Metopimazine API

Metopimazine API: Premium Quality Bulk Supply by Ayurvite Wellness Pvt. Ltd.

In the highly specialized field of pharmaceuticals, the quality and consistency of Active Pharmaceutical Ingredients (APIs) are critical to the efficacy and safety of medicinal products. Ayurvite Wellness Pvt. Ltd. is a leading exporter of Metopimazine API, committed to delivering superior quality ingredients that meet global regulatory standards. Our state-of-the-art manufacturing facilities, dedicated research and development team, and stringent quality assurance protocols make us the preferred partner for pharmaceutical companies worldwide. This detailed product page explores the various facets of Metopimazine API, including its chemical properties, mechanism of action, therapeutic uses, manufacturing excellence, and the unique benefits of partnering with Ayurvite Wellness.

What is Metopimazine API?

Metopimazine is a potent antiemetic and prokinetic agent belonging to the phenothiazine class of drugs. It is primarily used in the management of nausea and vomiting associated with various conditions, including chemotherapy-induced nausea, motion sickness, and postoperative recovery. As an API, Metopimazine serves as the active ingredient in a wide range of pharmaceutical formulations, ensuring the therapeutic efficacy of antiemetic medications.

Chemical Composition

Metopimazine Dihydrochloride is a well-defined chemical compound with specific properties that contribute to its pharmacological effects.

IUPAC Name: 1-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-yl)-N,N-dimethylpropan-2-amine dihydrochloride
Molecular Formula: C₂₀H₂₆N₂O₂·2HCl
Molecular Weight: 330.43 g/mol
CAS Number: 814-45-1

Chemical Specifications

Appearance: White to off-white crystalline powder
Purity: ≥ 99.0%
Solubility: Soluble in water, ethanol, and methanol
Melting Point: 200-205°C
pH: 7.0-7.5 (1% solution)

Mechanism of Action

Metopimazine Dihydrochloride functions primarily as an antagonist of dopamine D₂ receptors in the chemoreceptor trigger zone of the brain. By blocking these receptors, it effectively inhibits the action of dopamine, a neurotransmitter involved in the vomiting reflex. This action helps in preventing and controlling nausea and vomiting.

Dopamine Antagonism: Metopimazine binds to D₂ receptors, preventing dopamine from activating these receptors, thereby reducing the emetic response.
Prokinetic Effects: It also enhances gastrointestinal motility by stimulating the release of acetylcholine, which promotes peristalsis and improves gastric emptying.
Serotonin Receptor Interaction: Metopimazine exhibits affinity for certain serotonin receptors, contributing to its overall antiemetic profile.

Indications and Therapeutic Uses

Metopimazine Dihydrochloride API is utilized in the formulation of medications aimed at treating various conditions related to nausea and vomiting. Its primary therapeutic applications include:

Chemotherapy-Induced Nausea and Vomiting (CINV): Effective in managing acute and delayed nausea and vomiting associated with cancer chemotherapy.
Postoperative Nausea and Vomiting (PONV): Alleviates nausea and vomiting following surgical procedures, enhancing patient comfort and recovery.
Motion Sickness: Provides relief from nausea and vomiting caused by motion, such as in travel or other activities involving movement.
Gastrointestinal Disorders: Addresses nausea and vomiting associated with various gastrointestinal conditions, including gastritis and gastroenteritis.
Vertigo-Associated Nausea: Helps manage nausea and vomiting resulting from vertigo and other balance disorders.

Pharmacokinetics

Understanding the pharmacokinetic profile of Metopimazine Dihydrochloride is essential for optimizing its therapeutic use and ensuring patient safety.

Absorption: Well-absorbed from the gastrointestinal tract with peak plasma concentrations reached within 2-4 hours post-administration.
Distribution: Widely distributed throughout the body, including the central nervous system, due to its ability to cross the blood-brain barrier.
Metabolism: Metabolized in the liver via cytochrome P450 enzymes, primarily CYP3A4 and CYP2D6.
Excretion: Excreted mainly through renal pathways, with metabolites being eliminated in the urine.
Half-Life: Approximately 10-12 hours, allowing for multiple dosing regimens throughout the day.

