Product Name: Citalopram Hydrobromide
Batch NO.:20161015
Report Date :20161016
Perform Standard: USP36
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
Identification:HPLC
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%
Residual solvents
Acetone
undetected
Toluene
Ethanol NMT 0.5%
0.03%
Acetic acid
0.09%
2-Methyltetrahydrofuran
Benzene NMT 0.0002%
Related substance
Related Compound A Not more than 0.10%
0.01%
Related Compound B Not more than 0.10%
Related Compound C Not more than 0.10%
Related Compound D Not more than 0.10%
Related Compound E Not more than 0.10%
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%.
4-[4-Dimethylamino-1-(4’-fluorophenyl)-1-hydroxy-
1-butyl]-3- hydroxymethylbenzonitrile
NMT 0.10%.
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
Exam: 劉麗君 Analyst :張曉蕓 Checker: 孫新然
濟南健豐化工有限公司
聯(lián)系商家時請?zhí)峒癱hemicalbook,有助于交易順利完成!
濟南健豐