Description

Tandospirone Impurity 10 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) tandospirone. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of specific impurities in tandospirone API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity limits and demonstrate control strategies.
• Chemical Research and Synthesis: Acts as a key intermediate or reference compound for synthetic chemists working on the development or optimization of the tandospirone synthesis pathway.
• Quality Assurance/Quality Control (QA/QC): Used in routine batch release testing to ensure tandospirone drug substances and products meet predefined purity specifications.

Basic Information

Item	Detail
Product Name	Tandospirone Impurity 10
CAS No.	105981-33-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1,4-Dioxaspiro[4.5]decane-8-methanamine, 2-[4-(4-(2-pyrimidinyl)-1-piperazinyl]butyl]-, (8R)-; (8R)-2-[4-[4-(2-Pyrimidinyl)-1-piperazinyl]butyl]-1,4-dioxaspiro[4.5]decane-8-methanamine; Tandospirone Related Compound; Tandospirone Process Impurity; SM-3997 Impurity; Sediel Impurity
EINECS	Contact for details

Quality Control

Every batch of Tandospirone Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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