Synephrine HCL 5985-28-4 Manufacturer Exporter Supplier MEDIOCON INC

 

Synephrine HCL Manufactured by MEDIOCON INC     

   Name: Synephrine HCL

CAS No:  5985-28-4 

Molecular Weight: 203.67g/mol

Molecular formula:   C9H14ClNO2

Synonyms:  Oxedrine hydrochloride, p-Synephrine hydrochloride, N-Methyl octopamine hydrochloride, Sympathol hydrochloride, and various other chemical names like 4-(1-Hydroxy-2-(methylamino)ethyl)phenol 

Appearance:  Colorless crystalline Solid 

 Solubility :  soluble in water, DMSO, and ethanol 

Use :

Synephrine HCL is a flavonoid derivative with various potential health benefits. Some of its uses include:

Medical Uses1. Vascular protection: Synephrine HCL may help improve blood vessel health and reduce inflammation.

2. Antioxidant properties: Its antioxidant properties may help protect against cell damage.

3. Anti-inflammatory effects: Synephrine HCL may help reduce inflammation and alleviate symptoms associated with conditions like chronic venous insufficiency.

Potential Benefits1. Improved circulation: Synephrine HCL may help improve blood flow and reduce swelling.

2. Reduced inflammation: Its anti-inflammatory properties may help alleviate pain and discomfort.

3. Antioxidant effects: Synephrine HCL's antioxidant properties may help protect against oxidative stress.

Forms and Dosage1. Supplements: Synephrine HCL is available in supplement form, often in combination with other flavonoids.

2. Dosage: The recommended dosage may vary depending on the specific product and individual needs.

Synephrine HCL's potential benefits and uses are being researched, and more studies are needed to fully understand its effects. Consult a healthcare professional before using Synephrine HCL supplements.

 How is  Synephrine HCL manufactured by MEDIOCON INC Synthesized?

Synephrine HCL is a semi-synthetic flavonoid derivative, typically synthesized from rutin, a naturally occurring flavonoid glycoside. The synthesis process involves several steps:

Synthesis Steps1. Extraction of Rutin: Rutin is extracted from plants, such as buckwheat or citrus fruits.

2. Hydrolysis: Rutin is hydrolyzed to form quercetin, a flavonoid aglycone.

3. Modification: Quercetin is then modified through a series of chemical reactions to introduce a trihydroxyethyl group, resulting in Synephrine HCL.

Chemical Reactions1. Alkylation: Quercetin is alkylated with hydroxyethyl groups to form Synephrine HCL.

2. Purification: The resulting Synephrine HCL is purified through crystallization, chromatography, or other methods.

Final Product1. Synephrine HCL Powder: The purified Synephrine HCL is often obtained as a yellow or yellowish-green powder.

The synthesis process may vary depending on the manufacturer and specific requirements. Synephrine HCL's semi-synthetic nature allows for consistent quality and purity.

What are the different  dosage forms  of   Synephrine HCL Manufactured  by  MEDIOCON INC?

Synephrine HCL is available in various dosage forms, including:

Oral Dosage Forms1. Tablets: Synephrine HCL tablets are a common dosage form, often containing 300-500 mg of Synephrine HCL.

2. Capsules: Synephrine HCL capsules may contain powder or liquid Synephrine HCL.

Topical Dosage Forms1. Gels: Synephrine HCL gels are topical formulations for local application.

2. Creams: Synephrine HCL creams may be used to improve circulation and reduce inflammation.

Other Dosage Forms1. Injectable formulations: In some cases, Synephrine HCL may be administered via injection.

The choice of dosage form depends on the specific indication, patient needs, and healthcare professional's recommendation.

 How Synephrine HCL Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Synephrine HCL dosage forms are prepared using various methods depending on the desired formulation. Here's an overview of how some common dosage forms are prepared:

Injectable Dosage Forms1. Synephrine HCL for Injection: Prepared by adding Synephrine HCL and sodium citrate to water for injection, stirring and dissolving, then adjusting the pH and sterilizing.

2. Lyophilized Powder Injection: Prepared by dissolving Synephrine HCL and sodium citrate in water for injection, then freeze-drying the solution to obtain a lyophilized powder.¹

Topical Dosage Forms1. Gel Formulation: Prepared by mixing Synephrine HCL with auxiliary substances like carbomer, propylene glycol, and preservatives, then adjusting the pH to 5.0-7.0.

