Pharmacopeias monographs

On the basis of the data collected during the elaboration of the monograph and the specific data provided by a specific manufacturer on a specific substance, the Certificate of Suitability certifies that both types of data make it possible to conclude that the quality of the substance corresponds to the quality defined in the European Pharmacopeia monograph. 

Master File procedure is aimed at substances for which there is no European Pharmacopeia monograph. 

In conclusion, a procedure makes it possible to avoid duplication of work not only by manufacturers of raw materials and manufacturers of medicines (finished products) when they prepare licensing dossiers but also by the licensing authorities and pharmacopeia authorities when they assess these dossiers. Differences among the various European licensing authorities in approach and assessment of compliance with European Pharmacopeia monographs are also avoided, and clearer communications are facilitated. Finally, the procedure allows European Pharmacopeia monographs to be constantly updated to keep up with new developments in the world market. 

This guide is intended for the experts who participate in the elaboration of European Pharmacopeia monographs it establishes the general rules to be followed. This document specifies the philosophy behind the choice of techniques for identification testing of a substance and for the determination of the limit contents of impurities and the methods used to detect them. 

The specifications set up in a pharmacopeia monograph are minimum standards only. At the time of an approval for marketing authorization, the manufacturer on its behalf may set tighter specifications. 

There are specific difficulties in applying the test as written, particularly for radiopharmaceuticals based on technetium-99m, and these difficulties are acknowledged in the general pharmacopeia monograph on radiopharmaceuticals. 

Macroaggregates are obtained by aggregation of human serum albumin (HSA). HSA is isolated from donor blood and complies with the purity standards stated in the European Pharmacopeia, monographs 255 and 853) (Council of Europe 2004a, b) in accordance with EU and WHO requirements for biological substances (Council of Europe 1992 World Health Organization 1994). 

Council of Europe (2005) Technetium [ " Tc] sestamibi injection solution, European pharmacopeia monograph 1926. Maisonneuve, Sainte-Ruffine... 

Simple chemical laboratory procedures for biotin are restricted to pure materials as described in pharmacopeia monographs using alkaline titration. Similarly, spectral methods for determining native biotin are unknown in most samples except for highly purified materials as it has no useful absorption above 210 nm. To obtain suitable sensitivity and selectivity, biotin must first be derivatized. For example, the disruption of a / -hydroxy-azobenzene-2 -carboxylic acid (HABA) avidin complex by biotin, which binds to avidin with higher affinity, can be followed titrimetrically or spectroscopically to give useful determinations of biotin. 

Specifications for hGH products are defined by the governmental licensing authorities, eg, the U.S. Pood and Dmg Administration. Draft monographs for hGH have been prepared by both the EnitedStates Pharmacopia and the European Pharmacopeia commissions and should be formally adopted by 1995. These specifications are suitable for biosynthetic hGH. The much less purified pituitary-derived hGH has virtually disappeared from commercial production. An international reference standard for pituitary-derived hGH (lot 80/505) has been used for caUbration, particularly for bioassay purposes. A highly purified biosynthetic hGH standard (lot 88/624) has been prepared and should be formally adopted by 1995, or before. 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

The first official injection (morphine) appeared in the British Pharmacopoeia (BP) of 1867. It was not until 1898 when cocaine was added to the BP that sterilization was attempted. In this country, the first official injections may be found in the National Formulary (NF), published in 1926. Monographs were included for seven sterile glass-sealed ampoules. The NF and the United States Pharmacopeia (USP) published chapters on sterilization as early as 1916, but no monographs for ampoules appeared in USP until 1942. The current USP contains monographs for over 500 injectable products [1]. 

In contrast to aspirin itself, the U.S.P. monograph for aspirin tablets has undergone considerable changes. For some reason, U.S.P. does not use the ferric salt test for free salicylic acid, as does the British Pharmacopeia of 1973. Apparently, certain excipients such as citric and tartaric acid interfere with this reaction.77 Already in 1913, a double titration method was developed78 which was made an official method in 1926.79 This method was used as the assay method when the aspirin tablets monograph was introduced into U.S.P. XII in 1942. 

Reference Official USP Monograph for Dibasic Sodium Phosphate, U.S. Pharmacopeia and National... 

All FDA-approved drugs products must meet the quality requirements described in the U.S. Pharmacopeia (USP) (1,2). If a drug product is to be manufactured elsewhere in the world but marketed in the United States, compliance with existing USP-NF monographs is crucial. Non-compliance may result in the FDA blocking entry of the product into the U.S. market or removing the product from the market. For other markets compliance with USP standards is not binding. For... 

NDA) must be approved monographs structure-function claims truthful structure-function claims truthful structure-function claims use of ingredients listed in the U.S. Homeopathic Pharmacopeia... 

The main external review body in the biopharmaceutical and pharmaceutical industries is the Food and Drug Administration (FDA), but at some later stage it may be necessary to prepare a monograph for the quality control of a new product and this would be achieved by interacting with officials from the United States Pharmacopeia (USP) in order to have a section published in the pharmacopoeia. The purpose of this chapter, therefore, is to introduce both of these organizations and provide an understanding of their basic functions. 

The format of the modem pharmacopeia remains roughly similar to those early medieval compendia that effectively listed drugs or the crude galenicals made from them in individuals monographs. Of course, these early documents were written in Latin but nowadays about the only remaining traces of Latin are in the titles of occasional botanical descriptions, which have recently made a return to official pharmacy under the mbric of Nutritional Supplements. 

The addition of the National Formulary section to the pharmacopeia, followed more recently by the section of Nutritional Supplements, has resulted in a considerable increase in the numbers of substances described by an official monograph. These are mainly excipients and diluents for the NF and standards for the popular Nutritional Supplements (including my personal favorite, Chocolate). 

Harmonization may be carried out retrospectively for existing monographs or chapters or prospectively for new monographs or chapters. The three pharmacopeias have a commitment to respect the agreed working procedures and the associated time deadlines as an essential part of the harmonization procedure. The PDG has defined harmonization of a pharmacopeial monograph or general chapter as follows ... 

When using a fully harmonized pharmacopeial monograph or general chapter, an analyst will perform the same procedures and reach the same accept/reject decisions irrespective of which PDG pharmacopeia is referenced. This approach is called interchangeability, and each pharmacopeia will identify, in an appropriate manner, such a monograph or general chapter. 

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