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High Quality USP/EP/BP GMP DMF FDA Cefadroxil Oral Suspension CAS NO 66592-87-8 Producer

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  • AZ567
  • Dideu
  • 66592-87-8
  • C16H17N3O5S.H2O
  • 629-747-6
  • China
  • Oral Suspension
  • High quality
  • 99.0% Min
  • 99%-101%
  • Oral Suspension
  • Solubility in water
  • 1.0% max
  • 0.5% Max
  • 10 ppm Max
  • H-NMR
  • 0.5% Max
  • Medicine

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Cefadroxil Oral Suspension 

Action and use

Cephalosporin antibacterial.

Definition

Cefadroxil Oral Suspension is a suspension of Cefadroxil Monohydrate in a suitable flavoured vehicle. It is prepared by dispersing the dry ingredients in the specified volume of Water just before issue for use.

The dry ingredients comply with the requirements for Powders and Granules for Oral Solutions and Oral Suspensions stated under Oral Liquids.

Content of anhydrous cefadroxil, C16H17N3O5S 

When freshly constituted not more than 110.0% of the stated amount. When stored at the temperature and for the period stated on the label, during which the Oral Suspension may be expected to be satisfactory for use, not less than 90.0% of the stated amount.

Identification

A.  Carry out the method for thin-layer chromatography, Appendix III A, using a TLC silica gel plate (Merck silica gel 60 plates are suitable) and a mixture of 3  volumes of a 6.7% w/v solution of ninhydrin in acetone, 80  volumes of a 0.1m solution of disodium hydrogen orthophosphate and 120  volumes of a 0.1m solution of citric acid as the mobile phase. Impregnate the plate by development with a 5% v/v solution of n-tetradecane in hexane. Allow the solvent to evaporate and carry out the chromatography in the same direction as the impregnation. Apply separately to the plate 20 µl of each of the following solutions. For solution (1) dilute a volume of the oral suspension containing the equivalent of 0.2  g of anhydrous cefadroxil to 100  ml with water, filter and use the filtrate. Solution (2) contains 0.2% w/v of cefadroxil BPCRS in water. After removal of the plate, allow it to dry in air, spray with a 0.2% w/v solution of ninhydrin in absolute ethanol, heat the plate at 110° for 10  minutes and allow to cool. The principal spot in the chromatogram obtained with solution (1) is similar in position and size to that in the chromatogram obtained with solution (2).

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

Tests

Acidity

pH, 4.5  to 6.0, Appendix V L.

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute a volume of the oral suspension with sufficient of mobile phase A to produce a solution containing the equivalent of 0.1% w/v of anhydrous cefadroxil, mix, stir magnetically for 10  minutes, filter through a 0.45-µm filter and use the filtrate. Solution (2) contains 0.001% w/v of cefadroxil BPCRS in mobile phase A. Solution (3) contains 0.001% w/v of d-α-(4-hydroxyphenyl)glycine BPCRS (cefadroxil impurity A) in the mobile phase. Solution (4) contains 0.001% w/v of 7-aminodesacetoxycephalosporanic acid EPCRS (cefadroxil impurity B) in the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4  mm) packed with octadecylsilyl silica gel for chromatography (10 µm) (Lichrosorb RP-18 is suitable), (b) as mobile phases A and B with a flow rate of 1  ml per minute the solutions described below and (c) a detection wavelength of 254  nm.

Mobile phase A  Dissolve 5.44  g of potassium dihydrogen orthophosphate in 2000  ml of water and adjust the pH, if necessary, to 5.0 with a 1% w/v solution of potassium hydroxide.

Mobile phase B  Add 400  ml of acetonitrile to 600  ml of mobile phase A and adjust the pH, if necessary to 5.0 with a 2% v/v solution of orthophosphoric acid.

Inject 20 µl of each solution and record the chromatograms under the following conditions. Elute initially with mobile phase A. After 5  minutes, use linear gradient elution increasing the concentration of mobile phase B to 32% after 35  minutes. Elute isocratically for 25  minutes with a mixture of 32% of mobile phase B and 68% of mobile phase A. Carry out a linear gradient elution for 1  minute to 100% of mobile phase A and elute for a further 9  minutes with mobile phase A.

When the chromatograms are recorded under the conditions described above the retention time of cefadroxil is 14  to 20  minutes. If necessary, adjust the proportion of mobile phase A to mobile phase B to achieve the stated retention time.

The test is not valid unless the column efficiency, determined on the peak due to cefadroxil in the chromatogram obtained with solution (2), is at least 2000 theoretical plates per metre and the symmetry factor of the principal peak is at most 1.5.

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

In the chromatogram obtained with solution (1) the area of any peak corresponding to cefadroxil impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (1%), the area of any peak corresponding to cefadroxil impurity B is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (1%) and the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%). 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. For solution (1) shake a weighed quantity of the oral suspension containing the equivalent of 0.25  g of anhydrous cefadroxil with 250  ml of a phosphate buffer prepared by dissolving 13.6  g of potassium dihydrogen orthophosphate in sufficient water to produce 2000  ml and adjusting the pH, if necessary, to 5.0 with 10m potassium hydroxide for 5  minutes; filter and use the filtrate. Solution (2) contains 0.1% w/v of cefadroxil BPCRS in the buffer solution. Solution (3) contains 0.005% w/v of cefadroxil BPCRS and 0.05% w/v of amoxicillin trihydrate BPCRS in the buffer solution.

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm × 4.6  mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm or 10 µm) (Hypersil ODS is suitable), (b) as the mobile phase at a flow rate of 1.0  ml per minute a mixture of 4  volumes of acetonitrile and 96  volumes of a 0.272% w/v solution of potassium dihydrogen orthophosphate and (c) a detection wavelength of 254  nm.

The assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to cefadroxil and amoxicillin is at least 5.0. If necessary, adjust the acetonitrile content in the mobile phase.

Determine the weight per ml of the oral suspension, Appendix V G, and calculate the content of C16H17N3O5S, weight in volume, using the declared content of C16H17N3O5S in cefadroxil BPCRS.

Repeat the procedure using a portion of the oral suspension that has been stored at the temperature and for the period stated on the label during which it may be expected to be satisfactory for use.

Storage

The dry ingredients should be stored at a temperature not exceeding 30°.

For the following tests prepare the Oral Suspension as directed on the label. The suspension, examined immediately after preparation unless otherwise indicated, complies with the requirements stated under Oral Liquids and with the following requirements.

Labelling

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




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.

Oral Suspension 1Oral Suspension 15Oral Suspension 46

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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