Synephrine 94-07-5 Manufacturer Exporter Supplier MEDIOCON INC
Synephrine Manufactured
by MEDIOCON INC
Name: Synephrine
CAS No: 94-07-5
Molecular Weight: 167.21g/mol
Molecular formula: C9H13NO2
Synonyms: p-Synephrine; Oxedrine; 4, β-Dihydroxy-N-methylphenethylamine
Appearance: colorless crystalline Solid.
Solubility : Soluble in water
Use :
Synephrine
is a multifaceted compound with various uses, ranging from medical applications
to weight loss and sports performance enhancement. Here are some of its primary
uses:
- Medical
Applications
- Decongestant: Synephrine is used to
relieve nasal congestion caused by colds and hay fever, with noticeable effects
within 15-30 minutes.
- Pupil Dilation: Ophthalmic formulations
of synephrine are used to dilate pupils during eye exams or surgeries.
- Hypotension Treatment: Synephrine
injections help treat low blood pressure caused by shock or anesthesia.
- Hemorrhoid Relief: Topical formulations
provide relief from hemorrhoid symptoms.
- Weight
Loss and Sports Performance
- Fat Burning: Synephrine increases
thermogenesis, helping the body burn more calories and fat, which can aid in
weight loss.
- Energy Enhancement: It provides more
energy for physical activities, making it popular among athletes and
individuals seeking to improve their workout performance.
- Appetite Suppression: Synephrine may help
reduce appetite, supporting weight loss efforts.
- Other
Potential Benefits
- Anti-Inflammatory Effects: Synephrine has
shown promise in reducing inflammation and oxidative stress.
- Antimicrobial Properties: Laboratory
studies suggest synephrine may inhibit the growth of certain bacteria and
fungi.
- Improved Concentration: Some users report
enhanced mental performance and focus when taking synephrine.
How
is Synephrine manufactured by MEDIOCON INC Synthesized?
Synephrine can be synthesized through various
methods, including:
- Chemical Synthesis: One method involves
reacting phenol with acetyl chloride or diacetyl oxide to produce phenol
acetate, which then undergoes Friedel-Crafts rearrangement, bromination,
amination, and reduction to form synephrine.
- Hoesch Acylation Reaction: Another method uses
phenol as the main raw material, reacting it with N-methylamino acetonitrile
hydrochloride in the presence of a Lewis acid catalyst to generate
corresponding ketimine, which is then hydrolyzed to obtain
1-(4-hydroxyphenyl)-2-(methylamino) acetophenone hydrochloride. This
intermediate is then reduced through Pd/C catalytic hydrogenation to produce
synephrine hydrochloride.
- Plant-Based Synthesis: Synephrine is also
naturally produced in certain plants, such as Citrus aurantium, through a
biosynthetic pathway involving tyrosine, tyramine, and N-methyltyramine.
- Derivative Synthesis: Researchers have also
synthesized synephrine derivatives, such as
2-(hexylamino)-1-(4-nitrophenyl)ethanol, which have shown potential anti-cancer
activity.¹ ²
The synthesized synephrine can be further
processed to obtain its hydrochloride or tartrate forms, which have various
applications in pharmaceuticals and dietary supplements.
What are
the different dosage forms of Synephrine
Manufactured by MEDIOCON INC?
Synephrine dosage forms vary depending on the intended use and product
formulation. Here are some common dosage forms and their corresponding dosages:
- Weight Loss and Energy Enhancement
- Typical Dosage: 4-20 mg of
synephrine per day, often found in standardized citrus aurantium extract
supplements (200-600 mg per pill, containing 3-6% synephrine).
- Effective Dosage: 10-53 mg of
synephrine per day has been shown to be effective for weight management.
- Athletic Performance
- Acute Intake: 100-200 mg of
bitter orange extract (containing synephrine) taken before exercise may enhance
athletic performance.
- Other Forms
- Injection: Synephrine
injections are used to treat hypotension caused by shock or anesthesia.
