สารบัญ

Category Antibacterial.

      Lincomycin Hydrochloride Injection is a sterile solution of Lincomycin Hydrochloride in Water for Injection. It contains an amount of Lincomycin Hydrochloride equivalent to not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C₁₈H₃₄N₂O₆S.

Description Clear, colourless to slightly yellow solution, having a slight odour.

Strength available 300 mg (base) per ml.

Dose Adults: Intramuscular, 600 mg every 12 to 24 hours or intravenous 600 mg to 1 g, administered over at least 1 hour, every 8 to 12 hours.

      Subconjunctival, 75 mg.

      The maximum total dose should not exceed 8 g daily.

      Children and infants: Intramuscular, 10 mg per kg of body weight every 12 to 24 hours. Intravenous, administered over at least 1 hour, 3.3 to 6.7 mg per kg of body weight every 8 hours; or 5 to 10 mg per kg of body weight every 12 hours.

Contra-indication; Warning; Precaution See under Lincomycin Hydrochloride, p. 123.

Packaging and storage Lincomycin Hydrochloride Injection shall be kept in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light and stored at a temperature not exceeding 30º.

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

Identification

      A. Add acetone to a volume of the injection containing 200 mg of lincomycin hydrochloride until precipitation begins and add a further 20 ml of acetone. Filter the precipitate, wash with two 10-ml quantities of acetone, dissolve the residue in the minimum of a mixture of 4 volumes of chloroform and 1 volume of methanol, evaporate to dryness and dry at 60º at a pressure not exceeding 2 kPa (about 15 Torr) for 4 hours: the infrared absorption spectrum of the residue is concordant with the spectrum obtained from Lincomycin RS (Appendix 2.1) or with the reference spectrum of Lincomycin.

      B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that of the Standard preparation, as obtained in the Assay.

pH 3.0 to 5.5 (Appendix 4.11).

Particulate matter Complies with the requirements described under “Particulate Matter in Injections (Smallvolume Injections, Appendix 4.27).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.5 Endotoxin Unit per mg of lincomycin.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5). 

      Mobile phase, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay under Lincomycin Hydrochloride, p. 123.

      Assay preparation Transfer an accurately measured volume of Lincomycin Hydrochloride Injection, equivalent to about 600 mg of lincomycin, to a 50-ml volumetric flask, dilute with Mobile phase to volume, and mix. Transfer 2.0 ml of this solution to a 25-ml volumetric flask, dilute with Mobile phase to volume, and mix.

      Calculation Calculate the potency of C₁₈H₃₄N₂O₆S in each ml of the Injection taken, using the declared potency of C₁₈H₃₄N₂O₆S in Lincomycin Hydrochloride RS.

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