Lysine56-87-1 Manufacturer, supplier, exporter by MEDIOCON INC

 

 

 

              Lysine, Manufactured by MEDIOCON INC

 

 Name:   Lysine

CAS No  :  56-87-1 (L-Lysine)

Molecular Weight : 146.19 g/mol

Molecular formula: C₆H₁₄N₂O₂

Synonyms

·       L-lysine, LYS, H-Lys-OH, Lysine acid, (S)-2,6-diaminohexanoic acid, α,ε-Diaminocaproic acid

·       Appearance: Typically a white to off-white crystalline powder or solid, which is odorless.

·       Solubility: Highly soluble in water (approx. 1.5 kg/L at 20 °C); insoluble in common neutral solvents such as ethanol, ethyl ether, acetone, and benzene.

·        

o   Uses : Nutritional Supplement: An essential amino acid in human and animal diets, often used as an additive in animal feed for pigs and poultry.

o   Medical/Health: Used in alternative medicine to treat or prevent cold sores caused by the herpes simplex virus, and studied for use in calcium absorption and bone health.

o   Biochemical Research: Employed in cell culture media, in studies of glycation mechanisms, and as a component in the formation of poly-lysine polymers.

o   Industrial: Used in cosmetic products for skin and hair conditioning properties. 

 

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

Mediocon Inc manufactures and supplies L-Lysine Hydrochloride as an Active Pharmaceutical Ingredient (API) and nutraceutical ingredient, which can be used to produce various dosage forms. The company itself produces L-lysine in bulk forms for other manufacturers to use in their finished products. 

Common dosage forms of lysine available in the market (not all necessarily made by Mediocon Inc as a finished product) typically include: 

·       Oral forms:

o   Tablets

o   Capsules

o   Liquids/Syrups (often as L-lysine monohydrochloride solution)

o   Powders (as a dietary supplement or food/feed additive)

o   Gummies

. 

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

MEDIOCON INC likely uses standard industry quality control methods for qualitative testing of Lysine. While specific proprietary information about the company's exact protocols is not available, common qualitative tests used in the manufacturing setting include

Ninhydrin reaction, Paper or Thin-Layer Chromatography (TLC), and adherence to established standards like the Food Chemical Codex (FCC) monograph. 

Common Qualitative Testing Methods 

• Ninhydrin Reaction: This is a general test for the presence of primary amines, including all alpha-amino acids like lysine. The sample is treated with ninhydrin reagent and heated, which results in a characteristic deep blue or purple color, confirming the presence of amino acids. A specific ninhydrin-ferric reagent method can also be used to test specifically for high concentrations of lysine.
• Chromatography (Paper or Thin-Layer Chromatography - TLC): In manufacturing, the identity of L-lysine is often confirmed using chromatographic techniques. The sample is spotted on a chromatography plate or paper and a solvent system (mobile phase) is allowed to move up it. The separated amino acids are then visualized using a revealing agent like ninhydrin spray. The resulting spot's retention factor (

value) is then calculated and compared to that of a known, pure L-lysine standard to confirm its identity.

• Solubility Test: A basic test to determine the physical properties of the product. The sample is checked for solubility in various solvents (e.g., water, ethanol) to ensure it matches the expected profile of L-lysine (or L-lysine monohydrochloride).
• Optical Rotation: L-lysine is an optically active compound. Measuring its specific optical rotation using a polarimeter helps confirm the correct stereoisomer (L-form) has been produced, which is crucial for pharmaceutical and nutritional applications.
• Mass Spectrometry (MS) and High-Performance Liquid Chromatography (HPLC): While often used for quantitative analysis, these sophisticated methods can also provide qualitative identification by confirming the mass-to-charge ratio and retention time of the compound, ensuring its purity and identity. 

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

Mediocon Inc manufactures Lysine (likely L-Lysine Monohydrochloride or a similar form) and uses standard pharmaceutical and quality control (QC) tests to ensure product quality. 

How Lysine Is Manufactured

Mediocon Inc likely produces Lysine using the widely adopted fermentation process. This process involves: 

·       Microbial Fermentation: The primary method involves the direct fermentation of a carbon source (such as molasses or starch) using genetically modified microbes, typically species of Brevibacterium or Corynebacterium glutamicum.

·       Purification and Processing: After fermentation, the cells are removed from the broth. The L-lysine broth is then concentrated, purified (e.g., via ion-exchange chromatography), and converted into a stable, solid form, such as L-lysine monohydrochloride or L-lysine sulfate. 

Tests Performed on Lysine (Qualitative and Quantitative) 

The specific qualitative and quantitative tests performed by Mediocon Inc adhere to established industry standards, such as those outlined in the European Pharmacopoeia or the Indian Pharmacopoeia. These tests ensure the identity, purity, and quality of the final product. 

