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Key Documents

PHR1797

Supelco

Imipramine Hydrochloride

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Imipramine hydrochloride, IMI, 10,11-Dihydro-N,N-dimethyl-5H-dibenz[b,f]azepine-5-propanamine hydrochloride, 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine hydrochloride

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About This Item

Empirical Formula (Hill Notation):
C19H24N2 · HCl
CAS Number:
Molecular Weight:
316.87
EC Number:
MDL number:
UNSPSC Code:
41116107
PubChem Substance ID:
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

Agency

traceable to BP 932
traceable to Ph. Eur. I0100000
traceable to USP 1338007

API family

imipramine

CofA

current certificate can be downloaded

packaging

pkg of 1 g

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)CCCN1c2ccccc2CCc3ccccc13

InChI

1S/C19H24N2.ClH/c1-20(2)14-7-15-21-18-10-5-3-8-16(18)12-13-17-9-4-6-11-19(17)21;/h3-6,8-11H,7,12-15H2,1-2H3;1H

InChI key

XZZXIYZZBJDEEP-UHFFFAOYSA-N

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.
Imipramine Hydrochloride is typically utilized for the treatment of depressive disorders due to its efficiency in uplifting the patients′ mood by interfering in the reuptake of norepinephrine or serotonin.

Application

Imipramine Hydrochloride may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations by chromatography and spectrophotometry techniques.
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 serotonin and norepinephrine transporters with Kis of 7.7 nM and 67 nM, respectively. Has little effect on the dopamine transporter (Ki = 25 μM).

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 LRAA8623 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictograms

Skull and crossbones

Signal Word

Danger

Hazard Statements

Hazard Classifications

Acute Tox. 2 Oral

Storage Class Code

6.1A - Combustible acute toxic Cat. 1 and 2 / very toxic hazardous materials

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable


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Second-order derivative spectrophotometric assay for imipramine hydrochloride and diazepam in pure admixtures and in dosage forms.
Umapathi P and Parimoo P
Journal of Pharmaceutical and Biomedical Analysis, 13(8), 1003-1009 (1995)
Application of two chemometric methods for the determination of imipramine, amitriptyline and perphenazine in content uniformity and drug dissolution studies.
Markopoulou CK, et al.
Journal of Pharmaceutical and Biomedical Analysis, 37(2), 249-258 (2005)
Simultaneous determination of imipramine hydrochloride and chlordiazepoxide in pharmaceutical preparations by spectrophotometric, RP-HPLC, and HPTLC methods.
Patel SK and Patel NJ
Journal of AOAC (Association of Official Analytical Chemists) International, 93(3), 904-910 (2010)
Simultaneous spectrophotometric estimation of imipramine hydrochloride and chlordiazepoxide in tablets.
Patel S, et al.
Indian Journal of Pharmaceutical Sciences, 71(4), 468-468 (2009)

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