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Lactitol Monohydrate

Test Specification...BP
Characters It occurs as white crystalline powder
Identification

Test A

Test B

Test C

Infrared absorption spectrophotometry.

Specific Optical rotation

Thin Layer Chromatography

Solubility Very soluble in water, slightly soluble in ethanol (96 %), practically insoluble in methylene chloride
Appearance of solution Solution is clear and not more intensely colored than reference solution BY7
Acidity or alkalinity Specified test.
Specific Optical rotation +13.5° to +15.5°
Related Substances Not more than 1.0%
Unspecified impurities Not more than 0.1%
Other related Substances Not more than 1.0%
Reducing Sugars Not more than 0.2%
Lead Not more than 0.5 ppm
Nickel Not more than 1 ppm
Water Between 4.5% to 5.5%
Sulphated Ash Not more than 0.1 %
Assay Not less than 96.5% and not more than 102.0% (anhydrous Substance)
Test Specifications...USP
Descriptions It occurs a white or light brown, odorless crystal.
Identification

Test A

(a) Infrared Absorption

Residue of Ignition Not more than 0.5 %
Heavy Metals Not more than 5 ppm
Related Compounds Not more than 1.5 %
Reducing sugars Not more than 0.2 %
Water Determinination Between 4.5 % – 5.5 %
Residual solvents Meets the requirements
Assay Not less than 98.0 % and not more than 101.0 % on anhydrous 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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