Description

S-Adenosyl-L-Methionine Impurity 1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for the quality control and method development of S-Adenosyl-L-Methionine (SAMe) pharmaceutical products, ensuring batch-to-batch consistency and regulatory compliance. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the development and production of SAMe-based therapeutics and nutraceuticals.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in S-Adenosyl-L-Methionine (SAMe) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, and LC-MS methods to monitor impurities and ensure product purity.
• Quality Control & Assurance (QC/QA): Serves as a critical component in routine quality control testing to comply with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Employed in forced degradation and long-term stability studies of SAMe to understand impurity profiles under various storage conditions.
• Research & Development: Used in biochemical and pharmacological research to study the metabolism, degradation pathways, and biological activity of SAMe and its related compounds.

Basic Information

Product Name	S-Adenosyl-L-Methionine Impurity 1
CAS No.	1334162-51-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	S-Adenosylmethionine Impurity 1; SAMe Impurity 1; AdoMet Impurity 1; (3S)-5'-[(3-Amino-3-carboxypropyl)methylsulfonio]-5'-deoxyadenosine Impurity; 5'-Deoxy-5'-(methylsulfonio)adenosine Impurity; SAM Impurity 1; S-Adenosyl-L-Methionine Related Compound 1
EINECS	Contact for details

Quality Control

Our S-Adenosyl-L-Methionine Impurity 1 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with every shipment to support your quality and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Reported on COA
Water Content (KF)	≤ 5.0%

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