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Zilpaterol-d7
Hydrocortisone EP Impurity C
Polymyxin B2
Olmesartan Medoxomil EP Impurity A
Canagliflozin 2,3-Dehydroxy Impurity
Ruxolitinib Impurity 19
Hydrocortisone EP Impurity N
4-Amino-1,3-dimethyl-2,6-dioxy-5-nitrosopyrimidine
Regorafenib Impurity 18
Vibegron Impurity 3
Title Zilpaterol-d7 Hydrocortisone EP Impurity C Polymyxin B2 Olmesartan Medoxomil EP Impurity A Canagliflozin 2,3-Dehydroxy Impurity Ruxolitinib Impurity 19 Hydrocortisone EP Impurity N 4-Amino-1,3-dimethyl-2,6-dioxy-5-nitrosopyrimidine Regorafenib Impurity 18 Vibegron Impurity 3
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Description

Zilpaterol-d7 is chemically (6R,7R)-6-Hydroxy-7-((propan-2-yl-d7)amino)-6,7,8,9-tetrahydro-2,9a-diazabenzo[cd]azulen-1(2H)-one.
Zilpaterol-d7 is supplied with detailed characterization data compliant with regulatory guideline. Zilpaterol-d7 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 Zilpaterol.

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.

Hydrocortisone EP Impurity C is chemically 11β,17-Dihydroxy-3,20-dioxopregn-4-en-21-yl acetate.
It is also known as Hydrocortisone Acetate (USP) ; Prednisolone Acetate EP Impurity A.
Hydrocortisone EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Hydrocortisone 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 Hydrocortisone.

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.

Polymyxin B2 is chemically N-[(S)-4-Amino-1-{[(2S,3R)-1-{[(S)-4-amino-1-oxo-1-({(3S,6S,9S,12S,15S,18S,21S)-6,9,18-tris(2-aminoethyl)-15-benzyl-3-[(R)-1-hydroxyethyl]-12-isobutyl-2,5,8,11,14,17,20-heptaoxo-1,4,7,10,13,16,19-heptaazacyclotricosan-21-yl}amino)butan-2-yl]amino}-3-hydroxy-1-oxobutan-2-yl]amino}-1-oxobutan-2-yl]-6-methylheptanamide (as per USP).
Polymyxin B2 is supplied with detailed characterization data compliant with regulatory guideline. Polymyxin B2 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 Polymyxin B.

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.

Olmesartan Medoxomil EP Impurity A is chemically 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-[[2′-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylic acid (as per EP) .
It is also known as Olmesartan (EP).
Olmesartan Medoxomil EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Olmesartan Medoxomil 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 Olmesartan.

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.

Canagliflozin 2,3-Dehydroxy Impurity is chemically (2R,3S,4R)-6-(3-((5-(4-Fluorophenyl)thiophen-2-yl)methyl)-4-methylphenyl)-2-(hydroxymethyl)-3,4-dihydro-2H-pyran-3,4-diol.
Canagliflozin 2,3-Dehydroxy Impurity is supplied with detailed characterization data compliant with regulatory guideline. Canagliflozin 2,3-Dehydroxy Impurity 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 Canagliflozin.

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.

Ruxolitinib Impurity 19 is chemically (R)-3-Cyclopentyl-3-(5-(dimethylamino)-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)propanenitrile.
Ruxolitinib Impurity 19 is supplied with detailed characterization data compliant with regulatory guideline. Ruxolitinib Impurity 19 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 Ruxolitinib.

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.

Hydrocortisone EP Impurity N is chemically 11β,17,21-Trihydroxy-21-(11β,17,21-trihydroxy-3,20-dioxopregn-4-en-21-yl)pregn-4-ene-3,20-dione.
It is also known as Hydrocortisone Symmetrical Dimer.
Hydrocortisone EP Impurity N is supplied with detailed characterization data compliant with regulatory guideline. Hydrocortisone 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 Hydrocortisone.

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.

4-Amino-1,3-dimethyl-2,6-dioxy-5-nitrosopyrimidine is chemically 6-Amino-1,3-dimethyl-5-nitrosopyrimidine-2,4(1H,3H)-dione.
4-Amino-1,3-dimethyl-2,6-dioxy-5-nitrosopyrimidine is supplied with detailed characterization data compliant with regulatory guideline. 4-Amino-1,3-dimethyl-2,6-dioxy-5-nitrosopyrimidine 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 Miscellaneous.

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.

Regorafenib Impurity 18 is chemically 4-(4-Amino-3-fluorophenoxy)-N-(2-fluoro-4-((2-(methylcarbamoyl)pyridin-4-yl)oxy)phenyl)picolinamide.
Regorafenib Impurity 18 is supplied with detailed characterization data compliant with regulatory guideline. Regorafenib Impurity 18 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 Regorafenib.

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 3 is chemically Methyl (2S,3R)-2-((tert-butoxycarbonyl)amino)-3-hydroxy-3-phenylpropanoate.
Vibegron Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Vibegron 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 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.

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CAS No 1217818-36-4 50-03-3 34503-87-2 144689-24-7       6632-68-4 2518234-85-8 136620-75-2
Inv. Status Custom Synthesis In Stock Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Inquire Custom Synthesis Custom Synthesis
Mol.F. C14H12D7N3O2 C23H32O6 C55H96N16O13 C24H26N6O3 C24H23FO4S C19H23N7 C42H58O10 C6H8N4O3 C25H19F2N5O4 C15H21NO5
ISP CAT No ISP-Z014D01 ISP-H008004 ISP-P150003 ISP-O006002   ISP-R044038 ISP-H008015 ISP-M039507 ISP-R039033 ISP-V042004
Mol.Wt. 268.4 404.5 1189.5 446.5 426.5 349.4 722.9 184.2 491.5 295.3