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High Quality USP/EP/BP GMP DMF FDA Gastro-resistant Erythromycin Capsules CAS NO Producer

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  • AZ422
  • Dideu
  • China
  • Gastro-resistant Erythromycin 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

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Gastro-resistant Erythromycin Capsules 

Action and use

Macrolide antibacterial.

Definition

Gastro-resistant Erythromycin Capsules contain Erythromycin. They are manufactured using gastro-resistant capsule shells or prepared by filling capsules with granules or particles covered with a gastro-resistant coating.


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

Identification

A.  Shake a quantity of the mixed capsule contents containing 0.1  g of Erythromycin with 5  ml of dichloromethane, decolourise, if necessary, with activated charcoal, filter through a 0.45-µm PTFE filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, after drying in vacuo at 60º for 10 minutes, is concordant with the reference spectrum of erythromycin (RS 123).


B.  Dissolve a quantity of the mixed capsule contents containing 3  mg of Erythromycin as completely as possible in 2  ml of acetone and add 2  ml of hydrochloric acid; an orange colour is produced which changes to red and then to deep purplish red. Add 2  ml of chloroform and shake; the chloroform layer becomes purple.

Tests

Related substances

Dissolution

Carry out the dissolution test for tablets and capsules, Appendix XII B1.


test conditions

(a)  Use Apparatus 1, rotating the basket at 50 revolutions per minute.


(b)  Use 900 ml of 0.06m hydrochloric acid, at a temperature of 37º, as the medium.


procedure

Place one capsule in the basket. After 1 hour remove the basket from the dissolution medium, replace the 0.06m hydrochloric acid with 900 ml of a 0.05m phosphate buffer solution pH 6.8, prepared as described below, previously held at 37° and immediately lower the basket into the dissolution medium and rotate at 50 revolutions per minute. After 1 hour withdraw a sample of the medium, filter (discarding the first 2 ml of filtrate), transfer 5 ml of the filtered solution to each of 2 volumetric flasks and then carry out the following procedures (A and B). Prepare the 0.05m phosphate buffer solution pH 6.8 in the following manner: Dissolve 136 g of potassium dihydrogen orthophosphate in 1000 ml of water; separately dissolve 17.9 g of sodium hydroxide in 1000 ml of water; mix the two solutions and dilute to 20 litres with water; the pH of the final solution is about 6.8.


Procedure A  Add 1 ml of 0.5m sulphuric acid, mix well and stand at room temperature for 1 hour. Add 1 ml of 1m sodium hydroxide and mix. Add 2 ml of a solution containing 2.76% w/v of sodium hydroxide and 6.24% w/v of anhydrous disodium hydrogen orthophosphate in water, mix, heat at 60° for 15 minutes and cool to room temperature in an ice bath. Add sufficient water to produce 25 ml and measure the absorbance of the final solution at the maximum at 236 nm, Appendix II B, using water in the reference cell.


Procedure B  Add 2 ml of a solution containing 2.76% w/v of sodium hydroxide and 6.24% w/v of anhydrous disodium hydrogen orthophosphate in water, mix, heat at 60° for 15 minutes and cool to room temperature in an ice bath. Add sufficient water to produce 25 ml and measure the absorbance of the final solution at the maximum at 236 nm, Appendix II B, using water in the reference cell.


determination of content

Measure the absorbances of suitable solutions of erythromycin A BPCRS in dissolution medium which have been prepared in a similar manner beginning at the words "transfer 5 ml of the filtered solution to each of 2 volumetric flasks …" and calculate the content of C37H67NO13 in the medium from the difference in absorbance obtained using procedures A and B and using the declared content of C37H67NO13 in erythromycin A BPCRS.


The amount of erythromycin released is not less than 80% of the stated amount.


Related substances

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


(1)  Dissolve a quantity of the mixed capsule contents containing 40  mg of Erythromycin in 10 ml of a mixture of 1 volume of methanol and 3  volumes of citro-phosphate buffer pH 7.0 (solvent A), filter and use the filtrate. 

(2)  0.4%  w/v of erythromycin A BPCRS in solvent A. 

