Psyllium Hydrophilic Mucilloid for Oral Suspension
» Psyllium Hydrophilic Mucilloid for Oral Suspension is a dry mixture of Psyllium Husk with suitable additives.
Packaging and storage— Preserve in tight containers.
Identification— Microscopically, it shows the presence of fragmented Psyllium Husk, as described for Histology—Husk in the section, Botanic characteristics, under Psyllium Husk.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 It meets the requirements of the tests for absence of Salmonella species and of Escherichia coli.
Swell volume— Transfer 250 mL of simulated intestinal fluid TS without enzymes to a glass-stoppered, 500-mL graduated cylinder. Gradually, with shaking, add an amount of Psyllium Hydrophilic Mucilloid for Oral Suspension, equivalent to 3.5 g of psyllium husk, and shake until a uniform, smooth suspension is obtained. Dilute with the same fluid to 500 mL. Shake the cylinder for about 1 minute every 30 minutes for 8 hours. Allow the gel to settle for 16 hours (total time 24 hours). Determine the volume of the gel: it is not less than 110 mL.
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Topic/Question Contact Expert Committee
Monograph Maged H. Sharaf, Ph.D.
Senior Scientist
1-301-816-8318
(DSB05) Dietary Supplements - Botanicals
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3445