Product Code : 11
Appearance
Yellowish or orange crystalline powder
Yellowish crystalline powder
Specific Rotation
+18 ~ +22o
19.2o
Ultraviolet Absorption
A256/A365=2.80 ~ 3.0
2.92
Chromatograms (HPLC)
Conforms
Identification (TLC)
Related Substance
Impurity A: <0.5%Impurity D: <0.6%Other impurity: <0.5%Total impurity: <1.0%
0.40.50.40.7
Free Amines
<1/6
Chromatographic purity
<2.0%
1.72%
Loss on drying
5.0% ~ 8.5%
7.7%
Residue on ignition
<0.2%
0.13%
Organic volatile impurities
Meet the requirements
Assay (on dried basis)
96.0 ~ 102.0%
97.30%
Conclusion: This batch complies with BP2005/ USP30 and in-house specifications
Storage: Preserve in well-closed, light-resistant containers
Shelf life: 48 months