Isoleucine 73-32-5 (f Manufacturer, exporter, supplier by MEDIOCON INC

 

 

 

              Isoleucine,,  Manufactured by MEDIOCON INC

 

 Name:   Isoleucine,

CAS No  :  73-32-5 (for L-isoleucine, the common naturally occurring form)

·       Molecular Weight : Approximately 131.17 g/mol

Molecular formula C₆H₁₃NO₂

·       Synonyms  

o   (2S,3S)-2-Amino-3-methylpentanoic acid

o   L-Ile

o   α-amino-β-methylvaleric acid

o   3-methyl-L-norvaline

·       Appearance: White crystalline powder or flakes

·       Solubility: Sparingly or partially soluble in water (~41.2 mg/mL at 25°C) and soluble in hot 1 M NH₄OH or 1 M HCl

 

Appearance : White crystals or crystalline powder; odorless

 Solubility:  Soluble in water (approx. 41.6 g/L at 25 °C); very slightly soluble in ethanol

o   Uses : Protein synthesis: Isoleucine is one of the essential amino acids used in the biosynthesis of proteins.

o   Nutritional supplement: It is a common ingredient in sports drinks, protein bars, and other nutritional products to enhance their value and support muscle growth and repair.

o   Pharmaceuticals: Used in the production of certain pharmaceutical drugs and as a component in parenteral nutrition formulations.

o   Food and feed industry: It can be used as a food additive, a flavor enhancer, and as an important component in animal feed formulations to promote growth. 

What are the different  dosage forms  of   Isoleucine,, , acid, Manufactured  by  MEDIOCON INC?

Mediocon Inc primarily offers Isoleucine as a bulk powder, which is used as an Active Pharmaceutical Ingredient (API) and a nutraceutical ingredient. They do not appear to manufacture finished, specific dosage form products of Isoleucine under their own label, but supply the raw material to other manufacturers for use in their formulations. 

Isoleucine in general is available in various common dosage forms on the market from other companies, which include:

·       Parenteral solutions/injections (intravenous)

·       Solid oral forms:

o   Tablets

o   Capsules

o   Oral powders/granules (for reconstitution) 

These dosage forms are generally part of multi-vitamin, protein, or complete nutrition products, as Isoleucine is an essential amino acid.

 

What are the appropriate Dosage forms of Isoleucine,, , acid, Manufactured  by  MEDIOCON   INC?                

MEDIOCON INC is a manufacturer and wholesaler of active pharmaceutical ingredients (APIs) and nutraceutical ingredients, including Isoleucine (amino acid), which means they primarily provide the raw material in powder form to other manufacturers. These other manufacturers then use it to create finished medicinal or supplement products in various dosage forms. 

Isoleucine is generally available in the market in the following dosage forms: 

·       Capsules

·       Tablets

·       Oral powders (often as part of a BCAA mixture or for mixing into drinks)

·       Parenteral solutions (injections/infusions) for intravenous use, typically as a component in a compound amino acid solution for nutritional support 

To find specific finished products containing Isoleucine from MEDIOCON INC, you would need to contact the company directly for a current list of their clients and the final products they manufacture. You can find contact information and learn more about their offerings on the Mediocon Inc website. 

  How is Isoleucine,, , acid, Manufactured by MEDIOCON  INC  Tested Qualitatively?

MEDIOCON INC performs qualitative testing on its Isoleucine product using industry-standard quality control (QC) methods, including High-Performance Liquid Chromatography (HPLC), Infrared (IR) and Nuclear Magnetic Resonance (NMR) spectroscopy for identity, and specific optical rotation measurements. 

Specific methods used for qualitative testing of Isoleucine include:

·       Identity Confirmation: IR and NMR spectroscopy are standard methods used to confirm the molecular structure and identity of Isoleucine.

·       Purity Assessment: HPLC is used to monitor purity and identify related substances or impurities, ensuring that any spot or peak other than the principal one is within specified limits.

·       Stereochemical Purity: The specific optical rotation of the final product is measured to confirm the presence of the desired L-isoleucine isomer and ensure the correct stereochemistry, which is crucial for biological activity.

