Midodrine Hydrochloride is an orally active sympathomimetic agent and alpha-adrenergic agonist used primarily for the management of symptomatic orthostatic hypotension. It is a prodrug that is converted to its active metabolite, desglymidodrine, which produces peripheral vasoconstriction and increases vascular tone.
Midodrine HCl is an important cardiovascular pharmaceutical API used in the manufacture of oral medicines for blood-pressure support.
Midodrine Hydrochloride is a specialized vasopressor / cardiovascular API requiring controlled manufacturing and analytical testing. Quality evaluation typically focuses on assay, identification, related substances, water content, residual solvents and other applicable pharmaceutical quality attributes.
CAS Number: 3092-17-9
Molecular Formula: C12H18N2O4·HCl
Molecular Formula as salt: C12H19ClN2O4
Molecular Weight: 290.74 g/mol
Chemical Name: 2-Amino-N-[2-(2,5-dimethoxyphenyl)-2-hydroxyethyl]acetamide monohydrochloride
Synonyms: Midodrine Hydrochloride, Midodrine HCl
Drug Class: Sympathomimetic / Alpha-Adrenergic Agonist
Therapeutic Class: Vasopressor / Antihypotensive Agent
Therapeutic Area: Cardiovascular
Primary Application: Orthostatic Hypotension
USP identifies Midodrine Hydrochloride as C12H18N2O4·HCl, molecular weight 290.74, with an assay range of 98.0–102.0% on the anhydrous basis.
Midodrine is converted to desglymidodrine, its pharmacologically active metabolite. Desglymidodrine acts as a selective alpha-adrenergic receptor agonist, producing peripheral vasoconstriction and increasing vascular resistance.
This results in:
Midodrine HCl API is primarily associated with:
The FDA chemistry documentation identifies Midodrine HCl as a blood-pressure medication used for orthostatic hypotension.
Midodrine Hydrochloride is primarily formulated as:
FDA documentation lists tablet strengths of 2.5 mg, 5 mg and 10 mg.
Midodrine Hydrochloride is described as an odorless, white crystalline powder. It is soluble in water and sparingly soluble in methanol. Its reported pKa is 7.8, pH is 3.5–5.5 for a 5% aqueous solution, and melting range is 200–203°C.
A controlled Midodrine HCl API manufacturing process may include:
Important analytical tests include:
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 3.5–5.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 200–203°C |