Description

Tandospirone Impurity 6 is a high-purity chemical reference standard used in the analytical profiling and quality control of the anxiolytic pharmaceutical, Tandospirone. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) units, and regulatory affairs departments focused on method development, validation, and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Tandospirone and its related substances.
• Method Development & Validation: Critical for developing and validating stability-indicating analytical methods, such as HPLC and UPLC, in accordance with ICH guidelines.
• Impurity Profiling & Characterization: Used to identify, track, and control specific impurities during the drug substance synthesis and formulation process to meet ICH Q3A/B requirements.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in forced degradation and long-term stability studies of Tandospirone API and finished dosage forms.
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity identification and specification data.
• Quality Control Testing: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and purity of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Tandospirone Impurity 6
CAS No.	1129675-92-8
Molecular Formula	C21H29N5O2
Molecular Weight	383.49 g/mol
Synonyms	1,4-Diazepine-4,7(1H,5H)-dione, 1-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-, (4aS,8aS)-rel-; (4aS,8aS)-1-[4-[4-(Pyrimidin-2-yl)piperazin-1-yl]butyl]hexahydro-1H-[1,4]diazepino[1,7-a]indole-4,7-dione; Tandospirone Related Compound 6; Tandospirone EP Impurity C; Tandospirone USP Impurity; SM-3997 Impurity
EINECS	Contact for details

Quality Control

Every batch of Tandospirone Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity and assigned chemical structure, is provided with each shipment to support your regulatory and analytical needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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