- Ophthalmic Formulation: Used
to dilate pupils and induce vasoconstriction.
- Intranasal Formulation: Used
to treat nasal congestion.
- Topical Formulation: Used to
relieve hemorrhoids.
It's essential to follow the manufacturer's dosage guidelines and consult
with a healthcare professional before taking synephrine supplements, especially
if you have pre-existing health conditions or take medications.
How
Synephrine Manufactured by MEDIOCON INC Dosage Forms are
prepared?
Synephrine dosage forms are prepared in various
ways depending on the intended use and product formulation. Here are some
common preparations:
- Injection Preparation: For intravenous or
intramuscular use, synephrine (phenylephrine hydrochloride) is typically
diluted with a compatible infusion fluid, such as sodium chloride 0.9% or
dextrose 5%. The usual preparation involves adding 10mg of phenylephrine (1mL
of 10mg/mL solution) to 100mL of infusion fluid, resulting in a 100 microgram/mL
solution.
- Rectal Preparation: For hemorrhoid treatment,
synephrine is often combined with other ingredients like pramoxine, glycerin,
and petrolatum. The rectal ointment or cream typically contains 0.25%
phenylephrine hydrochloride, and is applied externally to the affected area up
to 4 times daily.
- Dosage Forms: Synephrine is available in
various dosage forms, including¹ ² ³:
-
Injectable Solution: 10mg/mL ampoule, diluted before administration
-
Rectal Ointment/Cream: 0.25% phenylephrine hydrochloride, often combined with
pramoxine and other ingredients
-
Tablets/Liquid: Available in various concentrations, often used for weight loss
and athletic performance
It's essential to follow the manufacturer's
instructions and consult with a healthcare professional before using synephrine
products, especially if you have pre-existing health conditions or take
medications.
What are
the appropriate Dosage forms of Synephrine Manufactured by MEDIOCON INC?
The
appropriate dosage forms of synephrine vary depending on the intended use and
individual factors. Here are some general guidelines:
- Weight
Loss and Energy Enhancement:
- Typical Dosage: 4-20 mg of synephrine per
day, often found in standardized citrus aurantium extract supplements (200-600
mg per pill, containing 3-6% synephrine).
- Effective Dosage: 10-53 mg daily doses
have been shown to be effective for weight management.
-
Athletic Performance:
- Acute Intake: 100-200 mg of bitter orange
extract (containing synephrine) taken before exercise may enhance athletic
performance.
-
Recommended Dosage: Some studies suggest¹ ² ³:
- 30-50 mg: A recommended dosage range for
safe and effective use.
- 50 mg: Shown to increase resting
metabolic rate without increasing blood pressure.
- Up to 100 mg: Considered safe with no
significant cardiovascular effects.
It's
essential to follow the manufacturer's dosage guidelines and consult with a
healthcare professional before taking synephrine supplements, especially if you
have pre-existing health conditions or take medications.
When should
Synephrine Manufactured by MEDIOCON INC be taken?
The timing of synephrine intake depends on the intended use and
individual factors. Here are some general guidelines:
- Weight Loss and Energy Enhancement:
- Before Meals: Taking
synephrine 30-60 minutes before meals may help reduce appetite and increase fat
burning.
- In the Morning: Taking
synephrine in the morning may help boost energy and metabolism throughout the
day.
- Athletic Performance:
- Before Exercise: Taking
100-200 mg of bitter orange extract (containing synephrine) 30-60 minutes
before exercise may enhance athletic performance.
- General Guidelines:
- Start with a Low Dose: Begin
with a low dose and gradually increase as needed and under medical supervision.
- Avoid Taking Before Bedtime:
Synephrine can interfere with sleep due to its stimulating effects.
- Consult a Healthcare
Professional: Before taking synephrine, especially if you have pre-existing
health conditions or take medications
What
are the effects And Side effects of Synephrine Manufactured by MEDIOCON
INC?
Synephrine
is a natural stimulant found in citrus fruits, particularly bitter oranges,
that offers several benefits, including weight loss and enhanced physical
performance. However, its use can also lead to various side effects.
