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Primidone Impurity 1
Paracetamol EP Impurity D
Methyl Cholate
Fusidic Acid EP Impurity J
Dihydroxy Clorambucil
Alprostadil EP Impurity G
Ceftriaxone Impurity 3
Safinamide Impurity 9
Apixaban Impurity 64
Atorvastatin Oxirane Impurity
Placeholder
Omeprazole Impurity 42
Niraparib Impurity 36
10-Oxooctadecanoic acid
Cabozantinib Impurity 10
Dimethyl Succinate
Semaglutide D8
Pitavastatin Desfluoro Acetonide t-Butyl Ester
Title Primidone Impurity 1 Paracetamol EP Impurity D Methyl Cholate Fusidic Acid EP Impurity J Dihydroxy Clorambucil Alprostadil EP Impurity G Ceftriaxone Impurity 3 Safinamide Impurity 9 Apixaban Impurity 64 Atorvastatin Oxirane Impurity Naproxen Impurity 14 Omeprazole Impurity 42 Niraparib Impurity 36 10-Oxooctadecanoic acid Cabozantinib Impurity 10 Dimethyl Succinate Semaglutide D8 Pitavastatin Desfluoro Acetonide t-Butyl Ester
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Description

Primidone Impurity 1 is chemically N-Carbamothioyl-2-Phenylbutanamide.
Primidone Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Primidone 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 Primidone.

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.

Paracetamol EP Impurity D is chemically N-phenylacetamide.
It is also known as Acetaminophen USP Related Compound D ; Acetanilide ; Acetylaniline.
Paracetamol EP Impurity D is supplied with detailed characterization data compliant with regulatory guideline. Paracetamol 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 Paracetamol.

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.

Methyl Cholate is chemically Methyl (R)-4-((3R,5S,7R,8R,9S,10S,12S,13R,14S,17R)-3,7,12-trihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoate.
Methyl Cholate is supplied with detailed characterization data compliant with regulatory guideline. Methyl Cholate 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 Chenodeoxycholic 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.

Fusidic Acid EP Impurity J is chemically Ent-(17Z)-3β,11β-dihydroxy-4β,8,14-trimethyl-18-nor-5β,10α-cholesta-17(20),24-dieno-21(16β)-lactone (as per EP).
It is also known as 16-epi-deacetylfusidic acid 21,16-lactone (EP).
Fusidic Acid EP Impurity J is supplied with detailed characterization data compliant with regulatory guideline. Fusidic Acid EP Impurity J 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 Fusidic 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.

Dihydroxy Clorambucil is chemically 4-(4-(Bis(2-hydroxyethyl)amino)phenyl)butanoic acid.
Dihydroxy Clorambucil is supplied with detailed characterization data compliant with regulatory guideline. Dihydroxy Clorambucil 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.

Alprostadil EP Impurity G is chemically (5Z)-7-[(1R,2R,3R)-3-Hydroxy-2-[(1E,3S)-3-hydroxyoct-1-enyl]-5-oxocyclopentyl]hept-5-enoic acid  (as per EP).
It is also known as Dinoprostone.
Alprostadil EP Impurity G is supplied with detailed characterization data compliant with regulatory guideline. Alprostadil EP Impurity G 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 Alprostadil.

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.

Ceftriaxone Impurity 3 is chemically O-(Benzo[d]thiazol-2-yl) (E)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)ethanethioate.
Ceftriaxone Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Ceftriaxone 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 Ceftriaxone.

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.

Safinamide Impurity 9is chemically 4-((3-Fluorobenzyl)oxy)benzoic acid. Safinamide Impurity 9 is supplied with detailed characterization data compliant with regulatory guideline. Safinamide 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 Safinamide.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.

Apixaban Impurity 64 is chemically 1-(4-Nitrophenyl)-3-(2-oxopiperidin-1-yl)pyridin-2(1H)-one.
Apixaban Impurity 64 is supplied with detailed characterization data compliant with regulatory guideline. Apixaban Impurity 64 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 Apixaban.

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.

