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Amitriptyline hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a,d]cycloheptane-Δ5γ-propylamine hydrochloride, Amitriptyline hydrochloride, 3-(10,11-Dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine
Empirical Formula (Hill Notation):
C20H23N · HCl
CAS Number:
Molecular Weight:
EC Number:
MDL number:
PubChem Substance ID:

Quality Level


certified reference material
pharmaceutical secondary standard


current certificate can be downloaded


HPLC: suitable
gas chromatography (GC): suitable


pharmaceutical (small molecule)



pharmacopeia traceability

traceable to BP 16
traceable to PhEur Y0000563
traceable to USP 1029002

storage temp.


SMILES string




InChI key


Gene Information

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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. 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.


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.
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.

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.

Analysis Note

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


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.

Signal Word


Hazard Classifications

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

Storage Class Code

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



Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
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
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
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


HPLC Analysis of Tricyclic Antidepressants on Ascentis® Express 2.7 μm RP-Amide

-isomer basis, ≥98% (GC), 15% Z-isomer basis, powder; Norclomipramine hydrochloride, ~99% (TLC), powder; Imipramine hydrochloride solution, drug standard, 1.0 mg/mL in methanol; Amitriptyline hydrochloride, ≥98% (TLC), powder; Clomipramine hydrochloride, ≥98% (HPLC), powder

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