Description

Flupirtine Maleate Impurity D is a specified impurity associated with the active pharmaceutical ingredient Flupirtine Maleate. This high-purity reference standard is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and contract research organization (CRO) sectors who require reliable materials for ensuring drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Flupirtine Maleate drug substance and finished products.
• Analytical Method Development: Serves as a critical component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within acceptable limits as per ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability testing of Flupirtine Maleate formulations.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthesis routes for the API.

Basic Information

Product Name	Flupirtine Maleate Impurity D
CAS No.	1552323-75-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Flupirtine Impurity D; Flupirtine Maleate Related Compound D; Flupirtine EP Impurity D; Flupirtine USP Impurity D; Ethyl 2-amino-6-[(4-fluorobenzyl)amino]-3-pyridinecarboxylate maleate (related impurity); D-Impurity of Flupirtine Maleate; Flupirtine Maleate Specified Impurity D
EINECS	Contact for details

Quality Control

Our Flupirtine Maleate Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and conformity to specified standards. Certificates of Analysis (COA) with detailed chromatographic data are provided for every batch, supporting its use in GMP and research environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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