International Pharmaceutical Excipient chemical excipients

International Pharmaceutical Excipients Council (IPEC) guidelines, 21 168, 169 International Programme on Chemical Safety (IPCS), 18 540-541 International Society of Blood Transfusion (ISBT), 12 151... 

The International Pharmaceutical Excipient Council in the United States (Arlington, Virginia 703-521-3338) has issued a GMP guideline for excipient bulk pharmaceutical chemicals. In conjunction with both the European and Japanese Pharmaceutical Excipient Councils, the council is currently engaged in establishing international harmonization excipient monographs for the more popular pharmaceutical excipients. A list of important and popular pharmaceutical excipients is given in Table 1. 

The safety-toxicological testing of a new excipient for Europe or the United States is as extensive as that for an NCE and can take four to five years to complete. There are differences in the safety evaluation requirements for different types of formulations oral, parenteral and topical/transdermal. The International Pharmaceutical Excipients Council (IPEC Europe and IPEC-Americas) have been working on a protocol for the rational safety testing of excipients to aid the introduction of new chemical excipients (see Table 5.4). IPEC is a federation of three independent regional industry associations based in Europe, the United States and Japan who are focused on the applicable law, regulations and business practices of each region with respect to pharmaceutical excipients. 

Following the ICH (International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use) definition, an impurity is every separate chemical particle present in the active substance and final pharmaceutical product that is not the active substance or excipient. This includes all optical isomers, products of degradation, and polymorphic forms. The physicochemical properties and biological activity of dmg impurities can be similar or different to those of the active substance. Therefore, they can influence the human body in the same way as the medicinal product or differently [7] and lead to an increase or decrease in dmg activity. 

The International Journal of Pharmaceutics is the journal for pharmaceutical scientists concerned with the physical, chemical and biological properties of devices and delivery systems for medicines, vaccines and biologicals, including their design, manufacture and evaluation. TTiis includes evaluation of the properties of substances, excipients such as srufactants... 

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