Mannitol USP

WCode: 13-068
CAS Number: 69-65-8
Molecular Formula: C6H14O6
Molecular Weight: 182.17

 

SKU: 13-068 Category:

Applications

Mannitol is mainly used in pharmaceutical formulations and food applications, mainly as diluent and bulking agent in solid oral formulations such as tablets. It is also used in the food industry as a sweetener, bulking agent, anticaking agent, humectant, stabilizer, and texturizerIt’s found in chocolate, chewing gum, confections, powders, and tablets. 

Sales Specification

Description: White powder or free-flowing granular
Identification (IR): The infrared absorption spectrum of the preparation of the test specimen exhibits maxima only at the same wavelength as that of a similar preparation of the corresponding
Assay(on dried basis): 98.0-102.0%
Solubility: Slightly in alcohol, easily in water
Clarity : <1#Clarity Solution
Appearance of Solution : Clear and colorless
Melting Point: 165°C – 170 °C
Acidity: Not more than 0.30 ml of 0.020 N sodium hydroxide is required for neutralization.
Loss on Drying: ≤0.5%
Conductivity: ≤20 us/cm
Chloride : ≤0.007%
Sulphate : ≤0.01%
Reducing Sugars : ≤0.1% as glucose
Specific Rotation : Between+137°and+145°
Sum of Isomalt and Maltitol : ≤2.0%
Sorbitol :  ≤2.0%
Unspecified impurities :              ≤0.10%
Total impurities :  ≤2.0%
Disregard limit :              ≤0.05%
Heavy Metals : ≤10 ppm
Arsenic : ≤1.0 ppm
Lead : ≤0.5 ppm
Cadmium : ≤0.5 ppm
Mercury : ≤0.1 ppm
Nickel : ≤1.0 ppm
Particle Size : NLT 60% PASS 200MESH
NLT 95% PASS 80MESH
NLT 90% PASS 100MESH
Total Plate Count : <1000 cfu/g
Yeast &Mold : ≤100 cfu/g
E.Coli : Absence
Salmonella : Absence
Staphylococcus aureus : Absence
Bacterial Endotoxins : ≤2.5

Packing

25 kg cardboard drum

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