Description

Benserazide Impurity C CAS NO 787504-88-5 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 Benserazide, a key component in combination therapies 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 maintaining strict compliance with Good Manufacturing Practice (GMP) and international pharmacopeial standards.

Application

• Pharmaceutical Quality Control (QC): Serves as a certified reference material for the identification and quantification of Benserazide Impurity C in drug substances and finished products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity profiling.
• Stability Studies: Employed to monitor the formation of this specific degradation product in Benserazide under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development (R&D): Used in pharmacokinetic and metabolic studies to understand the degradation pathways of Benserazide.
• Contract Research Organizations (CROs): Utilized by CROs providing analytical testing services to the pharmaceutical industry.
• Pharmacopeial Standards: Can be used as a working standard in conjunction with official pharmacopeia monographs (e.g., USP, EP).

Basic Information

Item	Detail
Product Name	Benserazide Impurity C
CAS No.	787504-88-5
Molecular Formula	C10H15N3O5
Molecular Weight	257.25 g/mol
Synonyms	DL-Serine, 2-[(2,3,4-trihydroxyphenyl)methyl]hydrazide; Benserazide Related Compound C; Benserazide Degradation Product; Ro 4-5127 Impurity C; (RS)-2-Amino-3-hydroxy-N'-(2,3,4-trihydroxybenzyl)propanehydrazide; L-Dopa decarboxylase inhibitor impurity; 2-Hydrazino-3-hydroxy-N-(2,3,4-trihydroxybenzyl)propionamide
EINECS	Contact for details

Quality Control

Every batch of Benserazide Impurity C is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the highest standards for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical development under GMP and ICH Q3A/B guidelines.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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