Ichthammol 8029-68-3 Manufacturer Exporter Supplier MEDIOCON INC

 

 

Ichthammol Manufactured by MEDIOCON INC     

 

   Name: Ichthammol

CAS No:  8029-68-3

Molecular Weight: NA

Molecular formula:   C28H36S5O6(NH4)2.

Synonyms Ammonium bituminosulfonate, Ichthyol, Ammonium ichthosulfonate, Dark sulfonated shale oil, ammonium salt, Ichthammon, and Ictiol

Appearance Viscous, dark brown to brownish-black liquid

 Solubility :  miscible (completely soluble) in water and glycerol but is only slightly soluble in ethanol, fatty oils, and liquid paraffin

Use :

Ichthammol, also known as ichthyol, is a medicinal ingredient with various uses, particularly in dermatology. Some of its uses include:

- Skin conditions: Ichthammol is used to treat skin conditions like acne, eczema, psoriasis, and dermatitis due to its anti-inflammatory and antiseptic properties.

- Insect bites and stings: It can help relieve itching and reduce inflammation caused by insect bites and stings.

- Minor skin irritations: Ichthammol can be used to treat minor skin irritations, such as cuts, scrapes, and burns, due to its protective and soothing properties.

It's often found in topical creams, ointments, and pastes. However, it's essential to consult a healthcare professional before using ichthammol, especially if you have sensitive skin or allergies.

 How is  Ichthammol manufactured by MEDIOCON INC Synthesized?

Ichthammol is synthesized through a multi-step process:

- Step 1: Dry Distillation: The production of ichthammol begins with the dry distillation of sulfur-rich oil shale, also known as bituminous schists. This process releases a dark, tar-like substance.

- Step 2: Sulfonation: The resulting oil from the distillation process is then sulfonated, which involves the introduction of sulfur trioxide or fuming sulfuric acid to create a sulfonated shale oil.

- Step 3: Neutralization: The sulfonated oil is then neutralized with ammonia to form an ammonium salt, specifically ammonium bituminosulfonate or ammonium bituminosulphonate.

- Final Product: The resulting ichthammol is a dark brown, viscous substance with anti-inflammatory, antibacterial, and antifungal properties, making it useful for various medicinal applications, particularly in dermatology.¹ ²

 

The exact manufacturing process may vary depending on the producer, but Ichthyol-Gesellschaft, a company based in Austria, is one of the notable manufacturers of ichthammol. They produce high-purity ichthammol substances from bituminous carbonate rocks in compliance with Good Manufacturing Practice (GMP) standards.

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

Ichthammol is available in various dosage forms, including¹ ² ³:

- Topical Forms:

    - Ointment: Available in different strengths, such as 100 mg/1g, 500 mg, 850 mg, 20 g, 50% concentration, and 200 MG/G.

    - Cream: Available in 1% w/w concentration.

    - Lotion: Available in combination with glycerin, with a composition of Glycerin-900 gm and Ichthammol-100 gm in 20 ml.

    - Emulsion: Available in 88 g/100g concentration.

    - Suspension: Available for topical application.

- Rectal Forms:

    - Suppository: Used for rectal administration, often in combination with other ingredients like carvasept and levomenthol.

These dosage forms are used to treat various skin conditions, such as eczema, psoriasis, acne, insect bites, and minor skin infections. It's essential to consult a healthcare professional for proper guidance on using ichthammol and to determine the best dosage form for your specific needs.

 How Ichthammol Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Ichthammol dosage forms are prepared in various ways depending on the specific product and intended use. Here are some common preparations¹ ² ³:

- Ointment: Ichthammol ointment is typically prepared by mixing ichthammol with other ingredients like wool fat and yellow soft paraffin. The concentration of ichthammol can vary, but a common formulation is 10% ichthammol.

- Lotion: Ichthammol lotion is a liquid preparation that combines ichthammol with glycerin. The ratio of glycerin to ichthammol can vary, but a common formulation is 900 gm of glycerin to 100 gm of ichthammol in 20 ml of solution.

- Suppository: Ichthammol suppositories are prepared by inserting the suppository into the rectum, where it melts and releases the active ingredients. The dosage and administration of ichthammol suppositories vary depending on age and medical condition.

