Identification, synthesis, isolation and characterization of new impurity in metoprolol tartrate tablets.
A new unknown impurity was observed in accelerated stability studies of Metoprolol tartrate tablets. This impurity has been identified, synthesized and characterized through different spectral studies and confirmed as an adduct of lactose and Metoprolol formed by Maillard reaction.
Ipca Laboratories Ltd., Chemical Research Division, Kandivali Industrial Estate, Kandivali (W). Mumbai 400067, India.
R Buchi
RB
Reddy
Ipca Laboratories Ltd., Chemical Research Division, Kandivali Industrial Estate, Kandivali (W). Mumbai 400067, India. Electronic address: kishor.more@ipca.com.
Kishor R
KR
More
Ipca Laboratories Ltd., Chemical Research Division, Kandivali Industrial Estate, Kandivali (W). Mumbai 400067, India.
Leena
L
Gupta
Ipca Laboratories Ltd., Chemical Research Division, Kandivali Industrial Estate, Kandivali (W). Mumbai 400067, India.
Mukesh S
MS
Jha
Ipca Laboratories Ltd., Chemical Research Division, Kandivali Industrial Estate, Kandivali (W). Mumbai 400067, India.
Laki
L
Magar
D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D008790:Metoprolol / Q000138:chemical synthesis* / Q000302:isolation & purification*; D013607:Tablets
D013607:Tablets; D008790:Metoprolol
Amadori rearrangement; Lactose; Maillard; Metoprolol; Stability