Certification of Analysis
|
Product Name |
Levocetirizine HCL |
|
CAS No |
130018-87-0 |
|
Catalog No |
SC-19390 |
|
Quantity |
500g |
|
Batch No |
20130618 |
|
Product Date |
2013.06.18 |
|
Date of analysis |
2013.06.18 |
|
Items of analysis |
Specification |
Results |
|
Appearance |
White or almost white powder |
Almost white powder |
|
Absorbance |
342~378 |
370.02 |
|
Optical rotation |
+11.5~+14.5° |
+13.8° |
|
Identification |
Positive |
Conforms |
|
pH |
1.2~1.8 |
1.58 |
|
Loss on drying |
≤0.5% |
0.30% |
|
Residue on ignition |
≤0.2% |
0.01% |
|
Heavy metals |
≤10ppm |
Conforms |
|
S-enantiomer |
≤0.5% |
0.47% |
|
Individual impurity |
≤0.1% |
0.08% |
|
Total impurities |
≤0.3% |
0.23% |
|
Acetone |
≤0.5% |
0.10% |
|
Assay |
99.0%min |
99.19% |
|
Remark |
Declaration: For laboratory use by technically qualified individual only |
|
|
Conclusion |
It accords with the Enterprise Standard |
|
Analyst: Jack Fu Check: Anne Zhang Date: 2013-06-18
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