Description

Thiocolchicoside Ep Impurity G is a high-purity chemical reference standard, specifically identified as an impurity of the muscle relaxant Thiocolchicoside. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists working in the pharmaceutical and biotechnology sectors to ensure product purity and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of Thiocolchicoside-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for purity testing.
• Quality Control and Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., EP, USP).
• Stability Studies: Employed in forced degradation and shelf-life studies to track the formation of degradation products and assess drug substance stability.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research and Development: Used in synthetic chemistry and pharmacology research to study the metabolism, degradation pathways, and structure-activity relationships of Thiocolchicoside analogs.

Basic Information

Product Name	Thiocolchicoside Ep Impurity G
CAS No.	177991-81-0
Molecular Formula	C27H33NO9S
Molecular Weight	547.62 g/mol
Synonyms	Thiocolchicoside Impurity G; Thiocolchicoside Related Compound G; (3S,4S,5R,7S,8S,9S,12S,13S,14S,17S)-3-[(2S,3R,4S,5S,6R)-3,4-Dihydroxy-6-(hydroxymethyl)-5-(methylsulfanyl)oxan-2-yl]oxy-4,5,9,14-tetrahydroxy-10-methoxy-13-methyl-6-oxo-1,2,3,4,5,6,7,8,13,14,16,17-dodecahydro-7,10-methano-11H-cyclonona[5,6]naphtho[2,1-f]isoindol-11-one; Colchicoside thiomethyl ether impurity G; N-Methylcolchiceinamide thiomethyl ether impurity G
EINECS	Contact for details

Quality Control

Our Thiocolchicoside Ep Impurity G is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (NMR, MS). We provide comprehensive Certificates of Analysis (COA) detailing batch-specific results, ensuring traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopeial guidelines.

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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