Description

Carbidopa Impurity F is a designated reference standard used for the analytical profiling and quality control of Carbidopa, a key active pharmaceutical ingredient. This impurity is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by enabling precise identification and quantification during development and manufacturing. It is an essential material for analytical laboratories, quality assurance departments, and research institutions focused on pharmaceutical development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Carbidopa Impurity F in drug substances and products.
• Method Development and Validation: Crucial for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC testing of Carbidopa Active Pharmaceutical Ingredient (API) batches to monitor impurity levels against ICH guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Research and Development: Facilitates process chemistry research to understand impurity formation pathways and optimize synthesis routes for Carbidopa.

Basic Information

Product Name	Carbidopa Impurity F
CAS No.	1458640-32-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Carbidopa Related Compound F; Carbidopa EP Impurity F; Carbidopa USP Impurity F; (2S)-3-(3,4-Dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid impurity; L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid impurity; MK-486 Impurity F; Lodosyn Impurity F
EINECS	Contact for details

Quality Control

Our Carbidopa Impurity F is manufactured and handled under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chromatographic purity and spectroscopic identification, 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 identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

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

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