สารบัญ

Contents
MENU

CLOXACILLIN SODIUM FOR INJECTION

Category Antibacterial.

          Cloxacillin Sodium for Injection is a sterile material prepared from cloxacillin sodium with or without excipients. It contains the equivalent of not less than 95.0 per cent and not more than 105.0 per cent of the labelled amount of C19H18ClN3O5S.

Strengths available 250, 500, 1000, and 2000 mg (base).

Dose Adults and children weighing more than 20 kg: Intravenous, 250 to 500 mg every 6 hours.

Children up to 20 kg: Intravenous, 6.25 to 12.5 mg per kg of body weight every 6 hours.

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

Additional information It is a preferred drug for the treatment of mild to moderate Staphylococcal infections of the skin and soft tissue, respiratory and genitourinary tracts, and joints.
          See also under Penicillin V Potassium, p. 140.

Packaging and storage Cloxacillin 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 cloxacillin.

Identification Complies with the tests described under Cloxacillin Sodium Capsules, p. 88.

pH 5.0 to 7.0, in a 10.0 per cent w/v solution (Appendix 4.11).

Water Not more than 4.5 per cent w/w (Karl Fischer Method, Appendix 4.12). Use 0.3 g.

Iodine-absorbing substances Not more than 5 per cent, calculated on the anhydrous basis, when determined by the following method. Dissolve about 115 mg, accurately weighed, in sufficient mixed phosphate buffer pH 7.0 to produce 25.0 ml. To 10.0 ml add 10 ml of mixed phosphate buffer pH 4.0 and 10.0 ml of 0.01 M iodine VS and titrate immediately with 0.01 M sodium thiosulfate VS using starch mucilage, added towards the end of the titration, as indicator. Perform a blank determination (Residual Titrations, Appendix 6.17). The difference between the titrations represents the amount of iodineabsorbing substances present. Each ml of 0.01 M sodium thiosulfate is equivalent to 0.5039 mg of iodine-absorbing substances.

Bacterial endotoxins When tested as described in the “Test for Bacterial Endotoxins” (Appendix 8.5), it contains not more than 0.4 Endotoxin Unit per mg of cloxacillin.

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).
          Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Cloxacillin Sodium Capsules, p. 88.
          Assay preparation Dissolve an accurately weighed quantity of the mixed contents of 10 containers of Cloxacilin Sodium for Injection containing about 50 mg of cloxacillin in sufficient of Mobile phase to produce 50.0 ml. Dilute 5.0 ml of the solution to 50.0 ml with Mobile phase.
          Procedure Proceed as directed under Procedure in the Assay under Cloxacillin Sodium Capsules, p. 88.
          Calculation Calculate the content of C19H18ClN3O5S in a container of average content weight of the Injection taken, using the declared content of C19H18ClN3O5S in Cloxacillin Sodium RS.

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

MONOGRAPHS • CLOXACILLIN SODIUM FOR INJECTION
view 2,344 ผู้เข้าชม / View
หมายเหตุ / Note : TP II 2011 PAGE 89 - 90