Description

Mirogabalin Besylate is the besylate salt form of mirogabalin, a novel pharmaceutical compound. This active pharmaceutical ingredient (API) is valued for its targeted pharmacological activity and high purity, which are critical for the development of safe and effective finished dosage forms. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development of new therapeutic agents for neurological conditions.

Application

• Pharmaceutical API: Core active ingredient in the formulation of prescription medications.
• Neurological Disorder Research: Key compound in preclinical and clinical research for conditions involving neuropathic pain.
• Analytical Reference Standard: Used as a high-purity standard in quality control laboratories for HPLC, LC-MS, and other analytical methods.
• Drug Development: Serves as a critical intermediate in the synthesis and scale-up processes for new drug candidates.
• Clinical Trial Material (CTM): Supplied under GMP guidelines for use in human clinical studies.

Basic Information

Product Name	Mirogabalin Besylate
CAS No.	1138245-21-2
Molecular Formula	C17H28N2O3 • C6H6O3S
Molecular Weight	446.55 g/mol
Synonyms	(1R,5S,6S)-6-(aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-ene-6-acetic acid benzenesulfonate; Mirogabalin benzene sulfonate; Tarlige (brand name salt form); DS-5565; (1R,5S,6S)-3-Ethyl-6-(aminomethyl)bicyclo[3.2.0]hept-3-ene-6-acetic acid benzenesulfonate salt
EINECS	Contact for details

Quality Control

Our Mirogabalin Besylate is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality is assured through a comprehensive battery of tests including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting compliance with agreed specifications is provided with each batch. We support development and commercial needs with material produced under current Good Manufacturing Practice (cGMP) principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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