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N-Nitroso Desethyl Dicycloverine
Fesoterodine Related Impurity 4
Fesoterodine Related Impurity 7 HCl
Vibegron
Lumacaftor Impurity 2
Vibegron Impurity 10
Carteolol EP Impurity F
[13C7]-Luliconazole
Tucatinib Impurity 2
Fulvestrant Impurity 17
Bifonazole EP Impurity E
Clotrimazole Impurity 6
Fesoterodine Related Impurity 9
Title N-Nitroso Desethyl Dicycloverine Fesoterodine Related Impurity 4 Fesoterodine Related Impurity 7 HCl Vibegron Lumacaftor Impurity 2 Vibegron Impurity 10 Carteolol EP Impurity F [13C7]-Luliconazole Tucatinib Impurity 2 Fulvestrant Impurity 17 Bifonazole EP Impurity E Clotrimazole Impurity 6 Fesoterodine Related Impurity 9
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Description

N-Nitroso Desethyl Dicycloverine is chemically 2-(Ethyl(nitroso)amino)ethyl [1,1′-bi(cyclohexane)]-1-carboxylate.
It is also known as N-Nitroso Desethyl Dicyclomine.
N-Nitroso Desethyl Dicycloverine is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Desethyl Dicycloverine 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 Dicycloverine.

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.

Fesoterodine Related Impurity 4 is chemically (S)-3-(3-(Diisopropylamino)-1-phenylpropyl)-4-hydroxybenzaldehyde.
Fesoterodine Related Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Fesoterodine Related Impurity 4 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 Fesoterodine.

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.

Fesoterodine Related Impurity 7 HCl is chemically 2-((S)-3-(Diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate hydrochloride.
Fesoterodine Related Impurity 7 HCl is supplied with detailed characterization data compliant with regulatory guideline. Fesoterodine Related Impurity 7 HCl 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 Fesoterodine.

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.

Vibegron is chemically (S)-N-(4-(((2S,5R)-5-((R)-Hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide.
Vibegron is supplied with detailed characterization data compliant with regulatory guideline. Vibegron 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 Vibegron.

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.

Lumacaftor Impurity 2is chemically (Z)-3-(6-(2-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)but-2-enamido)-3-methylpyridin-2-yl)benzoic acid. Lumacaftor Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Lumacaftor Impurity 2 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 Lumacaftor.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.

Vibegron Impurity 10 is chemically (1S,2R)-2-amino-6-(4-nitrophenyl)-1-phenylhex-5-yn-1-ol hydrochloride.
Vibegron Impurity 10 is supplied with detailed characterization data compliant with regulatory guideline. Vibegron Impurity 10 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 Vibegron.

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.

Carteolol EP Impurity F is chemically 5-[(2RS)-2-Hydroxy-3-methoxypropoxy]-3,4-dihydroquinolin-2(1H)-one (as per EP).
Carteolol EP Impurity F is supplied with detailed characterization data compliant with regulatory guideline. Carteolol 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 Carteolol.

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.

[13C7]-Luliconazole is chemically (R,E)-2-(4-(2,4-dichlorophenyl-1,2,3,4,5,6-13C6)-1,3-dithiolan-2-ylidene-4-13C)-2-(1H-imidazol-1-yl)acetonitrile.
[13C7]-Luliconazole is supplied with detailed characterization data compliant with regulatory guideline. [13C7]-Luliconazole 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 Luliconazole.

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.

Tucatinib Impurity 2 is chemically 3-(4-Chloro-2-fluorobenzyl)-2-methyl-N-(5-methyl-1H-pyrazol-3-yl)-8-(morpholinomethyl)imidazo[1,2-b]pyridazin-6-amine. It is also known as Gandotinib. Tucatinib Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Tucatinib Impurity 2 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 Tucatinib.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.

Fulvestrant Impurity 17 is chemically (8R,9S,10R,13S,14S,17R)-13-methyl-3-oxo-2,3,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate.
Fulvestrant Impurity 17 is supplied with detailed characterization data compliant with regulatory guideline. Fulvestrant Impurity 17 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 Fulvestrant.

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.

Bifonazole EP Impurity E is chemically 1,4-Bis[(biphenyl-4-yl)phenylmethyl]-1H-imidazole (as per EP).
Bifonazole EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Bifonazole 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 Bifonazole.

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.

Clotrimazole Impurity 6 is chemically 2-(2-Chlorophenyl)-2,2-diphenylethan-1-ol.
Clotrimazole Impurity 6 is supplied with detailed characterization data compliant with regulatory guideline. Clotrimazole Impurity 6 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 Clotrimazole.

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.

Fesoterodine Related Impurity 9 is chemically (R)-2-(3-(Diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate.
Fesoterodine Related Impurity 9 is supplied with detailed characterization data compliant with regulatory guideline. Fesoterodine Related Impurity 9 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 Fesoterodine.

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.

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CAS No   2765390-15-4   1190389-15-1     2748462-60-2   1229236-86-5 66263-02-3 2469554-07-0   1208313-16-9
Inv. Status Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis In Stock
Mol.F. C17H30N2O3 C22H29NO2 C27H39NO3 : HCl C26H28N4O3 C24H18F2N2O5 C18H18N2O3 : HCl C13H17NO4 C713C7H9Cl2N3S2 C23H25ClFN7O C20H26O3 C41H32N2 C20H17ClO C25H35NO3
ISP CAT No   ISP-F002021 ISP-F002022 ISP-V042001 ISP-L117006 ISP-V042011   ISP-L047D01 ISP-T107003 ISP-F004041 ISP-B079006   ISP-F002024
Mol.Wt. 310.4 339.5 425.6 : 36.5 444.5 452.4 310.4 : 36.5 251.3 361.2 469.9 314.4 552.7 308.8 397.6