Description

Carbidopa Impurity D 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 research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers, analytical laboratories, and regulatory bodies focused on ensuring the purity, safety, and efficacy of Carbidopa-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Carbidopa Impurity D in drug substances and products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for Carbidopa.
• Quality Control & Assurance: Used in routine QC testing to monitor impurity profiles and ensure compliance with ICH Q3A/B guidelines and pharmacopeial monographs (USP, EP).
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the filing of Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) dossiers with agencies like the FDA and EMA.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Carbidopa Impurity D
CAS No.	934371-48-9
Molecular Formula	C10H14N2O4
Molecular Weight	226.23 g/mol
Synonyms	(2S)-3-(3,4-Dihydroxyphenyl)-2-methyl-2-aminopropanoic acid; L-α-Methyl-α-hydrazino-3,4-dihydroxybenzenepropanoic acid impurity; Carbidopa Related Compound D; Carbidopa Degradation Product; Carbidopa Process Impurity; Lodosyn Impurity D; MK-486 Impurity D
EINECS	Contact for details

Quality Control

Every batch of Carbidopa Impurity D is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis to meet the stringent requirements of pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific results is supplied with each shipment, ensuring traceability and compliance with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

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 unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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