Preparation and Application:

- Apply a thin layer of ichthammol ointment to the affected area, usually once or twice daily.

- For suppositories, insert the suppository well up into the rectum and hold for a few minutes to ensure melting and absorption.

- Lotions can be applied directly to the affected area or used as directed by a healthcare professional.

Important Considerations:

- Always follow the instructions provided by your healthcare professional or the product label.

- Avoid contact with eyes, nose, and mouth when applying ichthammol preparations.

- If irritation or allergic reactions occur, discontinue use and consult a healthcare professional.

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

Ichthammol comes in various dosage forms to suit different needs. Here are some of the most common forms:

 

- Topical Forms:

    - Ointment: Available in different strengths, such as 100 mg/1g, 500 mg, 850 mg, 20 g, 50% concentration, and 200 MG/G. Brands like CVS Ichthammol Ointment Salve and EGODERM OINTMENT fall under this category.

    - Cream: Found in concentrations like 1% w/w, often used for skin conditions.

    - Lotion: Some products combine ichthammol with glycerin, like Ichthammol Glycerin BPC, which contains 900 gm of glycerin and 100 gm of ichthammol in 20 ml solution.

    - Emulsion: Available in concentrations like 88 g/100g.

    - Suspension: Used topically, often in combination with other ingredients like salicylic acid.

- Rectal Forms:

    - Suppository: Used for conditions like hemorrhoids or anal fissures, often in combination with other ingredients like carvasept and levomenthol.

When using ichthammol, it's essential to follow the recommended dosage and application instructions provided by your healthcare professional or the product label. If you have any questions or concerns, don't hesitate to consult with a healthcare professional.

When should Ichthammol Manufactured by MEDIOCON INC be taken?

Ichthammol can be administered in various forms, and the timing depends on the specific product and condition being treated.

 

Topical Application:

 

- Apply a thin layer of ichthammol ointment to the affected area 1-2 times daily.

- For skin conditions like eczema, psoriasis, or acne, apply as directed by your healthcare professional.

 

Rectal Administration (Ichthammol Glycerin):

 

- Adults and children over 6 years: 1 suppository (2.30) per 24 hours.

- Children (2-6 years): 1 suppository (1.15) per 24 hours.

- Insert the suppository well up into the rectum, and it usually works within 15-60 minutes.¹

Important Considerations:

- Always follow the instructions provided by your healthcare professional or the product label.

- Avoid contact with eyes, nose, and mouth when applying ichthammol preparations.

- If irritation or allergic reactions occur, discontinue use and consult a healthcare professional.²

- For specific guidance on using ichthammol, consult with a healthcare professional or pharmacist.

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

Ichthammol is a medication with various effects on the skin, including:

- Therapeutic Effects:

    - Antimicrobial action: helps keep skin and scalp environments cleaner by curbing the growth of unwanted surface microbes.

    - Anti-inflammatory properties: reduces inflammation and itching associated with skin conditions like eczema, psoriasis, and acne.

    - Softening and soothing: helps soften built-up debris, making it easier to wash away.

 

- Common Side Effects:

    - Skin irritation: redness, itching, or burning sensation, especially in individuals with sensitive skin.

    - Allergic reactions: rash, hives, swelling, and difficulty breathing in rare cases.

    - Temporary skin discoloration: due to its dark color, ichthammol can stain skin, clothing, and bedding.

    - Unpleasant odor: a strong, tar-like smell that some users may find bothersome.

    - Dryness or flaking: especially if used too frequently on already dry skin.

 

- Precautions:

    - Patch test: perform a patch test before using ichthammol on a larger area to check for allergies.

    - Avoid contact with eyes, nose, and mouth: ichthammol can cause irritation and should be avoided in these areas.

    - Use with caution: in pregnant and breastfeeding women, as its safety has not been well-studied.

    - Consult a healthcare professional: if you experience severe side effects or have concerns about using ichthammol.

  How is Ichthammol Manufactured by MEDIOCON  INC  Tested Qualitatively?

