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

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 16; 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)

Description

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 K_is 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.

Footnote

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.

Safety Information

• Pictograms: GHS06,GHS08,GHS09
• Signal Word: Danger
• Hazard Statements: H301 - H319 - H361fd - H410
• Precautionary Statements: P202 - P264 - P273 - P280 - P301 + P310 - P305 + P351 + P338
• 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
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable