Description

Levocarnitine Impurity 4 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products containing Levocarnitine (L-Carnitine). It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference standard for the identification and quantification of a specific impurity in Levocarnitine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for quality control laboratories.
• Regulatory Compliance and Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Levocarnitine formulations under various stress conditions.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the pathways and by-products associated with Levocarnitine.
• Quality Assurance/Quality Control (QA/QC): A critical tool for in-process testing and batch release to ensure product specifications are met according to pharmacopeial standards (USP, EP).

Basic Information

Item	Detail
Product Name	Levocarnitine Impurity 4
CAS No.	41363-39-7
Molecular Formula	C7H15NO3
Molecular Weight	161.20 g/mol
Synonyms	L-Carnitine Impurity 4; (3R)-3-Hydroxy-4-(trimethylammonio)butanoate; 4-(Trimethylammonio)-3-hydroxybutyrate; 3-Hydroxy-4-trimethylammoniobutanoate; Deoxycarnitine; Carnitine Related Compound D; 3-Hydroxy-N,N,N-trimethyl-4-oxobutan-1-aminium
EINECS	Contact for details

Quality Control

Every batch of Levocarnitine Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles as determined by validated analytical methods (HPLC, NMR, MS).

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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