FARMACOPEEA EUROPEANA PDF

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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 of the Romanian Pharmacopoeia, the X th edition, contains general chapters, general and individual monographs, translated and harmonised from the European Pharmacopoeia, the 4th edition and the 4. Regarding that all the texts, gathered in the Supplement of the Romanian Pharmacopoeia, the Xth edition, are translated and harmonised from the European Pharmacopoeia; in case of litigations, the texts from the official versions published by the European Council in English and French will be referred to.

It has to be mentioned, also, that it may be possible for some modifications to occur in the subsequent editions and Addendums of the European Pharmacopoeia, with reference to the translated texts comprised in Supplement of the Romanian Pharmacopoeia, the Xth edition. The provisions of the Supplement of the Romanian Pharmacopoeia, the Xth edition, will come in force after its previous publishing by the National Medicines Agency.

Senior Pharm. Capitole generale…………………………………… Monografii………………………………………………28 1. Determinarea volumului extractibil pentru preparate parenterale………………………………………………. I………………………………………………………… Anexa nr. II - tabel Separanda…………………………………..

III — tabel Venena……………………………………. Forme farmaceutice………………………………………….. General statements………………………………………….. Other provisions applying to general chapters and monographs…………………………………………………. General chapters……………………………………………..

Abbreviations and symbols…………………………………. Units of the international system SI used in the pharmacopoeia and equivalence with other units……… Of the European Pharmacopoeia 4th edition 2. Uniformity of mass of single-dose preparations……… 2.

Uniformity of content of single-dose preparations……. Materials based on non-plasticised poly vinylchloride for containers for non-injectable, aqueous solutions.. Materials based on non-plasticised poly vinylchloride for containers for dry dosage forms for oral administration……………………………………………….. II — Table Separanda……………………………….. III — Table Venena …………………………………. Pharmaceutical dosage forms ………………………… Routes of administration ………………………………… 3. Standard solutions for limit tests………………………..

Buffer solutions…………………………………………… 4. Volumetric solutions ……………………………………..

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