Methyl Salicylate 24634-61-5 Manufacturer Supplier Exporter, MEDIOCON INC.

 

 

Methyl Salicylate Manufactured by MEDIOCON INC

 

   Name: Methyl Salicylate

CAS No : 24634-61-5

Molecular Weight : 150.22 g/mol

Molecular formula : C₈H₈O₃

·       Synonyms : Common Names: Oil of Wintergreen, Wintergreen Oil, Betula Oil, Sweet Birch Oil.

·       Chemical Names:

o   Methyl 2-hydroxybenzoate (IUPAC name).

o   2-Hydroxybenzoic acid methyl ester.

o   Salicylic acid methyl ester.

o   Methyl o-hydroxybenzoate.

·       Trade Names/Other Identifiers: Anthrapole ND, Ben Gay (ingredient), Exagien, Flucarmit, NSC 8204.

 

Appearance : Methyl salicylate appears as a clear, colorless to pale yellow or reddish oily liquid with a distinctive, strong, sweet, minty smell, often described as wintergreen or root beer, and is slightly soluble in water but mixes well with oils and alcohol. 

 

 Solubility : Methyl salicylate is sparingly soluble in water (around 0.7-0.74 g/L at room temp) due to its nonpolar nature, but it is highly soluble or miscible in organic solvents like ethanol, ether, chloroform, and oils, making it ideal for use in liniments, creams, and flavorings where it's dispersed in alcohol or oil bases.  

Uses : Methyl salicylate is used topically as a counter-irritant for muscle, joint, and arthritis pain, creating warmth to distract from deeper aches, and also in fragrances, flavorings (like wintergreen), cosmetics, and industrial applications like adhesives. 

 

 

  How Methyl Salicylate by MEDIOCON INC Synthesized?

Methyl salicylate (oil of wintergreen) is typically synthesized through an acid-catalyzed Fischer esterification reaction involving salicylic acid and methanol. While the exact proprietary process used by MEDIOCON INC is not specified in public information, the general industrial method is consistent. 

The general synthesis process involves three main stages:

1. Esterification Reaction

Salicylic acid and an excess of methanol are mixed in a reaction vessel. A strong acid catalyst, typically concentrated sulfuric acid, is added slowly while stirring. The mixture is then heated to reflux (around 80-100°C) for several hours (e.g., 1 to 6 hours) to allow the reaction to proceed to completion. The use of excess methanol helps shift the reaction equilibrium toward the formation of the ester product. 

2. Neutralization and Washing

After cooling, the reaction mixture is transferred to a separatory funnel. It is washed multiple times with a solution of sodium carbonate or sodium bicarbonate to neutralize the acid catalyst and remove any unreacted salicylic acid. The organic layer, which contains the crude methyl salicylate product, is separated from the aqueous layer. 

3. Purification (Distillation)

The crude organic product is washed again with water until neutral. The remaining water is removed, often by adding an anhydrous drying agent like anhydrous sodium sulfate or calcium chloride. The final step involves distillation, often under vacuum to lower the boiling point and prevent decomposition, to collect the pure methyl salicylate fraction (a clear, pale yellow liquid with a strong minty odor). 

This established method is favored in industrial production for its straightforward process and cost-effectiveness. 

 

What are the different  dosage forms of Methyl by  MEDIOCON INC?

MEDIOCON INC primarily deals with pharmaceutical raw materials, excipients, and intermediates, rather than finished dosage forms of a specific brand-name "Methyl" product. They do not manufacture a proprietary "Methyl" medication in various finished forms for direct patient use. 

However, they are involved in supplying ingredients like Methyl Paraben and Methylcellulose. In general pharmaceutical and nutraceutical applications, these "methyl" compounds are available in various dosage forms produced by the industry at large, which typically include: 

·       Tablets

·       Capsules

·       Powders (for reconstitution or direct use)

·       Solutions

·       Emulsions

·       Suppositories

·       Injectable/Parenteral forms 

MEDIOCON INC itself supplies these compounds as bulk powders or granules for use by other manufacturers who then produce the final dosage forms listed above. 

 

 

 How Methyl Salicylate by MEDIOCON INC Dosage Forms are prepared?

MEDIOCON INC's Methyl Salicylate is available in topical dosage forms such as creams, ointments, and gels. These are prepared by combining the active ingredient (methyl salicylate) with various inactive ingredients (excipients) using standard pharmaceutical manufacturing techniques, primarily incorporation or emulsification methods, depending on the specific product formulation. 

General Preparation Methods

The preparation of these dosage forms typically involves combining methyl salicylate (which acts as a topical analgesic) with a base and other excipients to achieve the desired consistency and stability. 

1. Ointment Preparation

Ointments are semi-solid preparations, and their manufacture often involves melting and incorporation. 

