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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
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Quality Level

300

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

SMILES string

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

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

InChI key

KFYRPLNVJVHZGT-UHFFFAOYSA-N

Gene Information

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

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.

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.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) 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.
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.

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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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Articles

LC-MS Analysis of Serum for a Wide Analyte Range Using a Novel HLB SPE Phase

Analysis of 20 pharmaceutical compounds in calf serum using Supel™ Swift HLB SPE cartridge for cleanup and LC-MS determination and another commercially available HLB cartridge for comparison.

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默克Supelco®标准物质不断推出或更新满足海关及法规要求的标准物质。每年我们约有上百种的新CRM或标准物质上市，在此我们尽可能多的列出满足海关及法规要求的标准物质。

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)
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)
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
View All Related Papers

Global Trade Item Number

SKUGTIN
PHR1384-1G04061835233885