Atorvastatin Oxirane Impurity  is chemically 3-(4-Fluorobenzoyl)-2-(2-methylpropyl)-N,3-diphenyl-2-oxiranecarboxamide.
Atorvastatin Oxirane Impurity  is supplied with detailed characterization data compliant with regulatory guideline. Atorvastatin Oxirane 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 Atorvastatin.

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.

Naproxen Impurity 14 is chemically 2-(5-Iodo-6-methoxynaphthalen-2-yl)propanoic acid. Naproxen Impurity 14 is supplied with detailed characterization data compliant with regulatory guideline. Naproxen 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 Naproxen.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.

Omeprazole Impurity 42 is chemically (S)-2-(((3,5-Dimethyl-4-nitropyridin-2-yl)methyl)sulfinyl)-5-methoxy-1H-benzo[d]imidazole.
Omeprazole Impurity 42 is supplied with detailed characterization data compliant with regulatory guideline. Omeprazole Impurity 42 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 Omeprazole.

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.

Niraparib Impurity 36 is chemically Tert-butyl (S,E)-3-(4-((2,3-bis(3-cyano-2-nitrophenyl)allyl)amino)phenyl)piperidine-1-carboxylate. Niraparib Impurity 36 is supplied with detailed characterization data compliant with regulatory guideline. Niraparib Impurity 36 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 Niraparib.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.

10-Oxooctadecanoic acid is chemically 10-Oxooctadecanoic acid.
It is also known as 10-Ketostearic acid.
10-Oxooctadecanoic acid is supplied with detailed characterization data compliant with regulatory guideline. 10-Oxooctadecanoic 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.

Cabozantinib Impurity 10 is chemically 1-((4-((7-Methoxy-6-(sulfooxy)quinolin-4-yl)oxy)phenyl)carbamoyl)cyclopropane-1-carboxylic acid.
Cabozantinib Impurity 10 is supplied with detailed characterization data compliant with regulatory guideline. Cabozantinib Impurity 10 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 Cabozantinib.

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.

Dimethyl Succinate is chemically Dimethyl Succinate.
Dimethyl Succinate is supplied with detailed characterization data compliant with regulatory guideline. Dimethyl Succinate 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.

Semaglutide D8 is chemically .
Semaglutide D8 is supplied with detailed characterization data compliant with regulatory guideline. Semaglutide D8 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 Semaglutide.

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.

Pitavastatin Desfluoro Acetonide t-Butyl Ester is chemically Tert-butyl 2-((4R,6S)-6-((E)-2-(2-cyclopropyl-4-phenylquinolin-3-yl)vinyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate.
Pitavastatin Desfluoro Acetonide t-Butyl Ester is supplied with detailed characterization data compliant with regulatory guideline. Pitavastatin Desfluoro Acetonide 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 Pitavastatin.

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
CAS No   103-84-4 1448-36-8 13011-12-6 34677-78-6 363-24-6 959246-33-4 405-85-6   1246818-88-1 2664845-95-6 853950-49-9 NA 4158-12-7 1628530-37-9 106-65-0    
Inv. Status Custom Synthesis In Stock Custom Synthesis In Stock In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis   Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis
Mol.F. C11H14N2OS C8H9NO C25H42O5 C29H44O4 C14H21NO4 C20H32O5 C13H10N4O2S3 C14H11FO3 C16H15N3O4 C26H24FNO3 C14H13IO3 C16H16N4O4S C33H32N6O6 C18H34O3 C21H18N2O9S C6H10O4 C187H283D8N45O59 C32H37NO4
ISP CAT No ISP-P090008 ISP-P007005   ISP-F020011   ISP-A110008   ISP-S033018 ISP-A062086 ISP-A037060 ISP-N007054 ISP-O004086 ISP-N031045 ISP-M039980   ISP-M039007 ISP-S072D03 ISP-P023024
Mol.Wt. 222.3 135.2 422.6 456.7 267.3 352.5 350.4 246.2 313.3 417.5 356.2 360.4 608.7 298.5 474.4 146.1 4121.7 499.7