Organic volatile impurities OVI

Administration (FDA) and other regulatory agencies around the world, more particularly with respect to the determination of organic volatile impurities (OVI s) as well as other impurities and related sub-stances, has resulted in more extensive use being made of GC in modern compendia, such as the USP 24th edition and the 1999 edition of the Perusal of the current USP indicates that many more GC applications have been introduced since the 22nd edition of the USP. New inclusions have been incorporated in the tables in this article. Similarly, the recent edition of the also includes numerous new applications. A list of compounds in the BP (which includes the European Pharmacopoeia) that use GC is included separately as an Appendix. 

A number of solvents that are used for the synthesis of the API or formulation of the drug product can be present in the drug product. The content of these solvents, which are commonly called organic volatile impurities (OVI), is generally determined by the OVI methods specified in the compendia. Their content is controlled by the guidelines offered by various bodies (see Chapter 2). Residual solvents can affect the stability of drug product (see Sections IV. D and E). 

Gas chromatography is an extremely useful technique for quantification. It can afford the desired resolution, selectivity, and ease of quantification. The chief limitation, however, is that the sample must be volatile or must be made volatile by derivatization. This technique is very practical for organic volatile impurities (OVI). 

When the process described above was scaled up to the kilo-laboratory, the API failed specifications for residual organic volatile impurity (OVI)/isopropanol (IPA) content. The measured levels were about 1%, whereas the specification is no more than 0.5%. Additional drying did not lower the OVI-IPA value to acceptable levels. More data were gathered as additional bench experiments were conducted. In the meantime two important project developments occurred ... 

IPA, isopropanol MTBE, methyl tert-butyl ether OVI, organic volatile impurity. 

OVI Organic volatile impurity SRF Carbon-black, ASTM designation... 

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