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ROMN
EDIIA A X-A
SUPLIMENT 2004
COMISIA DE COORDONARE A
FARMACOPEEI ROMNE
PREEDINTE:
SECRETAR:
MEMBRI
Farm.pr.
Otilia
Ulieru
Director
Direcia
General
Departament evaluare -
autorizare ANM
COLECTIV DE REDACTARE
Supliment 2004
PREFA
Romnia a aderat la Convenia privind elaborarea Farmacopeei
Europene, din cadrul Consiliului Europei i a devenit membru cu
drepturi depline ncepnd din 24.09.2003.
Parlamentul Romniei a adoptat legile pentru aderarea Romniei
la Convenie i la Protocolul la Convenia privind elaborarea
Farmacopeei Europene (Legile nr.148 din 03.04.2001 i nr.98 din
05.04.2002), care au fost promulgate prin Decretul nr. 159/2002
de Preedintele Romniei i publicate n Monitorul Oficial al
Romniei.
Convenia privind elaborarea Farmacopeei Europene a fost
adoptat la Strasbourg n 1964 i este format la ora actual din
32 de pri semnatare: Anglia, Austria, Belgia, Bosnia i
Heregovina, Republica Ceh, Cipru, Croaia, Danemarca, Elveia,
Estonia, Finlanda, Frana, Germania, Grecia, Irlanda, Islanda,
Italia, Letonia, Luxemburg, Macedonia, Norvegia, Olanda,
Portugalia, Romnia, Serbia i Muntenegru, Slovenia, Slovacia,
Spania, Suedia, Turcia, Ungaria, i Uniunea European.
Comisia Farmacopeei Europene este format din delegaiile
naionale ale prilor semnatare ale Conveniei.
Prin aderarea Romniei la Convenie standardele de calitate
ale Farmacopeei Europene vor deveni obligatorii pentru toate
medicamentele de uz uman i veterinar fabricate n Romnia,
ct i pentru cele din import.
Agenia Naional a Medicamentului a adoptat treptat o serie de
monografii i metode generale de analiz din Farmacopeea
European, care au devenit norme obligatorii n domeniul calitii
medicamentului din Romnia i care au fost publicate n
Suplimentele Farmacopeei Romne ediia a X-a.
Suplimentul 2004 al Farmacopeei Romne ediia a X-a este
redactat i publicat de Agenia Naional a Medicamentului, creia
i revine elaborarea Farmacopeei Romne i a Suplimentelor
Supliment 2004
PREFACE
Romania acceded to the Convention on the elaboration of the
European Pharmacopoeia, of the European Council and became
a full member starting with 24.09.2003.
The Romanian Parliament has adopted the Laws regarding
Romanias accession to the Convention on the elaboration of the
European Pharmacopoeia (Laws No. 148 from 03.04.2001 and
No. 98 from 05.04.2002), that were promulgated through the
Decree No. 159/2002 by the President of Romania and published
in the Romanian Official Monitor.
The Convention on the elaboration of the European
Pharmacopoeia was adopted in Strasbourg in 1964 and it is
signed in the present by 32 parties: Austria, Belgium, BosniaHerzegovina, Czech Republic, Cyprus, Croatia, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Iceland,
Italy, Latvia, Luxembourg, Macedonia, Norway, Netherlands,
Portugal, Romania, Serbia and Montenegro Slovenia, Slovakia,
Spain, Sweden, Switzerland, Turkey, United Kingdom and the
European Union.
By Romanias accession to the Convention, the quality
standards of the European Pharmacopoeia will become
mandatory for all the medicinal products for human and
veterinary use manufactured in Romania, as well as for all the
imported ones.
The National Medicines Agency has gradually adopted a series of
monographs and general analysis methods from the European
Pharmacopoeia, that have become mandatory standards in the
medicines quality domain within Romania and that have been
published in the Supplements of the Romanian Pharmacopoeia,
the Xth edition.
The Supplement 2004 of the Romanian Pharmacopoeia, the Xth
edition, has been drawn up and published by the National
Supliment 2004
CUPRINS
Prefa - Suplimentul 2004 al Farmacopeei Romne ediia a X-a
PREVEDERI GENERALE
1.1.