Qualitative testing of Ichthammol involves various methods to determine its presence, composition, and properties. Here are some of the ways Ichthammol is tested qualitatively¹ ² ³:

- Physical Properties: Ichthammol is identified by its characteristic pale yellow or brownish-black viscous liquid appearance and strong, distinctive odor.

- Sulfur Detection: Ichthammol contains sulfur, which can be detected using the flask combustion method or other chemical tests.

- Thiophene Sodium Detection: Thiophene sodium is a component of Ichthammol, and its presence can be detected using qualitative tests.

- Thin Layer Chromatography (TLC): TLC can be used to separate and identify the components of Ichthammol, although this method is more commonly used for detecting impurities or adulterants.

- Verification of OOS Results: In cases where Ichthammol test results are suspected to be out-of-specification (OOS), a thorough investigation is conducted to identify the cause of the error. This involves retesting the sample and evaluating the results to determine if the initial result was valid.

These qualitative tests help ensure the quality and authenticity of Ichthammol, which is essential for its use in pharmaceutical and cosmetic applications.

   Which tests are performed on Ichthammol Manufactured by  MEDIOCON INC ?

Ichthammol testing involves various methods to determine its quality, safety, and efficacy. Here are some tests performed on Ichthammol:

- Physical Properties Testing: Evaluating its characteristic appearance, clarity, color, and odor.

- Chemical Composition Analysis: Assessing its sulfur content, thiophene sodium, and other components using techniques like chromatography and spectroscopy.

- Photostability Testing: Determining its stability under light exposure, which is crucial for packaging and labeling purposes.

- In Vitro Studies: Investigating its principle of action, such as loosening skin and facilitating pus extraction, using 3D skin models.

- Clinical Trials: Evaluating its efficacy and safety in treating conditions like dandruff, eczema, and psoriasis, using scoring systems like Adherent Scalp Flaking Score (ASFS) and Visual Analogue Scale (VAS).

- Microbiological Testing: Assessing its antimicrobial properties against various microorganisms.

- Toxicity and Irritation Testing: Evaluating its potential skin irritation, allergic reactions, and toxicity.

- Stability Testing: Determining its shelf life and stability under different environmental conditions.

What are the challenges in Manufacturing of Banana Extract Manufactured by MEDIOCON   INC API?

The challenges in manufacturing banana extract API or banana fiber production are multifaceted. Here are some key difficulties faced in the production process:

 

- Raw Material Availability: Banana plants are primarily grown for fruit, limiting the supply of banana pseudostems for fiber extraction. This scarcity can cause fluctuations in availability and pricing.

- Labor-Intensive Extraction: Extracting banana fibers is a time-consuming process that requires skilled workers to manually strip the outer layers of the banana stalk and separate the fibers, leading to potential inconsistencies in fiber quality.

- Processing Difficulties: Banana fiber processing involves multiple steps, including decortication and cleaning, which can be technically challenging and require specialized equipment, increasing production costs.

- Quality Control: Variability in harvesting and processing can lead to inconsistent fiber quality, affecting its suitability for various applications and limiting competitiveness against other natural fibers.

- Environmental Impact: Although banana fiber is biodegradable, the processing methods may have environmental consequences, such as generating waste from chemical treatments, necessitating careful management to minimize pollution.

- Market Perception: Banana fiber products are still relatively niche and may not be widely recognized in global markets, requiring consumer education to promote awareness and adoption.

- Pest Susceptibility: Banana fiber can be vulnerable to degradation in humid conditions and pests, threatening the quality of banana plants.

- Economic Viability: Balancing cost with quality remains a challenge, as banana fiber can be more costly than cotton due to labor-intensive extraction and processing methods.

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

Manufacturing Ichthammol dosage forms poses several challenges, including¹ ²:

- Stability Issues: Ichthammol is susceptible to chemical and physical changes over time, leading to degradation, alteration of drug potency, and potential contamination.

- Poor Solubility: Ichthammol's solubility in liquid media can be a challenge, potentially leading to precipitation, sedimentation, or clogging of equipment.

- Product Uniformity: Interactions between active ingredients or excipients, as well as interactions with container materials, can affect product appearance, stability, or efficacy.

