WHO Drug Information Vol. 25, No. 2, 2011

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Consultation DocumentsWHO Drug Information Vol. 25, No. 2, 2011For an oral solution presented as single doses calculate the deliverable content ofvitamin A in IU per capsule from the expression: Α 326x V x d x 1900/ (100 x m), whereA 326is the absorbance at 326 nm, V is the total volume used for the dilution to give 10-15 IU per ml, m is the mass of sample used in g, AM is the average mass of theexpressed contents in g per capsule and 1900 is the factor to convert the specificabsorbances of esters of retinol into IU per g.If one or more of the ratios Α λ/Α 326exceeds the values given, or if the wavelength ofthe absorption maximum does not lie between 325 nm and 327 nm, use Method B.B. Carry out the test as described under 1.14.4 High-performance liquid chromatography,using a stainless steel column (15 cm x 4.6 mm) packed with particles of silicagel, the surface of which has been modified with octadecysilyl groups (5 µm). As themobile phase, use a mixture of 95 volumes of methanol R and 5 volumes of water R.Prepare the following solutions. For solution (1) transfer a quantity of the oral solutioncontaining the equivalent of about 100 000 IU of vitamin A, accurately weighed, into a100 ml volumetric flask. Dissolve immediately in 5 ml of n-pentane R. Add 40 ml of 0.1M tetrabutylammonium hydroxide TS in 2-propanol R. Swirl gently and allow themixture to stand for 10 minutes at a temperature between 60 ° and 65 °C, swirlingoccasionally. Allow to cool to room temperature, dilute to volume with 2-propanol Rcontaining 1 g/l butylated hydroxytoluene R, and homogenise carefully to avoid airbubbles. Dilute 5 ml of the resulting solution to 50 ml with 2-propanol R. For solution(2) transfer an amount of retinol acetate RS or retinol palmitate RS containing about100 000 IU of vitamin A, accurately weighed, into a 100 ml volumetric flask. Proceedas described for solution (1).Operate with a flow rate of 1 ml per minute. As a detector use an ultraviolet spectrophotometerset at a wavelength of about 325 nm.Inject alternately 10 µl each of solutions (1) and (2) and record the chromatograms for1.5 times the retention time of retinol.Measure the areas of the peak responses obtained in the chromatograms fromsolutions (1) and (2). Determine the weight per ml (1.3.1) and calculate the content ofvitamin A in IU per ml of the oral solution or, where appropriate, in IU delivered percapsule.150
WHO Drug Information Vol. 25, No. 2, 2011 Proposed INN: List 105International Nonproprietary Names forPharmaceutical Substances (INN)Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended InternationalNonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are underconsideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a namein the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substancein medicine or pharmacy.Lists of Proposed (1–101) and Recommended (1–62) International Nonproprietary Names can be found in Cumulative ListNo. 13, 2009 (available in CD-ROM only). The statements indicating action and use are based largely on informationsupplied by the manufacturer. This information is merely meant to provide an indication of the potential use of newsubstances at the time they are accorded Proposed International Nonproprietary Names. WHO is not in a positioneither to uphold these statements or to comment on the efficacy of the action claimed. Because of their provisional nature,these descriptors will neither be revised nor included in the Cumulative Lists of INNs.Dénominations communes internationales desSubstances pharmaceutiques (DCI)Il est notifié que, conformément aux dispositions de l'article 3 de la Procédure à suivre en vue du choix de Dénominationscommunes internationales recommandées pour les Substances pharmaceutiques les dénominations ci-dessous sont misesà l'étude par l'Organisation mondiale de la Santé en tant que dénominations communes internationales proposées.L'inclusion d'une dénomination dans les listes de DCI proposées n'implique aucune recommandation en vue de l'utilisationde la substance correspondante en médecine ou en pharmacie.On trouvera d'autres listes de Dénominations communes internationales proposées (1–101) et recommandées (1–62) dansla Liste récapitulative No. 13, 2009 (disponible sur CD-ROM seulement). Les mentions indiquant les propriétés et lesindications des substances sont fondées sur les renseignements communiqués par le fabricant. Elles ne visent qu'àdonner une idée de l'utilisation potentielle des nouvelles substances au moment où elles sont l'objet depropositions de DCI. L'OMS n'est pas en mesure de confirmer ces déclarations ni de faire de commentaires sur l'efficacitédu mode d'action ainsi décrit. En raison de leur caractère provisoire, ces informations ne figureront pas dans les listesrécapitulatives de DCI.Denominaciones Comunes Internacionales paralas Sustancias Farmacéuticas (DCI)De conformidad con lo que dispone el párrafo 3 del "Procedimiento de Selección de Denominaciones ComunesInternacionales Recomendadas para las Sustancias Farmacéuticas", se comunica por el presente anuncio que lasdenominaciones detalladas en las páginas siguientes están sometidas a estudio por la Organización Mundial de La Saludcomo Denominaciones Comunes Internacionales Propuestas. La inclusión de una denominación en las listas de las DCIPropuestas no supone recomendación alguna en favor del empleo de la sustancia respectiva en medicina o en farmacia.Las listas de Denominaciones Comunes Internacionales Propuestas (1–101) y Recomendadas (1–62) se encuentranreunidas en Cumulative List No. 13, 2009 (disponible sólo en CD-ROM). Las indicaciones sobre acción y uso que aparecense basan principalmente en la información facilitada por los fabricantes. Esta información tiene por objeto dar una ideaúnicamente de las posibilidades de aplicación de las nuevas sustancias a las que se asigna una DCI Propuesta. LaOMS no está facultada para respaldar esas indicaciones ni para formular comentarios sobre la eficacia de la acción que seatribuye al producto. Debido a su carácter provisional, esos datos descriptivos no deben incluirse en las listasrecapitulativas de DCI.151
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WHO Drug Information Vol. 25, No. 2, 2011

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