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Cefprozil Monohydrate EP Impurity I is chemically (2R)-2-[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino-2-[(2R)-4-carboxy-5-[(1E)-prop-1-enyl]-3,6-dihydro-2H-1,3-thiazin-2-yl]-acetic acid (as per EP);
(R)-2-{(R)-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido](carboxy)methyl}-5-[(E)-prop-1-enyl]-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (as per USP)
.
It is also known as E-Cefprozil open ring.
Cefprozil Monohydrate EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Cefprozil Monohydrate EP Impurity I 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 Cefprozil Monohydrate.

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