Description

Entacapone Impurity 10 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Entacapone, a medication used in the treatment of Parkinson's disease. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Entacapone API and finished dosage forms.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurity profiles.
• Quality Control (QC) Testing: Employed in routine QC testing of Entacapone batches to ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products during stability testing of pharmaceutical formulations.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Research and Development: Facilitates process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Entacapone Impurity 10
CAS No.	158693-01-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide; Entacapone Nitro Impurity; Entacapone Related Compound; (2E)-2-Cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide; Tolcapone Impurity; COMT Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Entacapone Impurity 10 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment 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 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	Yellow to brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.