Description

Carbidopa Impurity E is a specified impurity and degradation product of the active pharmaceutical ingredient Carbidopa, a key component in combination therapies for Parkinson's disease. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily used as a certified reference standard in research, development, and stringent quality control processes within the global pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Carbidopa drug substances and finished products.
• Analytical Research: Used in high-performance liquid chromatography (HPLC), mass spectrometry (MS), and other analytical techniques to identify, quantify, and characterize impurities.
• Regulatory Compliance: Essential for preparing regulatory submissions (e.g., for FDA, EMA) to demonstrate thorough impurity profiling and control strategies.
• Stability Studies: Employed to monitor the formation of degradation products in Carbidopa formulations under various stress conditions.
• Process Chemistry: Aids in the optimization of synthesis and purification processes by identifying and tracking specific impurity pathways.
• Pharmacopoeial Testing: Used to comply with testing requirements outlined in pharmacopoeias such as USP, EP, and BP for Carbidopa monographs.

Basic Information

Product Name	Carbidopa Impurity E
CAS No.	52514-63-3
Molecular Formula	C10H14N2O4
Molecular Weight	226.23 g/mol
Synonyms	(2S)-3-(3,4-Dihydroxyphenyl)-2-methyl-2-hydrazinopropanoic acid; L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid; Carbidopa Related Compound E; Carbidopa Degradant E; (S)-α-Hydrazino-3,4-dihydroxy-α-methylbenzenepropanoic acid; Lodosyn Impurity E
EINECS	Contact for details

Quality Control

Every batch of Carbidopa Impurity E is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Due to its hygroscopic nature, the container should be kept sealed in a desiccated area to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.