Online

Cart
You are here: Home » Products » Pharmaceutical Ingredient » Other Chemicals » High Quality USP/EP/BP GMP DMF FDA Mupirocin Nasal Ointment CAS NO Producer
Share to:

High Quality USP/EP/BP GMP DMF FDA Mupirocin Nasal Ointment CAS NO Producer

5 0 Reviews
Price: $ 0.08 / pcs
Quantity:
min order: 1 pcs
View wholesale prices
  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ539
  • Dideu
  • China
  • Mupirocin Nasal 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:

Email & Skype: support@dideu.com  Telephone:+86-29-89586682

Mobile:+86-15129568250; Whatsapp: +8615129568250

Mupirocin Nasal Ointment 

Action and use

Antibacterial.

Definition

Mupirocin Nasal Ointment contains Mupirocin Calcium in a suitable basis.


The nasal ointment complies with the requirements stated under Nasal Preparations and with the following requirements.

Content of mupirocin, C26H44O9

90.0 to 105.0% of the stated amount.

Identification

A.  Disperse a quantity of the nasal ointment containing the equivalent of 100 mg of mupirocin in a mixture of 20 ml of dichloromethane and 4 ml of 0.2m sodium borate buffer pH 8.4, with shaking, and centrifuge at 3000 revolutions per minute until separate layers are obtained. Remove and retain the upper aqueous layer and re-extract the lower layer with a further 4 ml of 0.2m sodium borate buffer pH 8.4. Combine the aqueous extracts, add 10 ml of dichloromethane to the combined extracts and centrifuge at 3000 revolutions per minute. Remove the upper aqueous layer and adjust the pH to about 4 with 1m hydrochloric acid (a slight cloudiness may be observed), add 10 ml of dichloromethane and centrifuge. Separate and retain the lower layer; add a further 10 ml of dichloromethane to the upper layer and centrifuge. Combine the dichloromethane extracts and evaporate to dryness at room temperature under a current of nitrogen; a jelly-like residue is obtained. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of mupirocin (RS 425).


B.  In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is the same as that of the principal peak in the chromatogram obtained with solution (2).

Tests

Related substances

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


(1)  Disperse a quantity of the nasal ointment containing the equivalent of 50 mg of mupirocin in 5 ml of a solution containing 3 volumes of tetrahydrofuran and 1 volume of water and shake vigorously on a mechanical shaker for 1 hour. Add 5 ml of a solution prepared by dissolving 13.6 g of sodium acetate in 1000 ml of water, mixing and adjusting the pH to 4.0 with glacial acetic acid, shake for a further 15 minutes. Allow the layers to separate and filter the lower aqueous layer (Whatman GF/F filter paper is suitable).

(2)  Dilute 1 volume of solution (1) to 50 volumes with a solution containing 3 volumes of tetrahydrofuran and 1 volume of water.


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.6 mm) packed with octylsilyl silica gel for chromatography (7 µm) (Zorbax C8 is suitable) fitted with a suitable stainless steel guard column packed with the same material.

(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 240 nm.

(f)  Inject 20 µl of each solution.


mobile phase

25 volumes of tetrahydrofuran and 75 volumes of a solution prepared by dissolving 7.7 g of ammonium acetate in 900 ml of water, adjusting the pH to 5.7 with 0.1m glacial acetic acid and diluting to 1000 ml with water.


When the chromatograms are recorded under the prescribed conditions the retention time of mupirocin is about 12 minutes. 


system suitability

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the peak due to mupirocin and the peak with a retention time relative to mupirocin of about 0.75 (mupirocin impurity C) is at least 3.5. 


limits

In the chromatogram obtained with solution (1):


the area of any peak corresponding to impurity C is not greater than 4% by normalisation;


the area of any other secondary peak is not greater than 1% by normalisation;


the sum of the areas of all the secondary peaks is not greater than 10% by normalisation. 

Assay

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


(1)  Disperse a quantity of the nasal ointment containing the equivalent of 10 mg of mupirocin in 50 ml of a solution containing 3 volumes of tetrahydrofuran and 1 volume of water and shake vigorously on a mechanical shaker for 1 hour. Add 50 ml of a solution prepared by dissolving 13.6 g of sodium acetate in 1000 ml of water, mixing and adjusting the pH to 4.0 with glacial acetic acid, shake for a further 15 minutes and filter (Whatman GF/F filter paper is suitable).

(2)  0.01% w/v of mupirocin lithium EPCRS in a solution containing 3 volumes of tetrahydrofuran and 1 volume of water.


chromatographic conditions

(a)  Use a stainless steel column (25 cm × 4.6 mm) packed with octylsilyl silica gel for chromatography (7 µm) (Zorbax C8 is suitable) fitted with a suitable stainless steel guard column packed with the same material.

(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 240 nm.

(f)  Inject 20 µl of each solution.


mobile phase

25 volumes of tetrahydrofuran and 75 volumes of a solution prepared by dissolving 7.7 g of ammonium acetate in 900 ml of water, adjusting the pH to 5.7 with 0.1m glacial acetic acid and diluting to 1000 ml with water.


When the chromatograms are recorded under the prescribed conditions the retention time of mupirocin is about 12 minutes. 


system suitability

The test is not valid unless, in the chromatogram obtained with solution (2), the resolution factor between the peak due to mupirocin and the peak with a retention time relative to mupirocin of about 0.75 (mupirocin impurity C) is at least 3.5. 


determination of content

Calculate the content of C26H44O9 in the nasal ointment using the declared content of C26H43O9Li in mupirocin lithium EPCRS. Each mg of C26H43O9Li is equivalent to 0.9882 mg of C26H44O9. 

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of mupirocin.

Impurities

The impurities limited by the requirements of this monograph include those listed under Mupirocin Calcium.




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.


Quality≥1000Unit,please send inquire:
Online Service

Product Inquiry

Customer Reviews

Trade Alert - Delivering the latest product trends and industry news straight to your inbox.

Customer Services
About Us
Chemicalorigin
Trade Services
 ©2020 Dideu Industries Group Limited