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High Quality USP/EP/BP GMP DMF FDA Cefaclor Capsules CAS NO 53994-73-3 Producer

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  • AZ388
  • Dideu
  • 53994-73-3
  • C15H14ClN3O4S
  • 258-909-5
  • China
  • Cefaclor Capsules
  • High quality
  • 99.0% Min
  • 99%-101%
  • Capsule
  • 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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Mobile:+86-15129568250; Whatsapp: +8615129568250

Cefaclor Capsules 

Action and use

Cephalosporin antibacterial.

Definition

Cefaclor Capsules contain Cefaclor.

The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of anhydrous cefaclor, C15H14ClN3O4S

95.0  to 105.0% of the stated amount.
Identification

A.  Shake a quantity of the contents of the capsules containing the equivalent of 0.3  g of anhydrous cefaclor with 100  ml of water, filter and dilute 1  ml of the filtrate to 100  ml with water. The light absorption, Appendix II B, in the range 190  nm to 310  nm, of the final solution exhibits a maximum only at 264  nm.


B.  In the Assay, the chromatogram obtained with solution (1) shows a peak with 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.


test conditions

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


(b)  Use 900 ml of water, at a temperature of 37°, as the medium.


procedure 

(1)  After 45 minutes withdraw a 10 ml sample of the medium, filter and dilute the filtered solution, if necessary, with sufficient water to produce a solution expected to contain the equivalent of about 0.025% w/v of anhydrous cefaclor. Measure the absorbance of the filtered sample at the maximum at 264 nm, Appendix II B, using water in the reference cell.


(2)  Measure the absorbance of a 0.025% w/v solution of cefaclor BPCRS in water using water in the reference cell.


determination of content 

Calculate the total content of anhydrous cefaclor, C15H14ClN3O4S, in the medium from the absorbances obtained and using the declared content of C15H14ClN3O4S in cefaclor BPCRS. 


Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a 0.27% w/v solution of sodium dihydrogen orthophosphate which has been adjusted to pH 2.5, if necessary, with orthophosphoric acid (solution A). The solutions should be freshly prepared. 


(1)  Shake a quantity of the contents of the capsules containing the equivalent of 0.5  g of anhydrous cefaclor with 200  ml of solution A, add sufficient of solution A to produce 250  ml and filter.


(2)  0.002% w/v of cefaclor BPCRS.


(3)  0.0025% w/v of cefaclor BPCRS and 0.005% w/v of delta-3-cefaclor EPCRS.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS-2 is suitable).


(b)  Use gradient 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 220 nm.


(f)  Inject 20 µl of each solution.


mobile phase 

Mobile phase A  A 0.78% w/v solution of sodium dihydrogen orthophosphate adjusted to pH 4.0 with orthophosphoric acid.


Mobile phase B  Mix 450  volumes of acetonitrile with 550  volumes of mobile phase A.


Equilibrate the column with a mixture of 5  volumes of mobile phase B and 95  volumes of mobile phase A for at least 15  minutes. Inject the solutions and carry out the following gradient elution.

1103-1012


system suitability 

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to cefaclor and delta-3-cefaclor is at least 2.0. If necessary, adjust the proportion of acetonitrile in the mobile phase.


limits 

In the chromatogram obtained with solution (1):


the area of any secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);


the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).


Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).

Assay

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


(1)  Shake a quantity of the powdered, mixed contents of 20 capsules containing the equivalent of 75  mg of anhydrous cefaclor with the mobile phase, add sufficient mobile phase to produce 250  ml and filter.

(2)  0.03% w/v of cefaclor BPCRS in the mobile phase.

(3)  0.03% w/v of each of cefaclor BPCRS and delta-3-cefaclor EPCRS in the mobile phase.


chromatographic conditions 

(a)  Use a stainless steel column (25  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Beckman Ultrasphere ODS and Supelcosil LC-18-DB are suitable).

(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 265 nm.

(f)  Inject 20 µl of each solution.


mobile phase 

Dissolve 1  g of sodium pentanesulphonate in a mixture of 780  ml of water and 10  ml of triethylamine, adjust the pH to 2.5 using orthophosphoric acid, add 220  ml of methanol and mix.


system suitability 

The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to cefaclor and delta-3-cefaclor is at least 2.5 and the symmetry factor of the peak due to cefaclor is at most 1.5.


determination of content 

Calculate the content of C15H14ClN3O4S in the capsules from the chromatograms obtained and using the declared content of C15H14ClN3O4S in cefaclor BPCRS. 

Storage

Cefaclor Capsules should be stored at a temperature not exceeding 30°.

Labelling

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




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.

Capsules 1CapsulesCapsules 106

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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