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PHR1384

Amitriptyline hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Amitriptyline hydrochloride, 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptane-Δ5γ-propylamine hydrochloride, 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine

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About This Item

Empirical Formula (Hill Notation):
C20H23N · HCl
CAS Number:
549-18-8
Molecular Weight:
313.86
NACRES:
NA.24
PubChem Substance ID:
329823361
UNSPSC Code:
41116107
EC Number:
208-964-6
MDL number:
MFCD00012537

Key Documents

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Product Name

Amitriptyline hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

KFYRPLNVJVHZGT-UHFFFAOYSA-N

InChI

1S/C20H23N.ClH/c1-21(2)15-7-12-20-18-10-5-3-8-16(18)13-14-17-9-4-6-11-19(17)20;/h3-6,8-12H,7,13-15H2,1-2H3;1H

SMILES string

Cl[H].CN(C)CC\C=C1\c2ccccc2CCc3ccccc13

grade

certified reference material
pharmaceutical secondary standard

agency

traceable to Ph. Eur. Y0000563
traceable to USP 1029002

API family

amitriptyline

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

Quality Level

300

Gene Information

human ... SLC6A2(6530), SLC6A4(6532)

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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.
To see an example of a Certificate of Analysis for this material enter LRAA1640 in the slot below. This is an example certificate only and may not be the lot that you receive.

Analysis Note

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

Application

Amitriptyline hydrochloride may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using spectrophotometric technique and reversed-phase high-performance liquid 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.

Biochem/physiol Actions

Tricyclic antidepressant; inhibits the norepinephrine and serotonin transporters with Kis of 100 nM and 14.7 nM, respectively; high in vitro affinity for α1-adrenoceptors, serotonin and muscarinic acetylcholine receptors.
Tricyclic antidepressant; norepinephrine and serotonin transporter inhibitor; high in vitro affinity for α1-adrenoceptors, serotonin and muscarinic acetylcholine receptors.

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. Amitriptyline hydrochloride is a drug, and a tricyclic antidepressant with anticholinergic activity. It is widely used in combination with chlordiazepoxide 7-chloro-2-(methyl-amino)-5-phenyl-3H-1,4-benzodiazepine-4-oxide for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

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Danger

Hazard Classifications

Acute Tox. 3 Oral - Aquatic Acute 1 - Aquatic Chronic 1 - Eye Irrit. 2 - Repr. 2

Storage Class

6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects

wgk

WGK 3

flash_point_f

Not applicable

flash_point_c

Not applicable

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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Spectrophotometric and chromatographic simultaneous estimation of amitriptyline hydrochloride and chlordiazepoxide in tablet dosage forms
Patel S, et al.
Indian Journal of Pharmaceutical Sciences, 71(4), 472-472 (2009)
Simultaneous spectrophotometric determination of amitriptyline hydrochloride and chlordiazepoxide in pharmaceutical tablets by multivariate calibration method
Sarrafi MHA, et al.
Journal of Chemistry, 6(S1), S111-S116 (2009)
Ming Yang et al.
Aquatic toxicology (Amsterdam, Netherlands), 151, 68-76 (2014-01-23)
Amitriptyline is a tricyclic antidepressant used for decades. It is present at low detectable concentrations in the aquatic environment, but relative few studies have focused on its ecotoxicological effects on non-target aquatic animals. The present study conducted an acute toxicity
Katja Kovacic et al.
The Journal of pediatrics, 164(5), 1104-1109 (2014-03-13)
To compare children with primary, chronic idiopathic nausea to those with secondary nausea associated with functional abdominal pain. Retrospective chart review of 45 children with a primary complaint of chronic nausea several times per week. Comparisons were made to prospectively
Mariola Herbet et al.
Acta poloniae pharmaceutica, 70(5), 913-917 (2013-10-24)
The aim of the present study was to assess the impact of combined therapy with rosuvastatin (10 mg/kg) and amitriptyline (10 mg/kg) on oxidation-reduction status in the blood of rats. After 2-week application of drugs alone or their combination, the
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