In Vivo Assay

Selection and distribution of the test animals. Use in the test healthy mice from the same stock, about 5 weeks old. The strain of mice used for this test must give a significant slope for the dose-response curve to the antigen mice with haplotype H-2q or H-2d are suitable. Healthy guinea-pigs weighing 300 g to 350 g (about 7 weeks old) from the same stock are also suitable. Use animals of the same sex. Distribute the animals in at least 7 equal groups of a number appropriate to the...

General Chapters

Thermal analysis (previously Thermogravimetry) 2.7.4. Assay of human coagulation factor VIII (previously Assay of blood coagulation factor VIII) 3.1.4. Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations (previously Polyethylene without additives for containers for preparations for parenteral use and for ophthalmic preparations) 3.1.5. Polyethylene with additives for containers for parenteral preparations and for ophthalmic...

Method Of Lethal Challenge

Selection and distribution of the test animals. Use in the test healthy guinea-pigs from the same stock, each weighing 250 g to 350 g. Distribute the guinea-pigs in not fewer than 6 equal groups use groups containing a number of animals sufficient to obtain results that fulfil the requirements for a valid assay prescribed below. If the challenge toxin to be used has not been shown to be stable or has not been adequately standardised, include 4 further groups of 5 guinea-pigs as unvaccinated...

Test For Neurovirulence Of Poliomyelitis Vaccine Oral

Monkeys used in the neurovirulence test comply with the requirements given in the monograph on Poliomyelitis vaccine oral (0215) and weigh not less than 1.5 kg. The pathogenicity for Macaca or Cercopithecus monkeys is tested in comparison with that of a reference virus preparation for neurovirulence testing by inoculation into the lumbar region of the central nervous system after sedation with a suitable substance, for example, ketamine hydrochloride. A sample of serum taken before the...

Determination Of The Activity Of The Challenge Toxin

If necessary, allocate the 3 dilutions made from the challenge toxin solution, 1 to each of the 3 groups of 5 guinea-pigs, and inject subcutaneously 1.0 ml of each solution into each guinea-pig in the group to which that solution is allocated. The activity and stability of the challenge toxin are determined by carrying out a suitable number of determinations of the 50 per cent paralytic dose. It is then not necessary to repeat the determination for each assay. READING AND INTERPRETATION OF...

Test In Chicken Embryo Fibroblast Cells

Prepare 7 monolayers of primary or secondary chicken embryo fibroblasts, from the tissues of 9- to 11-day-old embryos, each monolayer having an area of about 25 cm2. Maintain 2 monolayers as negative controls and treat these in the same way as the 5 monolayers inoculated with the test vaccine, as described below. Remove the culture medium when the cells reach confluence. Inoculate 0.1 ml of test vaccine onto each of 5 of the monolayers. Allow adsorption for 1 h and add culture medium. Incubate...

Tests For Extraneous Agents In Viral Vaccines For Human

In those tests that require prior neutralisation of the virus, use specific antibodies of non-human, non-simian origin if the virus has been propagated in avian tissues, the antibodies must also be of non-avian origin. To prepare antiserum, use an immunising antigen produced in cell culture from a species different from that used for the production of the vaccine and free from extraneous agents. Where the use of SPF eggs is prescribed, the eggs are obtained from a flock free from specified...

Monographs

The monographs below appear for the first time in the European Pharmacopoeia. They will be implemented on Botulinum toxin type A for injection (2113) Closantel sodium dihydrate for veterinary use (1716) Formoterol fumarate dihydrate (1724) Human coagulation factor VIII (rDNA) (1643) Propylene glycol dicaprylocaprate (2122) Avian viral vaccines tests for extraneous agents in seed lots (previously texts2.6.3,2.6.4, 2.6.5and 2.6.6) Tiamulin hydrogen fumarate for veterinary use (1659) Meningococcal...

Sialic Acid In Polysaccharide Vaccines

Transfer quantitatively the contents of one or several containers to a volumetric flask of a suitable volume that will give a solution with a known concentration of about 250 pg per millilitre of polysaccharide and dilute to volume with water R. Using a syringe, transfer 4.0 ml of this solution to a 10 ml ultrafiltration cell suitable for the passage of molecules of relative molecular mass less than 50 000. Rinse the syringe twice with water R and transfer the rinsings to the...

Bromophenol blue solution 1012801

Dissolve 0.1 g of bromophenol blue R in 1.5 ml of 0.1 M sodium hydroxide and 20 ml of alcohol R and dilute to 100 ml with water R. Test for sensitivity. To 0.05 ml of the bromophenol blue solution add 20 ml of carbon dioxide-free water R and 0.05 ml of 0.1 M hydrochloric acid. The solution is yellow. Not more than 0.1 ml of 0.1 M sodium hydroxide is required to change the colour to bluish-violet. Colour change pH 2.8 yellow to pH 4.4 bluish-violet . Bromophenol blue solution R1. 1012802....