Particulate analysis

Process controls include daily testing of water for injection (USP), conformation of fill doses and yields, checking and approving intermediate production tickets, and checking label identity and count. Finished product control includes all the tests necessary to ensure the potency, purity, and identity of the product. Parenteral products require additional tests, which include those for sterility, pyrogens, clarity, and particulate analysis, and for glass-sealed ampoules, leaker testing. 

Compilation of Water Quality Standards for Marine Waters 910992029 Consensus Method for Determining Groundwaters under the Direct Influence of Surface Water Using Microscopic Particulate Analysis (MPA)... 

R96001 Microscopic Particulate Analysis (MPA) for Filtration Plant Optimization 812B92007 Monitoring Requirements for Lead and Copper Rules Water Systems Serving 10,001 to 50,000 Persons... 

Throgmorton, J.A. and Axetell, K. (1978). Digest of Ambient Particulate Analysis and Assessment Methods. EPA-450/3-78-113, Research Triangle Park, North Carolina. 

Mix the sample thoroughly by shaking the sample container. Immediately pour 500ml of the sample into a clean 500-ml graduated cylinder. Use this 500ml of propellant for the particulate analysis ... 

Filter Particulate Analysis. In the laboratory, the filters were immediately placed in a desiccator for 24 hrs and then weighed. The particulate concentration was calculated from this weight and the previously determined tare weight of the filter. The filters were analyzed for mercury by a procedure previously reported by the author (11) consisting of boiling the filters in concentrated nitric acid. After being cooled, aliquots of these solutions were pipetted into the interchangeable sample tubes and analyzed by the direct aeration technique. 

Lipid particulate analysis can be achieved with most commercial laser particle counters. Compendial requirements for suspensions also allow for sizing via electron microscopy determinations, which can provide... 

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