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PHR1865

Duloxetine Hydrochloride

Name: Duloxetine Hydrochloride
Brand: SIAL

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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Properties

Quality Level

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)

Description

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

GHS07

signalword

Warning

hcodes

H302

pcodes

P301 + P312 + P330

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

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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Development and validation of UV-Visible spectrophotometric method for determination of Duloxetine

Samal, LIPSA and Prusty, AMARESH

International Journal of Pharmacy and Pharmaceutical Sciences, 11, 27-31 (2019)

Validated reversed-phase high-performance liquid chromatography method for simultaneous estimation of curcumin and duloxetine hydrochloride in tablet and self-nanoemulsifying drug delivery systems

Kumar B, et al.

Journal of Pharmacy Research, 11, 1166-1166 (2017)

Trace determination of duloxetine HCl in formulation and spiked human serum at a carbon paste electrode

Hassanein AM, et al.

American Journal of Analytical Chemistry, 8, 708-725 (2017)

Global Trade Item Number

SKU	GTIN
PHR1865-500MG	04061835220342