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N-Nitroso Bedaquiline Impurity 3
Dabigatran Impurity 18
Balsalazide USP Impurity 4
Dabigatran Impurity 53
N-Acetyl-D-Phenylalaninol
Deferasirox Impurity 17
Dabigatran Impurity 34
Tamoxifen EP Impurity E
Palbociclib Chlorobromo Impurity
Hydroxymethyl Ivacaftor
3-Cyanophthalide
Title N-Nitroso Bedaquiline Impurity 3 Dabigatran Impurity 18 Balsalazide USP Impurity 4 Dabigatran Impurity 53 N-Acetyl-D-Phenylalaninol Deferasirox Impurity 17 Dabigatran Impurity 34 Tamoxifen EP Impurity E Palbociclib Chlorobromo Impurity Hydroxymethyl Ivacaftor 3-Cyanophthalide
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Description

N-Nitroso Bedaquiline Impurity 3 is chemically N-(4-(6-Bromo-2-methoxyquinolin-3-yl)-3-hydroxy-3-(naphthalen-1-yl)-4-phenylbutyl)-N-methylnitrous amide.
N-Nitroso Bedaquiline Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. N-Nitroso Bedaquiline 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 Bedaquiline.

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.

Dabigatran Impurity 18 is chemically Isobutyl 3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate.
Dabigatran Impurity 18 is supplied with detailed characterization data compliant with regulatory guideline. Dabigatran 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 Dabigatran.

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 4 is chemically 2-(4-(4-Carboxybutanoyl)phenoxy)-5-((4-((2-carboxyethyl)carbamoyl)phenyl)diazenyl)benzoic acid.
Balsalazide USP Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Balsalazide USP 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 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.

Dabigatran Impurity 53 is chemically Ethyl 3-(4-chloro-3-(2-((4-cyanophenyl)amino)acetamido)-N-(pyridin-2-yl)benzamido)propanoate.
Dabigatran Impurity 53 is supplied with detailed characterization data compliant with regulatory guideline. Dabigatran 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 Dabigatran.

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-Acetyl-D-Phenylalaninol is chemically (R)-N-(1-Hydroxy-3-phenylpropan-2-yl)acetamide.
N-Acetyl-D-Phenylalaninol is supplied with detailed characterization data compliant with regulatory guideline. N-Acetyl-D-Phenylalaninol 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 Solriamfetol.

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.

Deferasirox Impurity 17 is chemically (E)-4-Amino-3-((4-carboxyphenyl)diazenyl)benzoic acid.
Deferasirox Impurity 17 is supplied with detailed characterization data compliant with regulatory guideline. Deferasirox 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 Deferasirox.

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.

Dabigatran Impurity 34 is chemically 4-(2-Chloro-N-methylacetamido)-3-(2-chloroacetamido)benzoic acid.
Dabigatran Impurity 34 is supplied with detailed characterization data compliant with regulatory guideline. Dabigatran Impurity 34 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 Dabigatran.

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.

Tamoxifen EP Impurity E is chemically 2-[2-[(EZ)-1,2-Diphenylbut-1-en-1-yl]phenoxy]-N,N-dimethylethan-1-amine 2-hydroxypropane-1,2,3-tricarboxylic acid. Tamoxifen EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Tamoxifen 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 Tamoxifen.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.

Palbociclib Chlorobromo Impurity is chemically 6-Bromo-2-chloro-8-cyclopentyl-5-methylpyrido[2,3-d]pyrimidin-7(8H)-one.
Palbociclib Chlorobromo Impurity is supplied with detailed characterization data compliant with regulatory guideline. Palbociclib Chlorobromo 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 Palbociclib.

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.

Hydroxymethyl Ivacaftor is chemically N-(2-(Tert-butyl)-5-hydroxy-4-(1-hydroxy-2-methylpropan-2-yl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide.
Hydroxymethyl Ivacaftor is supplied with detailed characterization data compliant with regulatory guideline. Hydroxymethyl Ivacaftor 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 Ivacaftor.

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.

3-Cyanophthalide is chemically 3-oxo-1,3-dihydroisobenzofuran-1-carbonitrile.
3-Cyanophthalide is supplied with detailed characterization data compliant with regulatory guideline. 3-Cyanophthalide 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.

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CAS No     1346606-62-9   52485-50-4 1914179-49-9   NA 1016636-76-2 1246213-23-9 27613-27-0
Inv. Status Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Limited Stock In Stock Custom Synthesis Custom Synthesis
Mol.F. C31H28BrN3O3 C36H45N7O5 C28H25N3O9 C26H24ClN5O4 C11H15NO2 C14H11N3O4 C12H12Cl2N2O4 C26H29NO : C6H8O7 C13H13BrClN3O C24H28N2O4 C9H5NO2
ISP CAT No ISP-B091018   ISP-B008007   ISP-S035017     ISP-T038006 ISP-P015051 ISP-I015018 ISP-M039265
Mol.Wt. 570.5 655.8 547.5 506.0 193.2 285.3 319.1 371.5 : 192.1 342.6 408.5 159.1