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PHR1953

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Fluoxetine Related Compound C

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
N-Methyl-N-[3-phenyl-3-(4-trifluoromethyl-phenoxy)-propyl]-succinamic acid
Empirical Formula (Hill Notation):
C21H22F3NO4
CAS Number:
Molecular Weight:
409.40
MDL number:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to USP 1279837

API family

fluoxetine

CofA

current certificate can be downloaded

packaging

pkg of 30 mg

application(s)

pharmaceutical

format

neat

storage temp.

2-30°C

SMILES string

CN(CCC(Oc1ccc(cc1)C(F)(F)F)c2ccccc2)C(=O)CCC(O)=O

InChI

1S/C21H22F3NO4/c1-25(19(26)11-12-20(27)28)14-13-18(15-5-3-2-4-6-15)29-17-9-7-16(8-10-17)21(22,23)24/h2-10,18H,11-14H2,1H3,(H,27,28)

InChI key

SAIPSZMZTANCFE-UHFFFAOYSA-N

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General description

Fluoxetine Related Compound C is an impurity of the selective serotonin reuptake inhibitor, fluoxetine. Fluoxetine is commonly used in the treatment of depression.
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.

Application

Fluoxetine Related Compound C may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulation by chromatography.
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.

Analysis Note

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

Other Notes

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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAB1420 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Exclamation markEnvironment

Signal Word

Warning

Hazard Statements

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Acute 1 - Aquatic Chronic 1

Storage Class Code

11 - Combustible Solids

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Fluoxetine
Analytical Profiles of Drug Substances, 19, 193-219 (1990)
Fluoxetine Delayed-Release Capsules
USP42/NF37: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 40(4), 1915-1915 (2015)
Nonaqueous capillary electrophoresis-electrospray-mass spectrometry for the analysis of fluoxetine and its related compounds
Cherkaoui S and Veuthey JL
Electrophoresis, 23(3), 442-448 (2002)

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