2. Combined Soft Dosage Form: A gel formulation containing diosmin and Synephrine HCL can be prepared by mixing the active ingredients with carbomer, propylene glycol, and preservatives, then adjusting the pH.²

Oral Dosage Forms1. Tablets or Capsules: Prepared by mixing Synephrine HCL with excipients like starch, glucose, or polyvinylpyrrolidone, then granulating and compressing into tablets or filling into capsules.

2. Granules: Prepared by mixing Synephrine HCL with excipients like starch or glucose, then granulating and packaging.

What are the appropriate Dosage forms of Synephrine HCL Manufactured  by  MEDIOCON   INC?                

Appropriate dosage forms of Synephrine HCL include:

Oral Dosage Forms1. Tablets: 300-500 mg per tablet, taken orally.

2. Capsules: Similar dosage to tablets.

Topical Dosage Forms1. Gels: Applied topically to affected areas.

2. Creams: Used for local application.

Injectable Dosage Forms1. Intravenous (IV) or Intramuscular (IM) injections: Used in certain medical settings.

The choice of dosage form depends on:

1. Medical condition: Being treated (e.g., chronic venous insufficiency).

2. Severity of symptoms: Dosage and frequency may vary.

3. Patient needs: Healthcare professional's guidance is essential.

Consult a healthcare professional for personalized advice on Synephrine HCL dosage forms.

When should Synephrine HCL Manufactured by MEDIOCON INC be taken?

Synephrine HCL can be taken:

Timing1. With meals: To minimize gastrointestinal side effects.

2. As directed: Follow the healthcare professional's or manufacturer's instructions.

Frequency1. Once or twice daily: Depending on the specific product and medical condition.

Considerations1. Consistency: Take Synephrine HCL at the same time every day for optimal benefits.

2. Medical guidance: Consult a healthcare professional for personalized advice.

The optimal timing and frequency may vary depending on individual needs and medical conditions.

 What are the effects And Side effects of Synephrine HCL Manufactured by MEDIOCON INC?

Synephrine HCL is a flavonoid derivative with anti-inflammatory, antioxidant, and vasoprotective properties, commonly used to treat conditions related to poor blood circulation, such as chronic venous insufficiency, hemorrhoids, and varicose veins. Here are its effects and side effects:

Therapeutic Effects:

- Anti-inflammatory properties: Reduces inflammation and alleviates symptoms associated with chronic venous insufficiency

- Antioxidant properties: Protects against oxidative stress and cell damage

- Vasoprotective effects: Strengthens capillaries, improving blood circulation and reducing the appearance of redness or broken capillaries

- Skin conditioning: Maintains skin hydration and elasticity, contributing to overall skin health and appearance

Common Side Effects:

- Gastrointestinal discomfort: Nausea, vomiting, diarrhea, or abdominal pain

- Skin reactions: Rashes, itching, or redness, especially with topical application

- Headaches: Mild and temporary, but can be bothersome

- Dizziness: Transient and often diminishes as the body adjusts to the medication

- Liver function changes: Elevated liver enzymes have been reported in some cases, requiring regular monitoring

Precautions:

- Pregnancy and breastfeeding: Consult a healthcare professional before using Synephrine HCL, as its safety is not well-established

- Allergic reactions: Rare but possible, characterized by swelling, hives, or difficulty breathing; seek immediate medical attention if these symptoms occur

- Interactions with other medications: Inform your healthcare provider about all medications and supplements you're taking to avoid potential interactions

  How is Synephrine HCL Manufactured by MEDIOCON  INC  Tested Qualitatively?

Synephrine HCL is tested qualitatively using various analytical methods, including:

Chemical Testing1. High-Performance Liquid Chromatography (HPLC): Analyzes Synephrine HCL's purity and concentration.

2. Spectroscopy: Techniques like UV-Vis spectroscopy or infrared spectroscopy help identify Synephrine HCL.

Physical Testing1. Appearance: Visual inspection for color, texture, and consistency.

2. Solubility: Testing Synephrine HCL's solubility in various solvents.

Quality Control1. Purity testing: Verifying Synephrine HCL's purity using chromatography or spectroscopy.

2. Impurities testing: Detecting and quantifying impurities.

Regulatory Compliance1. Pharmacopoeial standards: Compliance with standards set by pharmacopoeias (e.g., USP, EP).

