OF DELIVERED DOSES FROM - uspbpep.com

1 EUROPEAN PHARMACOPOEIA Test for deliverable mass or volumeFigure Schematic diagram of the volumetric method apparatusthe gas. The use of a diluent gas, such as helium, is thereforeunnecessary, although helium may be employed for otherpurposes, such as to measure the void only pure adsorbate gas, instead of a gas mixture, isemployed, interfering effects of thermal diffusion are avoidedin this prevent contamination of the clean surface, remove thesample tube, insert the stopper, and weigh it. Calculatethe weight of the sample. Attach the sample tube to thevolumetric apparatus. Cautiously evacuate the sample downto a pressure of Pa or the principle of operation of the instrument requires thedetermination of the void volume in the sample tube, forexample, by the admission of a non-adsorbed gas, such ashelium, this procedure is carried out at this point, followedby evacuation of the sample down to Pa or less.

2 Theadsorption of nitrogen gas is then measured as a Dewar vessel containing liquid nitrogen at 196 Cup to a defined point on the sample cell. Admit a sufficientvolumeofnitrogengastogivearela tivepressure,P/Poequal to Measure the volume adsorbed, the measurement ofVaatP/Povalues of minimum of three data points is required. Additionalmeasurements may be carried out, especially on those rareoccasions when non-linearity is obtained at aP/Povalueclose to Since non-linearity is often obtained atP/Poor below , values in this region are not ,thetreatmentofthedata,andthecalculation of the specific surface area of the sample aredescribed REFERENCE MATERIALSP eriodically verify the functioning of the apparatus usingappropriate reference materials of known surface area whichshould have a specific surface area similar to that of thesample to be UNIFORMITY OF MASSOF DELIVERED DOSES FROMMULTIDOSE CONTAINERSThe following test is intended for oral dosage forms suchas granules, powders for oral use and liquids for oral use.

3 Which are supplied in multidose containers provided atmanufacture with a measuring individually 20 DOSES taken at random from one ormore containers with the measuring device provided anddetermine the individual and average masses. Not more than2 of the individual masses deviate from the average massby more than 10 per cent and none deviates by more than20 per TEST FOR DELIVERABLEMASS OR VOLUME OF LIQUID ANDSEMI-SOLID PREPARATIONSThe test applies to liquid (solutions, emulsions andsuspensions) and semi-solid preparations supplied insingle-dose containers where only part of the contents PREPARATIONSE mpty as completely as possible the contents of onecontainer and determine the mass or volume of the contentsas appropriate. In the case of emulsions and suspensions, is not less than the amount stated on the PREPARATIONSE mpty as completely as possible the contents of onecontainer.

4 The mass of the contents is not less than thatwhich is stated on the (1)applytoallmonographsandothertexts263