Psyllium Hydrophilic Mucilloid for Oral Suspension
DEFINITION
Psyllium Hydrophilic Mucilloid for Oral Suspension is a dry mixture of Psyllium Husk with suitable additives.
IDENTIFICATION
• A. 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.
SPECIFIC TESTS
• 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.
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
Sample:
Psyllium Hydrophilic Mucilloid for Oral Suspension, equivalent to 3.5 g of psyllium husk
Analysis:
Transfer 250 mL of simulated intestinal fluid 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 fluid 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
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Maged H. Sharaf, Ph.D.
Principal Scientific Liaison 1-301-816-8318 |
(DS2010) Monographs - Dietary Supplements |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4484