Calcium Gluconate Injection 10ml 66905-23-5 Crystallization Lower Than 0.05%

Product Description

Calcium Gluconate Injection 10ml:1.0g

Identification—
A: Dissolve a quantity of it in water to obtain a test solution containing 10 mg per mL, heating in a water bath at 60 if necessary. Similarly, prepare a Standard solution of USP Potassium Gluconate RS in water containing 10 mg per mL. Apply separate 5-µL portions of the test solution and the Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel, and allow to dry. Develop the chromatogram in a solvent system consisting of a mixture of alcohol, water, ammonium hydroxide, and ethyl acetate (50: 30 :10: 10) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, and dry at 110 for 20 minutes. Allow to cool, spray with a spray reagent prepared as follows. Dissolve 2.5 g of ammonium molybdate in about 50 mL of 2 N sulfuric acid in a 100-mL volumetric flask, add 1.0 g of ceric sulfate, swirl to dissolve, dilute with 2 N sulfuric acid to volume, and mix. Heat the plate at 110 for about 10 minutes: the principal spot obtained from the test solution corresponds in color, size, and RF value to that obtained from the Standard solution.(ERR 1-Oct-2014)
B: A dilution of the Injection with water (1 in 5) responds to the tests for Calcium 191.
Bacterial endotoxins 85— It contains not more than 0.17 USP Endotoxin Unit per mg of calcium gluconate.
pH 791: between 6.0 and 8.2, except that in the case where it is labeled as intended for veterinary use only and as containing boric acid, it is between 2.5 and 4.5.
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