2.9.17. Test for Extractable Volume of Parenteral Preparations
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EUROPEAN PHARMACOPOEIA 5.0 2.9.17. Test for extractable volume of parenteral preparations Nozzle Diameter (d) of the outflow opening (millimetres) 1 10 ± 0.01 2 15 ± 0.01 3 25 ± 0.01 Figure 2.9.16.-1. — Flow funnel and nozzle. Nozzle is made of stainless, acid-resistant steel (V4A,CrNi) Dimensions in millimetres Figure 2.9.16.-2 Dimensions in millimetres 01/2005:20917 2.9.17. TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS Injections may be supplied in single-dose containers such as ampoules, cartridges or prefilled syringes filled with a volume of injection which is sufficient to permit administration of the nominal volume declared on the label. Compliance with the requirements for extractable volume is assured by filling with a volume in slight excess of the nominal volume to be withdrawn. The excess volume is determined by the characteristics of the product. The single-dose container does not hold a quantity relative to the nominal volume that would present a risk should the whole contents be administered. Suspensions and emulsions are shaken before withdrawal of the contents and before the determination of the density. Oily and viscous preparations may be warmed according to the instructions on the label, if necessary, and thoroughly shaken immediately before removing the contents. The contents are then cooled to 25 °C before measuring the volume. SINGLE-DOSE CONTAINERS Select one container if the nominal volume is 10 ml or more, 3 containers if the nominal volume is more than 3 ml and less than 10 ml, or 5 containers if the nominal volume is 3 ml or less. Take up individually the total contents of each container selected into a dry hypodermic syringe of a capacity not exceeding 3 times the volume to be measured, and fitted with a 21-gauge needle not less than 2.5 cm in length. Expel any air bubbles from the syringe and needle, then discharge the contents of the syringe without emptying the needle into a standardised dry cylinder (graduated to contain rather than to deliver the designated volumes) of such size that the volume to be measured occupies at least 40 per cent of its graduated volume. Alternatively, the volume of the contents in millilitres may be calculated as the mass in grams divided by the density. The contents of 2 or 3 containers with a nominal volume of 2 ml or less may be pooled for the measurement provided that a separate, dry syringe assembly is used for each container. The contents of containers holding 10 ml or more may be determined by opening them and emptying the contents directly into the graduated cylinder or tared beaker. The volume is not less than the nominal volume in the case of containers examined individually, or, in the case of containers with a nominal volume of 2 ml or less, is not less than the sum of the nominal volumes of the containers taken collectively. MULTI-DOSE CONTAINERS For injections in multidose containers labelled to yield a specific number of doses of a stated volume, select one container and proceed as directed for single-dose containers using the same number of separate syringe assemblies as the number of doses specified. The volume is such that each syringe delivers not less than the stated dose. CARTRIDGES AND PREFILLED SYRINGES Select one container if the nominal volume is 10 ml or more, 3 containers if the nominal volume is more than 3 ml and less than 10 ml, or 5 containers if the nominal volume is 3 ml or less. If necessary, fit the containers with the accessories General Notices (1) apply to all monographs and other texts 243
description
Test for EV
Transcript of 2.9.17. Test for Extractable Volume of Parenteral Preparations
EUROPEAN PHARMACOPOEIA 5.0 2.9.17. Test for extractable volume of parenteral preparations
Nozzle Diameter (d) of the outflowopening (millimetres)
1 10 ± 0.01
2 15 ± 0.01
3 25 ± 0.01
Figure 2.9.16.-1. — Flow funnel and nozzle. Nozzle is madeof stainless, acid-resistant steel (V4A,CrNi)
Dimensions in millimetres
Figure 2.9.16.-2
Dimensions in millimetres
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2.9.17. TEST FOR EXTRACTABLEVOLUME OF PARENTERALPREPARATIONSInjections may be supplied in single-dose containers such asampoules, cartridges or prefilled syringes filled with a volumeof injection which is sufficient to permit administration ofthe nominal volume declared on the label.Compliance with the requirements for extractable volumeis assured by filling with a volume in slight excess of thenominal volume to be withdrawn. The excess volume isdetermined by the characteristics of the product. Thesingle-dose container does not hold a quantity relative to thenominal volume that would present a risk should the wholecontents be administered.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 25 °C before measuring thevolume.
