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High Quality USP/EP/BP GMP DMF FDA Tylosin Tablets CAS NO 1401-69-0 Producer

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  • AZ373
  • Dideu
  • 1401-69-0
  • C46H77NO17
  • 215-754-8
  • China
  • Tylosin 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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Tylosin Tablets 

Action and useMacrolide antibacterial.

Definition

Tylosin Tablets contain Tylosin.

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

Identification

A.  Triturate a quantity of the powdered tablets containing 0.2  g of Tylosin with 20  ml of chloroform, filter, dry the chloroform by shaking with anhydrous sodium sulphate, filter and evaporate the filtrate to dryness. Dry the residue over phosphorus pentoxide at a pressure not exceeding 0.7  kPa for 1  hour. The infrared absorption spectrum of the dried residue, Appendix II A, is concordant with the reference spectrum of tylosin (RSV 46).


B.  Triturate a quantity of the powdered tablets containing 0.2  g of Tylosin with two 10  ml quantities of 0.1m hydrochloric acid, filter and dilute the filtrate to 100  ml with 0.1m hydrochloric acid. Dilute 10  ml of the resulting solution to 50  ml with 0.1m hydrochloric acid and then dilute 5  ml of this solution to 50  ml with the same solvent. The light absorption of the resulting solution, Appendix II B, in the range 230  to 350  nm, exhibits a maximum only at 290  nm. The absorbance at the maximum is about 0.94.


C.  To 10  ml of the solution obtained in test B add 1  ml of 2m sodium hydroxide, heat on a water bath for 20  minutes and cool. The light absorption, Appendix II B, in the range 250  to 430  nm, exhibits a maximum at 332  nm.

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 2, rotating the paddle at 50 revolutions per minute.

(b)  Use 900  ml of 0.01m hydrochloric acid, at a temperature of 37°, as the medium.


procedure 

Withdraw a sample of 10  ml of the medium, filter and dilute to 100  ml with 0.01m hydrochloric acid. Measure the absorbance of this solution at the maximum at 290  nm, Appendix II B, using 0.01m hydrochloric acid in the reference cell.


determination of content 

Calculate the total content of tylosin, C46H77NO17, in the medium taking 233 as the value of A(1%, 1  cm) at the maximum at 290  nm.


Composition

Carry out the method for liquid chromatography, Appendix III D, using the following solutions prepared immediately before use.


(1)  Shake a quantity of the powdered tablets taken for the Assay containing 0.2  g of Tylosin with 50  ml of methanol, filter and dilute 5  ml of the filtrate to 100  ml with a mixture of equal volumes of water and acetonitrile.

(2)  0.02% w/v of tylosin BPCRS in a mixture of equal volumes of water and acetonitrile.


chromatographic conditions 

(a)  Use a stainless steel column (20  cm × 5  mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Nucleosil C18 is suitable).

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

(c)  Use a flow rate of 1 ml per minute.

(d)  Use an ambient column temperature.

(e)  Use a detection wavelength of 290 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

0.85m sodium perchlorate in a 40% v/v solution of acetonitrile, the pH of the solution being adjusted to 2.5 using 1m hydrochloric acid.


system suitability 

The chromatogram obtained with solution (2) shows similar resolution to the reference chromatogram supplied with tylosin BPCRS. If necessary adjust the molarity of the sodium perchlorate or raise the temperature of the column to a maximum of 50°. The order of elution of the six major components of tylosin BPCRS in the chromatogram obtained with solution (2) is desmycinosyltylosin, tylosin C, tylosin B, tylosin D, an aldol impurity and tylosin A.


The column efficiency, determined using the peak due to tylosin A in solution (2), should be at least 22,000 theoretical plates per metre.


limits 

Calculate the percentage content of components by normalisation. In the chromatogram obtained with solution (1):


the content of tylosin A is not less than 80%;


the total content of tylosins A, B, C and D is not less than 95%.


Tyramine

Shake a quantity of the powdered tablets containing 50  mg of Tylosin with 5  ml of 0.03m orthophosphoric acid. Filter into a 25  ml graduated flask, add 1  ml of pyridine and 2  ml of a saturated solution of ninhydrin (approximately 4% w/v). Close the flask by covering with a piece of aluminium foil and heat in a water bath at 85° for at least 20  minutes. Cool rapidly and add sufficient water to produce 25  ml. Measure the absorbance of the resulting solution without delay at 570  nm, Appendix II B, using in the reference cell a solution prepared in the same manner but omitting the preparation being examined. The absorbance is not greater than that obtained by carrying out the procedure at the same time using 5  ml of a solution in 0.03m orthophosphoric acid containing 35 µg of tyramine per ml and beginning at the words 'add 1  ml...' (0.35%).

Assay

Weigh and powder 20  tablets. Transfer a quantity of the powdered tablets containing 0.2  g of Tylosin to a 100  ml graduated flask with the aid of three 10  ml quantities of methanol, swirl to dissolve the tylosin and add sufficient sterile phosphate buffer pH 7.0 to produce 100  ml. Filter and dilute 5  ml of the filtrate to 100  ml with sterile phosphate buffer pH 7.0. 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 tylosin in the tablets, taking each 1000  IU found to be equivalent to 1  mg of tylosin. The upper fiducial limit of error is not less than 97.0% and the lower fiducial limit of error is not more than 110.0% of the stated amount.




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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