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Aripiprazole Impurity 4
Nintedanib Impurity 1
Isoamyl Benzoate
L-Dehydro Ascorbic Acid
Dasatinib Impurity 44
Avanafil Impurity 29
Ramelteon Impurity 13
Avanafil Impurity 20
Avanafil Impurity 21
Hyperoside
Avanafil Related Compound 2
Avanafil Impurity 26
Avanafil Impurity 24
Avanafil Impurity 8 ((R)-Avanafil)
Avanafil Metabolite (M-16)
Avanafil Impurity 19
D-Galacturonic Acid
Title Aripiprazole Impurity 4 Nintedanib Impurity 1 Isoamyl Benzoate L-Dehydro Ascorbic Acid Dasatinib Impurity 44 Avanafil Impurity 29 Ramelteon Impurity 13 Avanafil Impurity 20 Avanafil Impurity 21 Hyperoside Avanafil Related Compound 2 Avanafil Impurity 26 Avanafil Impurity 24 Avanafil Impurity 8 ((R)-Avanafil) Avanafil Metabolite (M-16) Avanafil Impurity 19 D-Galacturonic Acid
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Description

Aripiprazole Impurity 4 is chemically 2(1H)​-​Quinolinone, 7-​[4-​[4-​(2,​3-​dichlorophenyl)​-​1-​piperazinyl]​butoxy]​-​3,​4-​dihydro-​1-​[4-​[(1,​2,​3,​4-​tetrahydro-​2-​oxo-​7-​quinolinyl)​oxy]​butyl]​-; 7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-1-[4-[(1,2,3,4-tetrahydro-2-oxo-7-quinolinyl)oxy]butyl]-2(1H)-quinolinone;.
Aripiprazole Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Aripiprazole 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 Aripiprazole.

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.

Nintedanib Impurity 1 is chemically Dimethyl 2-oxoindoline-3,6-dicarboxylate. Nintedanib Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Nintedanib Impurity 1 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 Nintedanib.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.

Isoamyl Benzoateis chemically Isopentyl benzoate. Isoamyl Benzoate is supplied with detailed characterization data compliant with regulatory guideline. Isoamyl Benzoate 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-2.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.

L-Dehydro Ascorbic Acid is chemically (R)-5-((S)-1,2-Dihydroxyethyl)furan-2,3,4(5H)-trione.
L-Dehydro Ascorbic Acid is supplied with detailed characterization data compliant with regulatory guideline. L-Dehydro Ascorbic Acid 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 Ascorbic Acid.

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.

Dasatinib Impurity 44 is chemically N1-(5-(2-Chloro-6-methylbenzoyl)thiazol-2-yl)-N2-(2-chloro-6-methylphenyl)oxalamide.
Dasatinib Impurity 44 is supplied with detailed characterization data compliant with regulatory guideline. Dasatinib Impurity 44 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 Dasatinib.

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.

Avanafil Impurity 29 is chemically (S)-(1-(4-((3-Chloro-4-methoxybenzyl)amino)-5-((pyrimidin-2-ylmethyl)carbamoyl)pyrimidin-2-yl)pyrrolidin-2-yl)methyl acetate.
Avanafil Impurity 29 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 29 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 Avanafil.

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.

Ramelteon Impurity 13 is chemically 2-(1,6,7,8-tetrahydro-2H-indeno[5,4-b]furan-8-yl)acetonitrile.
Ramelteon Impurity 13 is supplied with detailed characterization data compliant with regulatory guideline. Ramelteon Impurity 13 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 Ramelteon.

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.

Avanafil Impurity 20 is chemically (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-isopropyl-N-(isopropylcarbamoyl)pyrimidine-5-carboxamide.
Avanafil Impurity 20 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 20 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 Avanafil.

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.

Avanafil Impurity 21 is chemically Ethyl 4-((3,5-dichloro-4-methoxybenzyl)amino)-2-(methylthio)pyrimidine-5-carboxylate.
Avanafil Impurity 21 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 21 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 Avanafil.

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.

Hyperoside is chemically 2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-3-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)-4H-chromen-4-one.
Hyperoside is supplied with detailed characterization data compliant with regulatory guideline. Hyperoside 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.

Avanafil Related Compound 2 is chemically 4-((3-Chloro-4-methoxybenzyl)amino)-2-(methylthio)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide.
Avanafil Related Compound 2 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Related Compound 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 Avanafil.

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.

Avanafil Impurity 26 is chemically (s)-2-(2-(Hydroxymethyl)pyrrolidin-1-yl)-4-((4-methylbenzyl)amino)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide.
Avanafil Impurity 26 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 26 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 Avanafil.

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.

Avanafil Impurity 24 is chemically Ethyl 4-((2-chloro-4-methoxybenzyl)amino)-2-(methylthio)pyrimidine-5-carboxylate.
Avanafil Impurity 24 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 24 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 Avanafil.

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.

Avanafil Impurity 8 ((R)-Avanafil) is chemically (R)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide.
Avanafil Impurity 8 ((R)-Avanafil) is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Impurity 8 ((R)-Avanafil) 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 Avanafil.

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.

Avanafil Metabolite (M-16) is chemically 4-((4-((3-Chloro-4-methoxybenzyl)amino)-5-((pyrimidin-2-ylmethyl)carbamoyl)pyrimidin-2-yl)amino)-5-hydroxypentanoic acid.
Avanafil Metabolite (M-16) is supplied with detailed characterization data compliant with regulatory guideline. Avanafil Metabolite (M-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 Avanafil.

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.

Avanafil Impurity 19 is chemically (S)-4-((3-Chloro-4-methoxybenzyl)amino)-2-(2-(hydroxymethyl)pyrrolidin-1-yl)-N-isopropylpyrimidine-5-carboxamide.
Avanafil Impurity 19 is supplied with detailed characterization data compliant with regulatory guideline. Avanafil 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 Avanafil.

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.

D-Galacturonic Acid is chemically (2S,3R,4S,5R)-2,3,4,5-Tetrahydroxy-6-oxohexanoic acid.
D-Galacturonic Acid is supplied with detailed characterization data compliant with regulatory guideline. D-Galacturonic Acid 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.

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
CAS No 1424857-63-5 2514952-69-1 94-46-2 490-83-5   2265230-80-4 1217272-33-7 2520114-17-2 2250242-48-7 482-36-0 1364671-62-4   2520114-23-0 1638497-26-3   2520114-11-6 685-73-4
Inv. Status In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis Out of Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis
Mol.F. C36H42Cl2N4O4 C12H11NO5 C12H16O2 C6H6O6 C20H15Cl2N3O3S C25H28ClN7O4 C13H13NO C25H35ClN6O4 C16H17Cl2N3O3S C21H20O12 C19H19ClN6O2S C23H27N7O2 C16H18ClN3O3S C23H26ClN7O3 C23H26ClN7O5 C21H28ClN5O3 C6H10O7
ISP CAT No ISP-A001034 ISP-N023012 ISP-M161080 ISP-A079015   ISP-A052040 ISP-R008015 ISP-A052021 ISP-A052022 ISP-M039107 ISP-A052028 ISP-A052035 ISP-A052025 ISP-A052009 ISP-A052030 ISP-A052020 ISP-M039852
Mol.Wt. 665.7 249.2 192.3 174.1 448.3 526.0 199.3 519.0 402.3 464.4 430.9 433.5 367.9 484.0 516.0 433.9 194.1