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Amphotericin Oral Suspension
|Action and use|
Amphotericin Oral Suspension is a suspension of Amphotericin in a suitable flavoured vehicle.
Amphotericin Oral Suspension should not be diluted.
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.
To a quantity containing the equivalent of 35 mg of amphotericin B add 10 ml of dimethyl sulphoxide, mix, add sufficient methanol to produce 250 ml and mix. If the solution is not clear, centrifuge a portion until clear. Dilute 2 ml of the clear supernatant liquid to 100 ml with methanol. The light absorption of the resulting solution, Appendix II B, in the range 300 to 450 nm exhibits three maxima, at 362, 381 and 405 nm. The ratio of the absorbance at the maximum at 362 nm to that at the maximum at 381 nm is 0.5 to 0.6. The ratio of the absorbance at the maximum at 381 nm to that at 405 nm is about 0.9.
Content of tetraenes
Not more than 13.3% w/w of the stated amount of amphotericin B when determined by the following method. For solution (1) to a quantity containing the equivalent of 37.5 mg of amphotericin B add 5 ml of dimethyl sulphoxide and 25 ml of methanol and shake for 10 minutes, add sufficient methanol to produce 50 ml, mix thoroughly and filter. Dilute 4 ml of the filtrate to 50 ml with methanol. Prepare solution (2) by dissolving 50 mg of amphotericin B EPCRS in 5 ml of dimethyl sulphoxide, adding sufficient methanol to produce 50 ml and diluting 4 ml to 50 ml with methanol. For solution (3) dissolve 25 mg of nystatin EPCRS in 25 ml of dimethyl sulphoxide, dilute to 250 ml with methanol and dilute 4 ml of the resulting solution to 50 ml with methanol. Measure the absorbances of solutions (1) and (2) at the maximum at 282 nm and that of solution (3) at the same wavelength, Appendix II B, using a 0.8% v/v solution of dimethyl sulphoxide in methanol in the reference cell. Then measure the absorbance of solution (3) at the maximum at 304 nm and those of solutions (1) and (2) at the same wavelength. Calculate the A(1%, 1 cm) of the preparation being examined, at both wavelengths, each with reference to the content obtained in the assay. Calculate the A(1%, 1 cm) of nystatin EPCRS and of amphotericin B EPCRS, at both wavelengths, each with reference to the dried substance. Calculate the percentage content of tetraenes (x) from the expression:
x = F + 100 (B1S2-B2S1) / (N2B1-N1B2)
where S1 and S2 are the specific absorbances of the preparation being examined at 282 nm and 304 nm respectively, N1 and N2 are the specific absorbances of nystatin EPCRS at 282 nm and 304 nm respectively, B1 and B2 are the specific absorbances of amphotericin B EPCRS at 282 nm and 304 nm respectively and F is the declared content of tetraenes in amphotericin B EPCRS.
To a weighed quantity containing the equivalent of 0.5 g of amphotericin B add 60 ml of dimethyl sulphoxide and shake for 20 minutes. Add sufficient dimethyl sulphoxide to produce 100 ml, mix, filter (Whatman No. 1 filter paper is suitable) and dilute 10 ml of the filtrate to 50 ml with dimethyl sulphoxide. Carry out the microbiological assay of antibiotics, Appendix XIV A. The precision of the assay is such that the fiducial limits of error are not less than 95% and not more than 105% of the estimated potency.
Calculate the content of amphotericin B in the oral suspension taking each 1000 IU found to be equivalent to 1 mg of amphotericin B. The upper fiducial limit of error is not less than 90.0% and the lower fiducial limit of error is not more than 115.0% of the stated content.
|Storage||Amphotericin Oral Suspension should be protected from light and used within the period stated on the label.|
The quantity of active ingredient is stated in terms of the equivalent amount of amphotericin B. The label states the appropriate directions for using the preparation.
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.
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:
II)Nutrition Additive Industries
III)Daily-Use Chemical Products Industries & Agrochemicals
IV)Environmental Friendly Chemical And Chemurgy 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.