Cellulose Sodium Phosphate for Oral Suspension, chemical structure, molecular formula, Reference Standards

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 28.0percent and not more than 36.0percent calculated on the dried basis.

Packaging and storage— Preserve in tight containers.Store in a refrigerator.

Loss on drying á731ñ— Dry it at 105

for 3hours: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 capacityunder Cellulose Sodium Phosphate.

Procedure— Transfer an accurately weighed amount of Oral Suspension,equivalent to about 0.15g of cellulose sodium phosphate,to a 250-mLbeaker.Proceed as directed for Procedurein Calcium binding capacityunder Cellulose Sodium Phosphate,beginning with “Add 150.0mLof 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-3VSMS)/W,

in which Wis the weight,in g,of Cellulose Sodium Phosphate for Oral Suspension taken;and the other terms are as defined therein:not less than 1.8mmol per g,calculated on the dried basis,is found.

Free phosphate—

Standard preparation— Proceed as directed for Free phosphateunder Cellulose Sodium Phosphate.

Test preparation— Transfer an accurately weighed amount of Cellulose Sodium Phosphate for Oral Suspension,equivalent to about 2g of cellulose sodium phosphate,to a 250-mLbeaker.Proceed as directed for Free phosphateunder Cellulose Sodium Phosphate,beginning with “Add 100mLof water.”

Procedure— Proceed as directed for Free phosphateunder 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 Wis 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 phosphateunder Cellulose Sodium Phosphate.

Test preparation— Transfer an accurately weighed amount of Cellulose Sodium Phosphate for Oral Suspension,equivalent to about 250mg of cellulose sodium phosphate,to a 250-mLconical flask.Proceed as directed for Test preparationin Inorganic bound phosphateunder Cellulose Sodium Phosphate,beginning with “Rinse to the bottom.”

Procedure— Proceed as directed for Inorganic bound phosphateunder 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 Wis 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— Staff Liaison:Elena Gonikberg,Ph.D.,Scientist

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 412

Phone Number:1-301-816-8251