สารบัญ

Contents
MENU

AMPICILLIN SODIUM FOR INJECTION

Category Antibacterial.

          Ampicillin Sodium for Injection contains an amount of Ampicillin Sodium equivalent to not less than 90.0 per cent and not more than 115.0 per cent of the labelled amount of C16H19N3O4S.

Strengths available 125, 250 and 500 mg; 1 and 2 g (base); and 10 g (base, pharmacy bulk package.)

Dose Adults and children 20 kg of body weight and over: Intramuscular or intravenous, 250 to 500 mg every
6 hours. The total dosage should not exceed 14 g daily.
          Infants and children up to 20 kg of body weight: Intramuscular or intravenous, 12.5 mg per kg of body weight every 6 hours.

Contra-indication See under Penicillin V Potassium, p. 140.

Warning
          1. Phlebitis or thrombophlebitis may occur after repeated intravenous injections, particularly with use of concentrated solutions or continuous infusion.
          2. It should be given with caution to patients with infectious mononucleosis since they are susceptible to ampicillin-induced skin rashes.
          3. Intrathecally injection or too rapid intravenous administration may result in convulsive seizures. See also under Penicillin V Potassium, p. 140.

Precaution; Additional information See under Penicillin V Potassium, p. 140.

Packaging and storage Ampicillin Sodium for Injection shall be kept in Containers for Sterile Solids as described under “Parenteral Preparations” (Appendix 1.16), and stored at a temperature not exceeding 30º. The constituted solution should be used immediately after preparation and protected from freezing.

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

Identification
          A. 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.
          B. It yields the reactions characteristic of sodium salts (Appendix 5.1).

pH; Water Complies with the tests described under Ampicillin Sodium, p. 29.

Crystallinity It is crystalline (Method I, Appendix 4.14).

(Note Ampicillin for Injection in the freeze-dried form is exempt from this requirement.)

Constituted solution At the time of use, it complies with the requirements described under “Constituted Solutions” (Appendix 4.20).

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

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

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Diluent, Standard preparation,Resolution Solution, and Chromatographic system Proceed as directed in the Assay under Ampicillin Sodium, p. 29.
          Assay preparation 1 (Where it is represented as being in a single dose container,) Constitute Ampicillin Sodium for Injection in an accurately measured volume of Diluent, corresponding to the volume of solvent specified in the labeling. Withdraw all of the withdrawable contents, using a suitable hypodermic needle and syringe, and dilute quantitatively with Diluent to obtain a solution containing about 1 mg of ampicillin per ml. Use this solution promptly after preparation.
          Assay preparation 2 (Where the label states the quantity of ampicillin in a given volume of constituted solution) Constitute 1 container of Ampicillin Sodium for Injection in a volume of Diluent, accurately measured, corresponding to the volume of solvent specified in the labelling. Dilute an accurately measured portion of the constituted solution quantitatively with Diluent to obtain a solution having a concentration of about 1 mg of ampicillin per ml. Use this solution promptly after preparation.
          Procedure Proceed as directed under Procedure in the Assay under Ampicillin sodium, p. 29.
          Calculation Calculate the quantity, in mg, of C16H19 N3O4S in the container and in the volume of constituted solution taken using the declared content of C16H19N3O4S in Ampicillin RS. Where the test for Uniformity of dosage units has been performed using the procedure for content uniformity, use the average of these determinations as the Assay value.

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

MONOGRAPHS • AMPICILLIN SODIUM FOR INJECTION
view 2,333 ผู้เข้าชม / View
หมายเหตุ / Note : TP II 2011 PAGE 30 - 31