EUROPEAN PHARMACOPOEIA 6.0 2.9.18. Preparations for inhalation

Figure 2.9.16.-2

Dimensions in millimetres

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2.9.17. TEST FOR EXTRACTABLEVOLUME OF PARENTERALPREPARATIONS

Suspensions and emulsions are shaken before withdrawal ofthe contents and before the determination of the density.Oily and viscous preparations may be warmed according tothe instructions on the label, if necessary, and thoroughlyshaken immediately before removing the contents. Thecontents are then cooled to 20-25 °C before measuring thevolume.

SINGLE-DOSE CONTAINERS

Select 1 container if the nominal volume is 10 ml or more,3 containers if the nominal volume is more than 3 ml andless than 10 ml, or 5 containers if the nominal volumeis 3 ml or less. Take up individually the total contents ofeach container selected into a dry syringe of a capacity notexceeding 3 times the volume to be measured, and fittedwith a 21-gauge needle not less than 2.5 cm in length. Expelany air bubbles from the syringe and needle, then dischargethe contents of the syringe without emptying the needle intoa standardised dry cylinder (graduated to contain ratherthan to deliver the designated volumes) of such size that thevolume to be measured occupies at least 40 per cent of itsgraduated volume. Alternatively, the volume of the contentsin millilitres may be calculated as the mass in grams dividedby the density.

For containers with a nominal volume of 2 ml or less,the contents of a sufficient number of containers may bepooled to obtain the volume required for the measurementprovided that a separate, dry syringe assembly is used foreach container. The contents of containers holding 10 ml ormore may be determined by opening them and emptying thecontents directly into the graduated cylinder or tared beaker.

The volume is not less than the nominal volume in case ofcontainers examined individually, or, in case of containerswith a nominal volume of 2 ml or less, is not less thanthe sum of the nominal volumes of the containers takencollectively.

MULTI-DOSE CONTAINERS

For injections in multidose containers labelled to yield aspecific number of doses of a stated volume, select onecontainer and proceed as directed for single-dose containersusing the same number of separate syringe assemblies as thenumber of doses specified.The volume is such that each syringe delivers not less thanthe stated dose.

CARTRIDGES AND PREFILLED SYRINGES

Select 1 container if the nominal volume is 10 ml or more, 3containers if the nominal volume is more than 3 ml and lessthan 10 ml, or 5 containers if the nominal volume is 3 mlor less. If necessary, fit the containers with the accessoriesrequired for their use (needle, piston, syringe) and transferthe entire contents of each container without emptying theneedle into a dry tared beaker by slowly and constantlydepressing the piston. Determine the volume in millilitrescalculated as the mass in grams divided by the density.The volume measured for each of the containers is not lessthan the nominal volume.

PARENTERAL INFUSIONS

Select one container. Transfer the contents into a drymeasuring cylinder of such a capacity that the volume tobe determined occupies at least 40 per cent of the nominalvolume of the cylinder. Measure the volume transferred.The volume is not less than the nominal volume.

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2.9.18. PREPARATIONS FORINHALATION: AERODYNAMICASSESSMENT OF FINE PARTICLESThis test is used to determine the fine particle characteristicsof the aerosol clouds generated by preparations forinhalation.Unless otherwise justified and authorised, one of thefollowing apparatus and test procedures is used.Stage mensuration is performed periodically together withconfirmation of other dimensions critical to the effectiveoperation of the impactor.Re-entrainment (for apparatus D and E). To ensure efficientparticle capture, coat each plate with glycerol, silicone oilor similar high viscosity liquid, typically deposited froma volatile solvent. Plate coating must be part of methodvalidation and may be omitted where justified and authorised.Mass balance. The total mass of the active substance is notless than 75 per cent and not more than 125 per cent ofthe average delivered dose determined during testing foruniformity of delivered dose. This is not a test of the inhalerbut it serves to ensure that the results are valid.

APPARATUS A - GLASS IMPINGERThe apparatus is shown in Figure 2.9.18.-1 (see alsoTable 2.9.18.-1).

General Notices (1) apply to all monographs and other texts 287