Calcium Gluconate USP

Abstract
Calcium Gluconate is a mineral supplement manufactured by the neutralization of gluconic acid with lime or calcium carbonate. It is on the list of World Health Organization’s List of Essential Medicines.

 

Use/Application
Calcium Gluconate is used in the treatment of hypocalcaemia. It is also used to counteract an overdose of Magnesium Sulphate, to treat hydrofluoric burns and as a cardio protective agent in hypocalcaemia.

 

Identity
Chemical Name: Calcium Gluconate
Mol. Formula: C12H22CaO14.H2O
Mol. Weight: 448.39 g/mol
CAS No.: 66905-23-5

 

General Specifications

Test Specification
Characters White , crystalline, odorless, tasteless granules or powder
Identification

Test (A)

Test (B)

 

(a)Responds to the test for Calcium

(b) Infrared Absorption

Solubility Freely soluble in boiling water; sparingly (and slowly) soluble in water; insoluble in alcohol.
Loss on drying Not more than 2.0%
Chloride Not more than 0.07%
Sulphate Not more than 0.05%
Arsenic Not more than 3 ppm
Limit of iron Not more than 5 ppm
Limit of magnesium and alkali metals Not more than 0.4%
Limit of phosphate Not more than 0.01%
Limit of oxalate Not more than 0.01%
Heavy metals Not more than 20 ppm
Reducing substances Not more than 1.0%
Residual solvents Meets the requirements
Assay Not less than 98.5% and not more than 102.0%, calculated on the dried basis.

 

Shelf life, Storage and Packing

It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.

 

Other
GLP, cGMP (FDA) Approved, ISO 9001, ISO 14001, ISO 45001, ISO 17025, ISO 22000, FSSC 22000, FSSAI, Halal and Kosher certified.
We observe WHO Good manufacturing practice and Good laboratory practice.

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