·       Pharmacopoeial Compliance: The product undergoes testing to ensure it meets the specifications outlined in major pharmacopoeias (e.g., European Pharmacopoeia, Japanese Pharmacopoeia), which detail specific identification tests for amino acids.

·       Microbiological Quality: Appropriate microbiological tests are conducted to ensure the product meets quality standards, especially since it is often produced by fermentation. 

MEDIOCON INC emphasizes strict quality control for every batch, guaranteeing high purity and consistency suitable for pharmaceutical and dietary applications. 

   Which tests are performed on Isoleucine,, , acid, Manufactured by  MEDIOCON INC ?

The specific tests performed on Isoleucine manufactured by MEDIOCON INC are not publicly available in the provided search results. MEDIOCON INC is identified as a manufacturer and wholesaler, but their specific product data sheets or quality control documents were not found. 

Generally, Isoleucine (an amino acid) is tested according to standard pharmaceutical or chemical industry specifications, such as those outlined in the United States Pharmacopeia (USP) or European Pharmacopoeia (EP). These standard tests typically include: 

·       Appearance: Visual inspection for color and form (e.g., white crystals or crystalline powder).

·       Solubility: Checking if the substance dissolves correctly in a specified solvent.

·       Identification: Confirming the compound's identity using methods like Fourier-transform infrared spectroscopy (FTIR) or thin-layer chromatography (TLC).

·       Specific Rotation: Measuring the optical activity to ensure the correct stereoisomer (L-Isoleucine) is present.

·       Assay: Determining the purity and concentration of Isoleucine, often by titration or high-performance liquid chromatography (HPLC).

·       Loss on Drying: Measuring residual moisture content.

·       pH value: Checking the pH of a solution containing the substance.

·       Limits for Impurities: Testing for related substances, chlorides, sulfates, ammonium, and other potential impurities using techniques like amino acid analysis or chiral chromatography.

·       Melting Range: Determining the temperature range at which the substance melts. 

For cell culture grade products, an additional cell culture test may be performed to ensure compatibility. 

To get the exact list of tests and specifications for MEDIOCON INC's product, you would need to contact the manufacturer directly to request their specific Certificate of Analysis (CoA) or product data sheet. You can likely find contact information for MEDIOCON INC through the Exporters India supplier list or by searching their official website. 

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

Manufacturing banana extract as an API by MEDIOCON INC (hypothetical company) faces challenges like ensuring consistent raw material (banana) supply, optimizing complex extraction/purification for high yields (downstream processing), managing costs (energy, operation), scaling up without introducing impurities, meeting stringent pharma regulations (GMP, FDA), and developing sustainable, eco-friendly processes for biomass waste, requiring advanced tech for purification and consistency, as noted in general API manufacturing literature. 

Key Challenges in Banana Extract API Manufacturing:

1.    Raw Material Variability & Supply:

·       Consistency: Ensuring a steady supply of consistent quality banana biomass (peels, pseudo-stems) is crucial but difficult due to agricultural factors (weather, pests).

·       Waste Management: Handling large volumes of organic waste from banana cultivation efficiently for extraction poses environmental and logistical hurdles.

2.    Extraction & Purification (Downstream Processing):

·       Yield & Purity: Extracting target bioactive molecules (phenolics, fibers) efficiently while removing unwanted compounds is complex and impacts costs significantly.

·       Method Optimization: Choosing and optimizing methods (like Microwave-Assisted Extraction - MAE) for maximum yield and bioactive content requires precise control of power, time, and pH.

·       Scale-Up Issues: Processes that work in the lab might produce unexpected impurities or lower yields when scaled up, needing extensive R&D.

3.    Regulatory & Quality Control:

·       GMP Compliance: Meeting rigorous Good Manufacturing Practices (GMP) and international standards (FDA, EMA) for API production is costly and complex.

·       Impurity Profiling: Identifying and controlling impurities to acceptable levels is critical for drug safety and efficacy, requiring sophisticated analytical methods.