·       Melting and Mixing: Base ingredients like white beeswax and wool fat (or soft paraffin) are melted together, often over a water bath. The mixture is then allowed to cool while being continuously stirred.

·       Incorporation: Once the base has cooled but is still semi-solid, the methyl salicylate is gradually added and mixed uniformly to ensure even dispersion. 

2. Cream Preparation

Creams are emulsions (mixtures of oil and water) and require careful mixing of aqueous and oil phases. 

·       Phase Preparation: The oil phase ingredients (e.g., cetearyl alcohol, liquid paraffin) are heated and mixed separately from the aqueous phase ingredients (e.g., water, chlorocresol).

·       Emulsification: The two phases, typically at similar temperatures, are combined slowly under constant stirring until a stable, homogeneous cream is formed. Additional ingredients, such as emulsifiers (e.g., Span 20, Tween 80) and other active ingredients, are added during this process. 

3. Gel/Emulgel Preparation

Gels and emulgels involve dispersing gelling agents in an aqueous medium. 

·       Gel Formation: A gelling agent (e.g., Carbopol 934 P) is dispersed in purified water with constant stirring. The pH is then adjusted to form the gel base.

·       Drug Incorporation: The methyl salicylate, often first dissolved in an organic solvent or part of an emulsion phase, is then incorporated into the gel base to form the final product. 

Raw Material (Methyl Salicylate) Synthesis

The active ingredient itself, methyl salicylate, is typically synthesized industrially via a Fischer esterification reaction. This involves heating salicylic acid with an excess of methanol in the presence of a strong acid catalyst (like concentrated sulfuric acid) under reflux conditions to yield the ester and water. The crude product is then purified through processes like neutralization, washing, and distillation to achieve high purity. 

 

 

What are the appropriate Dosage forms of Methyl Salicylate by MEDIOCON  INC?

MEDIOCON INC is primarily a supplier of Active Pharmaceutical Ingredients (APIs) and intermediates, and search results do not specify that they manufacture finished dosage forms of Methyl Salicylate. They list Methyl Salicylate as an API/intermediate. 

However, the appropriate dosage forms for the use of Methyl Salicylate as a topical analgesic generally include: 

·       Creams

·       Ointments

·       Gels

·       Lotions

·       Sprays

·       Transdermal patches 

These forms are applied topically to the affected area for temporary relief of muscle and joint pain. 

 

 

When should Methyl Salicylate by MEDIOCON INC be taken?

Methyl Salicylate is a topical medication that should be applied to the affected area of the skin to relieve minor muscle and joint aches. It should not be taken by mouth as it can be toxic if swallowed. 

This medication should be used as needed for temporary relief of muscle and joint pain. It is applied topically to the affected area. 

Application Guidelines:

·       Apply a thin layer to the painful area and gently rub it in.

·       The frequency of application can vary depending on the product, but it is generally used on the affected area a limited number of times per day for adults and children 12 years and older.

·       For products like patches, follow the specific instructions on the packaging regarding how long to wear the patch and how many times per day it can be used.

·       If a regularly scheduled application is missed, apply it as soon as it is remembered. If it is close to the time for the next scheduled application, skip the missed one. Do not apply extra to make up for a missed application. 

Important Precautions:

·       This product is for external use only on clean, dry, and unbroken skin. Avoid contact with eyes, nose, mouth, or damaged skin.

·       Do not use heating pads or tight bandages on the treated area, as this can increase the risk of side effects like severe burns.

·       Avoid activities that raise skin temperature, such as hot baths, strenuous exercise, or sunbathing, immediately before or after applying the product.

·       Wash your hands with soap and water before and after application, unless the treatment is on your hands.

·       Discontinue use and consult a doctor if your condition does not improve, if symptoms last for more than 7 days, or if they disappear and return within a few days.

·       Children and teenagers with chickenpox, flu symptoms, or other undiagnosed illnesses should not use products containing methyl salicylate due to the risk of Reye's syndrome. Consult a physician before using this product on children under 12. 

 

 

 What are the effects And Side effects of Methyl Salicylate by MEDIOCON INC?

MEDIOCON INC is a manufacturer and wholesaler of pharmaceutical intermediates, and does not appear to produce a specific, finished methyl salicylate product for consumer use. Therefore, effects and side effects information is based on the general properties of methyl salicylate as a common active ingredient in over-the-counter topical pain relievers. 

Effects of Topical Methyl Salicylate

When applied to the skin, methyl salicylate (also known as wintergreen oil) is used to relieve minor aches and pains of muscles and joints. 

·       Pain Relief: It is used for conditions such as arthritis, backache, sprains, strains, and bruises.

·       Counterirritant: It works by causing the skin to feel a sensation of coolness followed by warmth. This sensation distracts the user's attention from the deeper muscle or joint pain.

