L-Proline 147-85-3 Manufacturer, Supplier, Exporter, MEDIOCON INC.

 

 

 

L-Proline Manufactured by MEDIOCON INC

 

   Name: L-Proline

CAS No: 147-85-3

Molecular Weight: 115.13 g/mol

Molecular formula:  C₅H₉NO₂

Synonyms : Common synonyms for L-Proline include (S)-Proline, (S)-2-Pyrrolidinecarboxylic Acid, 2-Pyrrolidinecarboxylic Acid, H-PRO-OH, L-PRO, and Proline (when context implies the L-isomer).

Appearance : L-Proline appears as a white to off-white crystalline powder or colorless crystals. 

 Solubility : L-Proline is highly soluble in water, with solubility around 162-1620 g/L (or 16.2-162 g/100mL) at room temperature (25°C), but it is generally insoluble in nonpolar solvents like ether and only moderately soluble in alcohols, with solubility increasing with temperature in various solvents.

Uses : L-proline is a non-essential amino acid primarily used as a key building block for collagen. It has various applications in human health, industry, and the natural world due to its unique structural properties. 

In Human Health and Supplements

L-proline is a crucial component of the proteins in skin, bones, tendons, and cartilage. 

·       Collagen Synthesis: Its most significant role is in the production of collagen, the main structural protein in the body, which helps maintain the strength and elasticity of connective tissues. This is why it is often found in anti-aging and skin care products (e.g., face serums, moisturizers).

·       Wound and Tissue Repair: Due to its role in collagen formation, L-proline supports the healing of skin injuries and the repair of muscle tissue after physical activity.

·       Joint and Bone Health: It helps regenerate cartilage and maintain joint function, potentially benefiting individuals with chronic joint discomfort or conditions like osteoarthritis.

·       Cardiovascular and Gut Health: L-proline contributes to the structural integrity of blood vessels and may support heart health by maintaining the tissues that make up artery walls. It also plays a role in healing the gut lining and improving immune function.

·       Energy Source: In certain cells, such as astrocytes in the brain, L-proline can serve as an effective energy substrate, especially when other sources like glucose are limited. 

In Industry and Biotechnology

L-proline also has a wide range of non-medical applications: 

·       Food Additive: It is used to enhance the nutritional value and taste of various foods and beverages, including bread, ice cream, and soy-based products. It improves the flavor of artificial sweeteners and the sourness of organic acids.

·       Brewing: In the brewing process, proline-rich proteins can be problematic as they combine with polyphenols to form haze (turbidity) in beer and wine.

·       Pharmaceuticals & Cosmetics: It is used as a precursor in the synthesis of certain drugs and as a stabilizing agent for proteins in pharmaceutical products. In cosmetics, it functions as a skin and hair conditioning agent.

·       Organic Chemistry: L-proline and its derivatives are used as asymmetric catalysts in organic synthesis reactions due to their unique structure. 

In Plants and Agriculture

In plants, L-proline is a vital molecule for survival in challenging environments. 

·       Stress Tolerance: Plants accumulate high concentrations of L-proline to protect cells from environmental stresses such as drought, high salinity, and extreme temperatures.

·       Growth Enhancement: It is an ingredient in some amino acid-based fertilizers to promote root development, flowering, and overall crop yield

 

 

How L-Proline is manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC. likely manufactures L-Proline via fermentation (using microorganisms like Micrococcus glutamicus or Corynebacterium) or chemical synthesis from precursors like glutamic acid, often involving reduction and cyclization steps, with fermentation being common for industrial scale due to efficiency and greener chemistry, though specific proprietary methods for MEDIOCON aren't detailed in general literature. 

Common Manufacturing Methods

·       Fermentation (Bioproduction):

o   This is a preferred industrial method, using specific bacteria (e.g., Micrococcus glutamicus, Corynebacterium species) that are cultured in nutrient-rich media.

o   These microbes convert carbon and nitrogen sources (like glucose, ammonium salts) into L-Proline, which is then recovered from the culture broth.

o   Key factors include adding biotin, ammonium, and chloride ions for optimal growth and production, as detailed in patents like US3650899A and US4444885A.

·       Chemical Synthesis:

o   Can start from L-glutamic acid, involving esterification and reduction.

o   Other routes might involve cyclization reactions, sometimes using catalysts or complex organic chemistry. 

How MEDIOCON Might Do It (General Industry Practice)

·       While MEDIOCON's specific process isn't public, they likely use fermentation for large-scale, cost-effective production, as it's a well-established, eco-friendly route for many amino acids.

·       They might also employ advanced biocatalysis, using enzymes or engineered microbes for high yield and purity, aligning with modern "green chemistry" principles. 

