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Determination of Foreign Organic Matter

Learn how to determine the Foreign Organic Matter in Pharmaceutical samples.
2018-05-23T13:28:35Z PrintOnline CoursesQuestion Forum No comments
✔ Technical Review by: | Last Verified:2018-05-23T13:28:35Z
The foreign organic matter is the material consisting of any or all of the listed
(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) Molds of insects or other animal contamination.

Method

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.




 is a prominent Pharmaceutical Quality Assurance expert, consultant and the founder of Pharmaguideline. With over 22 years of hands-on experience in cGMP-compliant manufacturing environments, he specializes in establishing validation protocols, sterile area controls and data integrity systems. Ankur routinely interprets international regulatory frameworks (including FDA, EMA and ICH guidelines) to help global pharmaceutical professionals ensure strict regulatory compliance and operational excellence. Connect with Ankur on LinkedIn. Need Help: Ask Question

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