Study On The Residual Solvents In Biochemical Drugs,Genic Drugs And The Preservative In Biological Products

Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of active substances or excipients, or in the preparation of medicinal products. The solvents are not completely removed by practical manufacturing techniques. Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements. Medicinal products should contain no higher levels of residual solvents than can be supported by safety data .In BP, USP and China Pharmacopoeia 2000, the contents of residual solvents in pharmaceuticals were all determined by GC.Preservatives are compounds that kill or prevent the growth of microorganisms, such as bacteria or fungi, such as phenol,formaldehyde and thimerosal. They are used in vaccines to prevent bacterial or fungal growth in the event that the vaccine is accidentally contaminated, as might occur with repeated puncture of multi-dose vials. The amount of preservatives in a biological product is important because of their toxicity. For biological products needing an antimicrobial preservative, acceptance criteria for preservative content may be appropriate. Release testing for preservative content should normally be performed.Research on the determination of the residual solvents in biochemical drugs, genic drugs and biological products by static headspace GC were carried out in this article.1. Rapid analytic methods by static headspace GC were established for the determination of the residual solvents in biochemical drugs, genic drugs. The methods mentioned above were proved to be simple, fast, and accurate with high reproducibility and effective for the quality control of the pharmaceuticals.2. To finish the study on the determination and methodology of the residual solvents in about 20 biochemical drugs, genic drugs. Petroleum ether and hexahydropyridine are always interest to manufacturers of pharmaceuticals. However, no adequate toxicological data was found. Manufacturers should supply justification for residual levels of these solvents in pharmaceutical products. Investigations in the determination of these three residual solvents were carried on in each monograph.