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Lactobionic Acid

Test Specification...BP
Characters It occurs as a white or almost white powder
Identification

Test A

Test B

(a) Infrared absorption spectrophotometry

(b)Thin Layer Chromatography

Solubility Freely Soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol.
Melting Point About 125OC with decomposition
Appearance of solution The solution is clear and not more intensely colored than reference solution Y5
Specific optical rotation +23.0O to +29.0O
Total Ash Not more than 0.2%
Heavy Metals Not more than 20 ppm
Reducing Sugars (as Glucose) Not more than 0.2%
Water Not more than 5.0%
Assay Not less than 98.0% and not more than 102.0% (anhydrous substances)
Test Specification...EP
Characters It occurs as a white or almost white powder
Identification

Test A

Test B

(a) Infrared absorption spectrophotometry

(b)Thin Layer Chromatography

Solubility Freely Soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol.
Melting Point About 125OC with decomposition
Appearance of solution The solution is clear and not more intensely colored than reference solution Y5
Specific optical rotation +23.0O to +29.0O
Total Ash Not more than 0.2%
Reducing Sugars (as Glucose) Not more than 0.2%
Water Not more than 5.0%
Microbial Contamination

TAMC

TYMC

Not more than 103 cfu/g

Not more than 102 cfu/g

Assay Not less than 98.0% and not more than 102.0% (anhydrous substances)
Test Specification...USP
Characters White or almost white powder.
Identification

Test A

Test B

(a) Infrared absorption spectrophotometry.

(b) Thin-layer chromatography

Solubility Freely soluble in water, slightly soluble in glacial acetic acid, in anhydrous ethanol and in methanol.
MP About 125 °C
Optical rotation Between + 23.0 to + 29.0
Articles of Botanical Origin Maximum 0.2%
Reducing sugars Maximum 0.2%
Heavy metals Maximum 20 ppm
Water Maximum 5.0%
Assay Not less than 98.0% and more than 102.0%, on the 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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