Thursday, July 2, 2009

Each g of the residue is equivalent to 09213 g of BaSO4BARlUM SULPHATE FOR SUSPENSION Barium Meal Barium Sulphate

Covet, digest in an oven at 8 far 16 hours and filter while still hot through a sintered-glass filter (porosity No. 4). washing the precipitate initially with a 05% We solution of potassium dichromate and finally with 2 ml of water Dry to constant weight at 105* Each g of the residue is equivalent to 09213 g of BaSO4BARlUM SULPHATE FOR SUSPENSION Barium Meal Barium Sulphate for Suspension is a dry mixture or Barium Sulphate with suitable flavours, colours, preservatives and suspending/dispersing agents Description: White or coloured, fine powder or granules. Storage. Store in well-closed containers STANDARDS Barium Sulphate for Suspension contains not less than 90.0 percent of BaSO4 Identification' A Ignite 1 g to constant weight 0.2 g of the residue complies with test A described under Barium Sulphate. 5. The residue reserved in test A complies with test B described under Barium Sulphate pH Between 4.0 and 8.0, determined in a 75% w/v suspension in water, Appendix 8.11 Soluble barium salts. To 10 g of an aqueous suspension containing 75% w/v of Barium Sulphate add 10 ml of dilute hydrochloric acid and 90 ml of water. Boil for 10 minutes, cool and filter Wash the residue with water and dilute the combined filtrate and washings to 100 ml with water Carefully evaporate 50 ml of the resulting solution to avoid charring, add 2 drops of dilute hydrochloric acid and 10 ml of hot water to the residue and filter. To the clear filtrate add 05 ml of dilute sulphuric acid and allow to stand for 30 minutes, no turbidity is produced.Water stability To 80 ml of water contained in a receiver, add 20 ml of an aqueous suspension of the substance being examined, containing 75% w/v of Barium Sulphate Mix thoroughly, allow to stand for 24 hours and decant the super natant liquid, the volume of the sediment is not greater than 5.0 ml Acid stability Cairy out the test of Water stability, using 20 ml of 0.1 M hydrochloric acid and 60 ml of water instead of 80 ml of water. The volume of the sediment is not greater tnan 5 0 ml and does not exceed the figure obtained in the test for Water stability by more than 2.5 ml Loss on drying: Not more than 1.0%, determined on 1 g by drying in an oven at 105° for 4 hours, Appendix 8.6. Assay. Carry out the Assay described under Barium Sulphate BCG VACCINE (FREEZE-DRIED) Bacillus Calmette-Guerin Vaccine BCG Vaccine {Freeze-dried} is a preparation containing live bacteria obtained from a strain derived from the bacillus of Calmette and Guerin and known to protect human beings against tuberculosis. The vaccine is prepared immediately before use by reconstitution from the dtied vaccine with a suitable diluent as per manufacturer's instructions The vaccine is produced on the basis of the seed-lot system. The strain which is of uniform composition is selected and maintained so as to preserve its stability, its power to sensitise human beings to tuberculin, its ability to protect laboratory animals against tuberculosis and to retain its relative nonpathogenicity for human beings and laboratory animals. The seed lot is maintained in a freeze-dried form at a temperature not exceeding -20 and is revived by transplanting on to a suitable medium. The cultures for harvesting are done on liquid medium and the harvested growth is separated by filtration in the form of a "cake" The "cake" is homogenised m a grinding flask and suspended in a suitable sterile liquid medium designed to preserve the antigenicity and the viability of the vaccine as determined by an appropriate method. The suspension is distributed into its final sterile containers and freeze-dried under conditions designed to prevent microbial contamination, particularly by virulent tubercle bacilli. The containers are sealed so as to prevent contamination or deterioration of the final vaccine. The vaccine contains no antimicrobial agent Category: Active immunising agent Dose Prophylactic, by intracutaneous injection as a single dose, 0.1 ,ml Description White pellet or powder which, when reconstituted, yields an opalescent and homogeneous suspension Storage Store in light-resistant glass containers at a temperature between 2 and 8. The vaccine should be used immediately after reconstitution Labelling. The label states (1) the number of viable particles,.(2) the name and volume of the liquid to be used for reconstituting the vaccine, (3) the storage conditions. (4) the date after which

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