Description

Levocarnitine Impurity CAS NO 6490-20-6 is a high-purity reference standard used in the analytical profiling and quality control of L-Carnitine and its pharmaceutical formulations. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by enabling the accurate identification and quantification of related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the global pharmaceutical and nutraceutical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Levocarnitine (L-Carnitine) API and finished drug products.
• Method Development & Validation: Critical for developing, validating, and transferring analytical methods (e.g., HPLC, UPLC, GC) in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels against strict pharmacopeial limits (USP, EP, JP) to ensure batch-to-batch consistency and regulatory compliance.
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and establish shelf-life.
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research on Metabolism & Degradation Pathways: Serves as a tool in metabolic studies and research into the degradation pathways of L-Carnitine.

Basic Information

Product Name	Levocarnitine Impurity
CAS No.	6490-20-6
Molecular Formula	C7H15NO3
Molecular Weight	161.20 g/mol
Synonyms	(R)-3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium hydroxide inner salt; D-Carnitine; (R)-Carnitine; Dextrocarnitine; (3R)-3-Hydroxy-4-(trimethylammonio)butanoate; D-(-)-Carnitine; Vitamin Bt (enantiomer); L-Carnitine enantiomer
EINECS	229-350-8

Quality Control

Every batch of Levocarnitine Impurity (CAS 6490-20-6) is manufactured and tested under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and mass spectrometry to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
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.