Cysteine, acid, Manufacturer, exporter, supplier by MEDIOCON INC

Cysteine, acid, Manufactured by MEDIOCON INC

Name: Cysteine, acid,

CAS No : 52-90-4 (L-cysteine)

Molecular Weight: 132.12 g/mol (anhydrous

Molecular formula C₃ H₇NO₂S

Synonyms: 2-Amino-3-sulfanylpropanoic acid, 2-amino-3-mercaptopropanoic acid, L-(+)-Cysteine, L-Cys, Half-cystine, E920 Aminosuccinic acid

· Asparagic acid

· Asparaginic acid

· L-2-Aminobutanedioic acid

· (S)-(+)-Aminosuccinic acid

· H-Asp-OH

Appearance : White crystalline powder or colorless crystals

Solubility : Freely soluble in water (approx. 277 g/L at 25 °C), sparingly soluble in ethanol, and insoluble in ether

Use :

· Precursor for the antioxidant glutathione, a flour treatment agent, flavor enhancer, and in various pharmaceutical and personal care products Industrial/Commercial It is used as a food additive (flavoring agent, nutritional fortifier), a component in sports nutrition supplements, a pharmaceutical ingredient, and for cell culture in manufacturing processes. The polymerized form, polycysteine, acid, is used as a biodegradable substitute for polyacrylate in applications like superabsorbent polymers.

How is Cysteine, acid, manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC's synthesis of L-Cysteine (acid form) likely involves fermentation or enzymatic processes, often starting from glucose or serine, or through chemical reduction of L-Cystine (derived from natural sources like feathers) using methods like electrolytic reduction, as modern manufacturers use fermentation for purity and to avoid animal-sourced concerns, with specific details often proprietary but generally following methods of microbial conversion or chemical reduction.

Common Manufacturing Methods for L-Cysteine:

1. Fermentation (Synthetic Route):

· Engineered microorganisms (like E. coli) are grown in a medium containing a carbon source (glucose) and a sulfur source (sulfate, thiosulfate).

· These microbes efficiently convert these raw materials into L-Cysteine, which is then secreted into the culture.

· This method produces high-purity, vegan-friendly L-Cysteine, avoiding animal-derived concerns.

2. Hydrolysis & Reduction of Natural Sources (Traditional Route):

· Animal feathers or hair (rich in cystine) are hydrolyzed (broken down with acid).

· L-Cystine is extracted and purified.

· The L-Cystine is then chemically reduced (e.g., electrolytically or with reducing agents like sodium borohydride) to yield L-Cysteine.

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

MEDIOCON INC. manufactures L-Cysteine Hydrochloride for injection, primarily as a stable, highly pure liquid composition in single-use containers, often used in parenteral nutrition for neonates and critically ill patients, though specific product names or broader dosage forms (capsules, powders) aren't detailed for this specific manufacturer in general searches. Common forms for Cysteine generally include injectables (solutions), powders, and potentially oral forms (capsules, tablets) for nutraceutical use, but MEDIOCON focuses on sterile injectable solutions.

Key Dosage Form for MEDIOCON INC.:

· Cysteine Hydrochloride Injection (USP): This is a sterile, aqueous solution, usually pH-adjusted with HCl, designed for intravenous use, often as a component in total parenteral nutrition (TPN).

General Cysteine Dosage Forms (Beyond this Manufacturer):

· Injectable Solutions: Standard for hospital use, especially for neonates and those unable to eat.

· Powders: Can be dissolved for injection or used in supplements.

· Capsules/Tablets: Common in the nutraceutical market for general supplementation.

How Cysteine, acid, Manufactured by MEDIOCON INC Dosage Forms are prepared?

Cysteine hydrochloride (acid form) dosage forms, like injections, are made by purifying L-cysteine (often from fermentation or hydrolysis of keratinous materials like hair/feathers), converting it to a stable hydrochloride salt using acid, and then formulating it with sterile water, other amino acids, and pH adjusters for injectable solutions, ensuring high purity for safety, often via controlled steps like nitrogen sparging and filtration.

General Preparation Steps (for injectable solutions):

1. Source & Purification: L-Cysteine is obtained, commonly through fermentation or acid hydrolysis of natural sources (like hair/feathers), then purified.

2. Salt Formation: L-Cysteine is reacted with hydrochloric acid (HCl) to form L-Cysteine Hydrochloride, a more stable form.

