Description

Carbidopa Ep Impurity F is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient Carbidopa. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Carbidopa API and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC or UPLC methods for Carbidopa.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure Carbidopa batches meet pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Carbidopa under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, DMF) by providing necessary impurity characterization data for health authorities.
• Research & Development: Used in R&D to study the degradation pathways and impurity profile of Carbidopa during synthesis and formulation processes.

Basic Information

Product Name	Carbidopa Ep Impurity F
CAS No.	96115-88-7
Molecular Formula	C10H14N2O4
Molecular Weight	226.23 g/mol
Synonyms	(2S)-3-(3,4-Dihydroxyphenyl)-2-methyl-2-hydrozinylpropanoic acid; Carbidopa Impurity F; Carbidopa Related Compound F; L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid impurity; EP Impurity F of Carbidopa; USP Carbidopa Related Compound F
EINECS	Contact for details

Quality Control

Every batch of Carbidopa Ep Impurity F is manufactured and analyzed under strict quality management systems. The product is characterized and qualified against pharmacopeial standards (EP, USP) using advanced analytical techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile to ensure it meets the stringent requirements for use as a reference standard.

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) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.