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High Quality USP/EP/BP GMP DMF FDA Hydrocortisone Acetate and Neomycin Eye Ointment CAS NO Producer

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  • AZ531
  • Dideu
  • China
  • Hydrocortisone Acetate and Neomycin Eye 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

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

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Hydrocortisone Acetate and Neomycin Eye Ointment 

Action and use

Corticosteroid + Aminoglycoside antibacterial.

Definition

Hydrocortisone Acetate and Neomycin Eye Ointment is a sterile preparation containing Hydrocortisone Acetate and Neomycin Sulphate in a suitable basis.


The eye ointment complies with the requirements stated under Eye Preparations and with the following requirements.

Content of hydrocortisone acetate, C23H32O6 

92.5  to 107.5% of the stated amount.

Identification

A.  Complies with test A for Identification described under Hydrocortisone and Neomycin Cream using the following solutions. For solution (1) add 10  ml of hexane saturated with acetonitrile to a quantity of the ointment containing 5  mg of Hydrocortisone Acetate and shake for 2  to 3  minutes. Add 10  ml of acetonitrile saturated with hexane , shake for 10  minutes and allow the layers to separate. Centrifuge, filter the acetonitrile layer if necessary, evaporate 5  ml to dryness and dissolve the residue in 5  ml of a mixture of equal volumes of chloroform and ethanol (96%) . Solution (2) contains 0.05% w/v of hydrocortisone acetate BPCRS in a mixture of equal volumes of chloroform and ethanol (96%) .


B.  In the Assay for hydrocortisone acetate the chromatogram obtained with solution (3) shows a peak with the same retention time as the peak due to hydrocortisone acetate in the chromatogram obtained with solution (1).


C.  Complies with test C for Identification described under Hydrocortisone and Neomycin Cream. For solution (1) shake a quantity containing 7000  IU of Neomycin Sulphate with 10  ml of chloroform , add 5  ml of water, shake, centrifuge and use the clear, upper layer.

Tests

Neamine

Complies with the test described under Hydrocortisone and Neomycin Cream. For solution (1) disperse a quantity containing 7000  IU of Neomycin Sulphate in 10  ml of chloroform , shake gently with 5  ml of water, centrifuge and use the aqueous layer.


Neomycin C

Complies with the test described under Hydrocortisone and Neomycin Cream.

Assay

For hydrocortisone acetate 

Carry out the method for liquid chromatography , Appendix III D, using the following solutions. Solution (1) contains 0.025% w/v of hydrocortisone acetate BPCRS and 0.050% w/v of fluoxymesterone BPCRS (internal standard) in chloroform . For solution (2) shake a quantity of the ointment containing 25  mg of Hydrocortisone Acetate with 20  ml of a 0.25% w/v solution of fluoxymesterone BPCRS in chloroform and several glass beads for 30  minutes. Centrifuge; to 10  ml of the clear, supernatant layer add sufficient chloroform to produce 50  ml.


The chromatographic procedure may be carried out using (a) a stainless steel column (30  cm × 3.9  mm) packed with silica gel for chromatography (10 µm) (µPorasil is suitable), (b) a mixture of 425  volumes of butyl chloride , 425  volumes of butyl chloride saturated with water, 70  volumes of tetrahydrofuran , 35  volumes of methanol and 30  volumes of glacial acetic acid as the mobile phase with a flow rate of 1  ml per minute and (c) a detection wavelength of 254  nm.


Calculate the content of C23H32O6 in the ointment using the declared content of C23H32O6 in hydrocortisone acetate BPCRS .

For neomycin sulphate

Dissolve a quantity containing 3500  IU in 50  ml of ether , extract the solution with three 30-ml quantities of sterile phosphate buffer pH 8.0 and discard the ether phase. Pass nitrogen through the combined aqueous extracts to remove dissolved ether, dilute to 100  ml with sterile phosphate buffer pH 8.0 and 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. 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 number of IU per g.

Labelling

The strength with respect to Neomycin Sulphate is stated as the number of IU (Units) per g.




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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