Description

Benserazide Hydrochloride Impurity C is a designated reference standard used for the analytical profiling and quality control of the active pharmaceutical ingredient, Benserazide Hydrochloride. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a known marker for identification and quantification during HPLC and related chromatographic analyses. It is an essential material for analytical laboratories, quality assurance departments, and research institutions involved in the development and manufacturing of pharmaceutical products containing Benserazide.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for method development, validation, and routine quality control testing of Benserazide Hydrochloride API.
• Analytical Method Development: Crucial for developing and optimizing HPLC, UPLC, or LC-MS methods to separate, identify, and quantify this specific impurity.
• Stability Studies: Used as a marker to monitor the formation of degradation products in stability testing of drug substances and finished dosage forms.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Pharmacopoeial Testing: Employed in testing to comply with pharmacopoeial monographs (e.g., USP, EP) that set limits for known and unknown impurities.
• Research & Development: Used in R&D to understand the degradation pathways and chemical behavior of Benserazide Hydrochloride.

Basic Information

Product Name	Benserazide Hydrochloride Impurity C
CAS No.	1353749-74-2
Molecular Formula	C10H15N3O5 • HCl
Molecular Weight	293.71 g/mol (Free base: 257.25 g/mol)
Synonyms	DL-Serine, 2-[(2,3,4-trihydroxyphenyl)methyl]hydrazide, hydrochloride; (RS)-2-Hydrazino-3-hydroxy-N-[(2,3,4-trihydroxyphenyl)methyl]propanamide hydrochloride; Benserazide HCl Impurity C; Benserazide Related Compound C; Ro 4-4602 Impurity C
EINECS	Contact for details

Quality Control

Every batch of Benserazide Hydrochloride Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual 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.