INTRODUCTION

Calcium Gluconate is the calcium salt of gluconic acid, an oxidation product of glucose, and contains 9.3% calcium, which is about one-third of the calcium in the strength of calcium chloride. It is an ingredient found in a variety of supplements and vitamins and is used to lower potassium in the blood. Calcium gluconate is used as a mineral supplement and medication when there is insufficient calcium in the diet. Supplementation may be done to treat or prevent osteoporosis or rickets, consequences of hypocalcemia.

Manufacture
It is made by mixing gluconic acid with calcium carbonate or calcium hydroxide

SynonymsCalcium di-(D-gluconate)
D-Gluconic acid calcium salt
CAS no.299-28-5
EINECS no.206-075-8
Molecular formulaC12H22CaO14
Molecular weight430.37
Structure

Applications

Calcium gluconate is used to prevent or treat calcium deficiencies. Oral calcium salts are used as dietary supplemental therapy for people who may not get enough calcium in their regular diet
Calcium gluconate is used as a cardioprotective agent in high blood potassium
Calcium gluconate is the antidote for magnesium sulfate toxicity

Calcium gluconate is also used as/for:

Hyperkalemia
Hypocalcemia tetany
Dietary Supplement
Hungry Bone Syndrome
Tumor Lysis Syndrome

SPECIFICATIONS – for injection, EP

TestUnitSpecification
AppearanceWhite or almost white, crystalline or granular powder
SolubilitySparingly soluble in water, freely soluble in boiling water
Identification
A. TLC
B. Reaction of Calcium



Shall pass the test
Shall pass the test
Appearance of solutionAt 60°C, solution S is not more intensely colored than reference solution B7. After cooling to 20°C, it is not more opalescent than reference suspension II.
pHBetween 6.4 and 8.3
Organic impurities & Boric acidShall pass the test
OxalatesppmMax 100
Sucrose & reducing sugarsNo red precipitate is formed
ChloridesppmMax 50
PhosphatesppmMax 100
SulphatesppmMax 50
IronppmMax 5
Magnesium & alkali metals%Max 0.4
Assay as C12H22CaO14H2O%Between 99.0 and 101.0
Microbial Contamination
Bacterial endotoxinsIU/gMax 167
Total aerobic microbial countCFU/gMax 10(square)

STORAGE
Store in a cool & dry place. Keep away from moisture.

PACKING
25 kg drum.

REGISTRATION / CERTIFICATION
US-DMF, CEP, EU-GMP, EU-WC (Written Confirmation)

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