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Sorafenib EP Impurity E is chemically 4,4′-[Carbonylbis(azanediyl-4,1-phenyleneoxy)]bis(N-methylpyridine-2-carboxamide) (as per EP)
N,N’-Bis{4-[2-(N-methylcarbamoyl)-4-pyridyloxy]phenyl}urea (as per USP).
It is also known as Sorafenib USP Impurity E.
Sorafenib EP Impurity E is supplied with detailed characterization data compliant with regulatory guideline. Sorafenib 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 Sorafenib.

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 52 is chemically Methyl 2-oxoindoline-6-carboxylate. Nintedanib Impurity 52 is supplied with detailed characterization data compliant with regulatory guideline. Nintedanib Impurity 52 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.

Trimethoprim Impurity 1 is chemically 5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4(1H,3H)-dione. Trimethoprim Impurity 1 is supplied with detailed characterization data compliant with regulatory guideline. Trimethoprim 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 Trimethoprim.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.

Norethindrone Acetate EP Impurity I is chemically 3-Ethoxy-17α-ethynylestr-3,5-dien-17β-ol acetate. It is also known as Norethindrone Acetate 3-Ethoxy Impurity ; Norethindrone Acetate 3-Ethyl Ether. Norethindrone Acetate EP Impurity I is supplied with detailed characterization data compliant with regulatory guideline. Norethindrone Acetate EP Impurity I 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 Norethindrone Acetate.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.