Quality Assurance and Manufacturing Excellence

At Ayurvite Wellness Pvt. Ltd., quality is the cornerstone of our manufacturing philosophy. Our Metopimazine Dihydrochloride API is synthesized and processed in compliance with the highest international standards, ensuring purity, potency, and safety.

Manufacturing Facilities

Our state-of-the-art manufacturing units are equipped with advanced technologies and operated by a team of experienced chemists and quality control experts. Located in key pharmaceutical hubs, our facilities adhere to stringent Good Manufacturing Practices (GMP) guidelines, ensuring consistent and reliable API production.

Quality Control Measures

Raw Material Verification: All raw materials undergo rigorous testing to confirm their identity, purity, and compliance with specifications before use.
In-Process Testing: Continuous monitoring during the synthesis and processing stages ensures adherence to quality parameters and early detection of deviations.
Final Product Testing: Comprehensive analytical testing, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Infrared (IR) spectroscopy, and dissolution studies, guarantees the API meets all required specifications.
Stability Testing: Our APIs undergo stability assessments to determine shelf-life and ensure efficacy over time under various storage conditions.

Certifications and Compliance

Ayurvite Wellness Pvt. Ltd. holds multiple certifications attesting to our commitment to quality and regulatory compliance:

ISO 9001:2015: Demonstrates our dedication to quality management systems.
cGMP Certification: Confirms our adherence to current Good Manufacturing Practices.
FDA Approval: Our manufacturing facilities are approved by the U.S. Food and Drug Administration, facilitating seamless export to global markets.
EU GMP Compliance: Ensures our APIs meet the stringent quality standards required by the European Union.

Regulatory Approvals

Navigating the complex landscape of global pharmaceutical regulations is a testament to our expertise and reliability. Ayurvite Wellness Pvt. Ltd. ensures that our Metopimazine Dihydrochloride API complies with the regulatory requirements of major markets, including:

United States (FDA)
European Union (EMA)
Japan (PMDA)
India (DCGI)
Middle East (SFDA, MFDS)
South East Asia (BPOM, TGA)

Our comprehensive documentation and quality assurance processes facilitate smooth regulatory approvals, enabling our clients to bring their products to market swiftly and efficiently.

Applications of Metopimazine API

Metopimazine Dihydrochloride API’s versatile pharmacological profile makes it a valuable ingredient in various pharmaceutical formulations. Key applications include:

Oral Tablets and Capsules: Widely used in the formulation of prescription medications aimed at treating nausea and vomiting associated with various conditions.
Syrups and Solutions: Incorporated into liquid formulations for patients who have difficulty swallowing solid dosage forms, offering easy administration and rapid onset of action.
Injectable Forms: Utilized in specialized formulations requiring intravenous or intramuscular delivery for acute management of severe nausea and vomiting.
Suppositories: Developed for patients who are unable to take oral medications, ensuring effective treatment of nausea and vomiting.
Combination Therapies: Employed in multi-API formulations to target multiple symptoms simultaneously, enhancing therapeutic outcomes.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Metopimazine API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Metopimazine Dihydrochloride API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Our Metopimazine Dihydrochloride API is manufactured under stringent quality controls, ensuring each batch meets the highest standards of purity and efficacy. We employ advanced analytical techniques and adhere to global quality benchmarks, providing our clients with reliable and consistent API supply.

Competitive Pricing

Understanding the financial dynamics of the pharmaceutical industry, we offer our Metopimazine Dihydrochloride API at competitive prices without compromising on quality. Our efficient manufacturing processes and economies of scale enable us to deliver cost-effective solutions to our clients.

Global Supply Chain Expertise

With an extensive global distribution network, Ayurvite Wellness Pvt. Ltd. ensures timely and secure delivery of Metopimazine Dihydrochloride API to any corner of the world. Our logistics team is adept at navigating international shipping regulations, ensuring smooth and hassle-free procurement for our clients.

Customization and Flexibility

We recognize that different clients have unique requirements. Whether it’s specific mesh sizes or customized packaging, we offer flexible solutions to meet your precise needs. Our dedicated R&D team works closely with clients to develop bespoke formulations that align with their product specifications.