Positive
Effects:
- Weight
Loss: Synephrine supports fat burning while providing energy, making it useful
for demanding physical activities and weight management.
-
Improved Concentration: It can contribute to improved mental performance and
focus.
-
Metabolism Boost: Synephrine increases thermogenesis, helping the body burn
more calories and fat.
- Mild
Appetite Suppressant: It can help reduce excessive calorie intake.
Side
Effects:
-
Cardiovascular Issues: Increased heart rate and blood pressure, potentially
leading to heart palpitations, tachycardia, and heart arrhythmia.
-
Neurological Effects: Anxiety, jitteriness, insomnia, and headaches due to its
stimulatory effect on the nervous system.
-
Gastrointestinal Issues: Nausea, vomiting, abdominal pain, and stomach upset,
particularly when consumed on an empty stomach.
-
Interactions with Medications: Synephrine may interact with certain
medications, such as MAOIs, blood pressure medications, and stimulants,
increasing the risk of adverse effects.¹ ² ³
Precautions:
- High
Blood Pressure and Heart Conditions: Individuals with these conditions should
consult a doctor before using synephrine.
-
Pregnancy and Breastfeeding: The safety of synephrine during these periods is
not well-established, so it's best to avoid its use unless advised by a
healthcare professional.
-
Combining with Other Stimulants: Avoid combining synephrine with other
stimulants like caffeine, as it may increase the risk of adverse effects.
How
is Synephrine Manufactured by MEDIOCON INC Tested
Qualitatively?
Synephrine
can be tested qualitatively using various methods, including:
-
High-Performance Liquid Chromatography (HPLC): This method is used to separate,
identify, and quantify synephrine in a mixture. It's often coupled with mass
spectrometry (MS) or diode-array detection for enhanced sensitivity and
specificity.
- Liquid
Chromatography-High Resolution Accurate Mass Mass Spectrometry (LC-HRAM-MS/MS):
This technique evaluates matrix effects and provides accurate quantification of
synephrine.
-
Targeted LC-HRAM-MS/MS: This method is used for the detection and
quantification of synephrine in various samples.
These
methods are commonly used for¹ ² ³:
- Dietary
Supplement Quality Control: To ensure the presence and accuracy of synephrine
labeling.
- Food
Adulteration Identification: To detect synephrine in food products.
-
Pharmaceutical Analysis: To quantify synephrine in pharmaceutical preparations.
Researchers
have also used these methods to analyze synephrine in various samples,
including⁴ ⁵:
- Citrus
Fruits and Products: To determine synephrine levels in different citrus species
and products.
-
Nutritional Supplements: To detect synephrine and other stimulants in
nutritional supplements.
Which
tests are performed on Synephrine Manufactured by MEDIOCON INC ?
Tests
performed on synephrine include:
-
High-Performance Liquid Chromatography (HPLC): To separate, identify, and
quantify synephrine in a mixture.
- Liquid
Chromatography-High Resolution Accurate Mass Mass Spectrometry (LC-HRAM-MS/MS):
To evaluate matrix effects and provide accurate quantification of synephrine.
-
Targeted LC-HRAM-MS/MS: For detection and quantification of synephrine in
various samples.
- Tail
Suspension Test: To assess antidepressant-like effects of synephrine in mice.
-
Reserpine-Induced Hypothermia: To evaluate the antidepressant effects of
synephrine.
- Forced
Swimming Test: To assess antidepressant-like effects of synephrine in mice.
- Binding
Experiments: To study the binding of synephrine to adrenergic receptors.
-
Vasoconstriction Assays: To evaluate the effects of synephrine on blood
vessels.
-
Lipolysis Assays: To assess the lipolytic effects of synephrine on fat cells.
These
tests help researchers understand synephrine's pharmacological effects,
potential therapeutic applications, and safety profile.
What are
the challenges in Manufacturing of Synephrine Manufactured by
MEDIOCON INC API?
