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CEFAZOLIN SODIUM FOR INJECTION

Category Antibacterial (first-generation cephalosporin).

          Cefazolin Sodium for Injection is a sterile material consisting of cefazolin sodium with or without excipients equivalent to not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of C14H14N8O4S3.

Strengths available 250 and 500 mg, 1 g (base); 5, 10 and 20 g (base, pharmacy bulk package).

Dose Adults: Deep intramuscular or intravenous, 1 to 6 g daily in divided doses every 6 to 8 hours.
          Children and infants: Deep intramuscular or intravenous, 25 to 100 mg per kg of body weight daily in divided doses every 6 to 8 hours.

Contra-indication; Warning; Additional information See under Cefazolin sodium, p. 40.

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.15 Endotoxin Unit per mg of cefazolin.

Packaging and storage Cefazolin Sodium for Injection shall be kept in Containers for Sterile Solids as described under “Parenteral Preparations” (Appendix 1.16), 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 cefazolin.

Identification
          A. The ultraviolet absorption spectrum of a 0.002 per cent w/v solution of the injection in 0.1 M sodium hydrogencarbonate exhibits maxima at the same wavelengths as that of a similar solution of Cefazolin Sodium RS, concomitantly measured (Appendix 2.2).
          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.
          C. It yields the reactions characteristic of sodium salts (Appendix 5.1).

pH 4.0 to 6.0, in a 10.0 per cent w/v solution (Appendix 4.11).

Water Not more than 6.0 per cent w/w (Karl Fischer Method, Appendix 4.12). Use 300 mg.

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

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Phosphate buffer pH 3.6, Phosphate buffer pH 7.0, Mobile phase, Internal standard solution, Standard preparation, Chromatographic system and Procedure Proceed as directed in the Assay described under Cefazolin sodium, p 40.

          Assay preparation 1 (where it is packaged for dispensing and is represented as being in a single-dose container) Constitute Cefazolin Sodium for Injection in a volume of water, accurately measured, corresponding to the volume of solvent specified in the labelling. Withdraw all of the contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with Phosphate buffer pH 7.0 to obtain a stock solution containing about 1 mg of cefazolin per ml. Transfer 5.0 ml of this solution to a 100-ml of volumetric flask, add 5.0 ml of Internal standard solution, dilute with Phosphate buffer pH 7.0 to volume, and mix.
          Assay preparation 2 (where the label states the quantity of cefazolin in a given volume of constituted solution) Constitute Cefazolin Sodium for Injection in an accurately measured volume of water corresponding to the volume of solvent specified in the labelling. Dilute an accurately measured volume of the constituted solution quantitatively with Phosphate buffer pH 7.0 to obtain a solution containing about 1 mg of cefazolin per ml. Transfer 5.0 ml of this solution to a 100-ml of volumetric flask, add 5.0 ml of Internal standard solution, dilute with Phosphate buffer pH 7.0 to volume, and mix.
          Calculation Calculate the content of C14H14N8O4S3 in each ml of the constituted Injection taken, using the declared content of C14H14N8O4S3 in Cefazolin RS.

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

MONOGRAPHS • CEFAZOLIN SODIUM FOR INJECTION
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หมายเหตุ / Note : TP II 2011 PAGE 42