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Brexpiprazole Impurity 43
Fluprednidene Acetate Impurity 5
Chlorambucil EP Impurity F
Dronedarone-D6
Ulipristal Acetate 17-Beta Isomer
Mebeverine EP Impurity N
Urapidil Impurity 11
7,8-Dihydropterin
Phenylalanine EP Impurity D
Balsalazide USP Impurity 3
Moxifloxacin Nitroso Impurity 12
Umifenovir Impurity 2
Difamilast Impurity 3
Mometasone Impurity 2
Title Brexpiprazole Impurity 43 Fluprednidene Acetate Impurity 5 Chlorambucil EP Impurity F Dronedarone-D6 Ulipristal Acetate 17-Beta Isomer Mebeverine EP Impurity N Urapidil Impurity 11 7,8-Dihydropterin Phenylalanine EP Impurity D Balsalazide USP Impurity 3 Moxifloxacin Nitroso Impurity 12 Umifenovir Impurity 2 Difamilast Impurity 3 Mometasone Impurity 2
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Description

Brexpiprazole Impurity 43 is chemically 7-(4-Bromobutoxy)-1-[4-[(2-oxo-1H-quinolin-7-yl)oxy] butyl]quinolin-2-one.
Brexpiprazole Impurity 43 is supplied with detailed characterization data compliant with regulatory guideline. Brexpiprazole Impurity 43 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 Brexpiprazole.

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.

Fluprednidene Acetate Impurity 5 is chemically 2-((8S,9R,10S,13S,14S,16R,17R)-17-acetoxy-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoethyl acetate.
Fluprednidene Acetate Impurity 5 is supplied with detailed characterization data compliant with regulatory guideline. Fluprednidene Acetate Impurity 5 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 Fluprednidene Acetate.

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.

Chlorambucil EP Impurity F is chemically 4-[4-[[2-[[4-[4-[[2-[[4-[4-[bis(2-chloroethyl)amino]phenyl]butanoyl]oxy]ethyl](2-chloroethyl)amino]phenyl]butanoyl]oxy]ethyl](2-chloroethyl)amino]phenyl]butanoic acid (as per EP).
Chlorambucil EP Impurity F is supplied with detailed characterization data compliant with regulatory guideline. Chlorambucil 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 Chlorambucil.

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.

Dronedarone-D6 is chemically N-(2-Butyl-3-(4-(3-(dibutylamino)propoxy-1,1,2,2,3,3-d6)benzoyl)benzofuran-5-yl)methanesulfonamide.
Dronedarone-D6 is supplied with detailed characterization data compliant with regulatory guideline. Dronedarone-D6 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 Dronedarone Hydrochloride.

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.

Ulipristal Acetate 17-Beta Isomer is chemically (8S,11R,13S,14S,17S)-17-Acetyl-11-(4-(dimethylamino)phenyl)-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate.
Ulipristal Acetate 17-Beta Isomer is supplied with detailed characterization data compliant with regulatory guideline. Ulipristal Acetate 17-Beta Isomer 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 Ulipristal.

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.

Mebeverine EP Impurity N is chemically 4-[Ethyl[(2RS)-1-(4-methoxyphenyl)propan-2-yl]amino]butyl 2-chloro-4,5-dimethoxybenzoate (as per EP).
Mebeverine EP Impurity N is supplied with detailed characterization data compliant with regulatory guideline. Mebeverine 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 Mebeverine.

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.

Urapidil Impurity 11 is chemically N1-(2-((2-Methoxyphenyl)amino)ethyl)propane-1,3-diamine.
Urapidil Impurity 11 is supplied with detailed characterization data compliant with regulatory guideline. Urapidil Impurity 11 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 Urapidil .

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.

7,8-Dihydropterin is chemically 2-Amino-7,8-dihydropteridin-4(3H)-one.
7,8-Dihydropterin is supplied with detailed characterization data compliant with regulatory guideline. 7,8-Dihydropterin 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 Sapropterin .

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.

Phenylalanine EP Impurity D is chemically (2S)-2-amino-3-methylbutanoic acid.
It is also known as Valine (EP) ; L-Valine (USP).
Phenylalanine EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Phenylalanine 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 Phenylalanine.

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.

Balsalazide USP Impurity 3 is chemically 5-((E)-(4-((2-Carboxyethyl)carbamoyl)-2-((E)-(4-((2-carboxyethyl)carbamoyl)phenyl)diazenyl)phenyl)diazenyl)-2-hydroxybenzoic acid.
Balsalazide USP Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Balsalazide USP Impurity 3 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 Balsalazide.

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.

Moxifloxacin Nitroso Impurity 12 is chemically Methyl 1-cyclopropyl-6-fluoro-8-hydroxy-7-((4aS,7aS)-1-nitrosooctahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate.
Moxifloxacin Nitroso Impurity 12 is supplied with detailed characterization data compliant with regulatory guideline. Moxifloxacin Nitroso Impurity 12 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 Moxifloxacin.

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.

Umifenovir Impurity 2 is chemically Ethyl 6,7-dibromo-4-((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate.
Umifenovir Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Umifenovir 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 Umifenovir.

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.

Difamilast Impurity 3 is chemically 3,4-Diisopropoxybenzamide.
Difamilast Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Difamilast Impurity 3 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 Difamilast.

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.

Mometasone Impurity 2 is chemically (8S,9R,10S,13S,14S,16R,17R)-9-Chloro-17-(2-chloroacetyl)-10,13,16-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl furan-2-carboxylate.
Mometasone Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Mometasone 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 Mometasone .

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       1132693-87-8 1655514-84-3     17838-80-1 72-18-4 1346606-53-8   153633-10-4 1369817-11-7  
Inv. Status Custom Synthesis In Stock In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock, 3-4 days for Dispatch Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis
Mol.F. C26H27BrN2O4 C26H33FO7 C42H55Cl4N3O6 C31H38D6N2O5S C30H37NO4 C25H34ClNO5 C12H21N3O C6H7N5O C5H11NO2 C27H24N6O9 C21H23FN4O5 C22H24Br2N2O3S C13H19NO3 C27H28Cl2O6
ISP CAT No ISP-B011046 ISP-F062009     ISP-U002019 ISP-M054013 ISP-U001016 ISP-S027028 ISP-P095005 ISP-B008006 ISP-M033044 ISP-U007004   ISP-M030028
Mol.Wt. 511.4 476.5 839.7 562.8 475.6 464.0 223.3 165.2 117.1 576.5 430.4 556.3 237.3 519.4