TEST ITEMS
|
SPECIFICATION
|
RESULTS
|
Description
|
: White Or Almost White Crystalline Powder
|
White Powder
|
Identification
|
: Infrared Absorption
|
Positive
|
Assay
|
: 97.0~103.0%
|
99.15%
|
Melting Point
|
: 33~37°C
|
34.5~36.5°C
|
Loss On Drying
|
: 0.5%max
|
0.30%
|
Specific Rotation
|
: +32°~ +36°(C=1 in dioxane)
|
+33.5°
|
Organic Volatile Impurities
|
: 2500PPm max
|
<1000PPm
|
Residual Solvents
|
: Meet the requirements.(USP29)
|
Confirms
|
Chromatographic purity
|
: sum of impurities:3.0%max
|
<3.0%
|
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