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TYPHOID POLYSACCHARIDE VACCINE

      Typhoid Polysaccharide Vaccine is a preparation of purified capsular Vi polysaccharide obtained from Salmonella typhi Ty 2 strain or some other suitable strain that has the capacity to produce Vi polysaccharide.

      Capsular Vi polysaccharide consists of partly 3-Oacetylated repeated units of 2-acetylamino-2-deoxyD-galactopyranuronic acid with α-(1 → 4) linkages.​

      The vaccine complies with the requirements stated under Vaccines, with the following modification.

Description Clear, colourless liquid, free from visible particles.

Strength available 25 μg of the Vi polysaccharide of Salmonella typhi per 0.5 ml.

Dose Adults and children 2 years of age and over: Intramuscular or subcutaneous, 0.5 ml.

Contra-indication It is not for intravenous administration.

Warning

1. It may cause pain, tenderness, erythema and induration at the injection site.

2. Fever, malaise, headache, myalgia, nausea, diarrhea, feverishness or vomiting may occur.

Expiration date When stored under the prescribed conditions, the expiration date is not later than 3 years after the date of the last satisfactory tests.

Labelling Complies with the “General Information for Biological Products”, p. 177. In addition the label on the container states (1) the number of micrograms of polysaccharide per human dose; (2) the total quantity of polysaccharide in the container.

Identification Carry out an identification test using a suitable immunochemical method (Appendix 14.5).

pH 6.5 to 7.5 (Appendix 4.11).

Content of O-acetyl groups Not less than 75 per cent and not more than 125 per cent of 0.085 μmol per dose (25 μg of polysaccharide).

      Standard acetylcholine chloride solution Prepare a solution containing 15 mg of acetylcholine chloride per ml.

      Standard acetylcholine curve Immediately before use, dilute 1.0 ml of Standard acetylcholine chloride solution to 50.0 ml with water for working dilution which contains 0.3 mg per ml of acetylcholine chloride. From this solution, accurately transfer 0.05, 0.1, 0.2, 0.4, and 0.8 ml, each in duplicate (one for reaction solution and the other for the correction solution) to 10 testtubes. Dilute with water to 1.0 ml and mix. Prepare a blank using 1.0 ml of water. Add 1.0 ml of a mixture of 2 volumes of water and 1 volume of hydrochloric acid to each of the correction tubes and to the blank. Add 2.0 ml of alkaline hydroxylamine TS to each tube. Allow the reaction to proceed for exactly 2 minutes and add 1.0 ml of a mixture of 2 volumes of water and 1 volume of hydrochloric acid to each of the reaction tubes. Add 1.0 ml of a 10 per cent w/v solution of iron(III) chloride in 0.1 M hydrochloric acid to each tube, stopper the tubes and shake vigorously to remove bubbles.

      Measure the absorbances of the acetylcholine chloride-containing solutions relative to the blank at 540 nm (Appendix 2.2). For each reaction solution, subtract the absorbance of the corresponding correction solution. Draw a calibration curve from the corrected absorbances for the five reference solutions and the corresponding contents of acetylcholine chloride.

      Procedure Place 1 ml of the vaccine in each of three tubes (two reaction solutions and one correction solution). Repeat the same procedure as directed under Standard acetylcholine curve beginning with “Prepare a blank...”. Measure the absorbances of the resulting solutions and, by reference to the Standard acetylcholine chloride curve, calculate the content of acetylcholine. Read from the curve the content of acetylcholine chloride in the vaccine being examined.

      Calculation Calculate the mean of the two values. One mole of acetylcholine chloride (181.66 g) is equivalent to 1 mole of O-acetyl (43.05 g).

Antimicrobial preservative Where applicable, determine the amount of antimicrobial preservative by a suitable physicochemical method. The content is not less than the minimum amount shown to be effective and not more than 115 per cent of the content stated on the label.

Assay Determine Vi polysaccharide by a suitable immunochemical method (Appendix 14.5), using a reference purified polysaccharide.

      The estimated amount of polysaccharide per dose is not less than 80 per cent and not more than 120 per cent of the content stated on the label. The confidence limits (P = 0.95) of the estimated amount of polysaccharide are not less than 80 per cent and not more than 120 per cent. 

MONOGRAPHS • TYPHOID POLYSACCHARIDE VACCINE
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หมายเหตุ / Note : TP II 2011 PAGE 279-280