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PHR1865

Duloxetine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(S)-Duloxetine hydrochloride, (γS)-N-Methyl-γ-(1-naphthalenyloxy)-2-thiophenepropanamine hydrochloride, (+)-(S)-N-Methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride, (+)-N-Methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine hydrochloride, LY-248686 hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C18H19NOS · HCl
CAS Number:
136434-34-9
Molecular Weight:
333.88
UNSPSC Code:
41116107
NACRES:
NA.24
MDL number:
MFCD06407958
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Quality Segment

300

grade

certified reference material, pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0001453, traceable to USP 1229817

API family

duloxetine

form

powder

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

application(s)

pharmaceutical

storage temp.

2-30°C

SMILES string

Cl.CNCC[C@H](Oc1cccc2ccccc12)c3cccs3

InChI

1S/C18H19NOS.ClH/c1-19-12-11-17(18-10-5-13-21-18)20-16-9-4-7-14-6-2-3-8-15(14)16;/h2-10,13,17,19H,11-12H2,1H3;1H/t17-;/m0./s1

InChI key

BFFSMCNJSOPUAY-LMOVPXPDSA-N

Gene Information

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

General description

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.

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.

Duloxetine Hydrochloride, a thiophene derivative, belongs to the class of selective serotonin-norepinephrine reuptake inhibitors (SNRI), used for its anti-depressant properties.

Application

This pharmaceutical secondary standard can also be used as follows:

  • Development of two voltammetry methods using carbon paste electrode, for the trace analysis of duloxetine hydrochloride in pharmaceutical dosage forms and human serum samples
  • Separation and estimation of curcumin and duloxetine hydrochloride by reversed-phase high-performance liquid chromatography (RP-HPLC) from bulk and pharmaceutical formulations
  • Determination of duloxetine in pure form by a UV-Vis spectrophotometric method, in accordance with the ICH Q2R1 guidelines
  • Multi-analysis of antidepressant drugs― vilazodone hydrochloride, agomelatine, and duloxetine hydrochloride along with vitamin B12 in their bulk, pharmaceutical formulations, and human urine samples using HPLC

Biochem/physiol Actions

Duloxetine hydrochloride is a dual serotonin/norepinephrine reuptake inhibitor (SNRI), widely used clinically as an antidepressant and anxiolytic.
Duloxetine hydrochloride is a dual serotonin/norepinephrine reuptake inhibitor (SNRI); antidepressant; anxiolytic.

Analysis Note

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

Other Notes

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.
To see an example of a Certificate of Analysis for this material enter LRAC1689 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

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pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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Certificates of Analysis (COA)

Lot/Batch Number

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