Description

Levocarnitine Impurity F CAS NO 6490-19-3 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in Levocarnitine (L-Carnitine) active pharmaceutical ingredients (APIs) and finished drug products. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical formulations by enabling accurate analytical method development and validation. It is an essential tool for quality control laboratories in the pharmaceutical industry, particularly those involved in the production and testing of metabolic and cardiovascular therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the quantitative analysis of Levocarnitine impurities.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, or GC methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability standard and for routine batch testing of Levocarnitine API and drug products to ensure impurity levels are within specified limits.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light).
• Pharmacopoeial Testing: Supports testing procedures aligned with USP, EP, or other pharmacopoeial monographs for Levocarnitine.

Basic Information

Item	Details
Product Name	Levocarnitine Impurity F
CAS No.	6490-19-3
Molecular Formula	C7H15NO3
Molecular Weight	161.20 g/mol
Synonyms	3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium inner salt impurity; (R)-3-Carboxy-2-hydroxypropyl)trimethylammonium hydroxide inner salt impurity; L-Carnitine Impurity F; Carnitine Impurity F; (3R)-3-Hydroxy-4-(trimethylammonio)butanoate impurity; Vitamin Bt related compound F; 1-Propanaminium, 3-carboxy-2-hydroxy-N,N,N-trimethyl-, inner salt, (2R)-
EINECS	Contact for details

Quality Control

Every batch of Levocarnitine Impurity F is manufactured under strict quality management systems and undergoes comprehensive analytical characterization. Identity, purity, and impurity profiles are confirmed using advanced techniques including HPLC, NMR, and Mass Spectrometry. Our products are designed to meet the stringent requirements for pharmaceutical reference standards. 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). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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