Reserpine

Reserpine USP

Written by

Reviewed by

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Gaurav Sood

Partner - HimPharm

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Dr B M Sood

Chairman - HimPharm

Reserpine USP Manufactured by HimPharm

Category: Phytochemical, Antipsychotic and Antihypertensive Drug
Trade Names: Serpalan, Serpasil, Raudixin
Routes of Administration: Oral, Intramuscular
ATC Code: C02AA01

Identifiers

  • CAS Number: 50-55-5
  • PubChem CID: 5770
  • ChemSpider ID: 5560
  • DrugBank ID: DB01364
  • UNII: JH5845JZ2A

Chemical and Physical Data

  • Molecular Formula C33H40N2O9
  • Molar Mass 608.68 g/mol

SMILES: CC1=CC2=C(C=C1)[N+]3[C@@H]4C@HOC7=C(C4=C(C=C7)O)O

InChI: InChI=1S/C33H40N2O9/c1-35-19-7-5-17-15-21(40-3)23-13-11-29(45-31(37)9-6-18-16-32(38)41-4)27(43-25(33(39)42-17)14-12-30(35)44-23)24-20(34(2)28(19)24)8-10-36/h5,7,11,13,15,17-18,20,23,27,29-30,36-37,39H,6,8-10,12,14,16H2,1-4H3/t17-,18-,20-,23-,27+,29+,30+/m1/s1

Introduction

Reserpine USP

Reserpine stands as an indole alkaloid renowned for its dual therapeutic roles as an antipsychotic and antihypertensive drug. It has been a cornerstone in managing high blood pressure and alleviating psychotic behaviors. 

As an indole alkaloid, Reserpine acts by depleting catecholamines, among other neurotransmitters, from peripheral sympathetic nerve endings. These substances play pivotal roles in regulating heart rate, cardiac contraction force, and peripheral resistance.

Reserpine

Impact of Reserpine on Pharmaceutical, Drug, and Natural Products Industry

Reserpine’s impact on the pharmaceutical, drug, and natural products industry is deep. Its efficacy in controlling hypertension, particularly when used in combination with thiazide diuretics or vasodilators, has significantly enhanced treatment options for patients with high blood pressure. 

Moreover, Reserpine’s ability to mitigate psychotic symptoms has revolutionized the field of psychiatry, offering relief to individuals grappling with mental health disorders.

Beyond its therapeutic applications, Reserpine has found utilization in veterinary medicine, serving as a long-acting tranquilizer for excitable or challenging horses. However, its misuse in sedating show horses underscores the importance of responsible drug administration and regulatory oversight.

In pharmaceutical manufacturing, Reserpine holds strategic importance as an Active Pharmaceutical Ingredient (API). 

Its production at HimPharm adheres to stringent quality standards outlined by the United States Pharmacopoeia (USP), ensuring consistency and efficacy in pharmaceutical formulations. HimPharm, a pioneering manufacturer, upholds these standards, catering to the bulk requirements of pharmaceutical and industrial consumers worldwide.

Understanding Reserpine

What is Reserpine?

Reserpine, with a chemical formula of C33H40N2O9, embodies a complex molecular structure critical for its pharmacological activities. Its mechanism of action involves the inhibition of neurotransmitter transporters, leading to the depletion of monoamine neurotransmitters from synaptic vesicles. This action underpins its therapeutic effects in managing hypertension and psychiatric disorders.

Uses of Reserpine

Reserpine’s varied pharmacological profile enables its utilisation across diverse medical domains. Primarily, it serves as a potent anti-hypertensive agent, exerting its effects by modulating sympathetic nervous system activity. In psychiatric practice, Reserpine offers relief from psychotic symptoms, enhancing patient outcomes in conditions like schizophrenia and bipolar disorder.

Physical Characteristics of Reserpine

Reserpine presents as a crystalline powder, typically white or pale yellow in colour, with a characteristic odour. Its solubility in water is limited, but it dissolves readily in organic solvents like ethanol and chloroform. This physical profile underscores its suitability for pharmaceutical formulation and compounding.

