Phenyramidol API

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

In the competitive landscape of pharmaceutical manufacturing, the quality and reliability of Active Pharmaceutical Ingredients (APIs) are paramount. Ayurvite Wellness Pvt. Ltd. stands as a beacon of excellence in the API export sector, offering high-quality Phenyramidol API to pharmaceutical companies worldwide. Our commitment to superior quality, stringent regulatory compliance, and customer-centric services makes us the preferred partner for bulk API procurement. This comprehensive product page delves into every aspect of Phenyramidol API, highlighting its significance, applications, manufacturing excellence, and the unparalleled advantages of partnering with Ayurvite Wellness.

What is Phenyramidol API?

Phenyramidol is a widely recognized combination drug primarily used for its antihistamine, antitussive, and sedative properties. The API form of Phenyramidol serves as the foundational component in the formulation of various pharmaceutical products aimed at alleviating allergy symptoms, suppressing coughs, and providing sedation.

Chemical Composition

Phenyramidol typically comprises two active pharmaceutical ingredients:

Triprolidine Hydrochloride: An antihistamine that mitigates allergic reactions by blocking histamine receptors.
Pseudoephedrine Hydrochloride: A decongestant that reduces nasal congestion by constricting blood vessels in the nasal passages.

The combination of these two compounds in Phenyramidol provides a synergistic effect, enhancing therapeutic efficacy while minimizing side effects.

Chemical Specifications

IUPAC Name:
- Triprolidine Hydrochloride: 1,2,3,4-tetrahydronaphthalen-1-yl-N,N-dimethyl-2-propanamine hydrochloride
- Pseudoephedrine Hydrochloride: (1S,2S)-2-methylamino-1-phenylpropan-1-ol hydrochloride
Molecular Formula:
- Triprolidine Hydrochloride: C₁₉H₂₃ClN₂O
- Pseudoephedrine Hydrochloride: C₁₀H₁₅NO₂·HCl
Molecular Weight:
- Triprolidine Hydrochloride: 345.97 g/mol
- Pseudoephedrine Hydrochloride: 198.63 g/mol

Mechanism of Action

Triprolidine Hydrochloride

Triprolidine is a first-generation antihistamine that exerts its effects by competitively inhibiting the action of histamine at H₁ receptors. By blocking these receptors, Triprolidine effectively reduces the physiological effects of histamine, such as vasodilation, increased vascular permeability, and smooth muscle contraction, thereby alleviating symptoms of allergic reactions like itching, sneezing, and runny nose.

Pseudoephedrine Hydrochloride

Pseudoephedrine acts as a sympathomimetic agent, primarily exerting its decongestant effects through the stimulation of α-adrenergic receptors. This stimulation leads to vasoconstriction in the nasal mucosa, reducing swelling and congestion. Additionally, Pseudoephedrine’s indirect action on dopamine receptors contributes to its stimulating effects, counteracting the sedative properties of Triprolidine.

Synergistic Effect

The combination of Triprolidine and Pseudoephedrine in Phenyramidol provides a balanced therapeutic profile. While Triprolidine mitigates allergic symptoms, Pseudoephedrine alleviates nasal congestion, ensuring comprehensive relief. Moreover, Pseudoephedrine’s stimulating effects help counteract the sedation induced by Triprolidine, offering patients a more functional state post-administration.

Indications and Therapeutic Uses

Phenyramidol API is integral in the formulation of medications designed to treat a variety of conditions related to allergies and respiratory congestion. Its primary indications include:

Allergic Rhinitis: Effective in managing symptoms such as sneezing, itching, and runny nose caused by seasonal or perennial allergies.
Common Cold: Alleviates nasal congestion and related discomforts associated with viral upper respiratory infections.
Hay Fever: Provides relief from airborne allergens that trigger hay fever symptoms.
Non-Allergic Rhinitis: Addresses nasal congestion without the presence of an allergic component.
Cough Suppression: Pseudoephedrine’s decongestant properties aid in reducing cough frequency by alleviating postnasal drip.
Seasonal Allergies: Offers comprehensive symptom relief during allergy seasons characterized by high pollen counts.

Pharmacokinetics

Understanding the pharmacokinetic profile of Phenyramidol’s constituents is crucial for optimizing therapeutic outcomes.