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

Manufacturing banana extract as an API by MEDIOCON INC faces challenges like ensuring consistent raw material supply (bananas/waste), complex purification (downstream processing) for pharmaceutical-grade purity, meeting stringent global GMP/regulatory standards (FDA, EMA), managing high costs (energy, operations), handling bio-waste (peels, pseudostems), and achieving economically viable, scalable, and sustainable processes, particularly around isolating specific bioactive compounds. 

Key Challenges:

1.    Raw Material & Consistency: Securing a continuous, quality supply of bananas or their byproducts (peels, pseudostems) is crucial, and variability in natural sources affects extract quality.

2.    Downstream Processing & Purification: Extracting specific Active Pharmaceutical Ingredients (APIs) from complex biomass requires advanced, cost-effective separation and purification techniques to achieve high purity and yield, which is a major hurdle.

3.    Regulatory Compliance (GMP): Meeting stringent Good Manufacturing Practices (GMP) and international standards (like US FDA, EMA) for API production requires significant investment and robust Quality Management Systems.

4.    Cost & Scalability: Developing processes that are both economically viable (considering energy, chemicals, labor) and scalable to meet market demand is a constant challenge.

5.    Bio-Waste Management: While banana waste offers potential, its large-scale collection, handling (odor, decomposition), and conversion into usable extracts poses environmental and logistical issues.

6.    Process Standardization: Ensuring batch-to-batch consistency for a natural product extract requires precise control over every step, from raw material sourcing to final isolation.

7.    Sustainability: Balancing resource-intensive extraction with environmental goals (reducing waste, using greener solvents/processes) is increasingly important. 

How Companies Address Them (General API Industry Context):

·       Investing in automation and digital monitoring.

·       Adopting Advanced Quality Management Systems (QMS) and sustainability audits.

·       Exploring innovative technologies for extraction and purification.

·       Focusing on green chemistry principles. 

For MEDIOCON INC specifically, these general challenges are amplified by the need to prove efficacy and purity for banana-derived compounds for pharmaceutical use, requiring significant R&D and compliance inve

 

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

 

Mediocon Inc supplies L-Lysine as an amino acid, but specific packaging details (like bag size, drums, etc.) for their product aren't in the search snippets; typically, Lysine HCl comes in large bulk bags (e.g., 25kg) for industrial use or smaller bottles/syrups for supplements, so contact Mediocon directly for precise packing information for their specific grade. 

·       What it is: Lysine is an essential amino acid, often sold as L-Lysine HCl (hydrochloride).

·       Common Packaging: For bulk API (Active Pharmaceutical Ingredient), it's often in 25kg bags or drums; for supplements (syrups, powders), it's in bottles (100ml, 200ml) or bulk tubs.

·       To find Mediocon's specifics: Visit their website, contact their sales, or check distributor listings like IndiaMART for their product details. 

In short, expect large bags for raw material or smaller bottles/containers for finished products, but confirm with Mediocon for their exact packaging.

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

The label for a Lysine dietary supplement manufactured by MEDIOCON INC must comply with U.S. Food and Drug Administration (FDA) regulations for dietary supplements and include specific mandatory statements. Key information includes: 

Mandatory Label Elements

·       Statement of Identity: The product name must clearly identify it as a "Lysine dietary supplement" or "Lysine supplement".

·       Net Quantity of Contents: The total amount of the product in the package (e.g., "100 capsules," "Net Wt 500 mg") must be stated.

·       "Supplement Facts" Panel: This panel is required to list specific nutrition information, including:

o   Serving Size and Servings Per Container.

o   The name of the dietary ingredient, which is Lysine (specifying the exact chemical form, such as L-lysine or lysine HCl).

o   The quantitative amount per serving.

o   An asterisk referring to a footnote stating "Daily Value Not Established" for lysine, as amino acids generally do not have an established Daily Value (DV).

·       Other Ingredients List: Any non-dietary ingredients (e.g., fillers, binders, flavors) must be listed below the "Supplement Facts" panel in descending order of predominance by weight.

·       Manufacturer Information: The name and place of business of the manufacturer, packer, or distributor must be listed. For MEDIOCON INC, this would appear as "Manufactured by MEDIOCON INC" along with the full street address (unless it is a current local listing), city, state, and zip code.

·       Adverse Event Reporting: A domestic U.S. phone number or mailing address where consumers can report a serious adverse event is required.

·       Warning Statements: Any necessary warnings related to the product's ingredients or use must be present (e.g., allergen information). 

Permissible Claims (If Used)

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

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

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