Isotretinoin 4759-48-2 Manufacturer Exporter MEDIOCON INC

 

 

Isotretinoin Manufactured by MEDIOCON INC     

 

   Name: Isotretinoin

 

   CAS No: 4759-48-2

 

Molecular Weight: 300.44 g/mol

  Molecular formula:   C₂₀H₂₈O₂

 

Synonyms:   13-cis-Retinoic acid

Appearance:   Yellow to orange crystalline powder.

 

   Solubility :  Practically insoluble in water, Soluble in organic solvents.

    Use :

Isotretinoin is used for:

 

1. Severe acne treatment: Especially for nodular, cystic, or conglobate acne.

2. Resistant acne: For acne that hasn't responded to other treatments.

 

It works by reducing sebum production, preventing clogged pores, and reducing inflammation.

      How is  Isotretinoin manufactured by MEDIOCON INC Synthesized?

Isotretinoin is synthesized through a multi-step process involving:

 

1. Vitamin A derivatives: Starting materials are often derived from vitamin A.

2. Chemical reactions: Various reactions, such as isomerization, condensation, and purification steps, are performed.

3. Purification: Crystallization and chromatography may be used to purify the final product.

 

The exact synthesis route may vary depending on the manufacturer and specific process.

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

Isotretinoin is available in various dosage forms, including:

 

1. Capsules: Oral capsules containing a liquid or powder formulation.

2. Soft gelatin capsules: Some products come in softgel capsules.

 

These dosage forms are typically taken orally, and the specific formulation may vary depending on the manufacturer and product.

  How Isotretinoin Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Isotretinoin dosage forms, such as capsules, are prepared through:

1. Formulation development: Mixing isotretinoin with excipients.

2. Encapsulation: Filling capsules with the formulated mixture.

3. Quality control: Testing for content uniformity, stability, and other parameters.

 

The preparation process involves ensuring the product meets regulatory standards and quality requirements.

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

Appropriate dosage forms of Isotretinoin include:

 

1. Oral capsules: Soft gelatin or hard gelatin capsules.

 

These dosage forms are designed for oral administration and are typically taken with food to enhance absorption.

When should Isotretinoin Manufactured by MEDIOCON INC be taken?

Isotretinoin is typically taken:

1. With food: To enhance absorption and minimize gastrointestinal side effects.

2. Once or twice daily: As directed by a healthcare provider, usually with breakfast and/or dinner.

Follow the specific dosing instructions provided by your healthcare provider or product label.    

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

Effects:

 

1. Reduces acne severity: Effective for severe, resistant acne.

2. Decreases sebum production: Helps prevent clogged pores.

3. Anti-inflammatory: Reduces inflammation associated with acne.

 

Common Side Effects:

 

1. Dry skin

2. Chapped lips

3. Dry eyes

4. Sensitivity to sunlight

5. Headaches

Less Common but Serious Side Effects:

1. Mood changes

2. Depression

3. Increased risk of inflammatory bowel disease

4. Musculoskeletal issues

5. Birth defects (if taken during pregnancy)

Monitoring and precautions are essential to minimize risks. 

 How is Isotretinoin Manufactured by MEDIOCON  INC  Tested Qualitatively?

Isotretinoin is tested qualitatively using various analytical techniques, including:

1. High-Performance Liquid Chromatography (HPLC): To detect and quantify isotretinoin.

2. Spectroscopy (IR, UV): To identify the molecular structure.

3. Mass Spectrometry (MS): To confirm molecular weight and structure.

These tests ensure the identity, purity, and quality of isotretinoin.

   Which tests are performed on Isotretinoin Manufactured by  MEDIOCON INC ?

Tests performed on Isotretinoin include:

 

1. Assay: To determine the amount of isotretinoin present.

2. Impurity testing: To detect and quantify impurities.

3. Content uniformity: To ensure consistent dosing.

4. Dissolution testing: To assess release characteristics.

5. Stability testing: To evaluate shelf life and storage conditions.

These tests ensure the quality, efficacy, and safety of isotretinoin products.

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

Challenges in manufacturing Isotretinoin API include:

1. Sensitivity to light and oxygen: Requires careful handling and storage.

2. Isomerization: Potential for formation of unwanted isomers.

3. Crystallinity: Controlling crystal form and polymorphism.

4. Purification: Ensuring high purity and removing impurities.

5. Stability: Maintaining stability during manufacturing and storage.

These challenges require specialized equipment, controlled environments, and precise process control.

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

Challenges in manufacturing Isotretinoin dosage forms include:

1. Light sensitivity: Protecting the product from light degradation.

2. Oxidation: Preventing oxidation and degradation.

3. Content uniformity: Ensuring consistent isotretinoin content.

4. Stability: Maintaining stability during manufacturing, storage, and shelf life.

5. Fill-finish operations: Handling and filling capsules under controlled conditions.

 

These challenges require specialized equipment, controlled environments, and precise process control to ensure product quality and efficacy.

What is the Packing for Isotretinoin Manufactured by MEDIOCON INC?

Isotretinoin packaging typically includes:

1. Light-resistant containers: To protect from light degradation.

2. Blister packs or bottles: Often made of materials that block light.

3. Secondary packaging: Cartons or boxes may include additional protection and information.

Packaging is designed to maintain product stability, efficacy, and safety. 

What is shelf life Of Isotretinoin Manufactured by MEDIOCON INC? 

The shelf life of Isotretinoin varies depending on:

1. Manufacturer: Different manufacturers may have different shelf lives.

2. Storage conditions: Typically requires storage at room temperature, protected from light and moisture.

Shelf life is usually specified on the product label or packaging, often ranging from 2 to 3 years.

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

The label claim for Isotretinoin should include:

1. Product name: Brand or generic name.

2. Strength: Amount of Isotretinoin per dosage unit.

3. Dosage instructions: Recommended dosing regimen.

4. Storage conditions: Requirements for temperature, light, and humidity.

5. Expiration date: Shelf life or expiration date.

6. Warnings and precautions: Important safety information.

7. Manufacturer information: Name and contact details.

This information ensures safe and effective use of the product.

Where can Isotretinoin Manufactured by MEDIOCON INC are procured?

Isotretinoin 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 Isotretinoin 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 Isotretinoin Manufactured by MEDIOCON INC products.

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