PRODUCT NAME: MANNITOL 97%MIN (USP/BP)

EXPIRY DATE:2019-08-04

Item

Specification

Appearance

White or almost white crystals or powder

Solubility

Freely soluble in water, practically insoluble in ethanol (96 per cent).

Identification

Specific Optical Rotation

+23° ~ +25°

Melting Point

165.0℃ ~ 170.0℃

Infrared Absorption

Conforms

Appearance of Solution

Clear and Colorless

Conductivity

≤20μS/cm

Reducing Sugars

≤0.1%

Related Substances

(Disregard

Limit≤0.05%)

A (Sorbitol)

≤2.0%

B+C (Maltitol+Isomalt)

≤2.0%

Unspecified

≤0.1%

Total

≤2.0%

Nickel

≤1ppm

Heavy Metals

≤5ppm

Loss On Drying

≤0.5%

Microbiological

TAMC

≤103cfu/g

TYMC

≤102cfu/g

E. Coli

Negative

Salmonella

Negative

Bacterial Endotoxins

<2.5IU/g

Assay

97.0%~102.0%

Conclusion

Comply With USP/BP Requirements.