European Pharmacopeia

Quality Control. Because fine chemicals are sold according to specifications, adherence to constant and strict specifications, at risk because of the batchwise production and the use of the same equipment for different products ia multipurpose plants, is a necessity for fine chemical companies. For the majority of the fine chemicals, the degree of attention devoted to quahty control (qv) is not at the discretion of the iadividual company. This is particularly the case for fine chemicals used as active iagredients ia dmgs and foodstuffs (see Fine chemicals, standards). Standards for dmgs are pubHshed ia the United States Pharmacopeia (USP) ia the United States (6) and the European Pharmacopeia ia Europe (7). 

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. 

European Pharmacopeia, 2nd ed., Maisoimeuve SA, Saiate Ruffine, Prance, 1984. 

Citric acid specifications are defined in a number of compendia including Vood Chemicals Codex (FCC), United States Pharmacopeia (USP), British Pharmacopeia (BP), European Pharmacopeia (EP), and Japanese Pharmacopeia (fP). 

FIGURE 9.20 Analysis of heparin. Eluent 0.1 M Na SO, pH 5. Flow rate I ml/min. Columns PSS Suprema 10 /nm, 100 + 1000, 8 x 300 mm. Oven temp 30 C. Detection UV at 234 and Ri. Standards PSS heparin standard. Caiibration According to European Pharmacopeia with PSS WINGPC Heparin Software Module. 

The dried capitula of Matricaria chamomilla L. (Asteraceae), or German chamomile, have been used as anti-inflammatory and antispasmodic remedies since very early times on account of its contents in bisabolol oxides the activity of which has been experimentally substantiated. The plant is listed in several European pharmacopeias, and is used in the form of tinctures, extracts, lotions, ointments, shampoos, and sunscreen products. 

The European Pharmacopoeia (Ph. Eur.) has also adopted some of the apparatus designs (12) described in the USP, with some minor modifications in the specifications. Small but persistent differences between the two have their origin in the fact that the American metal processing industry, unlike the European, uses the imperial rather than the metric system. In the European Pharmacopeia, official dissolution testing apparatus for special dosage forms (medicated chewing gum, transdermal patches) have also been incorporated (Table 2 provides an overview of apparatus in Ph. Eur.). 

Borka L. Review on crystal polymorphism of substances in the European Pharmacopeia. Pharm Acta Helv 1991 66 16-22. 

Abbreviations. JP, Japanese Pharmacopeia NF, National Formulary BP, British Pharmacopeia USP, Unitied States Pharmacopeia Ph Eur, European Pharmacopeia. 

Abbreviations. PhEur, European Pharmacopeia J Ph, Japanese Pharmacopeia. 

Several officially recognized compendia describe specifications for components and finished product (e.g., U.S. Pharmacopeia, Food Chemicals Codex, British Pharmacopeia, and European Pharmacopeia). These specifications have been established by an advisory board to each compendium and represent the views of many manufacturers and government based on a history of the component or product. Such specifications are reviewed and updated as the need arises when new information becomes available. These compendia are very useful and should always be used as a guide whenever possible. In the case of the USP, for example, if a monograph exists for a component or product, U.S. drug manufacturers are required to satisfy those specifications as a minimum requirement. 

Purified water, water for injection. European Pharmacopeia. 3rd ed. Strasbourg European Pharmacopeia Convention, pp. 1723-1724 (1996). 

European Pharmacopeia, 3rd ed., Council of Europe, Strasboug, France, 1997, p. 1726. 

U. Rose, In situ degradation A new concept for system suitability in monographs of the European Pharmacopeia./. Pharm. Biomed. Anal. 18 (1998), 1-14. 

European Pharmacopeia, Uniformity of dosage units. Chapter 2.9.40,2005. 

SMV, sample mean value RSD, relative standard deviation w, number of replicates USP, United State Pharmacopeia IP, Japanese Pharmacopeia EP, European Pharmacopeia. 

European Pharmacopeia, 5th edition. Council of Europe, 67075 Strasboury Cedex, Erance, 2005. 

Borka, L. (1995). Crystal polymorphism and related phenomena of substances in the European Pharmacopeia. An updated review for fasciculae 13 to 19. Pharmeuropa, 7, 586-93. [241]... 

Results of a survey of asbestos fibers in consumer cosmetic talc powders from Italian and international markets using electron microscopy, electron diffraction, and energy dispersive x-ray analysis showed that asbestos was detected in 6 of 14 talc samples from the European Pharmacopeia (Paoletti et al. 1984). Chrysotile was identified in 3 samples, 2 samples contained tremolite asbestos and anthophyllite asbestos, and 1 sample contained chrysotile and tremolite asbestos. The authors noted that, in all talc powders analyzed, fibrous talc particles frequently were present that were morphologically similar to amphibole asbestos fibers. Counting fibers as particles with aspect ratio >3 1 and width < 3 m, the percentages of particles that were asbestos fibers ranged from <0.03% to 0.13% for 4 samples, and were 18% to 22% for the other 2 samples. Paoletti et al. (1984) noted that the European Pharmacopeia, at that time, had not established analytical quality control of asbestos contamination. 

European Pharmacopeia, 3rd Ed. Supplement 2001, General Monograph 2.2.46, Chromatographic Separation Techniques 28-32. 

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