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ERYTHROMYCIN ETHYLSUCCINATE TABLETS

Category Antibacterial.

      Erythromycin Ethylsuccinate Tablets contain the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C37H67NO13.

Strength available 400 mg (base).

Dose Adults: 400 mg every 6 hours or 800 mg every 12 hours. The maximum total dose should not exceed 4 g per day.

      Children: 7.5 to 12.5 mg per kg of body weight every 6 hours or 15 to 25 mg per kg of body weight every 12 hours.

      Severe infections: 15 to 25 mg per kg of body weight every 6 hours.

Contra-indication; Warning; Precaution See under Erythromycin, p. 99. 

Additional information See under Erythromycin Ethylsuccinate, p. 99.

Packaging and storage Erythromycin Ethylsuccinate Tablets shall be kept in tightly closed containers, protected from light.

Labelling The label on the container states the quantity equivalent to the amount of erythromycin.

Identification

      A. Shake a portion of the powdered tablets equivalent to 100 mg of erythromycin with 5 ml of chloroform, decolourize, if necessary, with decolorizing charcoal, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, after drying at a pressure not exceeding 0.7 kPa (about 5 Torr), is concordant with the spectrum obtained from Erythromycin Ethylsuccinate RS (Appendix 2.1) or with the reference spectrum of Erythromycin Ethylsuccinate.

      B. Comply with the test for Identification B described under Erythromycin Ethylsuccinate for Oral Suspension, p. 105. For solution (A), add a volume of methanol to yield a solution containing the equivalent of 2.5 mg of erythromycin per ml and shake by mechanical means for 30 minutes. Centrifuge a portion of this mixture, and use the clear supernatant liquid.

      C. Comply with the test for Identification C described under Erythromycin Delayed-release Tablets, p. 102.

Loss on drying Not more than 4.0 per cent w/w after drying about 100 mg at 60º at a pressure not exceeding 0.7 kPa (about 5 Torr) for 3 hours (Appendix 4.15).

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).

      Dissolution medium: 0.01 M hydrochloric acid; 900 ml.

      Apparatus 2: 50 rpm.

      Time: 45 minutes.

      Procedure Determine the amount of C37H67NO13 dissolved by employing the following method.

      Colour reagent Slowly, and with constant mechanical stirring, add 325 ml of sulfuric acid to 173 ml of cold water. Allow the solution to cool, add 2 ml of a 2.5 per cent w/v solution of iron(III) chloride and 1 g of 4-dimethylaminobenzaldehyde, and stir to dissolve. Store in a low actinic flask. (Note Prepare this colour reagent on the day of use.)

      Standard solution Dissolve an accurately weighed quantity of Erythromycin RS in Dissolution medium to obtain a solution having a known concentration of about 0.44 mg per ml, using sonication if necessary to dissolve. (Note Use this Standard solution within 5.5 hours.)

      Test solution Filter and use the filtrate.

      Procedure To three separate 50-ml glass-stoppered conical flasks add 2.0 ml of Standard solution, 2.0 ml of Test solution, and 2.0 ml of Dissolution medium (to serve as the Blank), respectively. Place the flasks in an icebath for about 15 minutes. At precise 1-minute intervals add 10.0 ml of Colour reagent to Standard solution, Test solution and Blank, in turn. Immediately after adding Colour reagent, remove each flask from the ice bath, insert the stopper, mix, and allow to stand at room temperature for exactly 30 minutes. Sequentially measure the absorbances of Standard solution and Test solution at precise 1-minute intervals at the maximum at about 480 nm (Appendix 2.2), against the blank.

      Calculation Calculate the quantity, in mg, of C37H67NO13 equivalent dissolved by the expression:

0.9CP(AU/AS)

in which C is the concentration, in mg per ml, of Erythromycin RS in Standard solution, P is the designated content, in μg per mg, of erythromycin in Erythromycin RS, and AU and AS are the absorbances of Test solution and Standard solution, respectively.

      Tolerances Not less than 75 per cent (Q) of the labelled amount of C37H67NO13 is dissolved in 45 minutes.

Assay Blend not less than four Erythromycin Ethylsuccinate Tablets, accurately counted, for 4±1 minutes in a high-speed glass blender jar with a sufficient and accurately measured volume of methanol to give a stock solution containing the equivalent of not more than 5 mg of erythromycin per ml. Proceed as directed under the microbiological assay of erythromycin according to the “Microbiological Assay of Antibiotics” (Appendix 6.10).

Other requirements Comply with the requirements described under “Tablets” (Appendix 1.16).

MONOGRAPHS • ERYTHROMYCIN ETHYLSUCCINATE TABLETS
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หมายเหตุ / Note : TP II 2011 PAGE 106 - 107