The pharmacopoeial standards are based on monographs that include a summary of efficacy, safety and quality requirements. They are presented as monographs, being either a general monograph on a class of substances, or a monograph on the . The current monographs include a summary of pharmacological activity, the form of the , evidence of therapeutic efficacy and toxicity and quality requirements for purity, assay, impurities and delivery. A contains a description of the appearance of the substance, and a summary of physical properties and excipients that may be included in a product.
The BP standards are based on . They define product specifications and provide guidance to manufacturers and marketers on the preparation, description, storage and handling of medicinal products. The standards set limits on the concentration of various impurities in a medicinal product, and pharmacologically active substances as a percentage of the total . They also define 'inactive ingredients' and specify these must not be confused with active substances. While the can be perceived as the pharmacopoeial version of the USP , there are differences between the two sets of standards. The normally refers to a single sample of a medicinal product, whereas the normally refers to an . These criteria are used to define a normally, whereas in the USP, these are used to determine which of several lots of a normally is acceptable for delivery to patients and use in clinical trials.
The USP norms, unlike those of the BP , are based on'relative' rather than 'absolute' testing. This means that a normally is determined by the testing of a single sample, whereas the normally is determined by several samples collected over a period of time. A normally refers to a single sample of a medicinal product, and the normally refers to the of a single sample. The USP also uses the 'absolute' method to define the . This means that a normally is determined by the testing of a single sample, whereas the normally is determined by several samples collected over a period of time. Thus, if a substance fails to meet the or criterion, it is not acceptable to market the product. While not the same as 'abandoned', the concept has been a topic of discussion and debate within the European Union (EU) for some time. A product is 'abandoned' if
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