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High Quality USP/EP/BP GMP DMF FDA Norfloxacin Tablets CAS NO 70458-96-7 Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
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  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ252
  • Dideu
  • 70458-96-7
  • C16H18FN3O3
  • 274-614-4
  • China
  • Norfloxacin Tablets
  • High quality
  • 99.0% Min
  • 99%-101%
  • Tablet
  • 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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Norfloxacin Tablets 

Action and use

Fluoroquinolone antibacterial.

Definition

Norfloxacin Tablets contain Norfloxacin.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of norfloxacin, C16H18FN3O3

95.0  to 105.0% of the stated amount.
Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, protected from light, using a silica gel GF254 precoated plate which has been previously washed with methanol and allowed to dry in air (Analtech plates are suitable) and a mixture of 8  volumes of water, 14  volumes of diethylamine, 20  volumes of toluene, 40  volumes of chloroform and 40  volumes of methanol as the mobile phase. Apply separately to the plate 50 µl of each of the following solutions. For solution (1) add 2  ml of water to a quantity of whole tablets containing 0.4  g of Norfloxacin and disperse with the aid of ultrasound. Add 100  ml of a solution containing 50  volumes of dichloromethane and 50  volumes of a solution prepared by adding 9  ml of hydrochloric acid to 1000  ml of methanol, mix with the aid of ultrasound until a uniform suspension is produced, add sufficient of the same solvent mixture to produce 200  ml and centrifuge 25  ml of the final solution. For solution (2) dissolve, with the aid of ultrasound, 50  mg of norfloxacin BPCRS in 15  ml of a solution containing 50  volumes of dichloromethane and 50  volumes of a solution prepared by adding 9  ml of hydrochloric acid to 1000  ml of methanol and add sufficient of the same solvent mixture to produce 25  ml. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254  nm and 365  nm). By each method of visualisation, the principal spot in the chromatogram obtained with solution (1) corresponds in position, colour and size to that in the chromatogram obtained with solution (2).


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

Tests

Related substances

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2, protected from light. Use as the medium 750  ml of an acetate buffer solution prepared in the following manner and rotate the paddle at 50 revolutions per minute. Add 14.3  ml of glacial acetic acid to 4500  ml of water, mix, add slowly with stirring 2.5  ml of a 50% w/v solution of sodium hydroxide and add sufficient water to produce 5000  ml. If necessary, adjust the pH to 4.0 with glacial acetic acid or a 50% w/v solution of sodium hydroxide. After 30  minutes, withdraw a sample of 20  ml of the medium, filter and dilute the filtrate with sufficient of the dissolution medium to give a solution expected to contain about 0.0016% w/v of Norfloxacin. Measure the absorbance of this solution, Appendix II B, at 313  nm using dissolution medium in the reference cell. Calculate the total content of norfloxacin, C16H18FN3O3, in the medium from the absorbance obtained from a 0.0016% w/v solution of norfloxacin BPCRS in the dissolution medium and using the declared content of C16H18FN3O3 in norfloxacin BPCRS. The amount of norfloxacin released is not less than 85% of the stated amount.

Assay

Weigh and powder 20  tablets. Carry out the method for liquid chromatography, Appendix III D, protected from light, using the following solutions. For solution (1) add 80  ml of the mobile phase to a quantity of the powdered tablets containing 0.1  g of Norfloxacin, mix with the aid of ultrasound for at least 5  minutes, add sufficient of the mobile phase to produce 200  ml, mix and dilute 10  volumes of this solution to 25  volumes with the mobile phase. Solution (2) contains 0.02% w/v of norfloxacin BPCRS in the mobile phase.


The chromatographic procedure may be carried out using (a) a stainless steel column (30  cm × 3.9  mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 µm) (Waters µBondapak C18 is suitable) maintained at 40°, (b) a mixture of 150  volumes of acetonitrile and 850  volumes of 0.1% v/v solution of orthophosphoric acid as the mobile phase with a flow rate of 2  ml per minute and (c) a detection wavelength of 275  nm.


Inject 10 µl of each solution. Precondition the column using 0.01m anhydrous sodium dihydrogen orthophosphate, adjusted to pH 4.0 with orthophosphoric acid, at a flow rate of 0.5  ml per minute for 8  hours. Equilibrate the column with the mobile phase for about 30  minutes before starting the chromatography. When the chromatograms are recorded under the conditions described above, the retention time of norfloxacin is about 5  minutes.


The assay is not valid unless the symmetry factor of the principal peak in the chromatogram obtained with solution (2) is less than 2.0.


Inject solution (2) six times. The assay is not valid unless the relative standard deviation of the area of the principal peak is at most 2.0%.


Calculate the content of C16H18FN3O3 in the tablets using the declared content of C16H18FN3O3 in norfloxacin BPCRS.

Storage

Norfloxacin Tablets should be protected from light and moisture.




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.

2316

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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