Description

Tiropramide Impurity A is a designated reference standard used for the identification, qualification, and quantification of related substances in the active pharmaceutical ingredient Tiropramide. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and compliance with stringent regulatory guidelines. It is essential for research and development, method validation, and routine quality control in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical testing of Tiropramide API.
• Method Development and Validation: Used to establish and validate chromatographic methods (HPLC, UPLC) for impurity profiling.
• Quality Control (QC) Testing: Employed in routine batch release testing to monitor and control impurity levels in Tiropramide drug substance and finished products.
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (heat, light, humidity).
• Regulatory Compliance: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity characterization data for health authorities like the FDA and EMA.
• Research and Development: Aids in process chemistry optimization to understand and minimize impurity formation during synthesis.

Basic Information

Product Name	Tiropramide Impurity A
CAS No.	14325-35-0
Molecular Formula	C17H20N2O2
Molecular Weight	284.36 g/mol
Synonyms	Tiropramide Related Compound A; 2-(4-Methylpiperazin-1-yl)-N-[2-(2-oxo-2,3-dihydro-1H-indol-3-yl)ethyl]acetamide; 3-[2-[[2-(4-Methyl-1-piperazinyl)acetyl]amino]ethyl]-1,3-dihydro-2H-indol-2-one; Tiropramide Impurity; Tiropramide EP Impurity A; Tiropramide USP Impurity A
EINECS	Contact for details

Quality Control

Our Tiropramide Impurity A is manufactured and handled under strict quality management systems. Each batch is characterized and tested using validated analytical methods, including HPLC, NMR, and MS, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support compliance with cGMP, USP, and EP requirements for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.