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PHR1736

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Venlafaxine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Venlafaxine hydrochloride, (+/-)-1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride, Effexor
Empirical Formula (Hill Notation):
C17H27NO2 · HCl
CAS Number:
99300-78-4
Molecular Weight:
313.86
MDL number:
MFCD03658865
UNSPSC Code:
41116107
PubChem Substance ID:
329823583
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to BP 835
traceable to Ph. Eur. Y0000587
traceable to USP 1711268

API family

venlafaxine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Cl[H].COc1ccc(cc1)C(CN(C)C)C2(O)CCCCC2

InChI

1S/C17H27NO2.ClH/c1-18(2)13-16(17(19)11-5-4-6-12-17)14-7-9-15(20-3)10-8-14;/h7-10,16,19H,4-6,11-13H2,1-3H3;1H

InChI key

QYRYFNHXARDNFZ-UHFFFAOYSA-N

Gene Information

human ... SLC6A2(6530) , SLC6A4(6532)

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General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
Venlafaxine Hydrochloride is the hydrochloride salt of venlafaxine, a non-tricyclic antidepressant and serotonin-norepinephrine-dopamine reuptake inhibitor.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Venlafaxine Hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase high performance liquid chromatography technique. It is also used as a secondary pharmaceutical standard for the determination of venlafaxine in pharmaceutical formulations using liquid chromatography technique.

Biochem/physiol Actions

Venlafaxine 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.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB7761 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Environment
GHS09

Hazard Statements

H411

Precautionary Statements

P273 - P391 - P501

Hazard Classifications

Aquatic Chronic 2

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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RP-HPLC estimation of venlafaxine hydrochloride in tablet dosage forms
Baldania LS, et al.
Indian Journal of Pharmaceutical Sciences, 70(1), 124-124 (2008)
Victoria C de Leeuw et al.
Neurotoxicology, 76, 1-9 (2019-10-09)
There is a need for in vitro tests for the evaluation of chemicals and pharmaceuticals that may cause developmental neurotoxicity (DNT) in humans. The neural embryonic stem cell test (ESTn) is such an in vitro test that mimics early neural
Stability indicating LC method for the estimation of venlafaxine in pharmaceutical formulations
Makhija NS and Vavia RP
Journal of Pharmaceutical and Biomedical Analysis, 28(6), 1055-1059 (2002)
Seham Alaiyed et al.
Journal of neurochemistry, 148(6), 810-821 (2019-01-31)
Drugs that target monoaminergic transmission represent a first-line treatment for major depression. Though a full understanding of the mechanisms that underlie antidepressant efficacy is lacking, evidence supports a role for enhanced excitatory transmission. This can occur through two non-mutually exclusive

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