Description

Carbidopa Impurity CAS NO 1176784-51-2 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 (API) Carbidopa, a key component in medications for Parkinson's disease. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material (CRM) for the identification and quantification of this specific impurity in Carbidopa API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation and levels of this impurity during forced degradation and long-term stability testing of pharmaceutical formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development (R&D): Used in synthetic chemistry and pharmacology research to study the formation, properties, and potential impact of this impurity.
• Pharmacopeial Testing: Applied as a reference standard for testing against specifications outlined in USP, EP, or other international pharmacopeias.

Basic Information

Product Name	Carbidopa Impurity
CAS No.	1176784-51-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carbidopa Related Compound; Carbidopa Process Impurity; Carbidopa Degradant; (2S)-3-(3,4-Dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid impurity; L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid impurity; MK-486 Impurity; Lodosyn Impurity
EINECS	Contact for details

Quality Control

Every batch of Carbidopa Impurity (CAS 1176784-51-2) is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with GMP, ICH Q3A/B guidelines, and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
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.