Clemastine fumarate Clemastine USP40 Clemastine fumarate
Appearance: White or off-white crystalline powder
Solubility: Slightly soluble in methanol, very slightly soluble in water
Clarity and color of solution: The test solution is colorless or not more intensely colored than color matching fluid
Identification IR: IR spectrum of the sample corresponds to that of reference standard
TLC: Should be positive
HPLC: The retention time of the major peak in chromatograms corresponds to that in the reference standard
Specific rotation [α]D20: +15.0°~ +18.0°(C=1, in methanol)
pH: 3.2 ~ 4.2
Related substances:
4-Chlorobenzophenone
Individual impurity≤0.1%
Total impurities≤1.0%
Loss on drying: ≤0.5%
Heavy metals: ≤20ppm
Assay: 98.0% ~ 102.0%
Appearance: White or off-white crystalline powder
Solubility: Slightly soluble in methanol, very slightly soluble in water
Clarity and color of solution: The test solution is colorless or not more intensely colored than color matching fluid
Identification IR: IR spectrum of the sample corresponds to that of reference standard
TLC: Should be positive
HPLC: The retention time of the major peak in chromatograms corresponds to that in the reference standard
Specific rotation [α]D20: +15.0°~ +18.0°(C=1, in methanol)
pH: 3.2 ~ 4.2
Related substances:
4-Chlorobenzophenone
Individual impurity≤0.1%
Total impurities≤1.0%
Loss on drying: ≤0.5%
Heavy metals: ≤20ppm
Assay: 98.0% ~ 102.0%
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