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Lynestrenol EP Impurity C
Flucortolone 17-Carboxlic Acid
Beta Cyclodextrin
Isomalt EP Impurity B
Brimonidine Nitroso Impurity 3
Fluvoxamine Impurity 6
Duloxetine USP Related Compound H
Vigabatrin Impurity 4
Venetoclax Chloro Coupled Impurity
Terbutaline EP Impurity B
Romidepsin Impurity 6
6α-Hydroxyperoxy Testosterone
Indapamide EP Impurity C (HCl salt)
Montelukast (3S)-Hydroxy Benzoate
Bacitracin EP Impurity C
Indapamide EP Impurity B
Leflunomide Impurity 2
Carprofen Impurity 3
Lansoprazole Thiadiazine Impurity 1
Teduglutide Acetone Adduct Impurity
Phenylephrine Impurity 56
Sugammadex TPPO Analogue Impurity
Didesmethyl Chlorpheniramine Maleate
Mycophenolate Ether
Mesalazine EP Impurity R
Lysine EP Impurity A
Donepezil Impurity 17
Verapamil D3
Methotrexate Impurity 16
Title Lynestrenol EP Impurity C Flucortolone 17-Carboxlic Acid Beta Cyclodextrin Isomalt EP Impurity B Brimonidine Nitroso Impurity 3 Fluvoxamine Impurity 6 Duloxetine USP Related Compound H Vigabatrin Impurity 4 Venetoclax Chloro Coupled Impurity Terbutaline EP Impurity B Romidepsin Impurity 6 6α-Hydroxyperoxy Testosterone Indapamide EP Impurity C (HCl salt) Montelukast (3S)-Hydroxy Benzoate Bacitracin EP Impurity C Indapamide EP Impurity B Leflunomide Impurity 2 Carprofen Impurity 3 Lansoprazole Thiadiazine Impurity 1 Teduglutide Acetone Adduct Impurity Phenylephrine Impurity 56 Sugammadex TPPO Analogue Impurity Didesmethyl Chlorpheniramine Maleate Mycophenolate Ether Mesalazine EP Impurity R Lysine EP Impurity A Donepezil Impurity 17 Verapamil D3 Methotrexate Impurity 16
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Description

Lynestrenol EP Impurity Cis chemically 19-nor-17α-pregna-4,20-dien-17-ol (as per EP). Lynestrenol EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Lynestrenol 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 Lynestrenol.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.

Flucortolone 17-Carboxlic Acid is chemically (6S,8S,9S,10R,11S,13S,14S,16R,17S)-6-Fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylic acid.
Flucortolone 17-Carboxlic Acid is supplied with detailed characterization data compliant with regulatory guideline. Flucortolone 17-Carboxlic 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 Fluocortolone.

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.

Beta Cyclodextrin is chemically 2,4,7,9,12,14,17,19,22,24,27,29,32,34-Tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane, β-cyclodextrin.
It is also known as β-Cycloamylose ; β-Cycloheptaamylose ; β-Dextrin.
Beta Cyclodextrin is supplied with detailed characterization data compliant with regulatory guideline. Beta Cyclodextrin 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 Sugammadex.

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.

Isomalt EP Impurity Bis chemically D-mannitol (as per EP). Isomalt EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Isomalt EP Impurity B 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 Isomalt.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.

Brimonidine Nitroso Impurity 3 is chemically N-(5-Bromoquinoxalin-6-yl)-N-(1-(2,5-dioxotetrahydrofuran-3-yl)-4,5-dihydro-1H-imidazol-2-yl)nitrous amide.
Brimonidine Nitroso Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Brimonidine Nitroso 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 Brimonidine.

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.

Fluvoxamine Impurity 6 is chemically 1-((2-Aminoethoxy)amino)-5-methoxy-1-(4-(trifluoromethyl)phenyl)pentan-1-ol.
Fluvoxamine Impurity 6 is supplied with detailed characterization data compliant with regulatory guideline. Fluvoxamine Impurity 6 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 Fluvoxamine.

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.

Duloxetine USP Related Compound H is chemically (S)-4-(Methyl[3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl]amino)-4-oxobutanoic acid ;.
It is also known as Duloxetine USP Related Compound H ; (S)-Duloxetine Succinamide.
Duloxetine USP Related Compound H is supplied with detailed characterization data compliant with regulatory guideline. Duloxetine USP Related Compound H 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 Duloxetine.

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.

Vigabatrin Impurity 4 is chemically 5-Oxo-6-(2-oxo-3-vinylpyrrolidin-1-yl)hexanoic acid.
Vigabatrin Impurity 4 is supplied with detailed characterization data compliant with regulatory guideline. Vigabatrin 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 Vigabatrin.

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.

