Methyldopa
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Category：Chemical Additives MOQ:100KG Shipped directly from China
Introduction
Methyldopa, antihypertensive drug, α Receptor agonists are commonly used in tablets. This product is a kind of stimulant for vascular motor center α- Receptors, thus inhibiting the external sensory nerve, producing a hypotensive effect, accompanied by slowing down the heart rate, reducing the cardiac output, dilating the arterioles, significantly reducing the resistance of peripheral blood vessels, and not significantly reducing the cardiac output during long-term application.
Product Overview
Methyldopa is a centrally acting antihypertensive agent that functions as an α₂-adrenergic receptor agonist. It is primarily used to manage hypertension during pregnancy and in patients with renal impairment. This document outlines its physicochemical properties, pharmacological effects, and regulatory compliance.
Basic Physicochemical Properties
| Property | Specification | Test Method |
|---|---|---|
| Chemical Name | L-3-(3.4-Dihydroxyphenyl)-2-methylalanine | IUPAC nomenclature |
| Molecular Formula | C₁₀H₁₃NO₄ | Elemental analysis |
| Molecular Weight | 211.21 g/mol | Mass spectrometry |
| Appearance | White to pale yellow crystalline powder | Visual inspection |
| Solubility (25°C) | Sparingly soluble in water (~10 mg/mL) | USP <911> |
Pharmacological Profile
| Parameter | Value/Description | Reference Standard |
|---|---|---|
| Mechanism of Action | Converted to α-methylnorepinephrine in CNS | FDA label |
| Bioavailability | ~25% (oral) | Clinical studies |
| Half-life (t₁/₂) | 1.5–2 hours | Pharmacokinetic data |
| Protein Binding | <15% | In vitro studies |
| Excretion | 70% renal (unchanged) | EMA assessment report |
Therapeutic Applications & Dosage
| Medical Condition | Recommended Dosage | Maximum Daily Dose |
|---|---|---|
| Hypertension (adults) | 250–2000 mg/day (divided doses) | 3000 mg |
| Hypertension in pregnancy | 500–2000 mg/day | 3000 mg |
| Hypertensive emergencies | IV formulation available | Per physician discretion |
Pharmacopoeial Compliance
| Standard | Requirement | Compliance Status |
|---|---|---|
| USP-NF | Meets monograph standards | Compliant |
| Ph. Eur. | Conforms to EP 10.0 | Compliant |
| BP 2023 | Meets British Pharmacopoeia | Compliant |
| ICH Q3D (Impurities) | Heavy metals <20 ppm | Compliant |
| Residual Solvents | Class 2/3 limits per ICH Q3C | Compliant |
Stability & Storage Conditions
| Parameter | Specification |
|---|---|
| Storage temperature | 15–30°C (controlled room temp) |
| Shelf life | 24 months (unopened) |
| Light sensitivity | Protect from light |
| Packaging | Amber glass bottles or Alu-Alu blisters |
| Regulatory status | FDA/EMA-approved prescription drug |
Conclusion
Methyldopa remains a safe and effective antihypertensive, particularly in pregnancy and renal impairment. Its unique CNS-mediated mechanism and established safety profile make it a preferred choice in specific patient populations.
Disclaimer: The above content is for reference and communication only among industry insiders, and does not guarantee its accuracy or completeness. According to relevant laws and regulations and the regulations of this website, units or individuals who purchase related items should obtain valid qualifications and qualification conditions.
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