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Ritonavir EP Impurity N
Δ2-Cefditoren Pivoxil
Succinimide
Milbemycin EP Impurity C
Methylergometrine Nitroso Impurity
Piroxicam O-Isopropyl Impurity
Ticagrelor (1R,2R,3S,5S) Isomer
Orphenadrine D3
Fulvestrant EP Impurity A
Apixaban Impurity 57
Pitavastatin 5-Oxo Impurity Calcium Salt
Lumacaftor Amide
Pimecrolimus
7-Aminocephalosporanic Acid
Vilanterol Impurity 22
Febantel EP Impurity C
Nefopam Keto Amine Impurity
Bromocriptine Mesilate EP Impurity A
N-Acetyl-4-benzoquinone Imine
Title Ritonavir EP Impurity N Δ2-Cefditoren Pivoxil Succinimide Milbemycin EP Impurity C Methylergometrine Nitroso Impurity Piroxicam O-Isopropyl Impurity Ticagrelor (1R,2R,3S,5S) Isomer Orphenadrine D3 Fulvestrant EP Impurity A Apixaban Impurity 57 Pitavastatin 5-Oxo Impurity Calcium Salt Lumacaftor Amide Pimecrolimus 7-Aminocephalosporanic Acid Vilanterol Impurity 22 Febantel EP Impurity C Nefopam Keto Amine Impurity Bromocriptine Mesilate EP Impurity A N-Acetyl-4-benzoquinone Imine
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Description

Ritonavir EP Impurity N is chemically Thiazol-5-yl-methyl [(1S,3S,4S)-1-benzyl-3-hydroxy-4-[[(2S)-3-methyl-2-[[methyl[[2-(1-methylethyl)thiazol-4-yl]methyl]carbamoyl]amino]butanoyl] amino]-5-phenylpentyl]carbamate (as per EP);
Thiazol-5-ylmethyl (2S,4S,5S)-4-hydroxy-5-[(S)-2-{3-[(2-isopropylthiazol-4-yl)methyl]-3-methylureido}-3-methylbutanamido]-1,6-diphenylhexan-2-ylcarbamate (as per USP).
It is also known as Ritonavir 4-Hydroxy Isomer (USP).
Ritonavir EP Impurity N is supplied with detailed characterization data compliant with regulatory guideline. Ritonavir EP Impurity N 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 Ritonavir.

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.

Δ2-Cefditoren Pivoxil is chemically (Pivaloyloxy)methyl (6R,7R)-7-((Z)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((Z)-2-(4-methylthiazol-5-yl)vinyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-3-ene-2-carboxylate.
Δ2-Cefditoren Pivoxil is supplied with detailed characterization data compliant with regulatory guideline. Δ2-Cefditoren Pivoxil 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 Cefditoren Pivoxil.

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.

Succinimide is chemically 2,5-Diketopyrrolidine.
Succinimide is supplied with detailed characterization data compliant with regulatory guideline. Succinimide 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.

Milbemycin EP Impurity C is chemically (1′R,2R,4′S,5S,6R,8′R,10′E,13′R,14′E,16′E,20′R,21′R,24′S)-21′,24′-Dihydroxy-6-(propan-2-yl)-5,11′,13′,22′-tetramethyl 3,4,5,6-tetrahydrospiro[pyran-2,6′-[3,7,19]trioxatetracyclo[15.6.1.14,8.020,24]pentacosa[10,14,16,22]tetraen]-2′-one ;.
Milbemycin EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Milbemycin 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 Milbemycin.

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.

Methylergometrine Nitroso Impurityis chemically (6aR,9R)-N-((S)-1-hydroxybutan-2-yl)-7-methyl-4-nitroso-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide. Methylergometrine Nitroso Impurity is supplied with detailed characterization data compliant with regulatory guideline. Methylergometrine Nitroso 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 Methylergometrine.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.

Piroxicam O-Isopropyl Impurity is chemically 4-Isopropoxy-2-methyl-N-(pyridin-2-yl)-2H-benzo[e][1,2]thiazine-3-carboxamide 1,1-dioxide.
Piroxicam O-Isopropyl Impurity is supplied with detailed characterization data compliant with regulatory guideline. Piroxicam O-Isopropyl 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 Piroxicam.

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.

Ticagrelor (1R,2R,3S,5S) Isomer is chemically (1R,2R,3S,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. Ticagrelor (1R,2R,3S,5S) Isomer is supplied with detailed characterization data compliant with regulatory guideline. Ticagrelor (1R,2R,3S,5S) Isomer 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 Ticagrelor.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.

Orphenadrine D3 is chemically N-Methyl-N-(methyl-d3)-2-(phenyl(o-tolyl)methoxy)ethan-1-amine.
Orphenadrine D3 is supplied with detailed characterization data compliant with regulatory guideline. Orphenadrine 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 Orphenadrine.

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.

Fulvestrant EP Impurity A is chemically 7β-[9-[(RS)-(4,4,5,5,5-pentafluoropentyl)sulfinyl]nonyl]estra-1,3,5(10)-triene-3,17β-diol (as per EP) ; 7β-{9-[(4,4,5,5,5,-Pentafluoropentyl)sulfinyl]nonyl}estra-1,3,5(10)-triene-3,17β-diol (as per USP).
It is also known as Fulvestrant β-isomer ; 7β-Fulvestrant.
Fulvestrant EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Fulvestrant 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 Fulvestrant.

