Equilife Laboratories Private Limited

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

Clarithromycin EP Impurity K  is chemically (1S,2R,5R,6S,7S,8R,9R,11Z)-2-ethyl-6-hydroxy-9-methoxy-1,5,7,9,11,13-hexamethyl-8-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-3,15-dioxabicyclo[10.2.1]pentadeca-11,13-dien-4-one (3-O-decladinosyl-8,9:10,11-dianhydro-6-O-methylerythromycin A-9,12-hemiketal) (as per EP). Clarithromycin EP Impurity K  is supplied with detailed characterization data compliant with regulatory guideline. Clarithromycin EP Impurity K  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 Clarithromycin.

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

Fosfomycin Trometamol EP Impurity C is chemically 2-Amino-3-hydroxy-2-(hydroxymethyl)propyl dihydrogen phosphate. Fosfomycin Trometamol EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Fosfomycin Trometamol EP Impurity C 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 Fosfomycin.

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

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

It is a metabolite of Tacrolimus, Tacrolimus causes immunosuppression, through inhibition of the calcineurin-NFAT pathway.

Tacrolimus Impurity 8 is chemically (2R,4S,5R,6S,8S,10E,12R,15S,16R,17S,18E)-12-allyl-17-((1-(2-ethoxy-2-oxoacetyl)piperidine-2-carbonyl)oxy)-5,15-dihydroxy-19-((3R,4R)-4-hydroxy-3-methoxycyclohexyl)-4,6-dimethoxy-2,8,10,16,18-pentamethyl-13-oxononadeca-10,18-dienoic acid. Tacrolimus Impurity 8 is supplied with detailed characterization data compliant with regulatory guideline. Tacrolimus Impurity 8 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 Tacrolimus.

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

Dirithromycin EP Impurity C is chemically (9S)-9,11-[imino[(1RS)-2-(2-methoxyethoxy)ethylidene]oxy]-9-deoxo-11,12-dideoxyerythromycin . It is also known as Dirithromycin B. Dirithromycin EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Dirithromycin EP Impurity C 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 Dirithromycin.

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

Clarithromycin EP Impurity J  is chemically Erythromycin A (E)-9-oxime (as per EP). It is also known as Erythromycin A Oxime ;Roxithromycin Impurity C ;Erythromycin A (E)-9-oxime ;. Clarithromycin EP Impurity J  is supplied with detailed characterization data compliant with regulatory guideline. Clarithromycin EP Impurity J  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 Clarithromycin.

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

Tacrolimus Ring-opening Impurity is identified by CAS No. 1393890-33-9 and is chemically known as Tacrolimus Ring-opening Impurity.

Tacrolimus Ring-opening Impurity is provided with comprehensive characterization data in accordance with regulatory guidelines. It is suitable for use in analytical method development, method validation (AMV), Quality Control (QC) applications for Abbreviated New Drug Applications (ANDA) and commercial production of Tacrolimus. 

Tacrolimus Open Ring Impurity (USP) is chemically (3S,4R,5S,8R,12S,14S,15R,16S,18R,26aS,E)-8-Allyl-5,6,11,12,13,14,15,16,17,18,24,25,26,26a-tetradecahydro-5,15,20,20-tetrahydroxy-3-{(E)-2-[1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]- 1-methylvinyl}-14,16-dimethoxy-4,10,12,18-tetramethyl-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,19,21(4H,8H,20H,23H)-tetrone (as per USP). Tacrolimus Open Ring Impurity (USP) is supplied with detailed characterization data compliant with regulatory guideline. Tacrolimus Open Ring Impurity (USP) 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 Tacrolimus.

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



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