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PHR1394

Fluoxetine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Fluoxetine hydrochloride, FLX, (±)-N-Methyl-γ-[4-(trifluoromethyl)phenoxy]benzenepropanamine hydrochloride, LY-110,140 hydrochloride, Prozac®

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About This Item

Empirical Formula (Hill Notation):
C17H18F3NO · HCl
CAS Number:
56296-78-7
Molecular Weight:
345.79
NACRES:
NA.24
PubChem Substance ID:
329823368
UNSPSC Code:
41116107
EC Number:
260-101-2
MDL number:
MFCD00214288

Key Documents

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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

USP 1279804, traceable to Ph. Eur. F0253000

API family

fluoxetine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

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

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

Biochem/physiol Actions

Selective serotonin reuptake inhibitor; antidepressant.

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 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.

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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

11 - Combustible Solids

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

PHR1394-1G-PW: + PHR1394-1G:

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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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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)
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
Screening methods for impurities in multi-sourced fluoxetine hydrochloride drug substances and formulations
Wirth DD, et al.
Chromatographia, 46(9-10), 511-511 (1997)
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)
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