- Microbial Contamination: Ichthammol's liquid dosage forms are particularly susceptible to microbial contamination, which can proliferate rapidly and lead to product recall and safety concerns.

- Particle Aggregation: Solid particles in liquid formulations can aggregate over time, leading to sedimentation, inconsistent dosing, and potential blockages in drug delivery devices.

- Compatibility Issues: Errors in product dosing, packaging, or labeling can have serious consequences, including adverse events and product recalls.

- Manufacturing Process Failures: Deficiencies in the manufacturing process, such as inadequate quality control measures or equipment failures, can result in defective or unsafe products.

- Container Closure Integrity: Inadequate closure systems may allow the entry of oxygen or moisture, leading to product degradation, contamination, or decreased shelf-life.

- Foaming: Agitation and shear forces can lead to foam formation, affecting product stability, container closure system, and dosing accuracy.

 

Additionally, the manufacturing process may require careful control of environmental factors such as temperature and humidity to maintain the stability of the drug substance. Robust analytical methods are necessary to monitor the quality of the product at every stage.

What is the Packing for Ichthammol Manufactured by MEDIOCON INC?

Ichthammol packing varies depending on its intended use and product formulation. Here are some common packaging options:

- Tube Packaging: Ichthammol ointment often comes in tubes, such as 150gm tubes, made of plastic or laminated materials to ensure safe and hygienic application.

- Inner Bag and Carton: Some manufacturers pack ichthammol products in inner bags and cartons to protect the contents from light, moisture, and contamination.

- Disposable Diapers: When using ichthammol to treat hoof abscesses in horses, disposable diapers or maxi-pads are often used to hold the ointment in place, secured with duct tape.

- Duct Tape: Duct tape is used to secure the diaper or dressing, creating a bootie-like seal around the hoof to keep the ichthammol ointment in contact with the affected area.

- Other Packaging Options: Ichthammol products may also be packaged in bottles, jars, or other containers depending on the specific product and intended use.

What is shelf life Of Ichthammol Manufactured by MEDIOCON INC? 

Ichthammol's shelf life varies depending on the product and storage conditions. Here are some general guidelines¹ ² ³:

- Typical Shelf Life: 2 years from the manufacturing date for Ichthammol USP, as stated by UPI Chem.

- Specific Product Shelf Life:

    - Krins Life Sciences: 60 months (5 years) for Ichthammol pure, 50% concentration, stored at room temperature.

    - Ichthammol Glycerin BPC: 5 years, stored below 25°C (77°F) in well-closed containers.

 

To ensure the product's effectiveness and safety, it's essential to:

- Check the packaging or label for specific storage instructions and expiration dates.

- Store Ichthammol products in a cool, dry place, away from heat, sparks, and flames.

- Keep containers tightly closed to prevent contamination and degradation.

- Discard the product if it exceeds the recommended shelf life or shows signs of spoilage.

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

The label claim for Ichthammol should include the following information [1][2]:

- Product Name: The name of the product, such as Ichthammol Ointment or Ichthammol Glycerin.

- Active Ingredient: The concentration of Ichthammol, such as 10% or 20%.

- Net Quantity: The net weight or volume of the product.

- Usage Instructions: Directions for use, including application frequency and duration.

- Precautions: Warnings and precautions, such as avoiding contact with eyes, nose, and mouth, and discontinue use if irritation occurs.

- Storage Conditions: Instructions for storing the product, such as room temperature or refrigeration.

- Expiration Date: The expiration date or shelf life of the product.

- Manufacturer Information: The name and address of the manufacturer or distributor.

- Batch Number: The batch number or lot number of the product.

- CAUTION: A caution statement, such as "For external use only" or "Consult a doctor if symptoms persist".

 

Additionally, the label may include other information, such as:

- Indications: The product's intended use, such as treating skin conditions or relieving pain and inflammation.

- Side Effects: Potential side effects or adverse reactions.

- Contraindications: Situations or conditions under which the product should not be used.

Where can Ichthammol Manufactured by MEDIOCON INC are procured?

Ichthammol 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 Ichthammol 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 Ichthammol Manufactured by MEDIOCON INC products.

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

 

 

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