Description

Methyldopa is a synthetic amino acid derivative and a centrally-acting antihypertensive agent. It is a critical active pharmaceutical ingredient (API) valued for its efficacy in managing hypertension, particularly in specific patient populations. This compound is essential for pharmaceutical manufacturers developing prescription medications for cardiovascular conditions. Its reliable synthesis and high purity are paramount for ensuring drug safety and efficacy.

Application

• Primary Pharmaceutical Use: As the active ingredient in antihypertensive medications for the treatment of high blood pressure (hypertension).
• Specialized Treatment: Management of hypertension during pregnancy (gestational hypertension), where it is often a preferred therapeutic option.
• Formulation Development: Used in the R&D and production of various oral dosage forms, primarily tablets and capsules.
• Reference Standard: Serves as a chemical reference standard in analytical laboratories for quality control and method validation.
• Biochemical Research: Employed in pharmacological studies to investigate adrenergic mechanisms and cardiovascular physiology.

Basic Information

Item	Detail
Product Name	Methyldopa
CAS No.	555-30-6
Molecular Formula	C10H13NO4
Molecular Weight	211.22 g/mol
Synonyms	L-α-Methyldopa; (S)-2-Amino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic acid; Aldomet; Dopamet; Medomet; MK-351; L-Methyldopa; 3-Hydroxy-α-methyl-L-tyrosine
EINECS	209-098-8

Quality Control

Our Methyldopa is manufactured under strict quality management systems. It is tested to meet high-purity standards relevant for pharmaceutical applications, with specifications covering identity, assay, impurity profiles, and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each batch to ensure traceability, consistency, and compliance with customer and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Specific Rotation	-25.0° to -29.0° (c=2 in 1N HCl)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
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.