Category
Amisulpride
CAS Number
Amisulpride STD- 71675-85-9: IMP-A- 26116-12-1: IMP-B- 148516-54-5
Molecular Formula
Amisulpride STD- C₁₇H₂₇N₃O₄S: IMP-A- C₇H₁₆N₂: IMP-B- C₁₆H₂₅N₃O₄S
Molecular Weight
Amisulpride STD- 369.48 g/mol: IMP-A- 128.22 g/mol: IMP-B- 355.45 g/mol
Synonym

Amisulpride STD- 4-amino-N-[(1-ethylpyrrolidin-2-yl)methyl]-5-ethylsulfonyl-2-methoxybenzamide; Amisulpride - API (IP); Aminosultopride

Amisulpride EP Impurity A- [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine; 2-Pyrrolidinemethanamine,1-ethyl;Sulpiride EP Impurity A

Amisulpride EP Impurity B- 4-Amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl]methyl]-5-(ethylsulfonyl)-2-Hydroxybenzamide;4-amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl]methyl]-5-(ethylsulphonyl)-2-hydroxybenzamide

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Purity:

Above - 95.0%

Technical Data:

We will provide complete documentation support for every Standard Material. All analytical reports such as ¹H NMR, ¹³C NMR, Mass, FT-IR, HPLC Purity/GC Purity/QNMR Purity, Water content by KF/ Loss on Drying/TGA (Thermo-gravimetric Analysis). Certificate of Analysis with potency report. Each Standard Material SER (Structure Elucidation Report) with NMR, Mass, IR spectral interpretation. This whole analytical document can be included in eCTD, ANDA, DMF submissions to regulatory agencies.

Amisulpride for system suitability CRS refers to a certified reference standard of Amisulpride used in analytical methods (typically HPLC or related techniques) to verify that the chromatographic system is performing correctly before sample analysis. In this context, the CRS ensures parameters like resolution, peak symmetry, retention time, and reproducibility meet predefined acceptance criteria. It is essential in pharmaceutical quality control to confirm the reliability and accuracy of the system when analyzing Amisulpride or related compounds, helping maintain consistency and compliance with pharmacopeial standards.