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Raltegravir Impurity 14
Nicardipine USP Related Compound A
Vaborbactam Impurity 16
Vinorelbine EP Impurity I
Silibinin
N-Nitroso Mobocertinib Impurity 3
Rosuvastatin Acid t-Butyl Ester
Carvedilol Impurity 9
Fingolimod EP Impurity C
Carfilzomib Impurity 53
Gemcitabine Impurity 12
Brexpiprazole Impurity 52
Sapropterin Impurity 22
Copanlisib Impurity A
Fluoxetine EP Impurity C
Carbinoxamine Impurity 2
Verapamil D6
2,6-Dichloro-4-Cyanopyridine
6-Hydroxy Alosetron
Caffeine
Micafungin Serine Analog Impurity
Micafungin Impurity 15
Title Raltegravir Impurity 14 Nicardipine USP Related Compound A Vaborbactam Impurity 16 Vinorelbine EP Impurity I Silibinin N-Nitroso Mobocertinib Impurity 3 Rosuvastatin Acid t-Butyl Ester Carvedilol Impurity 9 Fingolimod EP Impurity C Carfilzomib Impurity 53 Gemcitabine Impurity 12 Brexpiprazole Impurity 52 Sapropterin Impurity 22 Copanlisib Impurity A Fluoxetine EP Impurity C Carbinoxamine Impurity 2 Verapamil D6 2,6-Dichloro-4-Cyanopyridine 6-Hydroxy Alosetron Caffeine Micafungin Serine Analog Impurity Micafungin Impurity 15
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Description

Raltegravir Impurity 14 is chemically 2-(4-((3-Fluorobenzyl)carbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl benzylcarbamate.
Raltegravir Impurity 14 is supplied with detailed characterization data compliant with regulatory guideline. Raltegravir Impurity 14 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 Raltegravir.

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.

Nicardipine USP Related Compound A is chemically 5-(Methoxycarbonyl)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3-carboxylic acid (as per USP). It is also known as Nicardipine Mono Acid (USP). Nicardipine USP Related Compound A is supplied with detailed characterization data compliant with regulatory guideline. Nicardipine USP Related Compound 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 Nicardipine.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.

Vaborbactam Impurity 16 is chemically (4S,7S)-4-((Tert-butyldimethylsilyl)oxy)-1,1,7-trichloro-7-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)heptan-2-one.
Vaborbactam Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Vaborbactam Impurity 16 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 Vaborbactam.

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.

Vinorelbine EP Impurity I is chemically Methyl (3aR,3a1R,4R,5S,5aR,10bR)-4-acetoxy-7-bromo-3a-ethyl-9-((2S,6R,8S)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methanoazecino[4,3-b]indol-8-yl)-5-hydroxy-8-methoxy-6-methyl-3a,3a1,4,5,5a,6,11,12-octahydro-1H-indolizino[8,1-cd]carbazole-5-carboxylate.
Vinorelbine EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Vinorelbine 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 Vinorelbine .

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.

Silibinin is chemically (2R,3R)-3,5,7-Trihydroxy-2-((2R,3R)-3-(4-hydroxy-3-methoxyphenyl)-2-(hydroxymethyl)-2,3-dihydrobenzo[b][1,4]dioxin-6-yl)chroman-4-one.
Silibinin is supplied with detailed characterization data compliant with regulatory guideline. Silibinin 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 Silibinin.

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.

N-Nitroso Mobocertinib Impurity 3 is chemically Isopropyl 2-((5-acrylamido-4-((2-(dimethylamino)ethyl)(methyl)amino)-2-methoxyphenyl)(nitroso)amino)-4-(1-methyl-1H-indol-3-yl)pyrimidine-5-carboxylate.
N-Nitroso Mobocertinib Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Mobocertinib 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 Mobocertinib.

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.

Rosuvastatin Acid t-Butyl Esteris chemically (3R,5S,6E)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl (methyl sulfonyl) amino]-5-pyrimidinyl]-3,5-dihydroxy- 6-heptenoic acid t-butyl ester.It is also known as tert-Butyl rosuvastatin.Rosuvastatin Acid t-Butyl Ester is supplied with detailed characterization data compliant with regulatory guideline. Rosuvastatin Acid t-Butyl Ester 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 Rosuvastatin.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.

Carvedilol Impurity 9 is chemically 3,3′-((Oxybis(ethane-2,1-diyl))bis(azanediyl))bis(1-((9H-carbazol-4-yl)oxy)propan-2-ol).
Carvedilol Impurity 9 is supplied with detailed characterization data compliant with regulatory guideline. Carvedilol 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 Carvedilol.

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.

Fingolimod EP Impurity C is chemically 2-Amino-2-(4-nonylphenethyl)propane-1,3-diol.
It is also known as Fingolimod Nonyl Impurity ; .
Fingolimod EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Fingolimod 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 Fingolimod.

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.

Carfilzomib Impurity 53 is chemically (R)-4-Methyl-N-((S)-1-(((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide.
Carfilzomib Impurity 53 is supplied with detailed characterization data compliant with regulatory guideline. Carfilzomib Impurity 53 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 Carfilzomib.

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.

Gemcitabine Impurity 12 is chemically ((2R,3R,5S)-3-(Benzoyloxy)-4,4-difluoro-5-hydroxytetrahydrofuran-2-yl)methyl benzoate.
Gemcitabine Impurity 12 is supplied with detailed characterization data compliant with regulatory guideline. Gemcitabine 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 Gemcitabine.

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.

Brexpiprazole Impurity 52 is chemically 7-(4-(4-(Benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butyl)quinolin-2(1H)-one.
Brexpiprazole Impurity 52 is supplied with detailed characterization data compliant with regulatory guideline. Brexpiprazole Impurity 52 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.