To get precise details, you would need to consult MEDIOCON INC.'s specific patent filings or technical documentation or their official product specifications.

 

 

 

What are the different  dosage forms of L-Proline Manufactured  by  MEDIOCON INC?

 

Mediocon Inc primarily functions as a manufacturer and wholesaler of L-Proline in powder form, which serves as an active pharmaceutical ingredient (API), an intermediate chemical, or a nutraceutical ingredient. They do not appear to manufacture finished dosage forms of L-Proline for end-users, but rather the raw material used by other companies to create various products. 

Based on general industry practices and products offered by various suppliers (not solely Mediocon Inc), L-Proline is commonly available in several forms:

·       Powder: This is the primary form manufactured and supplied by companies like Mediocon for bulk use in other products. It is versatile for various applications, including dietary supplements and skincare formulations.

·       Capsules and Tablets: These are common oral dosage forms for L-Proline as a convenient dietary supplement, but typically produced by other companies using the raw powder ingredient.

·       Liquids: L-Proline can be found in liquid form, often used in the food and beverage industry or as a highly concentrated solution in specialized applications.

·       Creams and Serums: In the skincare industry, L-Proline is an ingredient in topical products due to its collagen-boosting properties.

·       Injections: In some medical contexts, L-Proline may be available as an injectable solution, though this is a specialized form. 

Mediocon Inc focuses on providing the raw ingredient for these diverse applications rather than the final consumer-ready dosage forms. 

 

 

How L-Proline Manufactured by MEDIOCON INC Dosage Forms are prepared?

Mediocon Inc. primarily manufactures and exports L-Proline as a bulk active pharmaceutical ingredient (API) or nutraceutical ingredient (a white crystalline powder). They do not appear to manufacture finished dosage forms (like tablets or capsules) themselves, but rather supply the raw material to other companies for use in their own formulations. 

The general methods for preparing L-proline dosage forms (e.g., as part of a tablet or capsule) typically involve standard pharmaceutical manufacturing techniques used by the client companies that purchase the raw L-proline from Mediocon Inc. 

L-Proline Manufacturing Process (API)

Mediocon Inc. likely sources or produces L-proline through common industry methods to ensure high purity and meet regulatory standards (EUGMP, USFDA, etc.). General methods for producing pharmaceutical-grade L-proline include: 

·       Fermentation using specific microorganisms (e.g., Micrococcus glutamicus) in a nutrient medium.

·       Extraction from natural sources, such as protein hydrolysates.

·       Chemical synthesis. 

The resulting L-proline is a white crystalline powder, which is then sold as a raw ingredient. 

Preparation of Dosage Forms

Companies that purchase L-proline from Mediocon Inc. incorporate it into various dosage forms. For example, L-proline can be used:

·       As an active ingredient in dietary supplements (e.g., powders, capsules, tablets) for joint, tendon, and skin health.

·       As a co-former in co-crystal formulations with other drugs (APIs) to enhance properties like dissolution rate. This process often involves techniques like liquid-assisted grinding or wet co-grinding to form a powder that is then compressed into a tablet. 

The specific steps for creating the final dosage form involve standard pharmaceutical unit operations such as: 

·       Mixing the L-proline with excipients (binders, fillers, disintegrants, lubricants).

·       Granulation (wet or dry) to improve flowability and compressibility of the powder mixture.

·       Compression into tablets using a tablet press.

·       Encapsulation into hard-shell capsules.

·       Coating (if required) for taste masking, protection, or modified release.

·       Packaging the finished product in containers or blister packs.

 

 

What are the appropriate Dosage forms of L-Proline Manufactured  by  MEDIOCON   INC?

MEDIOCON INC primarily deals in L-Proline as a raw material in white crystalline powder form, which is used by other companies to manufacture finished dosage forms. They do not appear to manufacture finished dosage form products like tablets, capsules, or injections containing L-Proline for direct patient use. 

L-proline is an amino acid that serves as an Active Pharmaceutical Ingredient (API) or a nutraceutical ingredient. The "appropriate" dosage form is determined by the end-product manufacturer and the intended use. 

Common dosage forms for L-proline in the pharmaceutical and nutraceutical industries include:

·       Powders: Used as a bulk ingredient for compounding or as a standalone dietary supplement.

·       Capsules and Tablets: A common form for oral dietary supplements.

·       Oral Solutions/Drops: L-proline is soluble in water, making it suitable for liquid formulations.

·       Intravenous (IV) Solutions: In medical settings, L-proline is a component of parenteral nutrition (IV feeding) solutions, often combined with other amino acids and dextrose. 

