Determination of Weight Average Molecular Weight and Molecular Weight Distribution of Ferric Carboxy-maltose by HPGPC / 中国药房
China Pharmacy
; (12): 3066-3068, 2016.
Article
in Chinese
| WPRIM (Western Pacific)
| ID: wpr-504859
Responsible library:
WPRO
ABSTRACT
OBJECTIVE:
To establish a method for the determination of weight average molecular weight(Mw)and molecular weight distribution (D) of ferric carboxymaltose.METHODS:
HPGPC method was adopted to detect the Mw and D of 3 batches of Ferric carboxymaltose injection (imported) and its raw material (self-made). The determination was performed on TSK G4000 PWXL column with 0.1% sodium azide solution with the flow rate of 0.5 ml/min. The detector was refractive index detector;the column temperature was set at 35 ℃,and sample size was 20 μl. The results were calculated with GPC software.RESULTS:
RSDs of precision,stability and reproducibility tests were all lower than 3.0%(n=6);Mw and D of 3 imported samples were 157 667 and 1.30;those of self-made samples were 162 000 and 1.42.CONCLUSIONS:
The method has high precision,good stability,repeat-ability and durability. It can be used for the determination of Mw and D of ferric carboxymaltose.
Full text:
Available
Database:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2016
Document type:
Article