Tryptophan 73-22-3 Manufacturer, Supplier, Exporter, MEDIOCON INC.

 

 

 

Tryptophan Manufactured by MEDIOCON INC

 

   Name: Tryptophan 

CAS No: 73-22-3

Molecular Weight: 204.23 g/mol

Molecular formula: C₁₁H₁₂N₂O₂

 

Synonyms :  Amino-3-(1H-indol-3-yl)propionic acid

Appearance : Tryptophan appears as a white to off-white crystalline powder, sometimes described as amorphous, with a slightly bitter taste. 

  

 Solubility : Tryptophan is slightly soluble in water, with solubility increasing significantly with temperature (e.g., 11.4 g/L at 25°C to nearly 50 g/L at 100°C). 

Uses : Key Functions & Uses

·       Sleep Regulation: Helps create melatonin, which manages sleep cycles, potentially reducing insomnia and sleep apnea symptoms.

·       Mood & Mental Health: Essential for serotonin production, impacting mood, and used in alternative treatments for depression, anxiety, and PMS.

·       Energy & Metabolism: Converted into niacin (Vitamin B3) for energy production and DNA synthesis.

·       Protein Synthesis: As an essential amino acid, it's vital for building proteins, enzymes, and muscle.

·       Other Potential Uses: May help with smoking cessation, chronic pain, mania, and certain compulsive disorders. 

Sources of Tryptophan

·       Foods: Chicken, cheese, eggs, fish, milk, peanuts, pumpkin seeds, sesame seeds, soybeans, and sunflower seeds.

·       Supplements: Available as L-tryptophan or its derivative 5-HTP, often recommended by doctors for specific conditions. 

Important Considerations

·       Safety: While beneficial, tryptophan supplements can have side effects, so consulting a doctor before use is crucial.

·       Regulation: After being restricted, L-tryptophan is available again as a supplement but is also marketed as a prescription drug in some regions for major depression. 

 

 

How Tryptophan  is manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC is a wholesaler and manufacturer, but there is no specific, publicly available information describing their proprietary method for synthesizing tryptophan. Tryptophan is generally produced industrially through a microbial fermentation process using genetically modified bacteria. 

The general industrial production method involves the following key stages:

1.      Fermentation: The process typically starts with single-cell bacteria, such as Escherichia coli or Corynebacterium glutamicum, added to a nutrient-rich medium (commonly containing dextrose/glucose and ammonium hydroxide) in a large, aerated fermenter. The bacteria multiply and, through their metabolic pathways, convert the raw materials into L-tryptophan.

2.      Product Separation: After fermentation, the resulting broth is filtered to remove the solid biomass.

3.      Purification: The liquid containing the L-tryptophan is then subjected to a series of purification steps:

1.                  The pH is lowered, and the mixture is heated to facilitate binding to an ion-exchange resin.

2.                  The L-tryptophan is then eluted (washed off the resin) using an ethanol/water solution.

3.                  The ethanol is evaporated in a vacuum, and the remaining solution is cooled and its pH adjusted to the isoelectric point (around pH 5.8) to induce crystallization.

4.      Final Processing: The resulting crystals are filtered, washed to remove minor impurities that can cause discoloration, and dried to yield the final, highly purified L-tryptophan powder. 

The production process often involves using engineered bacterial strains to bypass natural feedback inhibition mechanisms, maximizing the yield of the desired amino acid. 

 

 

 

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

 

Information on Tryptophan dosage forms specifically manufactured by "MEDIOCON INC" is not directly available in the provided search results, which mainly discuss generic Tryptophan tablets and capsules (like Tryptan) from other companies (e.g., Bausch Health), but generally, L-Tryptophan is available as tablets (e.g., 250mg, 500mg, 750mg, 1g) and capsules (e.g., 500mg). 

General Tryptophan Dosage Forms:

·       Tablets: Common forms include film-coated tablets with strengths like 250mg, 500mg, 750mg, and 1g.

·       Capsules: Often found in 500mg strengths, sometimes formulated as soft gelatin capsules for better absorption.

·       Powder/Granules: Used as a raw material or sometimes as a supplement itself, in low or high-density forms. 

To find MEDIOCON INC's specific products:

·       You would need to search for their product catalog or contact them directly, as they might be a supplier of the active pharmaceutical ingredient (API) rather than a finished product manufacturer, or they might have a different brand name. 

Common Tryptophan Brands (Not MEDIOCON INC):

·       Tryptan: A well-known brand available as capsules and tablets (e.g., 500mg capsules, 250mg, 500mg, 750mg, 1g tablets). 

 

 

How Tryptophan Manufactured by MEDIOCON INC Dosage Forms are prepared?

