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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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.

Analysis Note

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

Footnote

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.

Recommended products

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Safety Information

• pictograms: GHS07
• signalword: Warning
• hcodes: H302
• pcodes: P301 + P312 + P330
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 3
• flash_point_f: Not applicable
• flash_point_c: Not applicable