Description

Crotonylbetaine (Carnitine Impurity) (Rg) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for ensuring the quality, safety, and regulatory compliance of pharmaceutical products, particularly those involving L-Carnitine and its derivatives. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in L-Carnitine API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for purity analysis.
• Quality Control & Assurance: Employed in routine QC testing to monitor and control impurity levels, ensuring batch-to-batch consistency and compliance with pharmacopeial standards (USP, EP).
• Stability Studies: Used to identify and track degradation products in forced degradation and long-term stability studies of Carnitine-based formulations.
• Metabolic Research: Acts as a biochemical tool in research studies investigating carnitine metabolism and related pathways.

Basic Information

Product Name	Crotonylbetaine (Carnitine Impurity) (Rg)
CAS No.	927-89-9
Molecular Formula	C7H13NO3
Molecular Weight	159.18 g/mol
Synonyms	(E)-4-(Carboxymethyl)-4-hydroxy-N,N,N-trimethyl-2-buten-1-aminium; (E)-Crotonylbetaine; (E)-3-Carboxy-2-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt; Crotonobetaine; L-Carnitine Impurity; Carnitine Related Compound A
EINECS	Contact for details

Quality Control

Every batch of our Crotonylbetaine (Carnitine Impurity) (Rg) is manufactured and tested under strict quality management systems. The product is characterized and released with a comprehensive Certificate of Analysis (COA) that includes data from HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis. Our quality protocols are designed to meet the exacting standards required for pharmaceutical reference materials.

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); ensure the container is kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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