The
challenges in manufacturing Synephrine API are similar to those faced in the
production of other Active Pharmaceutical Ingredients (APIs). Some of the key
challenges include¹ ² ³:
-
Regulatory Compliance: Synephrine manufacturers must comply with stringent
regulations set by regulatory agencies like the FDA and EMA, ensuring
consistency, safety, and efficacy of the API. This requires robust quality
management systems, thorough documentation, and adherence to Good Manufacturing
Practices (GMP).
- Complex
Chemistry: The synthesis of Synephrine involves complex chemical reactions and
processes, requiring a deep understanding of chemical reactions, process
optimization, and impurity control.
-
Impurity Control and Profiling: Identifying, minimizing, and consistently
controlling impurities is crucial to ensure product quality and prevent
regulatory setbacks. Advanced analytical methods like HPLC, LC-MS, and NMR are
used to detect trace impurities.
- Yield
Optimization: Achieving high yields while maintaining product quality is
essential for cost-effective production. This can be achieved through process
optimization, reaction kinetics, and real-time monitoring.
- Supply
Chain Management: Synephrine manufacturers rely on a network of suppliers for
raw materials, solvents, and reagents. Disruptions in the supply chain can lead
to production delays and quality issues, making it essential to build strong
relationships with reliable suppliers.
-
Environmental Sustainability: The manufacturing process of Synephrine can have
a significant environmental impact due to the use of chemicals, solvents, and
energy-intensive processes. Adopting green chemistry principles and sustainable
practices can help reduce the environmental footprint.
-
Technology Transfer: Transferring the manufacturing process from laboratory to
industrial scale poses technical and logistical hurdles. Detailed batch records,
SOPs, and pilot-scale runs can help streamline this process.
-
Cost-Efficiency and Scalability: Synephrine manufacturers need to balance
production costs with quality and regulatory requirements. This can be achieved
by optimizing synthetic routes, recycling solvents, and benchmarking costs.
- Quality
Control and Assurance: Maintaining high-quality standards throughout the
manufacturing process is essential to ensure the safety and efficacy of
Synephrine. This requires robust quality control systems, thorough testing, and
documentation.
By
understanding and addressing these challenges, manufacturers can ensure the
production of high-quality Synephrine API that meets regulatory standards and
customer expectations.
What are
the challenges in manufacturing of Synephrine Manufactured by
MEDIOCON INC ’s Dosage forms?
Manufacturing
synephrine dosage forms poses several challenges, including:
-
Regulatory Compliance: Ensuring consistency, safety, and efficacy of the dosage
form while adhering to Good Manufacturing Practices (GMP) and regulatory
guidelines.
- Complex
Formulation: Synephrine's hygroscopic nature can lead to clumping, making it
challenging to work with in various formulations.
-
Stability Issues: Maintaining the stability of synephrine in dosage forms,
particularly in liquid formulations, can be difficult due to chemical and
physical changes over time.
- Product
Uniformity: Ensuring uniform distribution of synephrine in solid dosage forms,
such as tablets or capsules, can be a challenge, especially with low-dose
formulations.
-
Scalability: Scaling up synephrine dosage form manufacturing while maintaining
consistency and quality can be a hurdle.
- Supply
Chain Management: Managing raw material sourcing, manufacturing, and
distribution can be complex, especially with potential supply chain
disruptions.
-
Technological Advancements: Adopting new technologies, such as 3D printing, can
be challenging due to regulatory uncertainty and the need for specialized
expertise.
-
Patient-Centric Design: Designing dosage forms that meet patient needs, such as
ease of administration and minimal side effects, can be a challenge.
- Quality
Control: Ensuring the quality of synephrine dosage forms through rigorous
testing and quality control measures is crucial to prevent defects and ensure
safety.¹ ² ³
To
overcome these challenges, manufacturers can adopt strategies such as⁴ ⁵:
- Process
Optimization: Optimizing manufacturing processes to improve efficiency, reduce
costs, and ensure consistency.
- Robust
Quality Control: Implementing robust quality control measures to detect defects
and ensure product quality.
