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Determination of Foreign Organic Matter

Learn how to determine the Foreign Organic Matter in Pharmaceutical samples.

Foreign organic matter is the material consisting of any or all of the following.
(1) Parts of the organ or organs from which the drug is derived other than the parts named in the definition and description or for which the limit is prescribed in the individual monograph.
(2) Any organs other than those named in the definition and description.
(3) Matter not coming from the source plant and
(4) Moulds, insects or other animal contamination.


Weigh 100 to 500 g, or the quantity specified in the individual monograph, of the original sample and spread it out in a thin layer. Inspect the sample with the unaided eye or with the use of a 6x lens and separate the foreign organic matter manually as completely as possible. Weigh and determine the percentage of foreign organic matter from the weight of the drug taken. Use the maximum quantity of sample for coarse or bulky drugs.

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