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Category Antibacterial; antirickettsial.

          Chloramphenicol Sodium Succinate for Injection contains an amount of Chloramphenicol Sodium Succinate equivalent to not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of C₁₁H₁₂Cl₂N₂O₅.

Strength available 1 g.

Dose Adults: Intravenous, 12.5 mg per kg of bodyweight every 6 hours. The maximum total dose shouldnot exceed 4 g daily.
          Children, infants and neonates 2 weeks of age andover: Where there is no alternative to the use ofchloramphenicol, intravenous, 12.5 mg per kg of bodyweight every 6 hours; or 25 mg per kg of body weight every 12 hours.
          Neonates up to 2 weeks of age and premature: Where there is no alternative to the use of chloramphenicol, intravenous, 6.25 mg per kg of body weight every 6 hours.
          In severe infections, such as bacteremia or meningitis, doses up to 75 to 100 mg per kg of body weightdaily may be used.
          Serum determinations are recommended in patients with impaired hepatic and/or renal function, and in neonates with immature metabolic functions may require a reduction in dose.

Warning; Precaution See under Chloramphenicol, p. 63.

Packaging and storage Chloramphenicol Sodium Succinate for Injection shall be kept in Containers for Sterile Solids as described under “Parenteral Preparations” (Appendix 1.16), protected from light.

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

Identification
          A. Carry out the test as described in the “Thin-layer Chromatography” (Appendix 3.1), using silica gel GF254 as the coating substance and a mixture of 1 volume of 2 M acetic acid, 14 volumes of methanol and 85 volumes of chloroform as the mobile phase. Apply separately to the plate, 2 μl of each of the following solutions. For solution (A) dissolve a suitable quantity of the injection in acetone to produce a solution containing the equivalent of 1 per cent w/v of chloramphenicol. Solution (B) contains 1 per cent w/v of Chloramphenicol Sodium Succinate RS and solution (C) contains 1 per cent w/v of Chloramphenicol RS. After removal of the plate, allow it to dry in air, and examine under ultraviolet light (254 nm): the two principal spots in the chromatogram obtained from solution (A) are similar in position and size to those in the chromatogram obtained from solution (B) and their positions are different from that of the principal spot in the chromatogram obtained from solution (C).
          B. Dissolve 10 mg in 1 ml of ethanol (50 per cent), add 3 ml of a 1 per cent w/v solution of calcium chloride and 50 mg of zinc powder and heat on a water-bath for 10 minutes. Filter the hot solution, allow to cool, add 0.1 ml of benzoyl chloride and shake for 1 minute. Add 0.5 ml of iron(III) chloride TS and 2 ml of chloroform and shake. The aqueous layer is light violet-red to purple.
          C. It yields the reactions characteristic of sodium salts (Appendix 5.1).

pH 6.4 to 7.0, in a 25 per cent w/v solution (Appendix 4.11).

Particulate matter Complies with the requirement described under “Particulate Matter in Injections” (Small-volume Injections, Appendix 4.27).

Specific rotation +5.0^º to +8.0^º, calculated on the anhydrous basis, determined in a 5.0 per cent w/v solution (Appendix 4.8).

Water Not more than 5.0 per cent w/w (Karl Fischer Method, Appendix 4.12).

Chloramphenicol and chloramphenicol disodium disuccinate Not more than 2.0 per cent of each. Carry out the test as described in the “High-Pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase; Reference solution (a); Reference solution (b); Chromatographic system; and Procedure Proceed as directed in the Chloramphenicol and chloramphenicol disodium disuccinate under Chloramphenicol Sodium Succinate, p. 68.
          Reference solution (c) Dissolve a sufficient amount of the contents of the sealed container to obtain a solution containing the equivalent of 0.18 per cent w/v of chloramphenicol in Mobile phase (stock solution C). Mix 10.0 ml of stock solution C, 5.0 ml of stock solution A and 5.0 ml of stock solution B and dilute to 100.0 ml with Mobile phase.
          Test solution Dilute 10.0 ml of stock solution C to 100.0 ml with Mobile phase.
          Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.2 Endotoxin Unit per mg of chloramphenicol.

Assay
          Standard preparation Dissolve an accurately weighed quantity of Chloramphenicol RS in water, and dilute quantitatively with water to obtain a solution having a known concentration of about 20 μg per ml.
          Assay preparation Constitute 1 container of Chloramphenicol Sodium Succinate for Injection as directed in the labelling. Dilute an accurately measured volume of the constituted solution quantitatively with water to obtain a solution having a concentration of about 20 μg of chloramphenicol per ml.
           Procedure Concomitantly measure the absorbances of Standard preparation at the maximum at about 278 nm, and Assay preparation at the maximum at about 276 nm, using water as the blank (Appendix 2.2).
          Calculation Calculate the content of C₁₁H₁₂Cl₂N₂O₅ in one container of the Injection taken, using the declared potency of Chloramphenicol RS.

Other requirements Complies with the requirements described under “Parenteral Preparations” (Appendix 1.16).