Description

Carbidopa Impurity 2 CAS NO 1361017-74-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Carbidopa, a key medication used in the treatment of Parkinson's disease. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining strict compliance with global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quality control and release testing of Carbidopa API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity monitoring.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require complete impurity identification and qualification data.
• Stability Studies: Employed to track the formation and growth of this specific impurity in Carbidopa formulations under various stress and shelf-life conditions.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.
• Pharmacopeial Testing: Applied as a system suitability standard in tests prescribed by USP, EP, or other pharmacopeias for Carbidopa monographs.

Basic Information

Item	Details
Product Name	Carbidopa Impurity 2
CAS No.	1361017-74-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(S)-2-Amino-3-(3,4-dihydroxybenzyl)-2-methylpropanoic acid impurity; Carbidopa Related Compound; Carbidopa Degradant; Lodosyn Impurity; MK-486 Impurity; (2S)-2-Amino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic acid impurity; Carbidopa Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Carbidopa Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation, purity assessment, and impurity profiling using advanced chromatographic and spectroscopic techniques. Certificates of Analysis (COA) containing batch-specific data are available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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