Description

Levocarnitine Impurity 3 CAS NO 101396-87-6 is a high-purity chemical reference standard used for the identification and quantification of process-related impurities in Levocarnitine (L-Carnitine) active pharmaceutical ingredients (APIs). This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products. It is primarily required by analytical laboratories, quality control departments, and R&D teams within the pharmaceutical and biotechnology industries for method development, validation, and routine batch testing.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for identifying and quantifying specific impurities in Levocarnitine drug substances and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or GC analytical methods for purity testing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, JP).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to regulatory bodies like the FDA and EMA.
• Stability Studies: Used to track the formation of degradation products in Levocarnitine formulations under various stress conditions.
• Research & Development: Aids in synthetic route optimization and process chemistry by helping to identify and eliminate impurity formation during API manufacturing.

Basic Information

Product Name	Levocarnitine Impurity 3
CAS No.	101396-87-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	L-Carnitine Impurity 3; (R)-Carnitine Impurity 3; 3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium Impurity; Carnitine Related Compound C; Levocarnitine Related Substance 3; 1-Propanaminium, 3-carboxy-2-hydroxy-N,N,N-trimethyl-, (2R)-; (R)-3-Carboxy-2-hydroxy-N,N,N-trimethylpropan-1-aminium
EINECS	Contact for details

Quality Control

Our Levocarnitine Impurity 3 is manufactured under strict quality control protocols to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is characterized and tested using advanced analytical techniques, including HPLC, GC-MS, and NMR, to confirm identity, purity, and potency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications. Our quality system is designed to support compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Keep the container sealed to protect the contents from moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.