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ITEM NAME: GUAIFENESIN BP/USP EXPIRY DATE:5 YEARS CAS NO.: |
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ITEMS |
SPECIFICATIONS |
RESULTS |
|
APPEARANCE |
WHITE CRYSTALLINE POWDER |
WHITE CRYSTALLINE POWDER |
|
INDENTIFICATION |
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IR |
CONFORM TO RS SPECTRUM |
CONFORM TO RS SPECTRUM |
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UV |
CONFORM TO RS SPECTRUM |
CONFORM TO RS SPECTRUM |
|
CHEMICAL TEST |
POSITIVE |
POSITIVE |
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MELTING RANGE |
78-82°C |
80.0~81.0°C |
|
LOSS ON DRYING |
≤0.5% |
0.10% |
|
HEAVY METALS |
≤0.0025% |
<0.0025% |
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RELATED SUBSTANCES |
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β-ISOMER |
≤1.5% |
0.12% |
|
GUAIACOL |
≤0.03% |
0.01% |
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BISETHER |
≤0.5% |
0.05% |
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1,3-BIS(2-METHOXYPHENOXY)PROPAN-2-OL |
≤0.5% |
0.01% |
|
OTHER INDIVIDUAL UNKNOWN IMPURITY |
≤0.10% |
0.02% |
|
SUM OF ALL IMPURITIES |
≤1.0% |
0.08% |
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RESIDUAL SOLVENT |
≤0.5% |
0.10% |
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ASSAY |
98.0 – 102.0 |
99.8% |
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CONCLUSION: |
QUANLIFIED UP TO USP32. |
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