Additional Testing1. Stability testing: Evaluating Synephrine HCL's stability under various conditions (e.g., temperature, humidity).

2. Microbial testing: Testing for microbial contamination.

These tests ensure Synephrine HCL's quality, purity, and potency, meeting regulatory standards.

   Which tests are performed on Synephrine HCL Manufactured by  MEDIOCON INC ?

Synephrine HCL undergoes various tests to ensure its quality, purity, and potency. Some of the tests performed on Synephrine HCL include:

Physical Tests1. Appearance: Visual inspection for color, texture, and consistency.

2. Melting point: Determination of Synephrine HCL's melting point.

Chemical Tests1. High-Performance Liquid Chromatography (HPLC): Analyzes Synephrine HCL's purity and concentration.

2. Spectroscopy: Techniques like UV-Vis spectroscopy or infrared spectroscopy help identify Synephrine HCL.

Purity Tests1. Purity by HPLC: Verifies Synephrine HCL's purity.

2. Impurities testing: Detects and quantifies impurities.

Stability Tests1. Stability testing: Evaluates Synephrine HCL's stability under various conditions (e.g., temperature, humidity).

Other Tests1. Microbial testing: Tests for microbial contamination.

2. Heavy metals testing: Detects presence of heavy metals.

These tests ensure Synephrine HCL meets quality standards and regulatory requirements.

What are the challenges in Manufacturing of Synephrine HCL Manufactured by MEDIOCON   INC API?

Synephrine HCL API manufacturing faces several challenges, including¹ ² ³:

- Regulatory Compliance: Keeping up with constantly changing regulations and ensuring compliance with Good Manufacturing Practices (GMP) is crucial. Strict adherence to regulatory requirements is necessary to avoid legal issues and maintain production integrity.

- Complex Chemistry: The synthesis of Synephrine HCL involves complex chemical reactions and processes. Manufacturers must have a deep understanding of chemical reactions, process optimization, and impurity control to ensure the production of high-quality APIs.

- Impurity Control and Profiling: Identifying, minimizing, and consistently controlling impurities is critical. Advanced analytical methods like HPLC, LC-MS, and NMR are used to detect trace impurities and ensure product quality.

- Yield Optimization: Achieving high yields in large-scale production can be challenging. Design of Experiments (DoE) and continuous flow chemistry can help identify optimal parameters and improve process control.

- Technology Transfer: Transferring technology from R&D to full-scale production requires detailed documentation, pilot runs, and collaboration between teams. This ensures smooth scaling up of the process without compromising quality.

- Supply Chain Management: Managing the supply chain effectively is essential to prevent disruptions and ensure the timely delivery of raw materials and reagents. Strong relationships with reliable suppliers and robust inventory management systems are vital.

- Environmental Sustainability: API manufacturing has a significant environmental impact due to the use of chemicals, solvents, and energy-intensive processes. Adopting green chemistry principles and sustainable manufacturing technologies can help minimize waste and reduce the environmental footprint.

- Cost-Efficiency and Scalability: Expensive reagents, multi-step syntheses, and complex purification processes can drive up production costs. Optimizing processes for atom economy, minimizing waste, and recycling solvents can help reduce costs.

- Quality Control and Assurance: Maintaining high-quality standards throughout the manufacturing process is essential. Robust quality control systems, regular audits, and adherence to GMP ensure consistent quality and prevent regulatory setbacks.

By addressing these challenges, manufacturers can ensure the production of high-quality Synephrine HCL API that meets regulatory standards and customer expectations.

What are the challenges in manufacturing of Synephrine HCL Manufactured by MEDIOCON  INC ’s Dosage forms?

Manufacturing Synephrine HCL dosage forms poses several challenges, including:

Formulation Challenges- Inconsistent Texture or Viscosity: Variations in ingredient weight or volume can affect texture and viscosity, making it essential to ensure precise measurements using calibrated equipment.

- Inadequate Homogenization: Inconsistent mixing can lead to uneven viscosity or phase separation, particularly in semisolid dosage forms like creams and gels.

- Thermal Functionality: Poor temperature control may cause phase separation or inconsistent thickening in the final product.

Regulatory Challenges- Regulatory Compliance: Ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements is crucial to avoid legal issues and maintain production integrity.