Triprolidine Hydrochloride

Absorption: Rapidly absorbed from the gastrointestinal tract.
Distribution: Widely distributed throughout the body, including crossing the blood-brain barrier, which contributes to its sedative effects.
Metabolism: Metabolized primarily in the liver via oxidation and conjugation pathways.
Excretion: Excreted mainly through renal routes as unchanged drug and metabolites.

Pseudoephedrine Hydrochloride

Absorption: Well-absorbed from the gastrointestinal tract with peak plasma concentrations achieved within 1-3 hours post-administration.
Distribution: Distributes extensively in body tissues, with significant penetration into the nasal mucosa.
Metabolism: Minimal metabolism; primarily excreted unchanged in the urine.
Excretion: Eliminated predominantly via renal pathways.

Quality Assurance and Manufacturing Excellence

At Ayurvite Wellness Pvt. Ltd., quality is the cornerstone of our manufacturing philosophy. Our Phenyramidol 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 HPLC, GC, 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 Phenyramidol 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 Phenyramidol API

Phenyramidol 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 over-the-counter and prescription medications aimed at relieving allergy symptoms and nasal congestion.
Syrups and Solutions: Incorporated into liquid formulations for pediatric and adult populations, offering easy administration and rapid onset of action.
Injectable Forms: Utilized in specialized formulations requiring intravenous or intramuscular delivery.
Suspensions and Granules: Developed for patients who have difficulty swallowing solid dosage forms.
Combination Therapies: Employed in multi-API formulations to target multiple symptoms simultaneously, enhancing therapeutic outcomes.

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

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

Uncompromising Quality

Our Phenyramidol 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 Phenyramidol 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 Phenyramidol 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, customized packaging, or tailored dosage forms, 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 are committed to sustainable and ethical manufacturing practices. Our processes minimize environmental impact, and we adhere to ethical labor practices, ensuring that our operations contribute positively to society and the planet.

Manufacturing Process of Phenyramidol API

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

Synthesis of Triprolidine Hydrochloride

Raw Material Preparation: High-purity starting materials are selected and subjected to preliminary purification.
Chemical Synthesis: Triprolidine is synthesized through a multi-step chemical reaction involving the alkylation of appropriate precursors under controlled conditions.
Purification: The crude product undergoes crystallization and recrystallization to remove impurities, ensuring a high degree of purity.
Hydrochloride Formation: The purified base is converted into its hydrochloride salt form through acidification, enhancing solubility and stability.
Drying and Milling: The final product is dried and milled to achieve the desired particle size and consistency.

Synthesis of Pseudoephedrine Hydrochloride

Raw Material Preparation: Select high-grade precursors are purified to eliminate contaminants.
Chemical Synthesis: Pseudoephedrine is synthesized via reduction of appropriate nitro precursors under controlled conditions.
Purification: The intermediate product undergoes purification steps, including filtration and crystallization, to attain high purity levels.
Hydrochloride Formation: The base is converted into its hydrochloride salt by reaction with hydrochloric acid, improving solubility.
Drying and Milling: The final salt is dried and milled to the specified particle size for uniformity in formulations.

Combination and Quality Control

Blending: Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride are blended in precise ratios to ensure uniform distribution.
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

Phenyramidol 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 Phenyramidol API has a shelf life of 24 months from the date of manufacture when stored under optimal conditions.

Safety and Handling

Handling Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 Phenyramidol API

Partnering with Ayurvite Wellness Pvt. Ltd. for your Phenyramidol 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

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

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.

Frequently Asked Questions (FAQs)

1. What is Phenyramidol API used for?

Phenyramidol API is primarily used in the formulation of medications aimed at treating allergies, nasal congestion, and coughs. It combines the antihistamine Triprolidine Hydrochloride with the decongestant Pseudoephedrine Hydrochloride to provide comprehensive symptom relief.

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

Our Phenyramidol 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 Phenyramidol 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 Phenyramidol API?

Our Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 Phenyramidol 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 unwavering commitment to quality, regulatory excellence, and customer satisfaction. Our Phenyramidol API embodies these values, offering pharmaceutical manufacturers a reliable, high-quality ingredient essential for developing effective and safe 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 Phenyramidol API, please visit our contact page at https://apiexporter.com/contact/.

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