氢溴酸西酞普兰

TEST

Specification

Result of analysis

Appearance

White or almost white crystalline power

almost white crystalline power

Completeness of solution

NMT 0.040

0.012

Identification:

Infrared Absorption

Conforms to spectrum of Citalopram hydrobromide RS

Conforms to spectrum of Citalopram hydrobromide RS

Identification:HPLC

The retention time of the major peak of sample solutions conforms to that of Citalopram hydrobromide RS

The retention time of the major peak of sample solutions conforms to that of Citalopram hydrobromide RS

Identification: Bromide

It responds to the tests for Bromide

Complies

Specific rotation

Between -0.20°~+0.20°(at 20℃)

-0.08°(20℃)

PH

Between 5.5~6.5

6.2

Water

NMT 0.5%

0.3%

Residues on ignition

NMT 0.1%

0.02%

Heavy metals

NMT 0.002%

Complies

Residual solvents

Acetone

undetected

Toluene

undetected

Ethanol NMT 0.5%

0.03%

Acetic acid

0.09%

2-Methyltetrahydrofuran

undetected

Benzene NMT 0.0002%

undetected

Related substance

Related Compound A Not more than 0.10%

0.01%

Related Compound B Not more than 0.10%

undetected

Related Compound C Not more than 0.10%

0.01%

Related Compound D Not more than 0.10%

undetected

Related Compound E Not more than 0.10%

undetected

Single unknown Impurity Not more than 0.10%

RRT =0.56:0.01%

RRT =0.60:0.01%

RRT =0.81:0.01%

1-(3-Dimethylaminopropyl)-1-(4’-fluorophenyl)-5-

(4-dimethylaminobutyryl)-1,3-dihydrobenzofuran NMT 0.10%.

undetected

4-[4-Dimethylamino-1-(4’-fluorophenyl)-1-hydroxy-

1-butyl]-3- hydroxymethylbenzonitrile  

NMT 0.10%.

undetected

Total Impurity Not more than 0.5%

0.06%

Assay

98.0~102.0% calculated on anhydrous basis

101.4%

Conclusion: The above material complies with USP 36