Meropenem EP impurity B

Chromatographic determination of polymerized impurities in meropenem
Shan-Ying Cai1, Chang-Qin Hu
Journal of Pharmaceutical and Biomedical Analysis 37 (2005) 585–589
 
Determination of Meropenem by Capillary Electrophoresis Using Direct Injection of Serum
Toshihiro Kitahashi, Itaru Furuta
Journal of Chromatographic Science, Volume 43, Issue 8, September 2005, Pages 430–433
 
Development of quantitative method for analysis of Meropenem and Amoxycillin by RP-HPLC method
Nitin Deshmukh*, Rachna Patel, Prabhat K. Das
pharmaceutical and biological evaluations August 2016; vol. 3 (Issue 4): 431-436.

Meropenem EP impurity B is chemically (4R,5S,6S)-3-[[(3S,5S)-1-[(2S,3R)-2-[(2S,3R)-5-carboxy-4-[[(3S,5S)-5-[(dimethylamino)carbonyl]pyrrolidin-3-yl]sulfanyl]-3-methyl-2,3-dihydro-1H-pyrrol-2-yl]-3-hydroxybutanoyl]-5-[(dimethylamino)carbonyl]pyrrolidin-3-yl]sulfanyl]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid (as per EP). Meropenem EP impurity B is supplied with detailed characterization data compliant with regulatory guideline. Meropenem EP impurity B can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Meropenem.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.