Biological substances, monographs

In principle, a certificate can be granted for any substance (active substances, excipients) such as organic or inorganic substances, substances produced by fermentation as indirect gene products, and products with risk of TSE for which a monograph published in the European Pharmacopeia exists. Excluded, however, are biological substances such as proteins, products obtained from human tissues, vaccines, blood products, and preparations. 

Control of biological substances was difficult to contain within a pharmacopocial monograph, for it demanded the use of biological standardization, as the purity and the potency of these substances could not be measured by chemical means. The Therapeutic Substances Act (TSA) aimed to regulate the manufacture and sale of such substances and to provide standards to which they must conform, to regulate their labeling and, to a certain... 

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). 

Since the CRSs and BRPs are officially certified by the European Pharmacopoeia Commission, which adopts the reports establishing their suitability for the intended use, it should be noted that neither certificates of analysis nor data which are not relevant to the use of the substances as defined by the Ph. Eur. monograph, are provided with the reference products or substances. Information required for the correct use of the chemical reference substance or biological reference preparation is provided. The label on the vials or ampoules gives ... 

Coordination compounds play an important role in modern human life [287]. In this respect, the controlled synthesis is of paramount significant in the modeling and creation of substances with physicochemical and practical properties programmed in advance, in particular those useful in medicine and biology. The examination of this problem is beyond the limits of the present monograph, but we will examine here the most important problems, in our opinion, discussed in 1990-2002. 

In 1970, scientists from the Pharmaceutical Analysis Section of the Academy of Pharmaceutical Sciences began to plan a cooperative venture to compile and publish a series of volumes entitled the Analytical Profiles of Drug Substances. The aim of the series was to provide information not available in the official compendial monograph of a drug substance, such as physical or chemical data, methods of synthesis, and pathways of physical or biological degradation and metabolism. Klaus Florey became the first editor of the series, and between 1972 and 1991 he edited the first 20 volumes in the Analytical Profiles series. 

The Merck Index 13th CD-ROM Edition is an encyclopedia of chemicals, drugs and biologicals with over 10,000 monographs on single substances or groups of related compounds. 

Pharmaceutical products can be sterilized by steam sterilization, dry-heat sterilization, filtration sterilization, gas sterilization, and ionizing-radiation sterilization. The USP provides monographs and standards for biological indicators required to test the validity of the sterilization process. These products must also be tested for pyrogens—fever-producing substances that arise from microbial contamination most likely thought to be endotoxins or lipopolysaccharide in the bacterial outer cell membrane. 

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