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 57 is chemically Ethyl 5-chloropentanoate.
Apixaban Impurity 57 is supplied with detailed characterization data compliant with regulatory guideline. Apixaban Impurity 57 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.

Pitavastatin 5-Oxo Impurity Calcium Salt  is chemically Calcium (R,E)-7-(2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl)-3-hydroxy-5-oxohept-6-enoate.
Pitavastatin 5-Oxo Impurity Calcium Salt  is supplied with detailed characterization data compliant with regulatory guideline. Pitavastatin 5-Oxo Impurity Calcium 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 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.

Lumacaftor Amide is chemically 1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)cyclopropane-1-carboxamide.
Lumacaftor Amide is supplied with detailed characterization data compliant with regulatory guideline. Lumacaftor Amide 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 Lumacaftor.

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.

Pimecrolimus is chemically (3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-3-[(1E)-2-[(1R,3R,4S)-4-Chloro-3-methoxycyclohexyl]-1-methyl-ethenyl]-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,26,26a-hexadecahydro-5,19-dihydroxy-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3Hpyrido[2,1-c][1,4]oxaazacyclotricosine-1,17,20,21(4H,23H)-tetrone.
Pimecrolimus is supplied with detailed characterization data compliant with regulatory guideline. Pimecrolimus 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 Pimecrolimus.

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.

7-Aminocephalosporanic Acid is chemically (6R,7R)-3-(Acetoxymethyl)-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (as per USP).
It is also known as 7-ACA.
7-Aminocephalosporanic Acid is supplied with detailed characterization data compliant with regulatory guideline. 7-Aminocephalosporanic 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 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.

Vilanterol Impurity 22 is chemically (R)-4-(2-((6-(2-((2,6-Dichlorobenzyl)oxy)ethoxy)hexyl)amino)-1-hydroxyethyl)-2-(ethoxymethyl)phenol.
Vilanterol Impurity 22 is supplied with detailed characterization data compliant with regulatory guideline. Vilanterol 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 Vilanterol.

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.

Febantel EP Impurity C is chemically Methyl [5-(phenylsulfanyl)-1H-benzimidazol-2-yl]carbamate (as per EP).
It is also known as Fenbendazole.
Febantel EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Febantel 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 Febantel.

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.

Nefopam Keto Amine Impurity is chemically (2-(((2-Hydroxyethyl)(methyl)amino)methyl)phenyl)(phenyl)methanone. Nefopam Keto Amine Impurity is supplied with detailed characterization data compliant with regulatory guideline. Nefopam Keto Amine 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 Nefopam.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.

Bromocriptine Mesilate EP Impurity A is chemically (6aR,9R)-5-Bromo-7-methyl-N-[(2R,5S)-2-(1-methylethyl)-5-(2-methylpropyl)-3,6-dioxo-2,3,5,6,9,10-hexahydro-8H-oxazolo[3,2-a]pyrrolo[2,1-c]pyrazin-2-yl]-4,6,6a,7,8,9-hexahydroindolo[4,3-fg]quinoline-9-carboxamide (as per EP).
It is also known as 2-bromoanhydro-α-ergocryptine (EP).
Bromocriptine Mesilate EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Bromocriptine Mesilate 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 Bromocriptine Mesilate.

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-4-benzoquinone Imine is chemically N-(4-Oxocyclohexa-2,5-dien-1-ylidene)acetamide.
N-Acetyl-4-benzoquinone Imine is supplied with detailed characterization data compliant with regulatory guideline. N-Acetyl-4-benzoquinone Imine 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.

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
CAS No 202816-62-4 148774-47-4 123-56-8 77855-81-3   118854-49-2 2435586-11-9 1185011-75-9 407577-53-1 2323-81-1 2180095-22-9 2071254-53-8 137071-32-0 957-68-6 1582675-85-1 43210-67-9 76528-10-4   50700-49-7
Inv. Status In Stock Custom Synthesis In Stock Custom Synthesis Inquire Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis In Stock In Stock In Stock In Stock In Stock In Stock In Stock Custom Synthesis Custom Synthesis
Mol.F. C37H48N6O5S2 C25H28N6O7S3 C4H5NO2 C33H48O7 C20H24N4O3 C18H19N3O4S C23H28F2N6O4S C18H20D3NO C32H47F5O3S C7H13ClO2 C25H21FNO4 : 1/2(Ca) C11H9F2NO3 C43H68ClNO11 C10H12N2O5S C26H37Cl2NO5 C15H13N3O2S C17H19NO2 C32H38BrN5O4 C8H7NO2
ISP CAT No ISP-R003015   ISP-M039305 ISP-M025004 ISP-M113011 ISP-P069014 ISP-T023094 ISP-O015D01 ISP-F004002 ISP-A062079 ISP-P023001 ISP-L117005 ISP-P033001   ISP-V031025 ISP-F083004 ISP-N029004 ISP-B089002 ISP-P057056
Mol.Wt. 720.9 620.7 99.1 556.7 368.4 373.4 522.6 272.4 606.8 164.6 418.4 : 1/2(40.1) 241.2 810.5 272.3 514.5 299.3 269.3 636.6 149.1