Quantitation Limit of Pharmaceuticals Determinedby UV-1800 UV-VIS Spectrophotometer

Introduction

Quality control and securing product safety are important in the manufacture of pharmaceutical products, so it is essential that substances other than those specifically approved are not included with the specified ingredients. Cleaning validation is one of the measures specified in the GMP standard, because cleaning of manufacturing equipment is essential for preventing contamination and cross contamination of pharmaceutical products. This means that contaminants from the environment must not become mixed in with the product ingredients, and residual substances adhering to the manufacturing equipment must not contaminate the next product to be processed by that equipment. To verify these requirements, the cleaning itself must be evaluated, and the analytical instruments typically used for cleaning validation are the ultraviolet-visible spectrophotometer, the total organic carbon analyzer, and the high-performance liquid chromatograph. The quantitation limit of an analytical instrument is the limit value at which residual sample can be quantitated. To determine whether or not the analytical instrument to be used for conducting cleaning validation can quantitate down to the permissible level of the residual substance, it is important to determine the quantitation limit. Here we introduce the determination of quantitation limit for the Shimadzu UV-1800 ultraviolet-visible spectrophotometer by absorption photometry, with samples consisting of detergent A used for cleaning in the pharmaceutical field, and the typically used pharmaceutical materials acetylsalicylic acid and isopropylantipyrine, presented along with the calculation method.

October 28, 2009 GMT