Description

Madopar is a pharmaceutical-grade combination product primarily composed of levodopa and benserazide, used in the treatment of Parkinson's disease. Its core value lies in providing a stable and effective therapeutic agent to manage motor symptoms and improve patient quality of life. This product is essential for pharmaceutical manufacturers and compounding facilities engaged in the production of neurological disorder medications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of solid oral dosage forms (e.g., tablets, capsules) for Parkinson's disease.
• Neurological Disorder Treatment: Key component in medications designed to manage symptoms such as tremors, rigidity, and bradykinesia.
• Drug Development & Research: Serves as a reference standard and raw material in preclinical and clinical research for neurodegenerative diseases.
• Hospital & Clinical Pharmacy Compounding: Used in specialized pharmacy settings for preparing patient-specific formulations where commercial dosage forms are unsuitable.

Basic Information

Product Name	Madopar
CAS No.	37270-69-2
Molecular Formula	C10H14N2O4 • C9H15N3O5 • HCl
Molecular Weight	Levodopa: 197.19 g/mol; Benserazide HCl: 293.70 g/mol
Synonyms	Levodopa/Benserazide; Benserazide Hydrochloride and Levodopa; Levodopa/Benserazide Hydrochloride; Madopar®; Prolopa®; 3-Hydroxy-L-tyrosine / DL-Serine 2-(2,3,4-trihydroxybenzyl)hydrazide hydrochloride; L-Dopa with Benserazide; Ro 8-0576/007
EINECS	Contact for details

Quality Control

Our Madopar is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Quality is assured through comprehensive testing, including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting compliance with relevant pharmacopoeial standards (e.g., USP, EP, JP) is provided with each batch.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its light-sensitive and easily oxidized nature, it is recommended to store under an inert atmosphere for long-term stability. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Description	White or almost white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with EP/USP <61>

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