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CAS No: | 79794-75-5 | Molecular Formula: | C22H23ClN2O2 |
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Molecular Weight: | 382.88300 | Melting Point: | 134-136 ° C |
Density: | 1.261 G/cm3 | Boiling Point: | 531.3 Cat 760 MmHg |
Flash: | 275.1ºC | Stability: | Stable, But May Be Thermally Sensitive - Refrigerated. Incompatible With Strong Oxidants. |
Storage Conditions: | 2-8ºC | Appearance: | White Or White-like Crystalline Powder, Odorless |
Solubility: | Soluble In Methanol, Ethanol Or Acetone; Slightly Dissolved In 0.1mol/L Hydrochloric Acid Solution; It's Almost Insoluble In Water. | Class: | Antihistamines. |
High Light: | pharma raw material,raw pharmaceutical materials |
Product |
LORATADINE |
batch No. |
190818 |
Mfg. date |
2019.08.18 |
Approval Date |
2019.08.18 |
Exp. date |
2021.08.17 |
Tests |
Results |
Specifications |
Appearance |
Complies |
White or off white crystalline powder |
Solubility |
Complies |
Freely soluble in acetone,in chloroform,in methanol and in toluene;insoluble in water. |
Identification |
Complies |
A. By IR absorption, To match with working standard. |
Complies |
B. The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. |
|
Melting Point |
133.5℃~136.3℃ |
132℃~ 137℃ |
Loss on drying |
0.12% |
≤0.5% |
Residue on ignitio |
0.03% |
≤0.1% |
Related substance |
Related compound A |
Not Detected |
≤ 0.1% |
Related compound B |
Not Detected |
≤ 0.1% |
Each individual unknown impurity |
0.03% |
≤ 0.1% |
Total impurities |
0.12% |
≤ 0.3% |
Heavy metal |
<10ppm |
≤10ppm |
Residual solvent |
Not Detected |
Isopropyl ether≤0.5% |
Not Detected |
Ethyl acetate≤0.5% |
|
Not Detected |
Toluene≤0.089% |
|
Assay |
99.74% |
98.5%-101.0% |
Conclusion: the material comform to the USP36 |
Structure:
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