MEDIOCON INC supplies L-proline as the raw material (API/nutraceutical ingredient), not the final consumer product.

 

 

 

When should L-Proline Manufactured by MEDIOCON INC be taken?

General information regarding L-Proline supplements typically includes information about potential usages, timing, and storage, and it is important to follow the instructions provided by the manufacturer. 

·       Timing: L-Proline supplements are often suggested to be taken on an empty stomach with water.

·       Consult a Physician: Before beginning any new supplement regimen, it is recommended to consult with a healthcare provider, particularly if you are pregnant, nursing, taking medications, or have existing medical conditions.

·       Storage: After opening, L-Proline products should generally be stored in a cool, dry place. 

Always follow the specific instructions and warnings provided on the product label of any L-Proline supplement you choose to use.

Disclaimer: This information is for general knowledge and should not be taken as medical advice. Consult with a healthcare professional before starting any new supplement regimen

 

 

 

 

 What are the effects And Side effects of L-Proline Manufactured by MEDIOCON INC?

Mediocon Inc. is primarily a manufacturer and exporter of pharmaceutical API intermediates, nutraceutical raw materials, and industrial chemicals, and does not appear to manufacture a specific, branded L-proline supplement for direct consumer use. The effects and side effects of L-proline are general to the amino acid itself, regardless of the manufacturer. 

Effects of L-Proline

L-proline is a non-essential amino acid vital for the human body. Its primary effects stem from its crucial role in collagen synthesis. 

·       Collagen Production: It is a key precursor for collagen, the most abundant protein in the body, found in skin, bones, tendons, cartilage, muscles, and blood vessels.

·       Tissue Repair & Wound Healing: By supporting collagen and connective tissue synthesis, L-proline aids in repairing skin damage (such as burns or incisions), regenerating cartilage, and healing the gut lining.

·       Joint and Cardiovascular Health: It is important for the proper functioning of joints and tendons and helps maintain and strengthen heart muscles and arterial walls, potentially reducing the risk of hardening of the arteries (arteriosclerosis).

·       Muscle Growth & Recovery: As a building block of protein, it supports muscle growth, development, and recovery from intense workouts.

·       Digestive Health: It strengthens the intestinal wall lining, which can be beneficial for overall gut health and conditions like leaky gut syndrome.

·       Antioxidant Support: Studies suggest L-proline supplementation can increase antioxidant activity in the body. 

Potential Side Effects

L-proline is generally considered safe when consumed in normal food amounts or as a supplement in standard doses (up to 3000 mg daily). Side effects are typically associated with very large doses or specific medical conditions. 

Potential side effects, especially with high doses, can include: 

·       Stomach pain, nausea, or diarrhea.

·       Kidney problems, including inflammation or failure (in very high doses).

·       Anxiety, sweating, tremors, or dizziness.

·       Potential interactions with certain medications, particularly those for type 2 diabetes (if using ipragliflozin L-proline). 

It is important to consult a healthcare professional before starting any new supplement regimen, especially if you have pre-existing kidney or liver conditions, or are pregnant or breastfeeding. 

 

 How is L-Proline Manufactured by MEDIOCON  INC  Tested Qualitatively?

Qualitative testing of L-proline manufactured by MEDIOCON INC would involve standard pharmaceutical testing methods to confirm the compound's identity, which are consistent with general industry practices for this amino acid

. While specific methods for MEDIOCON INC are not publicly detailed, common pharmacopeial (USP or Ph. Eur.) and laboratory methods for qualitative testing include: 

• Colorimetric Reactions (Isatin or Ninhydrin Tests): L-proline is unique because it is an imino acid (secondary amine), which gives a distinct color reaction compared to other amino acids.
• With ninhydrin, most amino acids turn purple; L-proline turns yellow. This color difference is a key qualitative identifier.
• With isatin, L-proline forms a distinct blue derivative.
• These reactions can be performed as spot tests in test tubes or on thin-layer chromatography (TLC) plates.
• Thin-Layer Chromatography (TLC): This method separates components of a mixture based on differential movement across a stationary phase. Comparing the sample's retention factor.

 

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   Which tests are performed on L-ProlineManufactured by  MEDIOCON INC ?

