Cellulose Sodium Phosphate for Oral Suspension
» Cellulose Sodium Phosphate for Oral Suspension contains Cellulose Sodium Phosphate. It has an inorganic bound phosphate content of not less than 28.0 percent and not more than 36.0 percent calculated on the dried basis.
Packaging and storage— Preserve in tight containers. Store in a refrigerator.
Loss on drying 731 Dry it at 105 for 3 hours: it loses not more than 10.0% of its weight.
Calcium binding capacity—
Standard calcium solution and Standard edetate disodium titrant—Proceed as directed for Calcium binding capacity under Cellulose Sodium Phosphate.
Procedure— Transfer an accurately weighed amount of Oral Suspension, equivalent to about 0.15 g of cellulose sodium phosphate, to a 250-mL beaker. Proceed as directed for Procedure in Calcium binding capacity under Cellulose Sodium Phosphate, beginning with “Add 150.0 mL of Standard calcium solution.” Calculate the calcium binding capacity, in mmol per g, of the portion of undried Cellulose Sodium Phosphate for Oral Suspension taken by the formula:
(150MS 3VS MS) / W
in which W is the weight, in g, of Cellulose Sodium Phosphate for Oral Suspension taken; and the other terms are as defined therein: not less than 1.8 mmol per g, calculated on the dried basis, is found.
Free phosphate—
Standard preparation— Proceed as directed for Free phosphate under Cellulose Sodium Phosphate.
Test preparation— Transfer an accurately weighed amount of Cellulose Sodium Phosphate for Oral Suspension, equivalent to about 2 g of cellulose sodium phosphate, to a 250-mL beaker. Proceed as directed for Free phosphate under Cellulose Sodium Phosphate, beginning with “Add 100 mL of water.”
Procedure— Proceed as directed for Free phosphate under Cellulose Sodium Phosphate. Calculate the percentage of free phosphate in the portion of Cellulose Sodium Phosphate for Oral Suspension taken by the formula:
(4000 / W)(AU / AS)
in which W is the weight, in mg, of undried Cellulose Sodium Phosphate for Oral Suspension taken; and the other terms are as defined therein: not more than 6.0%, calculated on the dried basis, is found.
Inorganic bound phosphate—
Standard preparation— Proceed as directed for Inorganic bound phosphate under Cellulose Sodium Phosphate.
Test preparation— Transfer an accurately weighed amount of Cellulose Sodium Phosphate for Oral Suspension, equivalent to about 250 mg of cellulose sodium phosphate, to a 250-mL conical flask. Proceed as directed for Test preparation in Inorganic bound phosphate under Cellulose Sodium Phosphate, beginning with “Rinse to the bottom.”
Procedure— Proceed as directed for Inorganic bound phosphate under Cellulose Sodium Phosphate. Calculate the percentage of total phosphate in the portion of Cellulose Sodium Phosphate for Oral Suspension taken by the formula:
(10,000 / W)(AU / AS)
in which W is the weight, in mg, of Cellulose Sodium Phosphate for Oral Suspension taken; and the other terms are as defined therein. Calculate the percentage of inorganic bound phosphate in the portion of undried Cellulose Sodium Phosphate for Oral Suspension by subtracting from this result the percentage of free phosphate.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
1-301-816-8251
(SM32010) Monographs - Small Molecules 3
USP35–NF30 Page 2584