Sapropterin Impurity 22 is chemically (1R,2S)-1-(2-Amino-4-hydroxy-7-((Z)-phenyldiazenyl)pteridin-6-yl)propane-1,2-diyl diacetate.
Sapropterin Impurity 22 is supplied with detailed characterization data compliant with regulatory guideline. Sapropterin Impurity 22 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.

Copanlisib Impurity A is chemically 2-Amino-N-(8-(3-(N-(2-hydroxyethyl)formamido)propoxy)-7-methoxy-2,3-dihydroimidazo[1,2-c]quinazolin-5-yl)pyrimidine-5-carboxamide.
Copanlisib Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Copanlisib 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 Copanlisib.

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.

Fluoxetine EP Impurity C is chemically N-Methyl-3-phenyl-3-(3-(trifluoromethyl)phenoxy)propan-1-amine.
Fluoxetine EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Fluoxetine 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 Fluoxetine.

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.

Carbinoxamine Impurity 2 is chemically 2-((2-Chlorophenyl)(pyridin-2-yl)methoxy)-N-methylethan-1-amine maleate.
Carbinoxamine Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Carbinoxamine 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 Carbinoxamine.

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.

Verapamil D6 is chemically 5-((3,4-Dimethoxyphenethyl)(methyl)amino)-2-(3,4-dimethoxyphenyl)-2-(propan-2-yl-1,1,1,3,3,3-d6)pentanenitrile hydrochloride.
Verapamil D6 is supplied with detailed characterization data compliant with regulatory guideline. Verapamil 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 Verapamil.

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.

2,6-Dichloro-4-Cyanopyridine is chemically 2,6-Dichloroisonicotinonitrile. 2,6-Dichloro-4-Cyanopyridine is supplied with detailed characterization data compliant with regulatory guideline. 2,6-Dichloro-4-Cyanopyridine 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 Niacin.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.

6-Hydroxy Alosetronis chemically 6-Hydroxy-5-methyl-2-((5-methyl-1H-imidazol-4-yl)methyl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-b]indol-1-one. 6-Hydroxy Alosetron is supplied with detailed characterization data compliant with regulatory guideline. 6-Hydroxy Alosetron 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 Alosetron.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.

Caffeineis chemically 1,3,7-Trimethyl-3,7-dihydro-1H-purine-2,6-dione (as per EP) ; 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl- (as per USP).It is also known as Theophylline EP Impurity A ; Pentoxifylline EP Impurity F.Caffeine is supplied with detailed characterization data compliant with regulatory guideline. Caffeine 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 Caffeine.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.

Micafungin Serine Analog Impurity is chemically Sodium 5-((1S,2S)-2-((2R,6S,9S,11R,12R,14aS,15S,16S,20S,23S,25aS)-20-((R)-3-amino-1-hydroxy-3-oxopropyl)-2,11,12,15-tetrahydroxy-6-(hydroxymethyl)-16-methyl-5,8,14,19,22,25-hexaoxo-9-(4-(5-(4-(pentyloxy)phenyl)isoxazol-3-yl)benzamido)tetracosahydro-1H-dipyrrolo[2,1-c:2′,1′-l][1,4,7,10,13,16]hexaazacyclohenicosin-23-yl)-1,2-dihydroxyethyl)-2-hydroxyphenyl sulfate.
Micafungin Serine Analog Impurity is supplied with detailed characterization data compliant with regulatory guideline. Micafungin Serine Analog 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 Micafungin .

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.

Micafungin Impurity 15 is chemically 5-((2S)-2-((6S,23S)-9-Amino-20-(3-amino-1-hydroxy-3-oxopropyl)-2,11,12,15-tetrahydroxy-6-((R)-1-hydroxyethyl)-5,8,14,19,22,25-hexaoxotetracosahydro-1H-dipyrrolo[2,1-c:2′,1′-l][1,4,7,10,13,16]hexaazacyclohenicosin-23-yl)-1,2-dihydroxyethyl)-2-hydroxyphenyl hydrogen sulfate.
Micafungin Impurity 15 is supplied with detailed characterization data compliant with regulatory guideline. Micafungin Impurity 15 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 Micafungin .

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.

Availability In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock
CAS No   74936-72-4     22888-70-6   355806-00-7   746594-44-5 2049025-45-6 143157-22-6 2137823-20-0   2132943-82-7 56161-72-9   1185032-80-7 32710-65-9 128486-89-5 58-08-2 1392514-04-3 208511-83-5
Inv. Status Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Inquire In Stock Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis In Stock Under Synthesis Custom Synthesis
Mol.F. C24H25FN4O5 C16H16N2O6 C23H40BCl3O4Si C45H53BrN4O8 C25H22O10 C31H35N9O6 C26H36FN3O6S C34H38N4O5 C20H35NO2 C40H57N5O7 C19H16F2O6 C41H47N5O2S2 C19H19N7O5 C22H26N8O5 C17H18F3NO C15H17ClN2O : C4H4O4 C27H32D6N2O4 : HCl C6H2Cl2N2 C17H18N4O2 C8H10N4O2 C55H68N9O23S : Na C34H50N8O20S
ISP CAT No ISP-R009033 ISP-N004002 ISP-V026020 ISP-V020011 ISP-S031001 ISP-M134004 ISP-R020042   ISP-F014007   ISP-G007025 ISP-B011057 ISP-S027047   ISP-F001004   ISP-V021D03 ISP-N008020 ISP-A134002   ISP-M022016 ISP-M022029
Mol.Wt. 468.5 332.3 525.8 857.9 482.4 614.7 537.6 582.7 321.5 719.9 378.3 706.0 425.4 482.5 309.3 276.8 : 116.1 460.6 : 36.5 173.0 310.4 194.2 1255.2 : 23.0 922.9