Pharmacopoeia standards

There is a practical distinction between pharmacopoeia standards and manufacturers release specifications, although both comprise sets of tests to which a given product should conform. Release specifications are applied at the time of manufacture of a pharmaceutical product to confirm its appropriate quality but they also need to have a predictive value, to support the notion that the manufacturer is responsible for the product during its entire shelf-life. In many cases pharmacopoeial monographs are based on the specifications developed by the manufacturers of innovator (originator) products. 

The spectrum of tests to be employed comprises methods from microbiology, immunology, protein and peptide biochemistry, genetic engineering and physico-chemical methods as well as animal experimentation. If these exist, for example in pharmacopoeias, standard method descriptions have to be followed. 

Currently, there are no U.S. Pharmacopeia or European Pharmacopoeia standard tests for characterizing the output of respiratory solutions or suspensions generated by air-jet or ultrasonic nebulizers. 

Pancreatic enzyme supplements are used to treat people who lack pancreatic secretions. Pancreatm, the British Pharmacopoeia standard, is an extract of pancreas, and contains enzymes with proteinase, amylase, and lipase activity most commercial formulations are similar or identical (SEDA16, 358). 

The Council exempted certain classes of medicines from the registration process subject to certain conditions being met (e.g., manufactured in accordance with GMP and meeting certain pharmacopoeia standards). Examples of such medicines are ... 

Although the component or components responsible for senna s effect have not been definitively identified, most pharmacopoeias standardize senna based on its sennoside B content. Both the German and European Pharmacopoeia require 2.5% for the leaves, 3.4% in the Alexandrian pods, and 2.2% in the Indian pods (Franz, 1993). 

The extracts are quantified. This may be quoted directly as the weight of nonvolatile materials per filter cartridge or per unit weight or per unit of surface area, according to which is most appropriate. Alternatively, extraciables may be quoted in relation to a pharmacopoeia oxidizable substances test. The primary purpose of this test is to monitor water quality, the inference being that the amount of materials extractable from the filter is no worse than the pharmacopoeia standards for water. 

The tests are carried out to pharmacopoeia standards (a pharmacopoeia is a technical text that contains tests for identification of products used in the pharmaceutical industry). For example, if we consider the previously mentioned products (chemical structures shown in Figure 11.1), they can be tested by HPLC-DAD under the European Pharmacopoeia (shortened to Ph Eur on packaging). Initially, the counterfeit products were identified by a wholesaler who noted a difference in the packaging by comparing results of bona fide tablets and the suspected counterfeit products, differences in the dose can be identified (see Figures 11.2 and 11.3). 

C, longa, which is official in Thai Herbal Pharmacopoeia 1 (THP1,1998) is not less than 7%v/w. In establishing the standard limit of content of volatile oil of herbs in national or international pharmacopoeiae, 12-20 authentic samples from various parts of the country or reliable sources have to be collected. Replicate determinations of the volatile oil content in each of these samples have to be carried out according to the pharmacopoeia standard method. Mean and standard error of the results are used to set the limit of content of volatile oil. 

Layer a Silica gel G coarser particles removed with the fine sieve of the Swiss Pharmacopoeia standard method (cf. p. 85) 10 cm run method for toxicological studies [10]. 

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