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CHLORAMPHENICOL CAPSULES

Category Antibacterial; antirickettsial.

          Chloramphenicol Capsules contain not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C11H12Cl2N2O5.

Strength available 250 mg.

Dose Adults: 12.5 mg per kg of body weight every 6 hours. The maximum total dose should not exceed 4 g daily.
          Where there is no alternative to the use of chloramphenicol.

          Children, infants and neonates 2 weeks of age and over: 12.5 mg per kg of body weight every 6 hours; or 25 mg per kg of body weight every 12 hours.
          Neonates up to 2 weeks of age and premature: 6.25 mg per kg of body weight every 6 hours.
          Serum determinations are recommended in patients with immature or impaired hepatic and/or renal function.

Warning; Precaution See under Chloramphenicol, p. 63.

Packaging and storage Chloramphenicol Capsules
shall be kept in tightly closed containers.

Identification Suspend a portion of the capsule contents containing 100 mg of chloramphenicol in 60 ml of water and extract with two 20-ml portions of petroleum ether (boiling range, 120º to 160º). Wash the combined extracts with two 15-ml portions of water, add the washings to the aqueous layer, extract with four 50-ml portions of ether, and evaporate the combined ether extracts. The residue complies with test A.
          A. Dissolve 10 mg of the residue in 2 ml of ethanol (50 per cent), add 4.5 ml of 1 M sulfuric acid and 50 mg of zinc powder and allow to stand for 10 minutes. Decant the supernatant liquid or filter if necessary. Cool the resulting solution in ice and add 0.5 ml of sodium nitrite TS. Allow to stand for 2 minutes and add 1 g of urea, followed by 1 ml of 2-naphthol TS and 2 ml of 10 M sodium hydroxide: a red colour is produced. Repeat the test omitting the zinc powder: no red colour is produced.
          B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.

Dissolution Carry out the test as described in the “Dissolution Test” (Appendix 4.24).
          Dissolution medium: 0.01 M hydrochloric acid; 900 ml.
          Apparatus 1: 100 rpm.
          Time: 30 minutes.
          Procedure Determine the amount of C11H12Cl2N2O5 dissolved from absorbances at the maximum at about 278 nm of filtered portions of the test solution, suitably diluted with Dissolution medium, if necessary, in comparison with a standard solution having a known concentration of Chloramphenicol RS in the same medium (Appendix 2.2).
          Tolerances Not less than 85 per cent (Q) of the labelled amount of C11H12Cl2N2O5 is dissolved in 30 minutes.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Chromatographic system and Procedure Proceed as directed in the Assay under Chloramphenicol, p. 63.
          Standard preparation Transfer about 25 mg of Chloramphenicol RS, accurately weighed, to a 200-ml volumetric flask, add 10 ml of water, and heat on a water-bath until completely dissolved. Cool to room temperature, dilute with Mobile phase to volume and mix.
          Assay preparation Dissolve a quantity of the mixed contents of 20 Chloramphenicol Capsules, accurately weighed, containing 2.5 g of chloramphenicol in 800 ml of water, warming if necessary to effect solution, and add sufficient water to produce 1000.0 ml. Dilute 5.0 ml to 100.0 ml with Mobile phase.
          Calculation Calculate the content of C11H12Cl2N2O5 in the portion of the Capsules taken, using the declared content of C11H12Cl2N2O5 in Chloramphenicol RS.

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

MONOGRAPHS • CHLORAMPHENICOL CAPSULES
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หมายเหตุ / Note : TP II 2011 PAGE 64 - 65