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D (-) MANNITOL
Confirms to USP
Mannite
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Article No.
4516A
Grade
Purity
97%
CAS No.
69-65-8
Molecular Formula
C
6
H
1
4
O
6
Molecular Weight
182.17
H.S. Code
2905.4300
Shelf Life
60 Months
Specifications
Appearance
White, crystalline powder or free-flowing granules
Identification (By IR)
Conforms
Assay (on dried basis)
97.0 – 102.0%
Related Substances
-
Sorbitol
NMT 2.0%
Disregard limit
NMT 0.05%
Sum of isomalt and maltitol
NMT 2.0%
Unspecified impurity
NMT 2.0%
Total impurity
NMT 2.0%
Reducing sugars
NMT 0.1%
Nickel (Ni)
NMT 1 µg/g
Melting point
165 – 170°C
Appearance of solution
The sample solution is clear and colourless; its clarity is the same as that of water, or its opalescence is not more pronounced than that of the reference suspension, and it is more intensely coloured than that standard solution
Loss on drying
NMT 0.5%
Conductivity
NMT 20 µS/cm at 25°C
Microbial enumeration tests and tests for specified microorganisms
-
Total aerobic count
NMT (10)3 cfu/g
Yeast and mould count
NMT (10)2 cfu/g
E.coli.
Negative
Revision Date:
25-May-2024
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