Typical Dosage Forms That Use L-Tryptophan Raw Material

Because Mediocon supplies ingredient powder only, the dosage forms below must be formulated by pharmaceutical or nutraceutical companies using Mediocon’s raw tryptophan:

1.      Oral Dosage Forms

o   Tablets

o   Capsules

o   Powders / sachets

o   Liquid oral solutions or syrups
These are common for dietary supplements containing L-tryptophan.
Example products on the market include capsules and tablets containing specified mg of L-tryptophan.

2.      Parenteral (Intravenous) Solutions

o   Tryptophan may be formulated into amino acid injection/infusion solutions for clinical nutrition (e.g., part of parenteral nutrition mixtures).
In such products, L-tryptophan is dissolved in sterile water with other amino acids and electrolytes for IV use.

3.      Functional Food / Nutraceutical Powders

o   Mediocon’s raw L-tryptophan can be blended into protein blends, amino-acid formulations, and functional health drinks.

🧪 How Dosage Forms Are Prepared from Mediocon’s Tryptophan

The preparation process of the final dosage forms depends on the type:

1. Tablet / Capsule Formulation

·       Ingredient screening and testing of Mediocon’s raw L-tryptophan powder.

·       Blending with excipients (fillers, binders, lubricants).

·       Tableting (for tablets) or encapsulation (for capsules) using standard pharmaceutical equipment.

·       Coating (if required).

·       Packaging and labeling according to regulatory guidelines.

These manufacturing steps follow standard pharmaceutical/nutraceutical formulation practices.

2. Oral Liquid / Syrup

·       Dissolve the amino acid in a suitable solvent system with flavoring and stabilizers.

·       Adjust pH and osmolality if needed.

·       Fill into bottles or sachets under hygienic conditions.

3. Injectable Amino Acid Solutions

·       Raw L-tryptophan and other amino acids are measured and dissolved under sterile conditions.

·       Solutions are sterilized and filled into sterile containers (bags or vials) for intravenous infusion.

·       Quality testing for sterility, pyrogens, and purity is critical.

 

 

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

While specific data for MEDIOCON Inc. is unavailable in these results, Tryptophan is generally available as oral tablets, capsules, powders, and solutions, and sometimes in injectable forms for parenteral nutrition, used for sleep, mood support, and as an essential amino acid, with common forms being solid oral dosages like capsules and tablets. 

Common Dosage Forms for Tryptophan (General)

·       Capsules & Tablets: Most common for dietary supplements and therapeutic use, offering convenient oral dosing.

·       Powders: Can be mixed into liquids or food, often used as an active pharmaceutical ingredient (API).

·       Solutions: Used for oral consumption or in parenteral (injectable) nutrition. 

To find specific forms from MEDIOCON Inc.:

·       Check their official website or product listings on pharmaceutical supplier sites.

·       Look for their L-Tryptophan product under specific dosage forms like "API," "Tablet," or "Capsule". 

 

When should Tryptophan  Manufactured by MEDIOCON INC be taken?

General Information Regarding Tryptophan Intake:

·       Absorption: Taking tryptophan when your stomach is empty may help prevent competition from other amino acids for absorption.

·       Consistency: Taking the supplement at consistent times can help maintain steady levels in your body.

·       Professional Guidance: Dosage and timing can vary based on individual conditions, so it is essential to follow a doctor's advice. 

Purpose of Tryptophan:

·       Tryptophan is a precursor to serotonin, a neurotransmitter that affects mood and sleep, and melatonin, a hormone that regulates sleep cycles.

·       It is often used to support sleep, manage anxiety, and may potentially aid in addressing depression. 

Important Considerations:

·       Potential Interactions: It is generally advised not to take tryptophan with St. John's wort or other supplements that can affect serotonin levels.

·       Possible Side Effects: Some individuals may experience side effects such as drowsiness, light-headedness, dry mouth, or digestive issues.

 

 

 What are the effects And Side effects of Tryptophan  Manufactured by MEDIOCON INC

Mediocon Inc is a supplier of L-tryptophan as a raw material or ingredient, not a specific branded consumer product; therefore, the effects and side effects are associated with L-tryptophan use in general. 

Effects of Tryptophan

Tryptophan is an essential amino acid that the body uses to produce: 

·       Serotonin: A neurotransmitter that helps regulate mood, sleep, appetite, and pain sensation.

·       Melatonin: A hormone that helps regulate the sleep-wake cycle.

·       Niacin (Vitamin B3): Needed for energy metabolism and DNA production. 

When taken as a supplement, L-tryptophan is used for a variety of conditions, including: 

·       Treating insomnia and improving sleep quality.

·       Acting as a potential natural antidepressant and stress reducer.

·       Helping manage symptoms of premenstrual syndrome (PMS) and hyperactivity in children. 