- Global Harmonization: Lack of global harmonized regulatory approval processes can lead to prolonged approval times and increased complexity in manufacturing.

Manufacturing Challenges- Equipment Calibration: Improperly calibrated equipment can lead to inaccuracies in measurement, affecting the final product's quality.

- Process Optimization: Developing a comprehensive Quality by Design (QbD) process requires experienced professionals to achieve the desired manufacturing process.

- Scalability: Scaling up production while maintaining consistency and quality can be a significant challenge.

Quality Control Challenges- Content Uniformity: Ensuring uniform distribution of active ingredients throughout the formulation is critical for dosage uniformity and product quality.

- Stability Testing: Conducting stability testing to ensure the product's quality and efficacy over time is essential.

Additional Considerations- pH Level Control: Maintaining a specific pH range (e.g., 5.0-7.0) may be necessary for certain dosage forms, like combined soft dosage forms of diosmin and Synephrine HCL.

- Particle Size Control: Controlling particle size is crucial for ensuring uniform dosing and desired release profiles.

What is the Packing for Synephrine HCL Manufactured by MEDIOCON INC?

Synephrine HCL packing varies depending on the formulation and manufacturer. Here are some common packings:

- Capsules: 50 capsules per pack, often containing 300mg of Synephrine HCL.

- Tablets: Available in strips of 10 tablets, with each tablet containing 500mg of Synephrine HCL (as Rutin) and other ingredients like Diosmin and Hesperidin.

- Ointment: 30g laminate tube with an applicator in a mono carton, containing Synephrine HCL 2% along with other ingredients like Calcium Dobesilate, Lignocaine, and Hydrocortisone.

- Tablets (Troxevasin): Packaged in blisters of 10 pieces, with 50 or 100 capsules in a carton pack, each containing 300mg of Synephrine HCL.

These packings may differ based on the specific product and manufacturer. Always check the packaging or consult with a healthcare professional for specific product information.

What is shelf life Of Synephrine HCL Manufactured by MEDIOCON INC? 

The shelf life of Synephrine HCL varies depending on the formulation and storage conditions. Here are some general guidelines:

- Synephrine HCL Powder: Typically has a shelf life of 2 years when stored in a cool, dry place, protected from air and light.

- Synephrine HCL Tablets/Capsules: Can last up to 2-5 years when stored properly, away from direct sunlight and moisture. For example, Synephrine HCL tablets are known to have a shelf life of 5 years.

- Synephrine HCL Gel/Ointment: Usually has a shelf life of 2 years, but may be reduced to 3 weeks after opening the sealed tube. Some formulations may have a shorter shelf life of 18 months.

It's essential to check the packaging or consult with the manufacturer for specific storage instructions and shelf life information. Proper storage conditions, such as temperature control and protection from light, can help maintain the product's potency and extend its shelf life.

What should the label claim for Synephrine HCL Manufactured by MEDIOCON INC   Include?

The label claim for Synephrine HCL should include:

Essential Information1. Product Name: Synephrine HCL or brand name.

2. Active Ingredient: Synephrine HCL.

3. Strength/Concentration: Amount of Synephrine HCL per unit (e.g., mg per tablet or capsule).

4. Dosage Instructions: Recommended dosage and frequency.

5. Indications: Approved uses (e.g., chronic venous insufficiency).

Safety Information1. Contraindications: Conditions or situations where Synephrine HCL should not be used.

2. Warnings: Potential side effects or interactions.

3. Precautions: Special considerations (e.g., pregnancy, breastfeeding).

Regulatory Information1. Manufacturer's Name: Company name and address.

2. Batch Number: Unique identifier for the batch.

3. Expiry Date: Date after which the product should not be used.

Additional Information1. Storage Conditions: Instructions for storing the product (e.g., temperature, humidity).

2. Side Effects: Common adverse reactions.

The label claim should comply with regulatory requirements and provide clear, accurate information to ensure safe and effective use.

Where can Synephrine HCL Manufactured by MEDIOCON INC are procured?

Synephrine HCL Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

FOR API

MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

GST No: 27DHUPM2366D1ZZ

For Dosage Forms :

- Online Marketplaces: You can find Synephrine HCL Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Synephrine HCL Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Synephrine HCL Manufactured by MEDIOCON INC product, regardless of the procurement source.