Equilife Laboratories Private Limited

Erythromycin EP Impurity N is chemically (3R,4S,5S,6R,7R,9R,11R,12S,13R,14R)-14-ethyl-4,6,7,12-tetrahydroxy-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (as per EP). It is also known as Erythronolide B (EP). Erythromycin EP Impurity N is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity N 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 Erythromycin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility

Erythromycin EP Impurity M is chemically (3R,4S,5S,6R,7R,9R,11R,12S,13R,14R)-6-(((2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyltetrahydro-2H-pyran-2-yl)oxy)-14-ethyl-7,12-dihydroxy-4-(((2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3-(hydroxymethyl)-5,7,9,11,13-pentamethyloxacyclotetradecane-2,10-dione. It is also known as Erythromycin G (EP). Erythromycin EP Impurity M is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity 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 Erythromycin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility

Erythromycin EP Impurity L is chemically (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(formylmethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (as per EP). It is also known as 3″-N-demethyl-3″-N-formylerythromycin A (EP) ; N-Demethyl-N-formylerythromycin. Erythromycin EP Impurity L is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity L 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 Erythromycin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility.