Amoxicillin USP Related Compound M

Chromatographic determination of high-molecular weight impurities in amoxicillin
CaiShan-YingHuChang-QinXuMing-Zhe
Journal of Pharmaceutical and Biomedical Analysis
Volume 31, Issue 3, 10 March 2003, Pages 589-596
 
Development and analytical validation of a multivariate calibration method for determination of amoxicillin in suspension formulations by near infrared spectroscopy
Maurício A.M.SilvaaMarcus H.FerreiraabJez W.B.BragaceMarcelo M.Senaade Talanta
Volume 89, 30 January 2012, Pages 342-351
 
Synthesis and Characterization of Potential Impurity in Amoxicillin
Panghal S
M.M. College of Pharmacy, Maharishi Markandeshwer University, Mullana, Ambala, Haryana, India.
Singh R
Satiate Research and Anatech Pvt. Ltd., HSIIDC, Barwala, Panchkula-134118, Haryana, India.
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE
Published By: Yashwant Labs Pvt. Ltd
Vol. 6 No. 01 (2015): International Journal of Pharmaceutical Quality Assurance

Amoxicillin USP Related Compound M is chemically (2S,5R,6R)-6-(2-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-2-((4S)-4-carboxy-5,5-dimethylthiazolidin-2-yl)acetamido)-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid (as per USP). It is also known as N-(penicillan-6-yl) Open Ring Amoxicillinamide (USP). Amoxicillin USP Related Compound M is supplied with detailed characterization data compliant with regulatory guideline. Amoxicillin USP Related Compound M 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 Amoxicillin.

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.