Venetoclax Chloro Coupled Impurity is chemically 2-((1H-Pyrrolo[2,3-b]pyridin-5-yl)oxy)-4-(4-((4′-(4-((4′-chloro-5,5-dimethyl-3,4,5,6-tetrahydro-[1,1′-biphenyl]-2-yl)methyl)piperazin-1-yl)-5,5-dimethyl-3,4,5,6-tetrahydro-[1,1′-biphenyl]-2-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-(((tetrahydro-2H-pyran-4-yl)methyl)amino)phenyl)sulfonyl)benzamide.
Venetoclax Chloro Coupled Impurity is supplied with detailed characterization data compliant with regulatory guideline. Venetoclax Chloro Coupled 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 Venetoclax.

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.

Terbutaline EP Impurity B is chemically 2-(tert-butyl)-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol. It is also known as Terbinafine USP Related Compound A. Terbutaline EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Terbutaline EP Impurity B 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 Terbutaline.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.

Romidepsin Impurity 6 is chemically (1S,4S,7Z,10S,17Z,22R)-7-ethylidene-4,22-diisopropyl-2-oxa-12,13,14-trithia-5,8,21,24-tetraazabicyclo[8.8.6]tetracos-17-ene-3,6,9,20,23-pentaone.
Romidepsin Impurity 6 is supplied with detailed characterization data compliant with regulatory guideline. Romidepsin Impurity 6 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 Romidepsin.

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.

6α-Hydroxyperoxy Testosterone is chemically (6S,8R,9S,10R,13S,14S,17S)-6-Hydroperoxy-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one. 6α-Hydroxyperoxy Testosterone is supplied with detailed characterization data compliant with regulatory guideline. 6α-Hydroxyperoxy Testosterone 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 Testosterone.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.

Indapamide EP Impurity C (HCl salt)is chemically (2RS)-2-Methyl-2,3-dihydro-1H-indol-1-amine hydrochloride.It is also known as Indapamide USP Related Compound B.Indapamide EP Impurity C (HCl salt) is supplied with detailed characterization data compliant with regulatory guideline. Indapamide EP Impurity C (HCl salt) 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 Indapamide.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.

Montelukast (3S)-Hydroxy Benzoate is chemically 2-[(3S)-(2-(7-Chloro-2-quinolinyl)-ethenyl-phenyl)-3-hydroxy-propyl)]-1-methoxycarbonylbenzene ;Methyl [E]-2-[(3S)-[3-[2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-3-hydroxypropyl] benzoate.
It is also known as Montelukast (3S)-Hydroxy Benzoate .
Montelukast (3S)-Hydroxy Benzoate is supplied with detailed characterization data compliant with regulatory guideline. Montelukast (3S)-Hydroxy 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 Montelukast.

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.

Bacitracin EP Impurity C is chemically 4,10-anhydro[N-[[(4R)-2-[(1S,2S)-1-amino-2-methylbutyl]-4,5-dihydro-1,3-thiazol-4-yl]carbonyl]-L-leucyl-D-α-glutamyl-L-valyl-L-lysyl-D-ornithyl-L-valyl-D-phenylalanyl-L-histidyl-D-α-aspartyl-L-asparagine] (as per EP).
It is also known as bacitracin D3, bacitracin C1a (EP).
Bacitracin EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Bacitracin 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 Bacitracin.

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.

Indapamide EP Impurity Bis chemically 4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulfamoylbenzamide.It is also known as Indapamide USP Related Compound A ; Dehydro Indapamide.Indapamide EP Impurity B is supplied with detailed characterization data compliant with regulatory guideline. Indapamide EP Impurity B 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 Indapamide.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.

Leflunomide Impurity 2 is chemically 3-Methylisoxazole-4-carboxylic Acid.
It is also known as Earlier CAT No = SZ-L032017.
Leflunomide Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Leflunomide 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 Leflunomide.

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.

Carprofen Impurity 3 is chemically 1-(9-Acetyl-6-chloro-9H-carbazol-2-yl)-2-chloropropan-1-one.
Carprofen Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Carprofen 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 Carprofen.

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.

Lansoprazole Thiadiazine Impurity 1 is chemically 4-Methylbenzo[4,5]imidazo[1,2-b]pyrido[1,2-d][1,2,4]thiadiazin-3-ol.
Lansoprazole Thiadiazine Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Lansoprazole Thiadiazine 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 Lansoprazole.

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.

Teduglutide Acetone Adduct Impurity is chemically . Teduglutide Acetone Adduct Impurity is supplied with detailed characterization data compliant with regulatory guideline. Teduglutide Acetone Adduct 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 Teduglutide.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.

Phenylephrine Impurity 56 is chemically (1S,4R)-1-(4-Hydroxy-3-methoxyphenyl)-2-methyl-1,2,3,4-tetrahydroisoquinoline-4,6-diol.
Phenylephrine Impurity 56 is supplied with detailed characterization data compliant with regulatory guideline. Phenylephrine Impurity 56 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 Phenylephrine.