Typical Quality Control Tests for L-Proline

1. Assay / Purity
Measures the actual content of L-Proline expressed as a percentage of the dried basis (e.g., ≥ 98.5% or ≥ 99%). This confirms the active ingredient concentration. Ajinomoto - AminoScience Division

2. Specific Rotation / Optical Rotation
Chiral testing to confirm correct stereochemistry (e.g., specific rotation between a set range like −84° to −86°). Ajinomoto - AminoScience Division

3. Appearance / Physical Description
Check for white crystalline powder, colorlessness of solution, etc. Ajinomoto - AminoScience Division

4. Identification Tests
Spectroscopy like Infrared (IR) and sometimes chromatography to verify the chemical structure is L-Proline. Ajinomoto - AminoScience Division

5. Loss on Drying
Determines moisture content; typically limited to ≤ 0.3–0.5%. Ajinomoto - AminoScience Division

6. Residue on Ignition / Sulfated Ash
Measures inorganic residue after combustion; typically ≤ 0.1%. Ajinomoto - AminoScience Division

7. Impurity & Related Substances
Thin-layer chromatography (TLC) or HPLC to measure unspecified impurities and ensure they are below limits. Ajinomoto - AminoScience Division

8. Chloride, Sulfate, Ammonium
Inorganic impurity tests with set maximums (e.g., ≤ 0.02–0.05%). Ajinomoto - AminoScience Division

9. Heavy Metals
Testing for metals like Pb (lead), Fe (iron), etc. with strict maximum ppm limits. Ajinomoto - AminoScience Division

10. Arsenic
Often reported at a maximum of ≤ 1 ppm. Ajinomoto - AminoScience Division

11. Microbial / Microbiological Tests (if food/biotech grade)
Total plate count, yeast/mold, coliforms, depending on grade (food/biotech). Not always required for pure chemical grade unless specified

 

 

What are the challenges in manufacturing of L-Prolineby MEDIOCON  INC ’s Dosage forms?

·       Formulation Challenges related to Physicochemical Properties:

o   Solubility and Dissolution Rate: L-proline can be used as a co-crystal former to enhance the dissolution rate of poorly soluble active pharmaceutical ingredients (APIs), but formulating L-proline itself into certain dosage forms might present solubility challenges that require specific techniques like co-crystallization or particle size reduction.

o   Hygroscopicity: Some oral dosage forms, such as fast-dissolving films or tablets, can be highly hygroscopic (absorb moisture from the air), which affects their stability and requires specialized low-humidity manufacturing environments and appropriate packaging.

o   Particle Size and Flowability: Achieving a consistent and optimal particle size distribution during milling and crystallization is crucial. Very small particles (fines) can lead to poor powder flow, issues with blend uniformity, tool binding, and tablet press overheating during solid oral dose manufacturing.

·       Processing Challenges:

o   Taste and Mouthfeel: When used in dosage forms meant to dissolve in the mouth (e.g., oral disintegrating tablets), L-proline, which has a sweet taste, needs careful taste-masking and formulation to avoid a gritty mouthfeel and ensure patient compliance.

o   Stability: L-proline stability can be affected by interaction with other components (e.g., ascorbic acid), requiring careful pre-formulation studies and potentially specialized stabilizing excipients.

o   Process Scale-Up: Transitioning from lab-scale formulation development to commercial-scale manufacturing often involves significant challenges with maintaining consistent process dynamics, material build-up in equipment, and the need for re-validation and new control strategies.

·       Regulatory and Quality Control:

o   Regulatory Compliance: Adhering to stringent regulatory standards like WHO GMP guidelines requires robust quality management systems, rigorous testing at every stage, and thorough documentation.

o   Contamination Control: In shared manufacturing facilities, preventing cross-contamination between different products (e.g., traces of other APIs or lubricating oils) is a persistent challenge that demands strict cleaning validation protocols.

o   Supply Chain Management: Like many pharmaceutical manufacturers in certain regions, dependency on external sources (e.g., for specific raw materials or API intermediates) can pose supply chain risks and cost management issues. 

 

 

What is shelf life Of L-Prolineby MEDIOCON INC?

 

There's no specific shelf life mentioned for a "MEDIOCON INC" L-Proline, but general L-Proline (an amino acid) is typically stable under recommended conditions (cool, dry, away from light/moisture, strong oxidizers), with suppliers like Sigma-Aldrich suggesting storage at 2-30°C, implying a long stability, often with a retest date rather than strict expiration, but checking the specific supplier's Safety Data Sheet (SDS) is crucial for exact guidance. 

 

What should the label claim for L-Proline Manufactured by MEDIOCON INC Include?

The label for an L-Proline product manufactured by MEDIOCON INC and marketed as a dietary supplement in the U.S. must comply with the FDA's Dietary Supplement Health and Education Act (DSHEA) and associated regulations. The label must include mandatory statements and can feature permitted claims, provided they are truthful and non-misleading. 

 

Where can L-Proline Manufactured by MEDIOCON INC are procured?

L-ProlineManufactured 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 L-ProlineManufactured 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 L-ProlineManufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the L-ProlineManufactured by MEDIOCON INC product, regardless of the procurement source.