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Methyldopa is a well-established centrally acting antihypertensive agent, primarily used for the treatment of high blood pressure (hypertension). It works by stimulating central α2-adrenergic receptors, which reduce sympathetic outflow from the central nervous system, resulting in decreased peripheral vascular resistance and lowered blood pressure.
At Bluepill Express, we offer high-purity Methyldopa API manufactured under WHO-GMP, ISO 9001:2015, and cGMP conditions. Our Methyldopa is widely supplied to global markets, ensuring reliable efficacy, excellent stability, and precise compliance with international pharmacopoeial standards (IP/BP/USP/EP).
Therapeutic Uses
- Management of essential hypertension (high blood pressure)
- Preferred antihypertensive drug during pregnancy (safe and effective)
- Used in combination therapy with diuretics or other antihypertensive agents
- Helps in preventing stroke, kidney damage, and heart failure caused by high blood pressure
Mechanism of Action
Methyldopa acts as a centrally acting α2-adrenergic agonist. After conversion into α-methylnorepinephrine in the brain, it activates α2-receptors, reducing sympathetic nerve impulses. This results in:
- Vasodilation and reduced cardiac output
- Lowered blood pressure
- Minimal effect on heart rate and renal blood flow
Unlike peripheral antihypertensive drugs, Methyldopa’s central action ensures steady blood pressure control without abrupt drops.
Pharmacological Information
| Parameter | Details |
|---|---|
| Chemical Name | (S)-2-Amino-3-(3,4-dihydroxyphenyl)-2-methylpropanoic acid |
| Molecular Formula | C10H13NO4 |
| Molecular Weight | 211.22 g/mol |
| CAS Number | 555-30-6 |
| Therapeutic Category | Antihypertensive / α2-Adrenergic Agonist |
| Pharmacopoeial Standards | IP / BP / USP / EP |
Physical & Chemical Properties
| Property | Description |
|---|---|
| Appearance | White to yellowish-white crystalline powder |
| Odor | Odorless |
| Taste | Slightly bitter |
| Melting Point | 290°C (decomposes) |
| Solubility | Slightly soluble in water; insoluble in ethanol and chloroform |
| pH (1% solution) | 4.0 – 6.0 |
| Assay (on dried basis) | 98.0% – 102.0% |
Technical Specifications
| Test | Specification |
|---|---|
| Appearance | White crystalline powder |
| Identification | IR / UV / HPLC – Complies |
| Assay (Purity) | 98.0% – 102.0% |
| Loss on Drying | ≤ 1.0% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.3% (individual), ≤ 0.5% (total) |
| Heavy Metals | ≤ 10 ppm |
| Specific Rotation | +23° to +27° |
| Storage Conditions | Store below 25°C in a tightly closed container, away from light and moisture |
Applications
- Used in oral antihypertensive formulations (tablets and capsules)
- Preferred for pregnancy-induced hypertension (PIH)
- Used in combination therapy with hydrochlorothiazide, amlodipine, or atenolol
- Suitable for generic, branded, and institutional formulations
Documentation Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Data (as per ICH guidelines)
- Drug Master File (DMF) – available on request
Packaging & Export Details
| Packaging Type | Net Weight |
|---|---|
| HDPE Drum | 25 kg |
| Fiber Drum | 25 kg |
| LDPE Inner Bag | 1 kg / 5 kg / 10 kg |
Labeling Includes: Product name, batch number, manufacturing & expiry date, net weight, storage conditions.
Shelf Life: 5 years (stored below 25°C)
Export Markets: Africa, Asia, Middle East, Latin America, CIS nations
