Sodium Bicarbonate Injection Sodium Bisulfite

JP XVI Official Monographs / Sodium Bisulfite 1393 of water: the pH of this solution is between 7.9 and 8.4. responds to the Qualitative Tests <1.09> for sodium salt and for bicarbonate. Purity (1) Clarity and color of solution—Dissolve 1.0 g of Sodium Bicarbonate in 20 mL of water: the solution is pH <2.54> 7.0–8.5 clear and colorless. Bacterial endotoxins <4.01> Less than 5.0 EU/mEq. (2) Chloride <1.03>—To 0.40 g of Sodium Bicarbonate add 4 mL of dilute nitric acid, heat to boil, cool, and add 6 Extractable volume <6.05> It meets the requirement. mL of dilute nitric acid and water to make 50 mL. Perform Foreign insoluble matter <6.06> Perform the test according the test using this solution as the test solution. Prepare the to Method 1: it meets the requirement. control solution with 0.45 mL of 0.01 mol/L hydrochloric acid VS (not more than 0.040z). Insoluble particulate matter <6.07> It meets the require- (3) Carbonate—Dissolve 1.0 g of Sodium Bicarbonate in ment. 20 mL of freshly boiled and cooled water with very gentle Sterility <4.06> Perform the test according to the Mem- swirling at a temperature not exceeding 159C. Add 2.0 mL brane filtration method: it meets the requirement. of 0.1 mol/L hydrochloric acid VS and 2 drops of phenol- phthalein TS: no red color develops immediately. Assay Measure exactly a volume of Sodium Bicarbonate (4) Ammonium—Heat 1.0 g of Sodium Bicarbonate: the Injection, equivalent to about 2 g of sodium hydrogen car- gas evolved does not change moistened red litmus paper to bonate (NaHCO3), titrate with 0.5 mol/L sulfuric acid VS, blue. and proceed as directed in the Assay under Sodium Bicar- (5) Heavy metals <1.07>—Dissolve 4.0 g of Sodium Bi- bonate. carbonate in 5 mL of water and 4.5 mL of hydrochloric acid, Each mL of 0.5 mol/L sulfuric acid VS andevaporateonawaterbathtodryness.Dissolvethe ＝ 84.01 mg of NaHCO residue in 2 mL of dilute acetic acid, 35 mL of water and 1 3 drop of ammonium TS, dilute with water to 50 mL, and per- Containers and storage Containers—Hermetic containers. form the test using this solution as the test solution. Prepare Plastic containers for aqueous injections may be used. the control solution as follows: evaporate 4.5 mL of hydrochloric acid to dryness, and add 2 mL of dilute acetic acid, 2.0 mL of Standard Lead Solution and water to make 50 mL Sodium Bisulfite (not more than 5 ppm). (6) Arsenic <1.11>—Dissolve 1.0 g of Sodium Bicar- Sodium Hydrogen Sulfite bonate in 3 mL of water and 2 mL of hydrochloric acid, and perform the test using this solution as the test solution (not 亜硫酸水素ナトリウム more than 2 ppm).

Assay Weigh accurately about 2 g of Sodium Bicarbonate, NaHSO3:104.06 dissolve in 25 mL of water, and titrate with 0.5 mol/L sulfuric acid VS. When the color of the solution changes from Sodium Bisulfite is a mixture of sodium hydrogen- blue to yellow-green, boil with caution, cool, and continue sulfite and sodium pyrosulfite. the titration <2.50> until a greenish yellow color develops (in- It contains not less than 64.0z and not more than dicator: 2 drops of bromocresol green TS). 67.4z of sulfur dioxide (SO2: 64.06). Each mL of 0.5 mol/L sulfuric acid VS Description Sodium Bisulfite occurs as white granules or

＝ 84.01 mg of NaHCO3 powder, having the odor of sulfur dioxide. It is freely soluble in water, and practically insoluble in Containers and storage Containers—Tight containers. ethanol (95) and in diethyl ether. A solution of Sodium Bisulfite (1 in 20) is acid. Sodium Bicarbonate Injection It is slowly affected by air or by light. Identification A solution of Sodium Bisulfite (1 in 20) re- 炭酸水素ナトリウム注射液 sponds to the Qualitative Tests <1.09> for sodium salt and for bisulfite. Sodium Bicarbonate Injection is an aqueous solu- Purity (1) Clarity and color of solution—Dissolve 1.0 g tion for injection. of Sodium Bisulfite in 10 mL of water: the solution is clear It contains not less than 95.0z and not more than and colorless. 105.0z of the labeled amount of sodium hydrogen (2) Thiosulfate—Dissolve 1.0 g of Sodium Bisulfite in 15 carbonate (NaHCO3: 84.01). mL of water, add slowly 5 mL of dilute hydrochloric acid, shake, and allow to stand for 5 minutes: no turbidity is pro- Method of preparation Prepare as directed under Injec- duced. tions, with Sodium Bicarbonate. (3) Heavy metals <1.07>—Dissolve 1.0 g of Sodium Bi- Description Sodium Bicarbonate Injection is a clear, color- sulfite in 10 mL of water, add 5 mL of hydrochloric acid, less liquid. andevaporateonawaterbathtodryness.Totheresidueadd 2 mL of dilute acetic acid and water to make 50 mL, and Identification To a volume of Sodium Bicarbonate Injec- perform the test using this solution as the test solution. Pre- tion, equivalent to 1 g of Sodium Bicarbonate according to pare the control solution as follows: evaporate 5 mL of hy- the labeled amount, add water to make 30 mL: the solution