·       Anti-inflammatory: When absorbed through the skin, it is hydrolyzed into salicylic acid, which has anti-inflammatory properties, helping to reduce swelling and inflammation in the affected area. 

Side Effects of Topical Methyl Salicylate 

Most side effects are localized to the application site and are generally mild. However, serious side effects, though rare, can occur, especially with overuse, application to broken skin, or accidental ingestion. 

Common Side Effects (usually mild)

·       Skin irritation or redness at the application site.

·       A mild burning, stinging, or tingling sensation.

·       Itching or a rash. 

Serious Side Effects (require immediate medical attention)

·       Severe skin reactions: Blistering, swelling, or severe pain at the application site.

·       Increased or unusual pain in the treated area.

·       Symptoms of systemic toxicity (salicylate poisoning): Nausea, vomiting, ringing in the ears (tinnitus), dizziness, headache, or rapid breathing.

·       Allergic reaction signs: Rash, severe itching, swelling of the face/tongue/throat, severe dizziness, or trouble breathing.

·       Signs of stomach bleeding (if enough product is absorbed systemically or accidentally ingested): Black/tarry stools or vomit that looks like coffee grounds. 

Important Precautions

·       Do not apply to open wounds, damaged, or irritated skin.

·       Avoid using a heating pad or tight bandage on the treated area, as this can increase absorption and the risk of serious side effects, including severe burns.

·       The product should be kept out of the reach of children. Ingestion of even a small amount (e.g., a teaspoon) can be life-threatening and is equivalent to a large number of aspirin tablets.

·       Consult a healthcare provider before use in children and teenagers with chickenpox, flu, or other viral illnesses due to the risk of Reye's syndrome.

·       Do not use after 30 weeks of pregnancy without a doctor's advice. 

Always follow the instructions on the product label and consult a doctor or pharmacist with any concerns. You can report side effects to the FDA at 1-800-FDA-1088. 

 

 

 How is Methyl Salicylate by MEDIOCON  INC  Tested Qualitatively?

Qualitative testing of Methyl Salicylate (oil of wintergreen) by manufacturers like MEDIOCON INC is typically performed using its distinct physical properties and standard analytical techniques as outlined in pharmacopoeial standards (e.g., USP/NF, Ph. Eur.)

. 

Qualitative Identification Methods 

• Organoleptic Assessment: The primary qualitative test is its distinct characteristic odor of wintergreen. It is a colorless or yellowish to reddish oily liquid.
• Spectroscopy:
• Ultraviolet (UV) Spectroscopy: A solution of methyl salicylate exhibits a specific maximum absorption wavelength (

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) at approximately 237 nm when scanned in the 200–400 nm range, which helps confirm its identity and purity.

• Infrared (IR) Spectroscopy: IR spectroscopy is performed to elucidate and confirm the molecular structure of the compound by comparing its unique spectral fingerprint to a known standard.
• Solubility Test: Methyl salicylate is sparingly soluble in water but miscible with alcohol and other organic solvents. Solubility tests can confirm these expected physical properties.
• Chemical Agent Detection Paper: In specific military or safety contexts where it is used as a simulant, M8 and M9 chemical agent detection papers respond to methyl salicylate as they would to mustard agents, indicating the presence of the compound. 

These qualitative tests ensure the identity and quality of the raw ingredient before it is used in formulations.

 

 

 

   Which tests are performed on Methyl Salicylate Manufactured by  MEDIOCON INC ?

The specific quality control tests performed on Methyl Salicylate manufactured by MEDIOCON INC are not publicly disclosed in the search results. However, as a manufacturer and wholesaler in the pharmaceutical sector, MEDIOCON INC likely performs standard quality control (QC) analyses to ensure its product meets purity and quality attributes required by regulatory bodies like the US Pharmacopeia (USP). 

General tests for methyl salicylate in pharmaceutical applications typically include:

·       Identity and Purity Confirmation:

o   Spectrophotometry: The material is assayed using ultraviolet-visible (UV-Vis) and infrared (IR) absorption spectroscopy to confirm its chemical structure and ensure the drug is pure.

o   Chromatography: High-Performance Liquid Chromatography (HPLC) is often used to determine the purity and identify any potential adulterants or impurities, such as thymol.

·       Chemical and Physical Property Evaluation:

o   Physical Appearance: Visual inspection for color, homogeneity, and consistency.

o   pH Measurement: Determination of the pH of the substance or a solution containing it.

o   Solubility: Confirmation of solubility characteristics in various solvents like water or alcohol.

·       Potency/Assay: Quantitative analysis to ensure the concentration of methyl salicylate meets the specified standards.

·       Stability Studies: Testing is conducted over time and under various storage conditions (temperature, humidity) to assess the product's shelf life and stability. 

 

 

What are the challenges in manufacturing of Methyl Salicylate MEDIOCON  INC ’s Dosage forms?