Regulatory Support

Navigating regulatory landscapes can be challenging. Our team of regulatory experts provides comprehensive support, assisting clients in obtaining necessary certifications and ensuring compliance with regional and international regulations. This support accelerates the time-to-market for your pharmaceutical products.

Sustainability and Ethical Practices

At Ayurvite Wellness Pvt. Ltd., we prioritize sustainable and ethical manufacturing practices. Our processes are designed to minimize environmental impact, and we adhere to ethical labor standards, ensuring that our operations contribute positively to society and the environment.

Manufacturing Process of Metopimazine API

The synthesis of Metopimazine Dihydrochloride API involves meticulous processes to ensure the highest quality and efficacy. Below is an overview of our manufacturing process:

Synthesis of Metopimazine Base

Raw Material Preparation: High-purity starting materials are selected and subjected to preliminary purification to eliminate impurities.
Chemical Synthesis: Metopimazine is synthesized through a multi-step chemical reaction involving the condensation of appropriate precursors under controlled conditions.
Purification: The crude Metopimazine base undergoes recrystallization and other purification techniques to achieve the desired purity level.
Characterization: The purified base is characterized using analytical techniques such as Nuclear Magnetic Resonance (NMR), Infrared (IR) spectroscopy, and mass spectrometry to confirm its structure and purity.

Formation of Metopimazine Dihydrochloride

Hydrochloride Salt Formation: The purified Metopimazine base is reacted with hydrochloric acid to form the dihydrochloride salt, enhancing its solubility and stability.
Crystallization: The reaction mixture is crystallized to obtain pure Metopimazine Dihydrochloride crystals.
Drying and Milling: The crystals are dried under controlled conditions and milled to achieve the desired particle size and consistency.

Quality Control and Assurance

Blending: Metopimazine Dihydrochloride is blended to ensure uniform distribution of the API.
Final Quality Testing: Comprehensive testing, including assay, purity, and dissolution studies, is conducted to verify that the API meets all specified criteria.
Packaging: The finished API is packaged in moisture-proof and contamination-resistant containers, ensuring stability and longevity.

Stability and Shelf Life

Metopimazine Dihydrochloride API manufactured by Ayurvite Wellness Pvt. Ltd. exhibits excellent stability under recommended storage conditions. Our stability testing ensures that the API maintains its efficacy, potency, and safety over its intended shelf life.

Storage Conditions: Store in a cool, dry place away from direct sunlight and moisture.
Shelf Life: Typically, the Metopimazine Dihydrochloride API has a shelf life of 24 months from the date of manufacture when stored under optimal conditions.

Safety and Handling

Handling Metopimazine Dihydrochloride API requires adherence to safety protocols to ensure the well-being of personnel and maintain product integrity.

Safety Precautions

Personal Protective Equipment (PPE): Wear appropriate PPE, including gloves, safety goggles, and lab coats, to prevent direct contact.
Ventilation: Ensure adequate ventilation in the workspace to avoid inhalation of dust or vapors.
Storage: Store the API in labeled, secure containers away from incompatible substances.

First Aid Measures

Inhalation: Move to fresh air immediately. Seek medical attention if symptoms persist.
Skin Contact: Rinse affected area with plenty of water. Remove contaminated clothing and seek medical advice if irritation occurs.
Eye Contact: Rinse thoroughly with water for at least 15 minutes and seek medical assistance.
Ingestion: Rinse mouth and seek medical attention immediately.

Disposal Considerations

Dispose of Metopimazine Dihydrochloride API and its containers in accordance with local, regional, and national regulations. Avoid releasing the substance into the environment to prevent contamination.

Packaging and Delivery

Ayurvite Wellness Pvt. Ltd. offers flexible packaging solutions tailored to the specific needs of our clients. Our Metopimazine Dihydrochloride API is available in bulk quantities to facilitate ease of handling and storage.

Packaging Options

Bulk Packaging: Available in 10 kg, 25 kg, 50 kg, and 100 kg drums for large-scale manufacturing needs.

Delivery Logistics

Our robust logistics network ensures timely and secure delivery of Metopimazine Dihydrochloride API to any destination worldwide. We collaborate with trusted shipping partners to facilitate efficient transportation, whether by air, sea, or land.

