100.46% antidepressant drug Venlafaxine hydrochloride/Venlafaxine HCL
CAS No.:99300-78-4
Molecular Formula:C17H28ClNO2
Formula Weight: 313.86
Apearance:white crystalline powder
Purity:100.46%
Venlafaxine hydrochloride is an antidepressant. The mechanism of the antidepresant action of venlafaxine in humans is associated with its potentiation of neurotransmitter activity in the CNS. Venlafaxine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and weak inhibitor of dopamine reuptake. Venlafaxine has no significant activity for muscarinic, histaminergic, or α-1 adrenergic receptors in vitro. Venlafaxine does not possess MAO inhibitor activity
The COA:
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Product name |
venlafaxine hydrochloride |
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CAS No. |
99300-78-4 |
Outer Packing |
25kg/drum |
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Production date |
July 2015 |
Shelf life |
June 2020 |
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Standard adopted |
USP/IHT |
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Items of analysis |
Specification |
Results |
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description
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off-white to white,crystalline |
white crystalline powder
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solubility
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soluble in methanol and in water
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complies
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A.IR absorption spectrum |
sample spectrum should be concordant with that of the USP Venlafaxine hydrochlorider RS
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sample spectrum was concordanted with reference standard spectrum
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B.by HPLC |
The retentiontime of the major peak of the sample solution corresponds to that of the standard solution,as obtained in the assay |
complies
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C.Test for chloride |
to comply
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complies
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descyelohexanol venlafaxine |
not more than 0.15%
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0.028%
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didesmethyl venlafaxine |
not more than 0.15%
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below detectable limit
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venlafaxine related compound A |
not more than 0.15%
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below detectable limit
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deoxy venlafaxine
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not more than 0.15% |
below detectable limit
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any unknown individual impurity
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not more than 0.1%
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0.052%
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total impurities
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not more than 0.5%
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0.12%
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assay(by HPLC) |
98.0%-102.0% calculated on the dried basis
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100.46%
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CLASS 1 |
solvents mentioned in (467) class 1 are not used in the process
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CLASS 2 |
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methanol |
not more than 3000ppm
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446 ppm
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toluene |
not more than 890 ppm
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28 ppm
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CLASS 3 |
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acetone
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not more than 5000ppm
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iso propyl alcohol |
not more than 5000ppm |
1510ppm
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Conclusion |
Qualified |
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