General Side Effects of Tryptophan Supplements

Common side effects of L-tryptophan supplements can include: 

·       Drowsiness and dizziness

·       Nausea, vomiting, stomach pain, diarrhea, gas, and heartburn

·       Dry mouth and loss of appetite

·       Headache and blurry vision

·       Muscle pain and weakness

·       Hypersensitivity reactions (rash, itching, hives, swelling, wheezing) 

Serious Warnings and Precautions

·       Serotonin Syndrome: Taking L-tryptophan with other medications that increase serotonin levels (like SSRIs or MAOIs) can lead to a potentially life-threatening condition called serotonin syndrome, which involves symptoms like high fever, confusion, rapid heart rate, and muscle stiffness.

·       Eosinophilia-Myalgia Syndrome (EMS): In the late 1980s, contaminated L-tryptophan supplements were linked to cases of EMS, a serious neurological condition. While quality controls have improved, it is important to purchase supplements from reputable sources.

·       Specific Conditions: Use with caution in patients with diabetes mellitus, bladder cancer, or bipolar disorder, as tryptophan can worsen certain conditions.

·       Pregnancy and Breastfeeding: It is possibly unsafe to use L-tryptophan in amounts greater than those found in food during pregnancy. 

Always consult with a healthcare professional before starting any new supplement regimen to discuss potential risks and interactions. 

 

 

 

 How is Tryptophan  Manufactured by MEDIOCON  INC  Tested Qualitatively?

Common Qualitative Testing Methods for Tryptophan

Qualitative analysis methods are used to confirm the presence of tryptophan and verify its identity, as well as to check for specific impurities. 

·       Colorimetric Tests: These wet chemistry methods rely on a color change reaction specific to the indole ring structure of tryptophan.

o   Hopkins-Cole Test: This is a classic confirmatory test. Tryptophan's indole moiety condenses with glyoxylic acid (the Hopkins-Cole reagent) in the presence of concentrated sulfuric acid to produce a distinctive purple or violet color at the interface of the two liquid layers.

o   Ehrlich's Test (p-dimethylaminobenzaldehyde test): The Ehrlich reagent (p-dimethylaminobenzaldehyde) reacts with the indole group of tryptophan under acidic conditions, resulting in a colored complex.

o   Acree-Rosenheim Test: This test uses formaldehyde as the reagent, which condenses with tryptophan in an acidic environment to yield a violet color.

o   Ninhydrin Test: Like other amino acids, tryptophan reacts with ninhydrin to produce a purple-colored complex (Ruhemann's purple). Imino acids produce a yellow color instead. This test is a general identification test for the presence of amino acids.

·       Chromatographic Techniques: These are more specific and widely used in industrial settings for identification and purity checks, often in conjunction with detection methods.

o   High-Performance Liquid Chromatography (HPLC): This is a standard method used to separate tryptophan from other amino acids and potential impurities. Tryptophan can be detected spectrophotometrically at 280 nm because of its aromatic structure. The presence of a peak at the correct retention time confirms its identity, and the peak's purity can be assessed using techniques like a diode array detector.

o   Thin-Layer Chromatography (TLC): This method can be used for rapid, visual qualitative detection, potentially with a specific probe that changes color or fluoresces under UV light in the presence of tryptophan.

o   Mass Spectrometry (MS): Coupling HPLC with mass spectrometry (LC-MS/MS) offers high sensitivity and specificity, providing a definitive identification based on the molecule's mass-to-charge ratio and fragmentation pattern. 

 

 

 

   Which tests are performed on Tryptophan  Manufactured by  MEDIOCON INC ?

Physical and Chemical Analysis 

·       Appearance and Odor/Taste: Visual and sensory checks for physical characteristics (e.g., light yellow powder, special sour taste/odor in a sample description not specific to Mediocon).

·       Purity/Content (Assay): Measured using High Performance Liquid Chromatography (HPLC) to determine the exact percentage of L-Tryptophan (typically around 98-99% purity).

·       Loss on Drying (Moisture Content): A test to measure residual moisture.

·       Ash Content: Measures the inorganic residue remaining after ignition.

·       pH: The acidity or alkalinity of a solution of the product is measured.

·       Particle Size/Mesh Size: Determined to ensure consistency and suitability for specific applications.

·       Solvent Residues: Analysis for remaining organic solvents used in the manufacturing process.

·       Specific Impurity Analysis: Critical tests for potentially harmful related substances such as 1,1'-ethylidene-bis-l-tryptophan (EBT) and 1-methyl-1,2,3,4-tetrahydro-beta-carboline-3-carboxylic acid (MTCA) using HPLC, which were historically linked to health issues. 

Safety and Microbial Contamination

·       Heavy Metals Analysis: Testing for trace elements and heavy metals like lead (Pb), arsenic, cadmium, and mercury using methods like Inductively Coupled Plasma Mass Spectrometry (ICP-MS).

