Description

Midodrine Hydrochloride is a potent and selective α-1 adrenergic receptor agonist, widely recognized for its therapeutic applications. This compound is critical for the pharmaceutical industry, where consistent high purity and reliable supply are paramount for manufacturing effective and safe medications. It is primarily required by pharmaceutical manufacturers and research institutions developing treatments for conditions like orthostatic hypotension.

Application

• Active Pharmaceutical Ingredient (API): The primary application is as the key active component in prescription medications for the treatment of symptomatic orthostatic hypotension.
• Pharmaceutical Formulations: Used in the development and production of various solid oral dosage forms, such as tablets and capsules.
• Clinical Research: Serves as a reference standard and investigational material in pharmacokinetic, pharmacodynamic, and bioequivalence studies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of generic and branded drug products.
• Analytical Testing: Utilized as a high-purity standard in quality control laboratories for HPLC, UV, and other chromatographic assay methods.

Basic Information

Product Name	Midodrine Hydrochloride
CAS No.	133163-28-7
Molecular Formula	C12H18N2O4•HCl
Molecular Weight	290.74 g/mol
Synonyms	Midodrine HCl; (±)-Midodrine Hydrochloride; 2-Amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide Hydrochloride; ST-1085; Gutron® (brand name); Amatine; SM-105; Glycine, N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]-, amide, hydrochloride, (±)-
EINECS	Contact for details

Quality Control

Our Midodrine Hydrochloride is manufactured under strict quality management systems. It undergoes comprehensive analytical testing to ensure it meets stringent specifications for pharmaceutical use, including identity, purity, and impurity profiles. Certificates of Analysis (COA) detailing results from tests such as HPLC assay, related substances, residual solvents, and heavy metals are provided with each batch to ensure full traceability and compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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