Requirements
Description
White or almost white, crystalline or granular powder.
Solubility
Soluble in water, freely soluble in boiling water, slightly soluble in ethanol (96%)
a. Lactate (2.3.1) b. Magnesium (2.3.1)
Shall pass the test Shall pass the test
a. Clarity of the solution (2.2.1)
Not more opalescent than reference suspensoin II
pH on 5.0% solution (2.2.3)
Between 6.5 and 8.5
Chloride (2.4.4)
Max. 200 ppm
Sulphate (2.4.13)
Max. 400 ppm
Iron (2.4.9)
Max. 50 ppm
Heavy Metals (2.4.8)
Max 20 ppm
Loss on Drying (2.2.32)
Between 14.0% and 17.0%
Assay on dried basis (2.5.11)
98.0% - 102.0%
Particle Size #40 mesh (US) (pass through)
1. Method of testing as per EP as applicable.
2. In-house specs - Method of testing available on request.