Generaliti.21
1.2. Alte dispoziii aplicabile monografiilor i capitolelor
generale.24
1.3. Capitole generale...27
1.4. Monografii28
1.5. Abrevieri i simboluri.36
1.6. Sistemul internaional de uniti (SI) utilizat de
Farmacopeea European i corespondena cu alte
Uniti..40
MONOGRAFII DE FORME FARMACEUTICE
Glosar (01/2002 : 1502)..49
Capsule (01/2002 : 0016)...52
Comprimate (04/2002 : 0478)59
Creioane (01/2002 : 1154)..69
Granule (04/2003 : 0499)71
Gume medicamentoase masticabile (01/2002 : 1239)..76
Preparate
auriculare
(01/2002
0652)
..78
Preparate bucofaringiene (04/2002 : 1807).83
Preparate de inhalat (04/2003 : 0671)..94
Preparate farmaceutice presurizate (01/2002 : 0523).108
Preparate lichide pentru aplicaii cutanate (04/2003 : 0927)..110
Preparate lichide pentru uz oral (04/2003 : 0672)113
Preparate nazale (01/2002 : 0676).120
Preparate oftalmice (04/2003 : 1163).127
Preparate parenterale (01/2002 : 0520).135
Preparate pentru irigaii (01/2002 : 1116)..143
Preparate rectale (01/2002 : 1145).145
Preparate semisolide pentru aplicaii cutanate
(01/2002 : 0132).152
Preparate vaginale (01/2002 : 1164)..159
Pulberi orale (04/2003 : 1165).166
Pulberi pentru aplicaii cutanate (01/2002 : 1166)168
Sisteme terapeutice transdermice (01/2002 : 1011)171
Spume medicamentoase (01/2002 : 1105)...174
Tampoane medicamentoase (01/2002 : 1155).178
TEXTE REVIZUITE :
1. Din Farmacopeea European ediia a 4-a
2.9.5. Uniformitatea masei preparatelor unidoz181
2.9.6. Uniformitatea coninutului preparatelor unidoz...183
Supliment 2004
10
TEXTE SUPRIMATE
1. Din Farmacopeea European ediia a 4-a
2.9.21. Contaminarea cu particule: metode microscopice
11
Supliment 2004
12
Preparate endocervicale
Preparate intrauterine
Varia
2. Cile de administrare259
3. Ambalaje primare, sisteme de nchidere i de
administrare264
INDEX DE REACTIVI271
REACTIVI
(Necesari determinrilor prevzute n monografiile acestui Supliment )
4.1.1. Reactivi.280
4.1.2. Soluii etalon pentru controlul limitelor de impuriti.303
4.1.3. Soluii tampon..305
4.2.2. Soluii titrate.306
INDEX ALFABETIC...311
13
CONTENTS
Preface - Supplement 2004 of the Romanian Pharmacopoeia X th
edition
GENERAL NOTICES
1.1. General statements..21
1.2. Other provisions applying to general chapters and
monographs.24
1.3. General chapters..27
1.4. Monographs..28
1.5. Abbreviations and symbols.36
1.6. Units of the international system (SI) used in the
pharmacopoeia and equivalence with other units...40
(04/2003
..71
0499)
Supliment 2004
14
REVISED TEXTS
1. Of the European Pharmacopoeia 4th edition
2.9.5. Uniformity of mass of single-dose preparations181
2.9.6. Uniformity of content of single-dose preparations.183
2.9.17. Test for extractable volume of parenteral
15
preparations..185
3.1.10. Materials based on non-plasticised poly(vinylchloride)
for containers for non-injectable, aqueous solutions..187
3.1.11. Materials based on non-plasticised poly(vinylchloride)
for
containers
for
dry
dosage
forms
for
oral
administration..195
Water for injections (07/2002 : 0169).208
Water, purified (07/2002 : 0008)..203
2. Of the Romanian Pharmacopoeia Xth edition
Decision of the National Medicines Agency Scientific Council
No. 7 from the17th of January 2003, regarding the change of the
framing of certain pharmaceutical preparations from Separanda
or Venena category, from the Romanian Pharmacopoeia, Xth
edition.215
Annex no. I..216
Annex no. II Table Separanda..218
Annex no. III Table Venena .221
Order of the Minister of Health and Family No.95 from the 6 th of
February 2003, for approval of the National Medicines Agency
Scientific Council, No. 7 from the17th of January
2003,
regarding the change of the framing of certain pharmaceutical
preparations from Separanda or Venena category, from the
Romanian Pharmacopoeia, Xth edition 222
DELETED TEXTS
1. Of the European Pharmacopoeia 4th edition
2.9.21. Particulate contamination : microscope method
Supliment 2004
16
17
Intrauterine preparations
Miscellaneous
2. Routes of administration 259
3. Containers..264
REAGENTS INDEX..271
REAGENTS
(Use for requirement tests in this Supplement monographs)
4.1.1. Reagents..280
4.1.2. Standard solutions for limit tests..303
4.1.3. Buffer solutions305
4.2.2. Volumetric solutions ..306
ALPHABETICAL INDEX.311