Documentation: Comprehensive documentation, including Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS), and regulatory compliance certificates, accompany each shipment.
Tracking: Real-time tracking options are available to monitor the status of your order from dispatch to delivery.
Customs Clearance: Our experienced team assists with customs clearance processes to minimize delays and ensure smooth entry into the destination country.

Benefits of Choosing Ayurvite Wellness Pvt. Ltd. for Metopimazine API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Metopimazine Dihydrochloride API needs offers numerous advantages that set us apart in the pharmaceutical API export sector.

Uncompromising Quality

Competitive Pricing

Global Supply Chain Expertise

Customization and Flexibility

Regulatory Support

Sustainability and Ethical Practices

Frequently Asked Questions (FAQs)

1. What is Metopimazine Dihydrochloride API used for?

Metopimazine Dihydrochloride API is primarily used in the formulation of antiemetic medications aimed at treating nausea and vomiting associated with various conditions, including chemotherapy, surgery, motion sickness, and gastrointestinal disorders.

2. Does Ayurvite Wellness Pvt. Ltd. offer custom formulations of Metopimazine API?

Yes, we offer customized formulations to meet specific client requirements, including adjustments in mesh size and customized packaging formats.

3. What certifications does Ayurvite Wellness hold for Metopimazine Dihydrochloride API?

Our Metopimazine Dihydrochloride API is manufactured in facilities certified with ISO 9001:2015, cGMP, and holds approvals from regulatory bodies such as the US FDA, EU EMA, Japan PMDA, and more.

4. How does Ayurvite ensure the quality of Metopimazine Dihydrochloride API?

We implement rigorous quality control measures at every stage of the manufacturing process, including raw material verification, in-process testing, final product analysis, and stability testing to ensure the highest quality standards.

5. What is the typical shelf life of Metopimazine Dihydrochloride API?

Our Metopimazine Dihydrochloride API typically has a shelf life of 24 months when stored under recommended conditions—cool, dry places away from direct sunlight and moisture.

6. Can Ayurvite Wellness Pvt. Ltd. handle large-scale bulk orders of Metopimazine Dihydrochloride API?

Absolutely. Our manufacturing facilities have a total reactor volume exceeding 1200 KL, enabling us to accommodate extensive API requirements for large-scale pharmaceutical productions.

7. What packaging options are available for Metopimazine Dihydrochloride API?

We offer bulk packaging options in 10 kg, 25 kg, 50 kg, and 100 kg drums, tailored to meet large-scale manufacturing needs.

8. How does Ayurvite manage international shipments of Metopimazine Dihydrochloride API?

Our experienced logistics team ensures that all international shipments comply with local and international regulations. We provide comprehensive documentation, real-time tracking, and assist with customs clearance to ensure seamless delivery.

9. What safety measures are in place during the manufacturing of Metopimazine Dihydrochloride API?

Our manufacturing facilities adhere to stringent safety protocols, including the use of Personal Protective Equipment (PPE), proper ventilation systems, and secure storage practices to ensure the safety of our personnel and the integrity of the product.

10. How can I place an order for Metopimazine Dihydrochloride API with Ayurvite Wellness Pvt. Ltd.?

You can place an order or make an inquiry by visiting our contact page at https://apiexporter.com/contact/. Our customer service representatives will guide you through the ordering process and assist with any specific requirements you may have.

Conclusion

In the realm of pharmaceutical APIs, Ayurvite Wellness Pvt. Ltd. distinguishes itself through an unwavering commitment to quality, regulatory excellence, and customer satisfaction. Our Metopimazine Dihydrochloride API embodies these values, offering pharmaceutical manufacturers a reliable, high-quality ingredient essential for developing effective and safe antiemetic medications. Partner with us to leverage our expertise, state-of-the-art facilities, and global reach, ensuring your products meet the highest standards and achieve market success.

For inquiries, quotations, or further information about our Metopimazine Dihydrochloride API, please visit our contact page at https://apiexporter.com/contact/.

Quantity	10 kg, 25 kg, 50 kg, 100 kg