Equilife Laboratories Private Limited

Azithromycin EP Impurity B is chemically 3-Deoxyazithromycin (as per EP & USP) ; (2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl4,10-dihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa6-azacyclopentadecan-15-one (as per USP). It is also known as Azithromycin B (EP & USP). Azithromycin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Azithromycin 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 Azithromycin.

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

Chemical Name: 3-Deoxyazithromycin (as per EP & USP) ; (2R,3R,4S,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl4,10-dihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa6-azacyclopentadecan-15-one (as per USP)

 

Synonym: Azithromycin B

Erythromycin EP Impurity E is chemically (2R,3R,4S,5R,8R,9S,10S,11R,12R)-9-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-5-ethyl-3,4-dihydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-6,15-dioxabicyclo[10.2.1]pentadec-1(14)-en-7-one (as per EP). It is also known as Erythromycin A Enol ether (EP). Erythromycin EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity E 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

Azithromycin EP Impurity C is chemically 3″-O-demethylazithromycin (as per EP & USP) ; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one (as per USP). It is also known as Azithromycin C (EP & USP). Azithromycin EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Azithromycin 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 Azithromycin.

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

Chemical Name: 3″-O-demethylazithromycin (as per EP & USP) ; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14- heptamethyl-11-[[3,4,6-trideoxy-3-dimethylamino-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one (as per USP)

 

Synonym: Azithromycin C (EP & USP

Azithromycin EP Impurity E is chemically 3′-(N,N-didemethyl)azithromycin (as per EP & USP) ; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-amino-3,4,6-trideoxy-β-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one (as per USP). It is also known as Amino Azithromycin (EP & USP). Azithromycin EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Azithromycin EP Impurity E 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 Azithromycin.

Chemical Name: 3′-(N,N-didemethyl)azithromycin (as per EP & USP) ; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3-amino-3,4,6-trideoxy-β-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one (as per USP)

Synonym: Amino Azithromycin (EP & USP)

Erythromycin EP Impurity C is chemically (2S,4aR,4′R,5′S,6′S,7R,8S,9R,10R,12R,14R,15R,16S,16aS)-7-ethyl-5′,8,9,14-tetrahydroxy-4′-methoxy-4′,6′,8,10,12,14,16-heptamethyl-15-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]hexadecahydrospiro[5H,11H-1,3-dioxino[5,4-c]oxacyclotetradecin-2,2′-pyrane]-5,11-dione (as per EP). It is also known as Erythromycin E (EP). Erythromycin EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin 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 Erythromycin.

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

Azithromycin EP Impurity G is chemically 3′-N-demethyl-3′-N-[(4-methylphenyl)sulfonyl]azithromycin (as per EP & USP) ; N-((2S,4S,6R)-2-(((2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-(((2R,4R,5S,6S)-5-hydroxy-4- methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-3,5,6,8,10,12,14-heptamethyl-15-oxo-1-oxa-6-azacyclopentadecan11-yl)oxy)-3-hydroxy-6-methyltetrahydro-2H-pyran-4-yl)-N,4-dimethylbenzenesulfonamide (as per USP). Azithromycin EP Impurity G is supplied with detailed characterization data compliant with regulatory guideline. Azithromycin EP Impurity G 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 Azithromycin.

The product can be used as reference standards and further traceability against pharmacopeial standards 

Erythromycin EP Impurity H 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-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione N-oxide (as per EP). It is also known as erythromycin A 3″-N-oxide (EP) ; Erythromycin A N-oxide. Erythromycin EP Impurity H is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity H 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.

