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Terbinafine hydrochloride Terbinafine hcl Terbinafine 99%
CERTIFICATE OF ANALYSIS
Product name |
Terbinafine HCl |
||
Batch No |
19020501 |
CAS No. |
78628-80-5 |
Manufacture Date |
2019-02-05 |
Expiry date |
2021-02 |
Report Date |
2019-02-15 |
Quantity |
1625kg |
Items |
Standard |
Results |
|
Appearance |
White or off-white powder |
Comply |
|
Identification |
A:IR |
Comply |
|
B: Chloride |
Comply |
||
Solubility |
Very slightly or slightly soluble in water, Freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone. |
Comply |
|
Melting point |
204-208°C |
204.5-206.2°C |
|
Related Substances |
N-methyl-C-(naphthalene-1-yl)methanamine |
≤0.10% |
Not Detected |
Cis-Terbinafine |
≤0.10% |
0.003% |
|
Trans-Isoterbinafine |
≤0.10% |
Not Detected |
|
4-Methylterbinafine |
≤0.10% |
0.019% |
|
Terbinafine dimer |
≤0.05% |
0.035% |
|
Any other individual impurity |
≤0.10% |
0.007% |
|
Total impurities |
≤0.3% |
0.07% |
|
Loss on drying |
≤0.50% |
0.17% |
|
Residue on ignition |
≤0.10% |
0.06% |
|
Assay |
98~102% (on the dried basis) |
99.75% |
|
Storage |
Keep tightly closed. Store in a cool dry place. |
||
Determination |
Complies with USP39 standard |
CERTIFICATE OF ANALYSIS
Product name |
Terbinafine HCl |
||
Batch No |
19020501 |
CAS No. |
78628-80-5 |
Manufacture Date |
2019-02-05 |
Expiry date |
2021-02 |
Report Date |
2019-02-15 |
Quantity |
1625kg |
Items |
Standard |
Results |
|
Appearance |
White or off-white powder |
Comply |
|
Identification |
A:IR |
Comply |
|
B: Chloride |
Comply |
||
Solubility |
Very slightly or slightly soluble in water, Freely soluble in anhydrous ethanol and methanol, slightly soluble in acetone. |
Comply |
|
Melting point |
204-208°C |
204.5-206.2°C |
|
Related Substances |
N-methyl-C-(naphthalene-1-yl)methanamine |
≤0.10% |
Not Detected |
Cis-Terbinafine |
≤0.10% |
0.003% |
|
Trans-Isoterbinafine |
≤0.10% |
Not Detected |
|
4-Methylterbinafine |
≤0.10% |
0.019% |
|
Terbinafine dimer |
≤0.05% |
0.035% |
|
Any other individual impurity |
≤0.10% |
0.007% |
|
Total impurities |
≤0.3% |
0.07% |
|
Loss on drying |
≤0.50% |
0.17% |
|
Residue on ignition |
≤0.10% |
0.06% |
|
Assay |
98~102% (on the dried basis) |
99.75% |
|
Storage |
Keep tightly closed. Store in a cool dry place. |
||
Determination |
Complies with USP39 standard |
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