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High Quality USP/EP/BP GMP DMF FDA Clarithromycin Tablets CAS NO 81103-11-9 Producer

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Price: $ 0.08 / Tablet
Quantity:
min order: 1 Tablet
View wholesale prices
  • Quantity Price
  • 1 $0.5
  • 10000 $0.2
  • 100000 $0.1
  • 300000 $0.08
  • AZ063
  • Dideu
  • 81103-11-9
  • C38H69NO13
  • 1806241-263-5
  • China
  • Clarithromycin 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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Clarithromycin Tablets

Action and use Macrolide antibacterial.

Definition

Clarithromycin Tablets contain Clarithromycin.

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

Content of clarithromycin, C38H69NO13 95.0  to 105.0% of the stated amount.
Identification

Shake a quantity of the powdered tablets containing 0.5  g of Clarithromycin with 10 ml of water and extract with 20  ml of dichloromethane. Separate the lower dichloromethane layer and centrifuge. Filter the supernatant (Whatman GF/C is suitable) and evaporate to dryness. The infrared absorption spectrum of the residue, Appendix II A, after drying under vacuum at room temperature for 2 hours, is concordant with the reference spectrum of clarithromycin (RS 424).

Tests

Related substances

Dissolution

Carry out the dissolution test for tablets and capsules, Appendix XII BI.


test conditions

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

(b)  Use 900 ml of a solution containing 1000  volumes of a 1.361%  w/v solution of sodium acetate and 350  volumes of 0.1m acetic acid, adjusted to pH 5.0 with 0.1m acetic acid, at a temperature of 37º ± 0.5º, as the medium.


procedure

After 45 minutes, withdraw a sample of the medium and filter. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. 


(1)  Use the filtered dissolution medium, diluted with mobile phase if necessary, to produce a solution expected to contain 0.011%  w/v of Clarithromycin. 

(2)  0.011% w/v of clarithromycin BPCRS in the mobile phase. 

(3)  0.011%  w/v of each of clarithromycin BPCRS and clarithromycin impurity E BPCRS in the mobile phase.


chromatographic conditions

(a)  Use a stainless steel column (15  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Superspher ODS2 is suitable).

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

(c)  Use a flow rate of 1.5 ml per minute.

(d)  Use a column temperature of 50°.

(e)  Use a detection wavelength of 210 nm.

(f)  Inject 50 µl of each solution.


mobile phase

35  volumes of 0.067m potassium dihydrogen orthophosphate and 65  volumes of methanol adjusted to pH 4.0 with orthophosphoric acid.


When the chromatograms are recorded under the prescribed conditions the approximate retention times for clarithromycin and clarithromycin impurity E are 4 and 6 minutes respectively. 


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.0. 


determination of content

Calculate the total content of clarithromycin, C38H69NO13, in the medium using the declared content of C38H69NO13 in clarithromycin BPCRS.


Related substances

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


(1)  Disperse a quantity of powdered tablets containing 75  mg of Clarithromycin in 40  ml of a mixture of equal volumes of acetonitrile R1 and water (solution A), mix with the aid of ultrasound, add sufficient solution A to produce 50  ml and filter through a Whatman GF/C filter and then through a 0.45-µm PTFE filter.

(2)  Dilute 5  volumes of solution (1) to 100  volumes with solution A. 

(3)  Dilute 10  volumes of solution (2) to 100  volumes with solution A. 

(4)  0.15% w/v of clarithromycin for peak identification EPCRS in solution A.


chromatographic conditions

(a)  Use a stainless steel column (10 cm x 4.6 mm) packed with octadecylsilyl silica gel for chromatography (3 µm) (Kingsorb C18 is suitable).

(b)  Use gradient elution and the mobile phases described below.

(c)  Use a flow rate of 1.1 ml per minute.

(d)  Use a column temperature of 40°.

(e)  Use a detection wavelength of 205 nm.

(f)  Inject 10 µl of each solution.


mobile phase

Mobile phase A  A 0.476% w/v solution of potassium dihydrogen orthophosphate, adjusted to pH 4.4 with either 2m orthophosphoric acid or a 4.5% w/v solution of potassium hydroxide, filtered through a C18 filtration kit (3M Empore is suitable).


Mobile phase B  acetonitrile R1.


Use the following gradient.


3


When the chromatograms are recorded using the prescribed conditions the retention times relative to clarithromycin (retention  time  =  about  11  minutes) are: impurity  I  =  about  0.38; impurity  A  =  about  0.42; impurity  J  =  about  0.63; impurity  L  =  about  0.74; impurity  B  =  about  0.79; impurity  M  =  about  0.81; impurity  C  =  about  0.89; impurity  D  =  about  0.96; impurity  N  =  about  1.15; impurity  E  =  about  1.27; impurity  F  =  about  1.33; impurity  P  =  about  1.35; impurity  O  =  about  1.41; impurity  K  =  about  1.59; impurity  G  =  about  1.72; impurity  H  =  about  1.82.


system suitability

The test is not valid unless:


in the chromatogram obtained with solution (2) the symmetry factor of the peak due to clarithromycin is less than 1.75; 


in the chromatogram obtained with solution (4) the peak to valley ratio is at least 3.0 where Hp  is the  height above the baseline of the peak due to impurity  D and Hv  is the  height above the baseline of the lowest point of the curve separating this peak from the peak due to clarithromycin;


the chromatogram obtained with solution (4) closely resembles the chromatogram supplied with clarithromycin for peak identification EPCRS.


limits

Identify any peaks in the chromatogram obtained with solution (1) corresponding to impurities G and H using solution (4) and multiply the areas of these peaks by the corresponding correction factors; impurity G, 0.27; impurity H, 0.15. 


In the chromatogram obtained with solution (1):


the area of any secondary peak is not greater than twice the area of the principal peak in the chromatogram obtained with solution (3) (1%) and not more than four such peaks have an area greater than 0.8 times the area of the principal peak in the chromatogram obtained with solution (3) (0.4%);


the sum of the areas of all the secondary peaks is not greater than 7 times the area of the principal peak in the chromatogram obtained with solution (3) (3.5%).


Disregard any peak with an area less than 0.2 times the area of the principal peak in the chromatogram obtained with solution (3) (0.1%). Disregard any peaks eluting before impurity I and after impurity H.

Assay

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


(1)  Finely powder a quantity of tablets containing 2 g of Clarithromycin and quantitatively transfer the powder to a volumetric flask using about 350 ml of methanol. Mix with the aid of ultrasound for 15 minutes, shake vigorously for 15 minutes, allow to cool, add sufficient methanol to produce 500 ml and mix. Filter the solution (Whatman GF/C paper is suitable), dilute 1 volume of the filtrate to 40 volumes with mobile phase and filter through a 0.45-µm filter.

(2)  0.01%  w/v of clarithromycin BPCRS in the mobile phase. 

(3)  0.01%  w/v of each of clarithromycin BPCRS and clarithromycin impurity E BPCRS in the mobile phase.


chromatographic conditions

The chromatographic conditions described under Dissolution may be used.


When the chromatograms are recorded under the prescribed conditions the approximate retention times for clarithromycin and clarithromycin impurity E are 4 and 6 minutes respectively. 


system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 2.0. 


determination of content 

Calculate the content of C38H69NO13 in the tablets using the declared content of C38H69NO13 in clarithromycin BPCRS.




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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