SINGLE-DOSE CONTAINERS
Select one container if the nominal volume is 10 ml ormore, 3 containers if the nominal volume is more than 3 mland less 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 hypodermic syringe of acapacity not exceeding 3 times the volume to be measured,and fitted with a 21-gauge needle not less than 2.5 cm inlength. Expel any air bubbles from the syringe and needle,then discharge the contents of the syringe without emptyingthe needle into a standardised dry cylinder (graduated tocontain rather than to deliver the designated volumes)of such size that the volume to be measured occupies atleast 40 per cent of its graduated volume. Alternatively, thevolume of the contents in millilitres may be calculated as themass in grams divided by the density.The contents of 2 or 3 containers with a nominal volume of2 ml or less may be pooled for the measurement providedthat a separate, dry syringe assembly is used for eachcontainer. 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 thecase of containers examined individually, or, in the case ofcontainers with a nominal volume of 2 ml or less, is notless than the sum of the nominal volumes of the containerstaken collectively.
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 one 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 volume is 3 mlor less. If necessary, fit the containers with the accessories
General Notices (1) apply to all monographs and other texts 243
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2.9.18. Preparations for inhalations EUROPEAN PHARMACOPOEIA 5.0
required 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.
APPARATUS A - GLASS IMPINGERThe apparatus is shown in Figure 2.9.18.-1 (see alsoTable 2.9.18.-1).
Figure 2.9.18.-1. – Apparatus A for the aerodynamicassessment of fine particlesDimensions in millimetres
(tolerances ± 1 mm unless otherwise prescribed)
Table 2.9.18.-1. – Component specification forFigure 2.9.18.-1
Code Item Description Dimen-sions*
A Mouthpieceadaptor
Moulded rubber adapter for actuatormouthpiece
B Throat Modified round-bottomed flaskground-glass inlet socketground-glass outlet cone
50 ml29/3224/29
C Neck Modified glass adapterground-glass inlet socketground-glass outlet coneLower outlet section of precision-boreglass tubingbore diameterSelected bore light-wall glass tubingexternal diameter
24/2924/29
14
17
D Upperimpingementchamber
Modified round-bottomed flaskground-glass inlet socketground-glass outlet cone
100 ml24/2924/29
E Coupling tube Medium-wall glass tubingground-glass coneBent section and upper verticalsectionexternal diameterLower vertical sectionexternal diameter
14/23
13
8
F Screwthread,side-armadaptor
Plastic screw capSilicone rubber ringPTFE washerGlass screwthread, thread sizeSide-arm outlet to vacuum pump,minimum bore diameter
28/1328/1128/1128
5
G Lower jetassembly
Modified polypropylene filter holderconnected to lower vertical section ofcoupling tube by PTFE tubingAcetal circular disc with the centresof four jets arranged on a projectedcircle of diameter 5.3 mm with anintegral jet spacer pegpeg diameterpeg protrusion
seeFigure2.9.18.-110
22
H Lowerimpingementchamber
Conical flaskground-glass inlet socket
250 ml24/29
* Dimensions in millimetres, unless otherwise stated.
Procedure for nebulisersIntroduce 7 ml and 30 ml of a suitable solvent into the upperand lower impingement chambers, respectively.Connect all the component parts, ensure that the assemblyis vertical and adequately supported and that the jet spacerpeg of the lower jet assembly just touches the bottom ofthe lower impingement chamber. Connect a suitable pumpfitted with a filter (of suitable pore size) to the outlet of theapparatus and adjust the air flow through the apparatus, asmeasured at the inlet to the throat, to 60 ± 5 litres/min.Introduce the liquid preparation for inhalation into thereservoir of the nebuliser. Fit the mouthpiece and connect itby means of an adapter to the device.Switch on the pump of the apparatus and after 10 s switchon the nebuliser.After 60 s, unless otherwise justified, switch off thenebuliser, wait for about 5 s and then switch off the pump ofthe apparatus. Dismantle the apparatus and wash the innersurface of the upper impingement chamber collecting thewashings in a volumetric flask. Wash the inner surface of
244 See the information section on general monographs (cover pages)
