Quality Control of Non-Sterile Drug Product According to United States’ Pharmacopeia Instruction

Abstract

Pharmaceutical products are classified into two groups according to the microbiological point of view: 1) sterile products and 2) non-sterile products. The sterilized term refers to the products that are free of any microorganisms. Their production is done under aseptic conditions, but the production of non-sterile products is not under aseptic conditions and therefore, they are not free of microorganisms; for this type of products legal authorities defined microbial limit ranges. The contamination of medicinal products by microorganisms can lead to adverse changes such as: change in physical attribute (appearance, color, smell, and viscosity), reduction of therapeutic effects, development of disease and ultimately the loss of consumer reliance. There have been reports about presence of unauthorized microorganisms in non-sterile medicinal products, which has led to more research and attention in this regard. In this paper, the methods for controlling the microbial quality of non-sterile drug products have been reviewed based on the latest version of United States Pharmacopoeia (USP), including <61>, <62>, and <1111> general chapters that can be used as a reliable source for researchers in the pharmacy industry and drug control labs.

Comparison of Murraya microbiological contamination and total flavonoid content on various drying methods

“…The TYMC and TPC test results can show the influence of the contents of the plant material [16,23,24] say that plant tissues can be used to imitate or change the phytochemicals of their hosts. Simplicia must be free of harmful organisms to be effective [25]. This research aims to determine the effect of drying methods on microbial contamination and total flavonoid content (TFC) of M. paniculata.…”