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Gastro-resistant Erythromycin Capsules
|Action and use|
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.
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.
Carry out the dissolution test for tablets and capsules, Appendix XII B1.
(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.
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.
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).
(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.
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.
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.
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%).
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.
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.
Gastro-resistant Erythromycin Capsules should be protected from light.
The impurities limited by the requirements of this monograph include those listed under Erythromycin.
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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:
II)Nutrition Additive Industries
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IV)Environmental Friendly Chemical And Chemurgy Industries
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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.