Source and Extraction of Reserpine

The primary botanical source of Reserpine is the Rauvolfia serpentina plant, indigenous to the Indian subcontinent. The plant’s roots contain high concentrations of Reserpine, making them the primary raw material for extraction. The extraction process involves solvent-based techniques, followed by purification and concentration to obtain pharmaceutical-grade Reserpine.

Importance of Reserpine

Reserpine’s importance lies in its dual therapeutic roles as an antihypertensive and antipsychotic agent. Its efficacy, coupled with its relatively favourable tolerability profile, positions it as a valuable treatment option for diverse patient populations. Furthermore, Reserpine’s natural origin aligns with the growing preference for plant-based medicines and holistic healthcare approaches.

Industries and Applications of Reserpine

Reserpine finds applications across various industries, including pharmaceuticals, veterinary medicine, and agriculture. In pharmaceuticals, it serves as a key ingredient in antihypertensive and antipsychotic formulations. In veterinary medicine, it facilitates the tranquilisation of animals, enhancing safety during handling and medical procedures. Additionally, Reserpine’s potential as a botanical insecticide highlights its significance in agricultural pest management strategies.

History of Reserpine

Reserpine’s discovery traces back to the mid-20th century when researchers identified its therapeutic potential in managing hypertension and psychiatric disorders. Its isolation from the Rauvolfia serpentina plant marked a significant milestone in pharmacological research, paving the way for the development of novel therapeutic agents. The subsequent elucidation of its pharmacological mechanisms solidified Reserpine’s position as a cornerstone in modern medicine.

Exploring Reserpine and its use in Pharmaceuticals, Health, and Drug Industry

Reserpine Uses and Properties

Reserpine exhibits diverse pharmacological properties, owing to its ability to modulate neurotransmitter levels in the central and peripheral nervous systems. As an antihypertensive agent, it acts by depleting catecholamines from sympathetic nerve endings, thereby reducing peripheral vascular resistance and lowering blood pressure. In psychiatric practice, Reserpine’s antipsychotic properties stem from its ability to deplete dopamine and serotonin levels in the brain, attenuating psychotic symptoms and stabilizing mood.

List of Uses and Explanations

  • Antihypertensive: Reserpine’s ability to reduce blood pressure makes it invaluable in managing hypertension, especially in combination therapy regimens.
  • Antipsychotic: Reserpine offers relief from psychotic symptoms in conditions like schizophrenia and bipolar disorder, improving patient quality of life.
  • Tranquiliser: In veterinary medicine, Reserpine serves as a long-acting tranquiliser, facilitating the safe handling and management of excitable animals.

Additional Properties of Reserpine

Beyond its therapeutic uses, Reserpine exhibits additional properties with potential applications in various industries:

  • Insecticidal: Reserpine’s bioactivity against insects makes it a promising candidate for botanical insecticides, offering eco-friendly pest control solutions.
  • Botanical Medicine: Reserpine’s natural origin aligns with the growing demand for herbal remedies and plant-based medicines, reflecting consumer preferences for holistic healthcare approaches.

The Raw Material from which Reserpine is obtained: Natural Source for Reserpine

Raw Material Overview

Reserpine’s primary raw material is derived from the roots of the Rauvolfia serpentina plant, also known as Indian snakeroot. This botanical specimen, indigenous to South Asia, contains high concentrations of Reserpine and other biologically active alkaloids.

  • What is the Raw Material: The raw material for Reserpine extraction comprises the roots of the Rauvolfia serpentina plant. 
  • Where is it found: Rauvolfia serpentina is predominantly found in the tropical and subtropical regions of South Asia. 
  • What is its botanical name: Rauvolfia serpentina is the botanical name for the plant species from which Reserpine is derived.

Alternative Sources of Raw Material for Berberine Extraction

While Rauvolfia serpentina remains the primary source of Reserpine, alternative botanical specimens, such as Rauvolfia canescens and Rauvolfia vomitoria, also contain trace amounts of Reserpine. However, their commercial viability as sources of Reserpine raw material remains limited compared to Rauvolfia serpentina.

HimPharm Manufacturing Standards

HimPharm’s Role in Reserpine Production

HimPharm plays a pivotal role in Reserpine drug manufacturing , leveraging decades of expertise and state-of-the-art manufacturing facilities to ensure product quality and consistency. As a leading manufacturer of Active Pharmaceutical Ingredients (APIs), HimPharm adheres to stringent quality control measures and international regulatory standards throughout the production process.