The primary challenges in the manufacturing of methyl salicylate dosage forms relate to its high volatility, ensuring product stability and consistency, and managing the balance between skin permeation and formulation properties (like adhesion and viscosity). Specific details regarding MEDIOCON INC.'s proprietary challenges are not publicly available, but general industry challenges apply. 

Key manufacturing challenges include:

·       Volatility: Methyl salicylate has a high vapor pressure, making it prone to evaporation during the manufacturing process and throughout the product's shelf life. This makes achieving a consistent and accurate drug content in the final product difficult and necessitates specialized equipment and processes (e.g., using a vertical condenser to return evaporated liquids or specific solvent choices to minimize loss).

·       Stability: Methyl salicylate can degrade, particularly at higher temperatures or in certain conditions (e.g., hydrolysis to salicylic acid at a physiological pH of 7.4), which affects product integrity, color, and smell. Manufacturers must design the process to protect the active pharmaceutical ingredient (API) from degradation, potentially requiring controlled temperatures, specific excipients (stabilizers, antioxidants, buffering agents), and protective packaging.

·       Formulation Consistency and Scale-Up:

o   Viscosity and Homogeneity: Achieving a consistent viscosity and a smooth, homogeneous appearance is crucial for topical semi-solid products like gels, creams, and ointments. The order of ingredient addition and mixing speed are critical to maintain the desired microstructure, and these factors must be carefully controlled during scale-up from lab-bench to commercial production.

o   Process Equipment: Specialized equipment like raw material dispersers and in-line homogenizers require precise flow rates to avoid issues such as "fish eyes" (undispersed material) or over-shearing the formulation.

o   Flammability: Formulations with high alcohol or other flammable solvent content require specialized explosion-proof manufacturing suites.

·       Product Performance and Adhesion (for patches):

o   Skin Permeation vs. Adhesion: There is an unpredictable trade-off between ensuring the patch adheres well to the skin and allowing sufficient drug permeation. The choice of solvents and excipients significantly impacts these properties, and extensive experimentation is required to balance them effectively.

o   Mechanical Properties: The incorporation of methyl salicylate and various solvents can have unpredictable "plasticizing" or "anti-plasticizing" effects on the polymeric matrix of patches, influencing their tack force and peel strength. This requires careful selection and testing of all components to achieve the desired physical properties.

·       Raw Material and Supply Chain: The availability and quality of raw materials can be a general challenge in the pharmaceutical industry, contributing to potential drug shortages or variability in manufacturing. 

 

                                                                 

What is shelf life Of Methyl Salicylate by MEDIOCON INC?

The general shelf life for industrial or pure-grade methyl salicylate is typically 3 to 5 years from the date of manufacture when stored properly. 

For the most accurate and product-specific information regarding the batch you have, you should consult the product label or the manufacturer's official documentation. You can also contact MEDIOCON INC directly via their official email or website: 

·       Email: sales@mediocon.com

·       Website: www.mediocon.com 

 

 

 

What should the label claim for Methyl Salicylate by MEDIOCON INC   Include?

For a Methyl Salicylate product by MEDIOCON INC (likely a topical pain reliever), the label should include Active Ingredient (Methyl Salicylate [Concentration] & Purpose: Topical Analgesic), Uses, Warnings (External Use Only, Avoid Eyes/Mucous Membranes, Keep Out of Reach of Children, Stomach Bleeding Warning if NSAID), Directions (Adults & Children 2+, apply 3-4x daily), Other Information, and Inactive Ingredients, following FDA's Drug Facts Labeling guidelines for OTC products. 

Here's a breakdown of required sections:

·       Active Ingredient: Methyl Salicylate [Concentration] (e.g., 25%).

·       Purpose: Topical Analgesic.

·       Uses: For temporary relief of minor aches and pains of muscles and joints from simple backache, arthritis, strains, bruises, sprains.

·       Warnings:

o   For External Use Only.

o   Stomach Bleeding Warning (if it's an NSAID).

o   Keep out of reach of children.

o   Avoid contact with eyes, lips, nose, mucous membranes.

o   Do not tightly bandage or apply heat.

·       Directions: Adults & Children 2+; apply to affected area, no more than 3-4 times daily.

·       Other Information: Store properly (e.g., 20°-25°C).

·       Inactive Ingredients: List all other components (e.g., Aloe Vera, Carbomer, water).

·       Manufacturer Info: MEDIOCON INC, contact info. 

Key Consideration: Since Methyl Salicylate is an NSAID, the label must carry the NSAID stomach bleeding warning, which is a crucial safety requirement. 

 

 

 

Where can Methyl SalicylateManufactured by MEDIOCON INC are procured?

Methyl Salicylate 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 Methyl SalicylateManufactured 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 Methyl SalicylateManufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Methyl SalicylateManufactured by MEDIOCON INC product, regardless of the procurement source.