-ml quantities of water, dry with anhydrous sodium sulphate, evaporate to dryness and dissolve the residue in 1  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 chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to fusidic acid in the chromatogram obtained with solution (2).

Tests

Related substances

Tests

Acidity

pH, 4.8  to 5.2, Appendix V L.

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1)  Extract a quantity of the oral suspension containing the equivalent of 0.10  g of anhydrous fusidic acid with two 20-ml quantities of chloroform, evaporate the combined extracts to dryness and dissolve the residue in 20  ml of the mobile phase.

(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.

(3)  Dilute 20 µl of solution (1) to 100  ml with the mobile phase.

chromatographic conditions 

(a)  Use a stainless steel column (12.5  to 15  cm × 4  to 5  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Lichrospher 100 RP-18 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 235 nm.

(f)  Inject 20 µl of each solution.

(g)  For solution (1) allow the chromatography to proceed for at least 3.5  times the retention time of the principal peak. 

mobile phase 

10  volumes of methanol, 20  volumes of a 1% w/v solution of orthophosphoric acid, 20  volumes of water and 50  volumes of acetonitrile.

system suitability 

The test is not valid unless:

in the chromatogram obtained with solution (2), the resolution factor between the peaks corresponding to 3-ketofusidic acid and fusidic acid is at least 2.5;

in the chromatogram obtained with solution (3), the principal peak has a signal-to-noise ratio of at least 3.

If necessary, adjust the composition of the mobile phase.

limits 

In the chromatogram obtained with solution (1):

the sum of the areas of any secondary peaks is not greater than three times the area of the peak corresponding to fusidic acid in the chromatogram obtained with solution (2) (3%). 

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. 

(1)  Shake thoroughly a weighed quantity of the oral suspension containing the equivalent of 30  mg of anhydrous fusidic acid with 25  ml of the mobile phase, dilute to 50  ml with the mobile phase, filter and use the clear filtrate.

(2)  0.07% w/v of diethanolamine fusidate BPCRS in the mobile phase.  

chromatographic conditions 

(a)  Use a stainless steel column (20  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (LiChrosorb RP-18 is suitable).

(b)  Use isocratic elution and the mobile phase described below.

(c)  Use a flow rate of 1.5 ml per minute.

(d)  Use an ambient column temperature. 

(e)  Use a detection wavelength of 235 nm.

(f)  Inject 20 µl of each solution.

mobile phase 

10  volumes of methanol, 30  volumes of a 1% v/v solution of glacial acetic acid and 60  volumes of acetonitrile.

system suitability 

The Assay is not valid unless the column efficiency, determined using the principal peak in the chromatogram obtained with solution (2), is at least 14,000 theoretical plates per metre.

determination of content 

Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of C31H48O6, weight in volume, using the declared content of C31H48O6 in diethanolamine fusidate BPCRS.

Storage

Fusidic Acid Oral Suspension should be protected from light.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous fusidic acid.

When Fusidic Acid Oral Suspension is prescribed or demanded, no strength being stated, an Oral Suspension containing the equivalent of 250  mg of anhydrous fusidic acid in 5  ml 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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

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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