Psyllium Hydrophilic Mucilloid for Oral Suspension
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
1 DEFINITION
Psyllium Hydrophilic Mucilloid for Oral Suspension is a dry mixture of Psyllium Husk with suitable additives.
2 IDENTIFICATION
Botanic Characteristics
Microscopic: It shows occasional single and 2- to 4-compound starch granules, the individual grains being spheroidal plano to angular convex, 2–10 um in diameter, found embedded in the mucilage. Entire or broken epidermal cells are filled with mucilage. In surface view, the epidermal cells appear polygonal to slightly rounded. Mucilage stains red with ruthenium red TS and lead acetate TS. Some of the elongated and rectangular cells representing the lower part of epidermis and also radially swollen epidermal cells can be found.
3 SPECIFIC TESTS
Microbial Enumeration Tests 〈61〉andTests for Specified Microorganisms 〈62〉: It meets the requirements of the tests for absence of Salmonella species and of Escherichia coli.
Swell Volume
Sample: Psyllium Hydrophilic Mucilloid for Oral Suspension, equivalent to 3.5 g of psyllium husk
Analysis: Transfer 250 mL of simulated intestinal uid TS without enzymes to a glass-stoppered, 500-mL graduated cylinder. Gradually, with shaking, add the Sample, and shake until a uniform, smooth suspension is obtained. Dilute with the same uid to 500 mL. Shake the cylinder for 1 min every 30 min for 8 h. Allow the gel to settle for 16 h (total time, 24 h). Determine the volume of the gel. Acceptance criteria: NLT 110 mL
4 ADDITIONAL REQUIREMENTS
Packaging and Storage: Preserve in tight containers.