- Supply
Chain Resilience: Building resilient supply chains to mitigate disruptions and
ensure consistent raw material sourcing.
-
Technological Innovation: Adopting new technologies, such as continuous
manufacturing and 3D printing, to improve efficiency and product quality.
What is the
Packing for Synephrine Manufactured by MEDIOCON INC?
Synephrine
packing typically refers to nasal packing procedures where Neo-Synephrine
(phenylephrine) is used. Here's what you need to know:
Types of
Packing- Nasal Packing: Used to control nosebleeds (epistaxis) by applying
pressure to the bleeding site.
-
Neo-Synephrine Soaked Cotton Ball: Sometimes used in nasal packing procedures
to help reduce bleeding due to its vasoconstrictive properties.
Purpose-
Control Bleeding: The primary goal of nasal packing with Neo-Synephrine is to
stop bleeding by constricting blood vessels and applying pressure to the
bleeding site.
- Reduce Swelling:
Neo-Synephrine helps reduce swelling in the nasal passages, making it easier to
manage bleeding.
Precautions-
Avoid Blowing Nose: After nasal packing removal, avoid blowing your nose for at
least 2 days to prevent re-bleeding.
- Follow
Doctor's Instructions: Always follow your doctor's advice regarding nasal
packing and aftercare.¹ ²
Product
Availability- Neo-Synephrine Nasal Spray: Available over-the-counter in various
strengths, including extra strength formulas.
What is
shelf life Of Synephrine Manufactured by MEDIOCON INC?
Synephrine's
shelf life typically ranges from 2 to 3 years, depending on storage conditions
and the specific product formulation. Here are some general guidelines:
-
Standard Synephrine Powder: 2 years when sealed and stored away from direct
sunlight
- Citrus
Aurantium Extract (Synephrine): 2 years when expertly vacuum-packed in durable
drums
-
Synephrine HCl Powder: 36 months when stored in a cool, dry place
- Raw
Synephrine Powder: 2 years when stored properly
To
maximize shelf life, it's essential to¹ ² ³:
- Store
synephrine in a cool, dry place with temperatures between 15-25°C (59-77°F)
- Keep it
away from direct sunlight and moisture
- Use
airtight containers made of materials like glass or high-density polyethylene
(HDPE)
- Add
silica gel packets or moisture-absorbing agents to maintain a low-humidity
environment
Proper
storage and handling can help preserve synephrine's potency and effectiveness
throughout its shelf life.
What should
the label claim for Synephrine Manufactured by MEDIOCON
INC Include?
The label
claim for Synephrine should include the following information:
- Product
Name and Description: Clearly state the product name and description, including
the ingredient name (Synephrine) and its source (e.g., Citrus aurantium).
-
Concentration and Amount: Specify the concentration of Synephrine per serving
and the total amount per container.
- Serving
Size and Directions: Provide serving size instructions and recommended usage
guidelines.
- Warning
and Precautions: Include warnings and precautions for use, such as potential
interactions with medications or health conditions.
-
Ingredient List: List all ingredients used in the product, including any
fillers, binders, or other additives.
-
Manufacturer Information: Provide the manufacturer's name, address, and contact
information.
- Net
Weight or Quantity: State the net weight or quantity of the product.
- Storage
and Handling Instructions: Offer storage and handling instructions to maintain
product stability and potency.
-
Expiration Date or Shelf Life: Include an expiration date or shelf life to
ensure product freshness and potency.
-
Regulatory Compliance: Ensure compliance with relevant regulatory requirements,
such as Good Manufacturing Practices (GMP) and labeling regulations [1][2][3].
By
including this information, the label claim for Synephrine can provide
transparency and help consumers make informed decisions about their use of the
product.
Where can Synephrine
Manufactured by MEDIOCON INC are procured?
Synephrine
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 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
Manufactured by
MEDIOCON INC products.
Remember to ensure the quality and
authenticity of the Synephrine Manufactured by
MEDIOCON INC product, regardless of the procurement source.
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