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.

Sugammadex TPPO Analogue Impurity is chemically .
Sugammadex TPPO Analogue Impurity is supplied with detailed characterization data compliant with regulatory guideline. Sugammadex TPPO Analogue 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 Sugammadex.

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.

Didesmethyl Chlorpheniramine Maleate is chemically 3-(4-Chlorophenyl)-3-(pyridin-2-yl)propan-1-amine maleate.
Didesmethyl Chlorpheniramine Maleate is supplied with detailed characterization data compliant with regulatory guideline. Didesmethyl Chlorpheniramine Maleate 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 Chlorphenamine.

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.

Mycophenolate Ether  is chemically 2-Morpholinoethyl 3-(5-methoxy-2,6-dimethyl-9-oxo-3,4,7,9-tetrahydro-2H-furo[3,4-h]chromen-2-yl)propanoate.
Mycophenolate Ether  is supplied with detailed characterization data compliant with regulatory guideline. Mycophenolate Ether  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 Mycophenolate Mofetil.

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.

Mesalazine EP Impurity R is chemically 2-Hydroxy-3-nitrobenzoic acid (as per EP).
It is also known as 3-nitrosalicylic acid (EP).
Mesalazine EP Impurity R is supplied with detailed characterization data compliant with regulatory guideline. Mesalazine EP Impurity R 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 Mesalazine.

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.

Lysine EP Impurity Ais chemically (2S)-2-amino-4-methylpentanoic acid.It is also known as Leucine (EP) ; L-Leucine (USP).Lysine EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Lysine 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 Lysine.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.

Donepezil Impurity 17 is chemically 1-Benzylpiperidin-4-yl [1,1′-biphenyl]-2-ylcarbamate.
Donepezil Impurity 17 is supplied with detailed characterization data compliant with regulatory guideline. Donepezil 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 Donepezil.

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 D3 is chemically 5-((3,4-Dimethoxyphenethyl)(methyl-d3)amino)-2-(3,4-dimethoxyphenyl)-2-isopropylpentanenitrile.
Verapamil D3 is supplied with detailed characterization data compliant with regulatory guideline. Verapamil D3 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.

Methotrexate Impurity 16 is chemically (S)-4-(4-(((2,4-Diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)-5-ethoxy-5-oxopentanoic acid.
Methotrexate Impurity 16 is supplied with detailed characterization data compliant with regulatory guideline. Methotrexate 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 Methotrexate.

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 In stock In stock In stock In stock In stock In stock In stock
CAS No 5225-38-7 65557-55-3 7585-39-9 69-65-8   1349218-60-5 199191-66-7     94120-05-5 1611492-56-8 NA 31529-47-2 142569-69-5   63968-75-2 17153-20-7 114041-34-8 2518281-98-4 NA   2414905-35-2 23052-94-0   85-38-1 61-90-5 171723-80-1 152561-91-6 65148-63-2
Inv. Status Custom Synthesis In Stock In Stock Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Under Synthesis In Stock Limited Stock Custom Synthesis Custom Synthesis Custom Synthesis Under Synthesis Custom Synthesis In Stock Custom Synthesis In Stock Custom Synthesis In Stock Custom Synthesis Custom Synthesis
Mol.F. C20H30O C21H27FO4 C42H70O35 C6H14O6 C15H11BrN6O4 C15H23F3N2O3 C22H23NO4S C12H17NO4 C64H76ClN9O7S C13H19NO3 C24H36N4O6S3 C19H28O4 C9H12N2 : HCl C28H24ClNO3 C64H99N17O16S C16H14ClN3O3S C5H5NO3 C17H13Cl2NO2 C14H11N3OS C166H253N43O57S C17H19NO4 C82H119O48PS7 C14H15ClN2 : C4H4O4 C23H31NO7 C7H5NO5 C6H13NO2 C25H26N2O2 C27H35D3N2O4 C22H26N8O5
ISP CAT No ISP-L088004 ISP-F088002 ISP-S029008 ISP-I071003 ISP-B026063 ISP-F007029   ISP-V019026 ISP-V022025 ISP-T042003 ISP-R064010 ISP-T021073 ISP-I006007 ISP-M031046 ISP-B119007 ISP-I006003 ISP-L032016   ISP-L009032 ISP-T134004 ISP-P057078 ISP-S029041   ISP-M001025 ISP-M016019 ISP-L084002   ISP-V021D01 ISP-M019058
Mol.Wt. 286.5 362.4 1135.0 182.2 419.2 336.4 397.5 239.3 1150.9 237.3 526.7 320.4 148.2 : 36.5 458.0 1394.7 363.8 127.1 334.2 269.3 3795.2 301.3 2128.2 246.7 : 116.1 433.5 183.1 131.2 386.5 457.6 482.5