Calcium Lactate

Calcium Lactate is known as Antimicrobial preservative, buffering agent, crosslinking agent, tablet and capsule diluent, tablet binder, tablet filler, therapeutic agent, thickening agent. This product is available in Arvin Kala’s diverse product portfolio.

Description

Calcium lactate occurs as white or almost white, crystalline or granular powder. It is slightly efflorescent.
The structural formula of this substance is as follows:

Applications in Pharmaceutical Formulation or Technology

Calcium lactate is utilized as a bioavailability enhancer and a nutrient supplement in pharmaceutical formulations.
A spray-dried grade of calcium lactate pentahydrate has been employed as a tablet diluent in direct compression systems and has demonstrated good compactability. The pentahydrate form’s properties are considered superior to those of calcium lactate trihydrate in direct compression tablet formulations. The hydration state of calcium lactate and the particle size of the material can influence tablet properties: reducing particle size increases crushing strength, while storing tablets at elevated temperatures leads to dehydration and a subsequent reduction in crushing strength.
Calcium lactate has also been utilized as a source of calcium ions in the preparation of calcium alginate microspheres for controlled release.
Therapeutically, calcium lactate has been employed in formulations for treating calcium deficiency.

Stability and Storage Conditions
Calcium lactate can exist in various hydration states, including anhydrous, monohydrate, trihydrate, and pentahydrate. The pentahydrate form dehydrates rapidly at temperatures of 55°C and above, which is reported to result in some loss of crystallinity. Additionally, the crushing strength of tablets is reduced following the dehydration of calcium lactate pentahydrate.
Method of Manufacture
Calcium lactate is commercially produced by neutralizing lactic acid, which is derived from the fermentation of dextrose, molasses, starch, sugar, or whey, with calcium carbonate or calcium hydroxide.
Safety
Calcium lactate showed no toxic or carcinogenic effects when administered in drinking water at concentrations of 0%, 2.5%, and 5% to male and female rats over a period of two years.
Handling Precautions
Follow standard precautions suitable for the specific circumstances and the amount of material being handled.
Typical Properties

Acidity/alkalinity pH = 6.0 to 8.5 for a 10% aqueous solution for Puracal PP

Density (bulk) 0.56 g/; 0.3 to 0.5 g/for Puracal PP

Density (tapped) 0.67 g/

Density (true) 1.494 g/

Melting point >2008C for Puracal PP

Solubility Soluble in water, freely soluble in boiling water; very slightly soluble in ethanol (95%).

Chemical-physical values

Test Item Unit Specification
Lead
ppm
Max 2
Arsenic
ppm
Max 1
Mercury
ppm
Max 0.1
Cadmium
ppm
Max 1
Fluoride
ppm
Max 15
Volatile fatty acids
Passes tes
Total aerobic count
CFU/g
<1000
Total mold & yeast
CFU/g
<100
Test Item Unit Specification
Particle size
Mesh40, >95%
Content
%
NLT 98 NMT 101
PH (5% Solution)
NLT 6.0 NMT 8.0
Acidity (as lactic acid)
%
Max 0.45
Chloride
%
Max 0.05
Sulphate
%
Max 0.075
Heavy metal
ppm
Max 10
Magnesium & alkali salt
%
Max 1.0

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