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PHR1394

Supelco

Fluoxetine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
(±)-N-Methyl-γ-[4-(trifluoromethyl)phenoxy]benzenepropanamine hydrochloride, Prozac, LY-110,140 hydrochloride, FLX, Fluoxetine hydrochloride
Empirical Formula (Hill Notation):
C17H18F3NO · HCl
CAS Number:
Molecular Weight:
345.79
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 797
traceable to PhEur F0253000
traceable to USP 1279804

storage temp.

2-30°C

SMILES string

CNCCC(C1=CC=CC=C1)OC2=CC=C(C(F)(F)F)C=C2.[H]Cl

InChI

1S/C17H18F3NO.ClH/c1-21-12-11-16(13-5-3-2-4-6-13)22-15-9-7-14(8-10-15)17(18,19)20;/h2-10,16,21H,11-12H2,1H3;1H

InChI key

GIYXAJPCNFJEHY-UHFFFAOYSA-N

Gene Information

human ... 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.
Fluoxetine Hydrochloride is a selective serotonin-reuptake inhibitor used as an antidepressant. It is also utilized for the treatment of obsessive-compulsive disorders.

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.
Fluoxetine Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by various chromatography techniques.

Biochem/physiol Actions

Selective serotonin reuptake inhibitor; antidepressant.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3045 in the slot below. This is an example certificate only and may not be the lot that you receive.

Legal Information

Sold under license from Eli Lilly and Company.
Prozac is a registered trademark of Eli Lilly and Co.

Signal Word

Danger

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Dam. 1 - STOT RE 2 - STOT SE 3

Target Organs

Central nervous system

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

Determination of fluoxetine hydrochloride enantiomeric excess using high-performance liquid chromatography with chiral stationary phases
Olsen BA, et al.
Journal of Pharmaceutical and Biomedical Analysis, 17(4), 623-630 (1998)
Quality assessment of internet pharmaceutical products using traditional and non-traditional analytical techniques
Westenberger BJ, et al.
International Journal of Pharmaceutics, 306(1), 56-70 (2005)
Simultaneous RP-HPLC and HPTLC Estimation of Fluoxetine Hydrochloride and Olanzapine in Tablet Dosage Forms
Patel S and Patel NJ
Indian Journal of Pharmaceutical Sciences, 71(4), 477-477 (2009)
Screening methods for impurities in multi-sourced fluoxetine hydrochloride drug substances and formulations
Wirth DD, et al.
Chromatographia, 46(9-10), 511-511 (1997)
Brunno Rocha Levone et al.
Neurobiology of stress, 14, 100331-100331 (2021-05-18)
Current antidepressants are suboptimal due incomplete understanding of the neurobiology underlying their behavioral effects. However, imaging studies suggest the hippocampus is a key brain region underpinning antidepressant action. There is increasing attention on the functional segregation of the hippocampus into

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