4.    Cost & Sustainability:

·       High Costs: Energy, operational, and compliance costs for API production are substantial.

·       Environmental Footprint: Reducing the significant resource use (chemicals, water, energy) and managing waste streams sustainably is a growing demand.

5.    Technological Hurdles:

·       Process Intensification: Developing cost-effective, energy-efficient, and non-polluting technologies for extraction and purification remains a key technical requirement. 

By addressing these challenges with advanced techniques (like automation, PAT) and robust quality systems, companies aim to make natural extracts like banana API viable for pharmaceutical use. 

What is the Packing for Isoleucine,, , acid, Manufactured by MEDIOCON INC?

 

For L-Isoleucine from suppliers like those dealing with Mediocon Inc., packaging typically involves bulk quantities in 25 kg HDPE bags or drums for industrial/food grade, while smaller lab grades might come in bottles (e.g., 25g). Common packaging materials are bags, HDPE drums, or glass bottles, depending on the grade (Food, Pharma, Lab) and quantity, with common pack sizes being 25kg, 1kg, or smaller. 

Common Packaging Options:

·       Bulk (Food/Pharma Grade): 25 kg HDPE Bags, Drums.

·       Laboratory Grade: Smaller packs like 25g in Glass Bottles or other secure containers.

·       Other Sizes: 1 kg, 5 kg, 10 kg also available. 

Key Considerations:

·       Grade: Higher purity (e.g., cell culture, pharma) often uses more specialized packaging.

·       Supplier: Different distributors offer varying pack sizes and types.

·       Mediocon Inc.: While they supply various chemicals, their specific L-Isoleucine packaging would be detailed in their product documentation or via direct inquiry, but generally follows industry standards. 

What should the label claim for Isoleucine,, , acid, Manufactured by MEDIOCON INC   Include?

For a Isoleucine, product by MEDIOCON INC, the label should include its identity (Isoleucine,, Aminoacetic Acid), manufacturer (MEDIOCON INC), purity (e.g., 99%+ or Pharma Grade), physical form (white crystalline powder), chemical properties (formula C2H5NO2, smallest amino acid), intended use (cell culture, buffer, precursor), and compliance info (USP/EP tested if applicable), plus batch/expiry dates, storage, and directions, ensuring it meets regulatory standards for its specific application (food, pharma, lab). 

Essential Label Claims:

1.    Product Name: Isoleucine,.

2.    Chemical Name: Aminoacetic Acid / Aminoethanoic Acid.

3.    Manufacturer: Manufactured by MEDIOCON INC.

4.    Purity/Grade: E.g., 99%+; Pharma Grade; Tested to USP/EP standards (if applicable).

5.    Chemical Formula: C2H5NO2.

6.    Net Weight/Quantity: (e.g., 100g, 1kg).

7.    Appearance: White crystalline powder.

8.    Intended Use/Application:

1. "For laboratory, research, or cell culture use" (if not for human consumption).

2.    "Buffering agent," "Protein synthesis," "Neurotransmitter precursor" (functional claims).

9.    Storage Conditions: "Store in a cool, dry place," "Keep container tightly closed".

10. Batch Number & Expiry Date: Essential for traceability.

11. Safety/Handling: Appropriate hazard warnings (though generally safe, good practice).

12. Regulatory Info: FDA/ECHA registration if relevant to market. 

Example Layout:

·       MEDIOCON INC

·       Isoleucine, (Aminoacetic Acid)

·       Purity: 99% min. (Pharma Grade)

·       Formula: C2H5NO2 | MW: 75.07 g/mol

·       Appearance: White powder

·       Use: Cell Culture, Buffer, Synthesis.

·       Batch: [Batch No.] | Expiry: [MM/YYYY]

·       Storage: Cool, dry place. 

This covers the core requirements, but specific regulations depend on whether it's for a food additive, pharmaceutical excipient, or lab chemical. 

Where can Isoleucine,, , acid, Manufactured by MEDIOCON INC are procured?

Isoleucine,, , acid, 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 Isoleucine,, , acid, 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 Isoleucine,, , acid, Manufactured by MEDIOCON INC products.

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