The data from the Microscopic Method tends to be lower, so the pharmacopoeia makes up for the difference by having lower limits for the microscopic method. Both methods count particles greater than 10 μm and greater than 25 μm (and greater than 50 μm for USP Ophthalmic Solutions.). Note that other sizes may be counted upon request.
Bulk pharmaceutical chemicals (BPCs), can be obtained or synthesized from multiple sources and, therefore, it is very important that impurities in BCPs be carefully monitored and controlled. Recently British pharmacopoeia (BP), United State Pharmacopoeia (USP), and Indian pharmacopoeia (IP) started incorporating allowable limits of impurities present in drug substances or drug products (Kovaleski et al. 2007, Gad 2008). This article thoroughly reviews different impurities found in the pharmaceuticals by methods for isolation, extraction, and identity of possible impurities. 2b1af7f3a8