Sources of Particulate Matter
- The solution itself and its ingredients
- The production process and its variables (e.g., environment, equipment, personnel)
- The product's packaging
- The preparation of the product for administration (e.g., manipulating the product, the environment in which it is prepared)
USP < 788 > provides two methods to detect these particles: method 1 - Light Obscuration is the preferred method, unless the product is unsuitable due to viscosity or transparency, method 2 - microscopic analysis is applied. For all other solutions, they are first tested by method 1, if a solution fails to meet prescribed limits it may then be tested by method 2.