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Key Documents

PHR1679

Supelco

Atomoxetine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

(R)-Tomoxetine hydrochloride, (R)-N-Methyl-γ-(2-methyl­phenoxy)benzenepropanamine hydrochloride, Atomoxetine hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C17H21NO · HCl
CAS Number:
Molecular Weight:
291.82
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

agency

traceable to Ph. Eur. Y0001586
traceable to USP 1044469

API family

atomoxetine

CofA

current certificate can be downloaded

packaging

pkg of 500 mg

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

CNCC[C@@H](OC1=CC=CC=C1C)C2=CC=CC=C2.[H]Cl

InChI

1S/C17H21NO.ClH/c1-14-8-6-7-11-16(14)19-17(12-13-18-2)15-9-4-3-5-10-15;/h3-11,17-18H,12-13H2,1-2H3;1H/t17-;/m1./s1

InChI key

LUCXVPAZUDVVBT-UNTBIKODSA-N

Gene Information

human ... SLC6A2(6530)

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General description

Atomoxetine hydrochloride is a nonstimulant used in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adults.
Certified 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

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.
Atomoxetine hydrochloride may be used as a pharmaceutical reference standard for the determination of atomoxetine hydrochloride in pharmaceutical formulations by spectrophotometric method.

Biochem/physiol Actions

Norepinephrine uptake blocker.

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 LRAA6124 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Recommended products

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.

Storage Class

11 - Combustible Solids

wgk_germany

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable


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Colourimetric assay of atomoxetine hydrochloride by simple aurum coupling reaction in bulk and tablet dosage form.
Ishaq B M, et al.
Global Journal of Medical research, 13(7B) (2014)
Joshua Caballero et al.
Clinical therapeutics, 25(12), 3065-3083 (2004-01-30)
Attention-deficit/hyperactivity disorder (ADHD) occurs in approximately 3% to 10% of the pediatric population. Most of the drugs typically used to treat ADHD are stimulants, which, because of their addictive properties and potential for abuse, are controlled substances. Although these drugs

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