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Category Antibacterial. 

      Vancomycin Hydrochloride for Injection is a sterile dry mixture of Vancomycin Hydrochloride and a suitable stabilizing agent. It contains not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of vancomycin.

Strengths available 0.5, 1, 5 and 10 g (base).

Dose Adults: Intravenous infusion, 7.5 mg per kg of body weight or 500 mg every 6 hours; or 15 mg per kg of body weight or 1 g every 12 hours.

(Note After an initial loading dose of 750 mg to 1 g, but not less than 15 mg per kg of body weight, adults with impaired renal function may require a reduction in dose as indicated in the table. However, the preferred method is to adjust dosage based on serum vancomycin concentrations.)

      Children and infants: Intravenous infusion, 10 mg per kg of body weight every 6 hours; or 20 mg per kg of body weight every 12 hours.

      Neonates 1 week to 1 month of age: Intravenous infusion, 15 mg per kg of body weight initially, followed by 10 mg per kg of body weight every 8 hours.

      Neonates up to 1 week of age: Intravenous infusion, 15 mg per kg of body weight initially, followed by 10 mg per kg of body weight every 12 hours.

(Note Doses up to 60 mg per kg of body weight per day have been used in some infections (e.g., staphylococcal infections of the central nervous system.))

Warning; Precaution See under Vancomycin Hydrochloride, p. 168.

Packaging and storage Vancomycin Hydrochloride 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 (1) the quantity equivalent to the amount of vancomycin; (2) the total number of μg of activity contained in it; (3) the number of μg of activity per mg.

Identification The retention time of the major peak in the chromatogram of the Test solution A corresponds to that in the chromatogram of the Resolution solution, as obtained in the Chromatographic purity.

pH 2.5 to 4.5, in a 5.0 per cent w/v solution (Appendix 4.11).

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

Water Not more than 5.0 per cent w/w (Karl Fischer Method, Appendix 4.12); use 500 mg.

Heavy metals Not more than 30 ppm. (Method I, Appendix 5.2) Use 667 mg; for the Standard Preparation, use lead standard solution (1 ppm Pb.).

Chromatographic purity Carry out the test as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

      Triethylamine buffer, Mobile phase, Resolution solution, Chromatographic system, and Procedure Proceed as directed in the test for Chromatographic purity under Vancomycin Hydrochloride, p. 168.

      Test solution A Prepare a solution of the test substance in Mobile phase A containing 10 mg of vancomycin per ml.

      Test solution B Transfer 2.0 ml of Test solution A to a 50-ml volumetric flask, dilute with Mobile phase A to volume, and mix.

      Calculation Calculate the percentage of vancomycin B in the test substance by the expression:

2500r_B/(25r_B + r_A), 

in which r_B is the corrected area response of the main peak obtained in the chromatogram of Test solution B; and r_A is the sum of the corrected area responses of all the peaks, other than the main peak, in the chromatogram obtained from Test solution A: not less than 88.0 per cent of vancomycin B is found.

      Calculate the percentage of each other peak taken by the expression:

100r_Ai/(25r_B + r_A),

in which r_Ai is the corrected area response of any individual peak, other than the main peak, obtained in the chromatogram of Test solution A: not more than 4.0 per cent of any peak other than the main peak is found.

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendsix 8.5), it contains not more than 0.33 Endotoxin Unit per mg of vancomycin.

Assay Constitute a container of Vancomycin Hydrochloride for Injection in an accurately measured volume of water corresponding to the volume of diluent specified in the labelling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with water to obtain a solution containing about 1 mg of vancomycin per ml. Proceed as directed in the microbiological assay of vancomycin hydrochloride according to the “Microbiological Assay of Antibiotics” (Appendix 6.10) using an accurately measured volume of Vancomycin Hydrochloride for Injection, diluted quantitatively with Buffer No.3 to yield a solution having a concentration assumed to be equal to the median dose level of the Standard.

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