NaHCO3
Sodium Bicarbonate USP
84.01
Carbonic acid monosodium salt
Monosodium carbonate
Sodium Bicarbonate contains not less than 99.0 percent and not more than 100.5 percent of NaHCO3, calculated on the dried basis.
Labeling— Where Sodium Bicarbonate is intended for use in hem dialysis, it is so labeled.
Identification— A solution of it meets the requirements of the tests for Sodium 191 and for Bicarbonate.
Loss on drying— Dry about 4 g, accurately weighed, over silica gel for 4 hours: it loses not more than 0.25% of its weight.
Insoluble substances— Dissolve 1 g in 20 mL of water: the resulting solution is complete and clear.
Carbonate (where it is labeled as intended for use in hem dialysis)— The limit of carbonate is not more than 0.23%. to be determined as per tests defined.
Normal carbonate— Add 2.0 mL of 0.10 N hydrochloric acid and 2 drops of phenolphthalein TS to 1.0 g of Sodium Bicarbonate, previously dissolved without agitation in 20 mL of water at a temperature not exceeding 15 : the solution does not assume more than a faint pink color immediately.
Chloride—: a 0.35-g portion shows no more chloride than corresponds to 1.48 mL of 0.0010 N hydrochloric acid (0.015%). Limit of sulfur compounds— To pass the test
Aluminum (where it is labeled as intended for use in hem dialysis)— The limit is 2 µg per g.
Arsenic— The limit is 2 µg per g.
Calcium and magnesium (where it is labeled as intended for use in hem dialysis)
— the percentage of Ca in the specimen limit is 0.01%.
— the percentage of Mg in the specimen the limit is 0.004%.
Copper (where it is labeled as intended for use in hem dialysis)— Cu in the specimen the limit is 1 µg per g.
Iron (where it is labeled as intended for use in hem dialysis)— not more than 5µg per g.
Heavy metals—the limit is 5 µg per g.
Limit of ammonia— to pass the test
Limit of organics (where it is labeled as intended for use in hem dialysis)— To pass the test