(3)  0.02%  w/v of each of erythromycin B BPCRS and erythromycin  C BPCRS in solvent  A. 

(4)  0.012%  w/v of erythromycin A BPCRS in solvent  A. 

(5)  Dissolve 5  mg of N-demethylerythromycin A EPCRS in solution  (3), add 1  ml of solution  (2) and sufficient of solution  (3) to produce 25  ml. 

(6)  Transfer 40  mg of erythromycin A BPCRS to a glass vial and spread evenly such that it forms a layer not more than about 1  mm thick. Heat at 130° for 4  hours, allow to cool and dissolve in sufficient of solvent A to produce 10  ml (generation of impurities  E and  F). 


chromatographic conditions

(a)  Use a column (25  cm × 4.6  mm) packed with styrene-divinylbenzene copolymer (8  µm) with a pore size of 100  nm (PLRP-S is suitable).

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

(c)  Use a flow rate of 2.0 ml per minute.

(d)  Maintain the temperature of the column and at least one third of the tubing preceding the column at 70°.

(e)  Use a detection wavelength of 215 nm.

(f)  Inject 100 µl of each solution.


mobile phase

To 50  ml of a 3.5%  w/v solution of dipotassium hydrogen orthophosphate, adjusted to pH  9.0 with 1m orthophosphoric acid, add 400  ml of water, 165  ml of 2-methylpropan-2-ol and 30  ml of acetonitrile and dilute to 1000  ml with water.


For solution (1) allow the chromatography to proceed for 5 times the retention time of the peak corresponding to erythromycin A.


When the chromatograms are recorded using the prescribed conditions the retention time of erythromycin  A is about 15  minutes. The retention times relative to erythromycin  A are: impurity  A,  about  0.3; impurity  B,  about  0.45; erythromycin  C,  about  0.5; impurity  C,  about  0.9; impurity  D,  about  1.4; impurity  F,  about  1.5; erythromycin  B,  about  1.8; impurity  E,  about  4.3.


system suitability

The test is not valid unless, in the chromatogram obtained with solution (5), the resolution factor between the peaks corresponding to N-demethylerythromycin  A and erythromycin  C is at least 0.8 and the resolution factor between the peaks corresponding to N-demethylerythromycin  A and erythromycin  A is at least 5.5. If necessary, adjust the concentration of 2-methylpropan-2-ol in the mobile phase (180  ml has been found to be suitable) or reduce the flow rate to 1.5 or 1.0 ml  per  minute. 


limits

Identify any peaks in the chromatogram obtained with solution  (1) corresponding to impurities E and F using solution (6) and multiply the areas of these peaks by the corresponding correction factors: impurity E, 0.09; impurity F, 0.15. 


In the chromatogram obtained with solution  (1):


the area of any peak other than those peaks corresponding to erythromycin A, erythromycin B and erythromycin C, identified from the peaks in the chromatograms obtained with solutions (2) and (3), is not greater than the area of the principal peak in the chromatogram obtained with solution (4) (3%);


the sum of the areas of any such peaks is not greater than 2.3 times the area of the principal peak in the chromatogram obtained with solution (4) (7%). 


Disregard any peaks due to excipients and any peak with an area less than 0.02 times the area of the principal peak in the chromatogram obtained with solution (4) (0.06%).


Water

The contents of the capsules contain not more than 7.5% w/w of water, Appendix IX C, using 10% w/v of imidazole in methanol in the titration vessel.

Assay

Dissolve a quantity of the mixed contents of 20 capsules containing the equivalent of 25 mg of erythromycin as completely as possible in sufficient methanol to produce 100 ml and carry out the microbiological assay of antibiotics for erythromycin, 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 erythromycin in the capsules, taking each 1000 IU found to be equivalent to 1 mg of erythromycin. The upper fiducial limit of error is not less than 95.0% and the lower fiducial limit of error is not more than 110.0% of the stated content.

Storage

Gastro-resistant Erythromycin Capsules should be protected from light.

Impurities

The impurities limited by the requirements of this monograph include those listed under Erythromycin.




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

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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

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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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