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CEFTRIAXONE SODIUM FOR INJECTION

Category Antibacterial (third-generation cephalosporin).

Ceftriaxone Sodium for Injection is a sterile material prepared from Ceftriaxone Sodium with or without excipients. It contains an amount of ceftriaxone sodium equivalent to not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of C18H18N8O7S3.

Strengths available 0.25, 0.5, 1, 2, and 10 g (base).

Dose Adults: Deep intramuscular or intravenous, 1 to 2 g daily as a single dose or in 2 divided doses.
          Children and infants: Deep intramuscular or intravenous, 20 to 50 mg per kg of body weight once daily.

Contra-indication; Precaution; Additional information See under Ceftriaxone Sodium, p. 49.

Warning The preparation reconstituted with bacteriostatic water containing benzyl alcohol should not be used for intramuscular injection in neonates.
          See also under Ceftriaxone Sodium, p. 49.

Packaging and storage Ceftriaxone 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 ceftriaxone.

Identification
          A. The infrared absorption spectrum is concordant with the spectrum obtained from Ceftriaxone Sodium RS (Appendix 2.1) or with the reference spectrum of Ceftriaxone Sodium.
          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).

Clarity of solution A solution containing the equivalent of 1.20 per cent w/v of ceftriaxone in carbon dioxide-free water is clear (Appendix 4.1).

Crystallinity It is crystalline (Appendix 4.14).

pH 6.0 to 8.0, in a 12.0 per cent w/v solution (Appendix 4.11).

Water Not more than 11.0 per cent w/w (Karl Fischer Method, Appendix 4.12). Use 100 mg.

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

Related substances Carry out the test as described under Assay using Assay preparation 1, and Assay preparation 2. Allow the chromatography to proceed for at least twice the retention time of the principal peak.
     In the chromatogram obtained from the Assay preparation 1, determine the percentage content of related substances by using the area of the principal peak in the chromatogram obtained from the Assay preparation 2 (1.0 per cent) as a comparison area.
     Limits
          Disregard limit
Not more than 0.1 times the comparison area (0.1 per cent).
          Any impurity Not more than the comparison area (1.0 per cent).
          Total Not more than 5 times the comparison area (5.0 per cent).

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.20 Endotoxin Unit per mg of ceftriaxone.

Assay Carry out the determination as described in the
“High-pressure Liquid Chromatography” (Appendix
3.5).
          Mobile phase Dissolve 2 g of tetradecylammonium bromide and 2 g of tetraheptylammonium bromide in a mixture of 440 ml of water, 55 ml of 0.067 M phosphate buffer solution pH 7.0, 5 ml of citrate buffer solution pH 5.0 prepared by dissolving 20.17 g of citric acid in 800 ml of water, adjusting to pH 5.0 with 10 M sodium hydroxide and diluting to 1000.0 ml with water, and 500 ml of acetronitrile. Make adjustments if necessary.
          Standard preparation Dissolve about 30 mg of Ceftriaxone Sodium RS, accurately weighed, in Mobile phase and dilute to 100.0 ml with the same solvent.
          Resolution solution Dissolve an accurately weighed quantity of each of Ceftriaxone Sodium RS and Ceftriaxone Sodium E-isomer RS in Mobile phase to obtain a solution having each known concentration of 50 μg per ml.
          Assay preparation 1 Dissolve an accurately weighed quantity of the mixed contents of the 10 containers of Ceftriaxone Sodium for Injection with Mobile phase to produce a solution containing the equivalent of about 300 μg of ceftriaxone per ml.
          Assay preparation 2 Dilute 1.0 volume of Assay preparation 1 to 100.0 volumes with the Mobile phase.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with octadecylsilane silica microparticles (5 μm), (b) Mobile phase at a flow rate of about 1.5 ml per minute, and (c) an ultraviolet photometer set at 254 nm.
          To determine the suitability of the chromatographic system, chromatograph Resolution solution, and record the peak responses as directed under Procedure: the resolution factor between ceftriaxone and ceftriaxone sodium E isomer peaks is not less than 3.0. Chromatograph Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.0 per cent.
          Procedure Separately inject equal volumes (about 20 μl) of Standard preparation and Assay preparation 1 into the chromatograph, record the chromatograms, and measure the responses for the major peaks.
          Calculation Calculate the content of C18H18N8O7Sin each ml of the Ceftriaxone Sodium for Injection taken, using the declared content of C18H16N8O7S3.2Na.3 H2O in Ceftriaxone Sodium RS. Each mg of C18H16N8O7S3.2Na.3½H2O is equivalent to 0.8382 mg of C18H18N8O7S3.

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

MONOGRAPHS • CEFTRIAXONE SODIUM FOR INJECTION
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หมายเหตุ / Note : TP II 2011 PAGE 51 - 52