Guanethidine API | Guanethidine Monosulfate Pharmaceutical API Manufacturer in India

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Guanethidine API

Guanethidine is a peripheral adrenergic neuron-blocking agent that was historically used as an antihypertensive drug. It reduces sympathetic nervous system activity by interfering with the storage and release of norepinephrine from peripheral sympathetic nerve terminals.

Guanethidine is commonly encountered in pharmaceutical use as guanethidine monosulfate.

Guanethidine API Manufacturer in India

Guanethidine is a specialized cardiovascular pharmaceutical active ingredient. Its manufacture involves controlled chemical synthesis, purification and analytical testing to ensure consistent identity, purity, assay and impurity profile.

Chemical Information

CAS Number: 55-65-2
Molecular Formula: C10H22N4O2
Molecular Weight: 230.31 g/mol
Common Pharmaceutical Form: Guanethidine Monosulfate
Drug Class: Adrenergic Neuron Blocking Agent
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiovascular

Mechanism of Action

Guanethidine is transported into peripheral sympathetic nerve terminals through the norepinephrine transporter (NET). It becomes concentrated in storage vesicles and interferes with the release of norepinephrine.

The resulting reduction in peripheral sympathetic activity decreases vascular tone and cardiac stimulation, producing a reduction in blood pressure.

Pharmaceutical Applications

Guanethidine was developed primarily for the treatment of hypertension, particularly severe hypertension. Its use has declined substantially because newer antihypertensive medicines have more favorable safety and tolerability profiles.

Guanethidine in Blood Pressure Management

The antihypertensive action of guanethidine is associated with depletion and inhibition of peripheral norepinephrine release. This reduces sympathetic vasoconstrictor activity and can lower both vascular resistance and blood pressure.

Physical and Chemical Properties

Guanethidine is a synthetic, strongly basic guanidine-containing compound. The free compound has the molecular formula C10H22N4O2 and molecular weight 230.31 g/mol. Pharmaceutical preparations may use the sulfate salt to provide a suitable solid form.

Quality and Analytical Testing

Guanethidine API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Melting/decomposition range
  • Sulfate identification and content for the salt form
  • Particle-size analysis where applicable

Storage

Guanethidine should be stored in a tightly closed container under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should follow validated stability data and the applicable product-specific specification.

Pharmaceutical Research and Development

Guanethidine remains relevant as a reference compound for research involving peripheral sympathetic neurotransmission, norepinephrine transport and adrenergic neuron blockade.

Guanethidine API Summary

Guanethidine is a peripheral adrenergic neuron-blocking agent with CAS Number 55-65-2, molecular formula C10H22N4O2, and molecular weight 230.31 g/mol. It was historically used as an antihypertensive by reducing peripheral norepinephrine release and sympathetic activity.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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