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Sodium Chloride Apis Medical/Injectable Grade

Application: Used for produce sodium chloride injection.

Name of the productSodium Chloride
AppearanceWhite or almost white, crystalline powder or colourless crystals or white or almost white pearls. 
SolubilityFreely soluble in water, practically insoluble in anhydrous ethanol. 
IdentificationA. It gives the reactions of chlorides (2.3.1).
B. It gives the reactions of sodium (2.3.1).
Appearance of solutionSolution S is clear (2.2.1) and colourless (2.2.2, Method II).
Acidity or alkalinityTo 20 mL of solution S add 0.1 mL of bromothymol blue solution R1. No more than 0.5 mL of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator. 
BromidesMaximum 100 ppm. 
Ferrocyanides Dissolve 2.0 g in 6 mL of water R. Add 0.5 mL of a mixture of 5 mL of a 10 g/L solution of ferric ammonium sulfate R in a 2.5 g/L solution of sulfuric acid R and 95 mL of a 10 g/L solution of ferrous sulfate R. No blue colour develops within 10 min. 
IodidesMoisten 5 g by the dropwise addition of a freshly prepared mixture of 0.15 mL of sodium nitrite solution R, 2 mL of 0.5 M sulfuric acid, 25 mL of iodide-free starch solution R and 25 mL of water R. After 5 min, examine in daylight. The mixture shows no blue colour.
Nitrites To 10 mL of solution S add 10 mL of water R. The absorbance (2.2.25) is not greater than 0.01 at 354 nm. 
PhosphatesMaximum 25 ppm. 
SulfatesMaximum 200 ppm. 
AluminiumMaximum 0.2 ppm
ArsenicMaximum 1 ppm
BariumTo 5 mL of solution S add 5 mL of distilled water R and 2 mL of dilute sulfuric acid R. After 2 h, any opalescence in the solution is not more intense than that in a mixture of 5 mL of solution S and 7 mL of distilled water R.
IronMaximum 2 ppm
Magnesium and alkaline-earth metalsMaximum 100 ppm, calculated as Ca and determined on 10.0 g
Potassium Maximum 500 ppm
Heavy metalsMaximum 5 ppm. 
Loss on dryingMaximum 0.5 per cent
Bacterial endotoxinsLess than 5 IU/g
Assay99.0 per cent to 100.5 per cent (dried substance).

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