Description

Tiagabine Impurity 1 is a designated reference standard used in the analytical profiling and quality control of the antiepileptic drug Tiagabine Hydrochloride. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It serves as a key marker for identifying and quantifying process-related impurities during drug substance synthesis and final formulation testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, GC, or LC-MS analysis in quality control laboratories.
• Method Development and Validation: Essential for developing and validating analytical methods for Tiagabine Hydrochloride according to ICH guidelines.
• Stability Studies: Used to monitor the formation of degradation products in stability testing of Tiagabine drug products.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing impurity characterization data for drug master files (DMFs).
• Process Chemistry R&D: Aids in the optimization of synthetic pathways by identifying and tracking specific impurity formation.
• Pharmacopoeial Testing: Potential use in testing to meet monograph specifications for Tiagabine in pharmacopoeias like USP or EP.

Basic Information

Product Name	Tiagabine Impurity 1
CAS No.	109857-76-3
Molecular Formula	C20H25NO2S2
Molecular Weight	375.55 g/mol
Synonyms	(R)-(-)-N-[4,4-Bis(3-methyl-2-thienyl)-3-butenyl]nipecotic Acid; (R)-(-)-N-[4,4-Di(3-methylthien-2-yl)but-3-enyl]nipecotic Acid; Tiagabine Related Compound A; Tiagabine EP Impurity A; Tiagabine USP Impurity A; (3R)-1-[4,4-Bis(3-methyl-2-thienyl)-3-buten-1-yl]-3-piperidinecarboxylic Acid
EINECS	Contact for details

Quality Control

Every batch of Tiagabine Impurity 1 is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for use as a pharmaceutical reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

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

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