Description

Ademetionine 1,4-Butanedisulfonate Impurity 6 is a high-purity chemical reference standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities during the development and manufacturing of Ademetionine 1,4-Butanedisulfonate, a key pharmaceutical ingredient. It is primarily utilized by analytical laboratories, quality assurance departments, and R&D teams within the pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for identifying and quantifying this specific impurity in Ademetionine 1,4-Butanedisulfonate active pharmaceutical ingredient (API) batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control and Release Testing: Essential for routine QC testing to ensure API purity meets stringent pharmacopeial standards (e.g., USP, EP, ICH guidelines Q3A/B).
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity control strategies.
• Process Chemistry Optimization: Helps chemists understand and minimize the formation of this impurity during API synthesis and scale-up.

Basic Information

Product Name	Ademetionine 1,4-Butanedisulfonate Impurity 6
CAS No.	98544-67-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	S-Adenosylmethionine 1,4-Butanedisulfonate Impurity 6; Ademetionine Butanedisulfonate Related Compound 6; SAMe Butanedisulfonate Impurity 6; AdoMet 1,4-Butanedisulfonate Impurity 6; Process Impurity of Ademetionine 1,4-Butanedisulfonate; 98544-67-3; Ademetionine Disulfonate Impurity
EINECS	Contact for details

Quality Control

Every batch of Ademetionine 1,4-Butanedisulfonate Impurity 6 is manufactured and controlled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, purity, and strength.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 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.