Description

Levocarnitine Related Compound A (3-Carboxy-N,N,N-Trimethyl-2-Propen-1-Aminium Chloride) is a high-purity analytical reference standard, supplied as a 100 mg sample. This compound is critically important for quality control and research in the pharmaceutical industry, serving as a key impurity marker for the active pharmaceutical ingredient levocarnitine. It is essential for analytical chemists, quality assurance professionals, and R&D scientists working in pharmaceutical development, manufacturing, and regulatory compliance to ensure product purity and safety.

Application

• Pharmaceutical Impurity Profiling and Control: Primary use as a certified reference material for the identification and quantification of related substances in levocarnitine (L-carnitine) active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Stability Studies: Used as a benchmark to monitor the formation of degradation products in levocarnitine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance and Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive proof of impurity characterization and control strategies for drug master files (DMFs).
• Pharmacopoeial Testing: Applicable for testing against purity specifications outlined in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia) for levocarnitine.
• Research and Development: Used in metabolic and biochemical research to study the pathways and by-products associated with L-carnitine synthesis and metabolism.

Basic Information

Product Name	Levocarnitine Related Compound A (100 Mg)
CAS No.	6538-82-5
Molecular Formula	C7H14ClNO2
Molecular Weight	179.64 g/mol
Synonyms	3-Carboxy-N,N,N-Trimethyl-2-Propen-1-Aminium Chloride; (E)-4-(Trimethylammonio)but-2-enoate Chloride; (E)-3-Carboxy-N,N,N-trimethylprop-2-en-1-aminium Chloride; L-Carnitine Related Compound A; Carnitine Impurity A; Levocarnitine Impurity A; (2E)-4-(Trimethylammonio)but-2-enoate Chloride
EINECS	229-454-9

Quality Control

This analytical standard is manufactured under strict quality control protocols to ensure the highest levels of purity and consistency required for pharmaceutical analysis. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles. Our quality systems are designed to support compliance with cGMP (current Good Manufacturing Practice) guidelines and relevant pharmacopoeial standards (USP/EP). Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture, which can affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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