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Appearance
|
White, crystalline powder or free-flowing granules
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|
Identification (By IR)
|
Conforms
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|
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
|