Chemical Name: (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-(hydroxymethyl)-5,7,9,11,13-pentamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (as per EP)

Synonym: Erythromycin F (EP) ; 16-Hydroxyerythromycin

Erythromycin EP Impurity A 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-(hydroxymethyl)-5,7,9,11,13-pentamethyl-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 F (EP) ; 16-Hydroxyerythromycin. Erythromycin EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity A 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

Chemical Name: (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-(methylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (as per EP); (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-Ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-6-{[(2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (as per USP)

Synonym: Erythromycin USP Related Compound N ; 3″-N-Desmethylerythromycin A (EP) ; N-Demethylerythromycin A

Erythromycin EP Impurity B 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-(methylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione (as per EP); (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-14-Ethyl-7,12,13-trihydroxy-4-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl]oxy}-6-{[(2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl]oxy}-3,5,7,9,11,13-hexamethyloxacyclotetradecane-2,10-dione (as per USP). It is also known as Erythromycin USP Related Compound N ; 3″-N-Desmethylerythromycin A (EP) ; N-Demethylerythromycin A. Erythromycin EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin 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 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 I is chemically (1S,4S,5R,8R,9S,10S,11R,12R,14R)-5-ethyl-9-hydroxy-2,4,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-6,15,16-trioxatricyclo[10.2.1.11,4]hexadec-2-en-7-one (as per EP). It is also known as Erythralosamine (EP). Erythromycin EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin 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 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 F is chemically (15R,2R,3R,6R,7S,8S,9R)-7-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-3-[(2R,3R)-2,3-dihydroxypentan-2-yl]-13,15,2,6,8-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-14,15-dihydro-4-oxa-1(2,5)-furanacyclononaphan-5-one (as per EP). It is also known as pseudoerythromycin A enol ether (EP). Erythromycin EP Impurity F is supplied with detailed characterization data compliant with regulatory guideline. Erythromycin EP Impurity F 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

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 E is chemically 9,11-[imino(1-methylethylidene)oxy]-9-deoxo-11-deoxyerythromycin. Dirithromycin EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Dirithromycin EP Impurity E 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.

Dirithromycin EP Impurity D is chemically (9S)-9,11-[imino[(1RS)-2-(2-methoxyethoxy)ethylidene]oxy]-3′-O-demethyl-9-deoxo-11-deoxyerythromycin. It is also known as dirithromycin C. Dirithromycin EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Dirithromycin EP Impurity D 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.

• (E)-17-allyl-2, 14-dihydroxy-12-[(E)-2-(4-hydroxy-3-methoxycyclohexy)-1-methylvinyl]-23, 28-dimethoxy-1, 13, 19, 21-tetramethyl-11, 25-dioxa-4-azatricyclo[22.3.1.04.9]-octacos-18-ene-3, 10, 16, 26-tetrone

Tacrolimus Impurity VII is chemically known as (E)-17-allyl-2, 14-dihydroxy-12-[(E)-2-(4-hydroxy-3-methoxycyclohexy)-1-methylvinyl]-23, 28-dimethoxy-1, 13, 19, 21-tetramethyl-11, 25-dioxa-4-azatricyclo[22.3.1.04.9]-octacos-18-ene-3, 10, 16, 26-tetrone.

Tacrolimus Impurity VII 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.


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Clarithromycin EP impurity M is identified by CAS No. 127182-43-8 and is chemically known as (3R,4S,5S,6R,7R,9R,11S,12R,13S,14R,Z)-14-ethyl-12,13-dihydroxy-4-(((2R,4S,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-6-(((2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-10-(hydroxyimino)-7-methoxy-3,5,7,9,11,13-hexamethyl2-one ; Clarithromycin 9-Oxime..

Clarithromycin EP impurity M 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 Clarithromycin.


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(3R,4S,5S,6R,7R,9R,11S,12R,13S,14R,Z)-14-ethyl-12,13-dihydroxy-4-(((2R,4S,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyltetrahydro-2H-pyran-2-yl)oxy)-6-(((2S,3R,4S,6R)-3-hydroxy-6-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-10-(hydroxyimino)-7-methoxy-3,5,7,9,11,13-hexamethyl2-one ; Clarithromycin 9-Oxime.