The International Pharmacopoeia
This new edition consolidates the texts of the five separate volumes of the third edition. In preparing this consolidated edition the opportunity has been taken to review the General notices of the Pharmacopoeia. Certain additions and amendments have been made to the notices in order to clarify the interpretation of the Pharmacopoeia and to facilitate application of the requirements by the user.
The opportunity has also been taken to improve certain aspects of the layout and format of the publication. In this Fourth edition all the monograph texts are brought together in one section and the method texts in another. Each of these major sections are divided into appropriate sub-sections and the method texts are numbered for ease of cross-reference.
New monographs for the following antiretroviral substances are published in the Fourth edition: didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate.
Revision of the current monograph for Oral rehydration salts has been carried out to conform to the modified formula published in the 13th Model List of Essential Medicines (WHO Technical Report Series No. 920 2003) and in the WHO Model Formulary 2004. The revised formula has a reduced sodium chloride and glucose content providing a solution with a reduced osmolarity of 245 mOsm/l. Due to the improved effectiveness of the reduced osmolarity ORS solution, especially for children with acute non-cholera diarrhea, WHO and UNICEF now recommend that countries use and manufacture this formulation in place of the previously recommended ORS, i.e. the one published in the third edition of The International Pharmacopoeia, which has a total osmolarity of 311 mOsm/l.
Method texts that have been updated include, for example, the text on high performance liquid chromatography [HPLC]. This has been revised to clarify certain technical terms and to add advice on adjustment of chromatographic conditions, as recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004.
CD-ROM version: The International Pharmacopoeia CD-ROM
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1-cm layer 1.14.1 Thin-layer chromatography 1.7 Spectrophotometry 10mg/ml solution 10ml of water absorption spectrum accurately weighed acetone add 1ml ammonia 100g/l Apply separately Assay bleomycin calculated with reference CAS Reg Chemical name chloride chloroform chromatographic chamber coating substance colour is produced contains not less crystalline powder described under 1.14.1 described under 1.7 dichloromethane dilute Dissolve dried substance Dry to constant endotoxins ethanol 750g/l ether examine the chromatogram ﬁlter ﬁltrate ﬂask glacial acetic acid Graphic formula heavy metals hydrochloric acid hydrochloric acid 70g/l Identity tests infrared Limit test Loss on drying minutes mixture mobile phase Molecular formula obtained with solution odourless optical rotation perchloric acid 0.1mol/l potassium practically insoluble protected from light Related substances Relative molecular mass removing the plate Requirements Deﬁnition silica gel sodium hydroxide soluble soluble in water Spectrophotometry spectrum is concordant Storage substance per ml sufﬁcient Sulfated ash sulfuric acid test as described test substance titrate water-bath well-closed container
Page 1154 - When a ray of light passes from one medium to another, it is refracted so that the ratio of the sine of the angle of incidence to the sine of the angle of refraction is equal to the ratio of the velocities in the two media.
Page 473 - The estimated potency is not less than 80% and not more than 125% of the stated potency. The fiducial limits of error of the estimated potency (p — 0.95) are not less than 64% and not more than 156% of the stated potency. Storage Store in an airtight container, protected from light, at or below — 20°C.
Page 79 - ... control cells. Determine the cytopathic effect of virus quantitatively with a suitable method. Calculate the potency of the preparation to be examined by the usual statistical methods for a parallel line assay. The estimated potency is not less than 80% and not more than 125% of the stated potency. The fiducial limits of error of the estimated potency (p — 0.95) are not less than 64% and not more than 156% of the stated potency.
Page 1115 - A species of atom characterized by its mass number, atomic number, and nuclear energy state, provided that the mean life in that state is long enough to be observable . OECD (OCDE, ou Organisation de Cooperation et de De"veloppement Economiques) : Organisation for Economic Co-operation and Development.
Page 712 - To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures broad international distribution of its publications and encourages their translation and adaptation. By helping to promote and protect health and prevent and control disease, WHO's books contribute to achieving the Organization's principal objective - the attainment by all people of the highest possible level of health.
Page 1223 - Bronsted, who defines an acid as a substance which furnishes protons, and a base as a substance which combines with protons. Even broader is the definition of Lewis, who defines an acid as any material that will accept an electron pair, a base as any material that will donate an electron pair, and neutralization as the formation of a co-ordination bond between an acid and a base. The apparent strength of an acid or base is determined by the extent of its reaction with a solvent.
Page 14 - National Collection of Type Cultures, Central Public Health Laboratory, Colindale Avenue, London NW9 5HT, England.
Page 1160 - Beer's law within the range of about 75 to 125 per cent of the final concentration used in the assay. Under these circumstances, the absorbance found in the assay may be interpolated on the standard curve, and the assay result calculated therefrom. Such standard curves should be confirmed frequently, and always when a new colorimeter and new lots of reagents are put into use. In colorimetric assays that direct the preparation and use of a standard curve, it is permissible and preferable, when the...