Upholding International Quality Standards

HimPharm’s commitment to upholding international quality standards underscores its dedication to excellence. Through rigorous quality assurance protocols and adherence to Good Manufacturing Practices (GMP), HimPharm ensures that Reserpine and other plant-based APIs meet the highest quality benchmarks.

HimPharm’s Commitment to Fulfilling Bulk Requirements for Reserpine

HimPharm is a Reserpine API supplier that caters to the bulk requirements of pharmaceutical and industrial consumers worldwide, offering a reliable supply chain and scalable manufacturing capabilities. Whether servicing the needs of multinational pharmaceutical companies or niche market segments, HimPharm remains committed to fulfilling customer demands with efficiency and precision.

Reserpine Production Processes

Details of the Manufacturing Process of Reserpine

HimPharm is a Reserpine USP Manufacturer. The manufacturing process of Reserpine entails several key steps, each essential for ensuring product purity and potency:

Step 1: Raw Material Preparation: The roots of Rauvolfia serpentina undergo meticulous cleaning and drying to remove extraneous matter.

Step 2: Extraction: The dried roots are subjected to solvent-based extraction techniques to isolate Reserpine and other alkaloids.

Step 3: Purification: The crude extract undergoes purification processes, including filtration and chromatography, to remove impurities and contaminants.

Step 4: Concentration: The purified Reserpine extract is concentrated to enhance its potency and therapeutic efficacy.

Step 5: Quality Control Testing: Rigorous quality control testing is conducted at each stage of the Reserpine API production process to ensure compliance with pharmacopoeial standards and regulatory requirements for Reserpine quality standards.

Testing in Reserpine Manufacturing

Quality control testing in Reserpine manufacturing includes a range of analytical techniques and validation protocols:

  • Identity Testing: Verifying the authenticity and botanical identity of the raw material.
  • Purity Analysis: Assessing the purity of the Reserpine extract through chemical analysis and spectroscopic techniques.
  • Potency Assay: Determining the concentration of Reserpine and related alkaloids to ensure therapeutic efficacy.
  • Microbiological Testing: Screening for microbial contaminants to maintain product safety and sterility.
  • Stability Testing: Evaluating the stability of Reserpine formulations under various storage conditions to ensure shelf-life and product integrity.

Navigating Production Bottlenecks in Reserpine Manufacturing

In the dynamic landscape of pharmaceutical manufacturing, several challenges may arise during Reserpine production:

  • Raw Material Sourcing: Ensuring a consistent and reliable supply of high-quality botanical raw materials.
  • Process Optimization: Streamlining manufacturing processes to enhance efficiency and productivity.
  • Regulatory Compliance: Navigating complex regulatory requirements and ensuring adherence to international quality standards.
  • Supply Chain Logistics: Managing logistics and distribution channels to minimize lead times and ensure timely delivery of finished products.

HimPharm’s Manufacturing Advantage

HimPharm’s manufacturing advantage lies in its robust infrastructure, technological prowess, and unwavering commitment to excellence. By embracing innovation and best practices, HimPharm ensures seamless production workflows and optimal resource utilization, positioning itself as a preferred partner for Reserpine API manufacturing for pharmaceutical companies and industrial consumers worldwide.

Conclusion

In conclusion, Reserpine emerges as a versatile therapeutic agent with applications in managing hypertension, psychiatric disorders, and veterinary medicine. HimPharm’s contributions to Reserpine production underscore its commitment to quality, innovation, and customer satisfaction. 

As the pharmaceutical industry continues to evolve, HimPharm remains poised to meet the dynamic demands of the global market, driving progress and innovation in plant-based medicine.

Leveraging HimPharm’s expertise and manufacturing capabilities, stakeholders across the pharmaceutical, healthcare, and industrial sectors can access top-quality Reserpine and other plant-based APIs, ushering in a new era of healthcare innovation and patient care.

This comprehensive guide serves as a testament to the transformative power of Reserpine and HimPharm’s unwavering commitment to excellence in pharmaceutical manufacturing.

Write to or Call HimPharm to Request a Quote, COA, and MSDS.

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These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

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