·       Microbial Contamination: Checks for specific bacteria and fungi, including:

o   Total Bacterial Count.

o   Yeast and Mold counts.

o   Presence/Absence of specific pathogens like Salmonella and E. Coli.

·       Endotoxin Activity: Measured using the Limulus amoebocyte lysate (LAL) assay to ensure levels are within safe limits, particularly for pharmaceutical use. 

Manufacturers like MEDIOCON INC provide a Certificate of Analysis (COA) for specific product batches, which details the results of these quality control tests against the established standards. Customers would typically consult this document for precise information on the batch they received. 

 

 

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

General Manufacturing Challenges for Tryptophan:

1.      Purity & Fermentation Control: While fermentation (often with E. coli) is common, ensuring high purity and preventing unwanted byproducts is crucial, especially for pharmaceutical grades.

2.      Stability Issues: Tryptophan can be sensitive to light and heat, demanding careful control of manufacturing conditions and packaging to maintain efficacy, notes a post by the National Institutes of Health.

3.      Bioavailability & Delivery: Poor water solubility and absorption can limit effectiveness, requiring advanced formulation (e.g., nanoparticles, complexation) to improve how much the body actually uses, according to this article on ResearchGate.

4.      Taste Masking: L-tryptophan has a bitter taste, making it challenging to formulate palatable oral dosage forms (capsules/tablets).

5.      Regulatory Compliance: Meeting strict Good Manufacturing Practices (GMP) for consistent quality, safety, and efficacy adds complexity. 

To find specific details for MEDIOCON INC:

·       Check their official website or product documentation.

·       Search for their published clinical trial data or regulatory filings (e.g., with the FDA, EMA).

·       Look for industry reports mentioning their specific formulations or production methods.

 

 

 

What is shelf life Of Tryptophan  by MEDIOCON INC

While specific information for the shelf life of Tryptophan directly from MEDIOCON INC was not found in the search results, the general industry standard and information from other suppliers indicate a typical shelf life of 2 to 5 years when stored properly. .

 

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

The required information generally falls into two main areas: the principal display panel and the information panel. 

Mandatory Label Elements

The required statements that must be included are: 

·       Statement of Identity: The product name must include the words "Dietary Supplement" or "L-Tryptophan Supplement" and be displayed on the front (principal display) panel.

·       Net Quantity of Contents: The amount of the product in the package (e.g., number of capsules, net weight) must be on the principal display panel.

·       "Supplement Facts" Panel: This standardized panel must list the following information in a specific format:

o   Serving Size and Servings Per Container.

o   Each Dietary Ingredient: The name (L-Tryptophan) and the quantitative amount per serving by weight. For L-tryptophan, a symbol referring to the footnote "Daily Value not established" must be used.

o   Other Nutrients: Declaration of certain other nutrients (like total fat, sodium, etc.) if present in measurable amounts.

·       Ingredient List: All ingredients not listed in the "Supplement Facts" panel (e.g., inactive ingredients like binders, flavors, solvents) must be listed below the panel under the heading "Other Ingredients" in descending order of predominance by weight.

·       Name and Place of Business: The name and full U.S. mailing address (street address, city, state, zip code) of the manufacturer, packer, or distributor (in this case, MEDIOCON INC).

·       Adverse Event Reporting: A domestic U.S. phone number or mailing address for consumers to report serious adverse events. 

Permissible Claims and Necessary Disclaimer

Manufacturers may use certain claims, provided they are truthful and not misleading. 

·       Structure/Function Claims: Statements describing the role of L-Tryptophan in affecting the structure or function of the body (e.g., "supports mental well-being" or "helps regulate mood and sleep") are permitted.

·       Required Disclaimer: If a structure/function claim is used, it must be accompanied by the exact, FDA-mandated disclaimer adjacent to the claim(s): "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.". The manufacturer must also notify the FDA of the claim within 30 days of marketing the product.

·       Prohibited Claims: The label cannot include drug claims, which are claims that the product can "diagnose, treat, cure, or prevent any disease". 

Quality and Purity Considerations

While not a specific label claim requirement, the manufacturer is responsible for ensuring the product is safe and meets quality standards. This includes ensuring low levels of impurities such as 1,1'-ethylidene-bis-L-tryptophan (EBT), which has been historically linked to health conditions like eosinophilia-myalgia syndrome (EMS). The manufacturer should follow current Good Manufacturing Practices (cGMPs) to ensure identity, purity, strength, and composition. 

 

 

Where can Tryptophan  Manufactured by MEDIOCON INC are procured?

Valine  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 findTryptophan  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 forTryptophan  Manufactured by MEDIOCON INC products.

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