3. Sterilization & Dissolution: The purified L-Cysteine HCl is dissolved in Water for Injection (WFI) under sterile conditions, often with nitrogen sparging to remove oxygen.

4. Formulation: Other essential amino acids (like arginine, valine, etc.) and buffering agents are added, ensuring proper pH.

5. Filtration & Filling: The solution is filtered through sterile filters and

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

Mediocon Inc. primarily acts as a supplier of pharmaceutical raw materials, including Cysteine, acid in powder form, which is then used by other companies to manufacture finished dosage forms. They do not appear to manufacture finished, ready-to-use dosage forms of Cysteine, acid under their own brand for direct sale to consumers or patients.

Cysteine, acid products are generally available on the market in the following common dosage forms:

· Powders: This is the most common form in which Mediocon and other suppliers deal, typically for use as an active pharmaceutical ingredient (API) or nutraceutical ingredient. These powders are often mixed with excipients and further processed into finished products.

· Capsules

· Tablets

· Oral solutions/syrups

These finished products are typically produced by other pharmaceutical or nutraceutical companies that source the raw material from suppliers like Mediocon Inc. Consumers can find general information on the uses and typical dosages for these products on health information websites like WebMD.

When should Cysteine, acid, Manufactured by MEDIOCON INC be taken?

Cysteine (acid) from MEDIOCON INC is a prescription injectable amino acid, typically taken intravenously as part of Total Parenteral Nutrition (TPN) for neonates, infants, or adults with severe liver disease or malabsorption, to provide essential nutrition, not a general supplement for daily use; timing and dosage are strictly determined by a healthcare professional based on the patient's specific nutritional needs and condition, often requiring close monitoring.

Who Takes It & Why:

· Neonates & Infants: For nutritional support, especially preterm or sick newborns needing TPN.

· Pediatric/Adult Patients: With severe liver disease (hepatic encephalopathy) or malabsorption issues, requiring intravenous feeding.

· Purpose: To meet protein/amino acid requirements for growth and metabolic function when oral intake isn't possible.

This cysteine product, manufactured by MEDIOCON INC, is a sterile injectable amino acid solution designed for intravenous administration

What are the effects And Side effects of Cysteine, acid, Manufactured by MEDIOCON INC?

Cysteine is a semi-essential sulfur-containing amino acid vital for protein structure, detoxification, and antioxidant defense. Its primary effects stem from its role as a precursor to glutathione, a powerful antioxidant.

General effects of cysteine (or its common supplement form, N-acetylcysteine or NAC) supplementation may include:

· Antioxidant Support: Acts as a free radical scavenger and is essential for glutathione production, which helps protect cells from oxidative stress and damage.

· Detoxification: Supports the body's detoxification processes, helping to reduce the effects of toxic metals and certain drugs like acetaminophen (paracetamol).

· Respiratory Health: In its NAC form, it acts as a mucolytic agent, breaking down disulfide bonds in mucus to decrease its viscosity, which can help with conditions like chronic bronchitis and COPD.

· Immune System Support: Plays a role in regulating immune responses and can help boost immune function, particularly in individuals with deficiencies.

· Hair and Skin Health: A key component of keratin, cysteine provides strength and rigidity to hair and skin, potentially aiding in structural repair and reducing hair loss.

· Other potential uses: Studies have explored its use for male fertility, digestive health (ulcerative colitis), heart health, and certain neurological and psychiatric conditions (e.g., autism, schizophrenia).

Side Effects of Cysteine

When taken in appropriate doses, L-cysteine and NAC are generally considered safe for most adults. However, side effects can occur, particularly with high doses or in sensitive individuals.

Common side effects may include:

· Gastrointestinal disturbances (nausea, vomiting, diarrhea, bloating, gas, upset stomach).

· Generalized flushing and a warm sensation.

· Fever.

· Headache and drowsiness.

Serious, though rare, side effects can include:

· Allergic reactions (rash, itching, difficulty breathing, swelling of the face, lips, tongue, or throat).

· Bleeding issues, as it might slow blood clotting.

· Kidney stones in individuals with the rare genetic condition cystinuria.

· Liver problems in rare cases.

Important Considerations:

· Cysteine supplements can interact with medications for diabetes and high blood pressure, potentially causing blood sugar

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

To qualitatively test L-Cysteine (acid form), manufacturers use methods targeting its reactive sulfhydryl (-SH) group, primarily the Sodium Nitroprusside test, which creates a color change (orange-red) for detection, or specialized techniques like Iodine Titration, UV-Vis Spectroscopy after derivatization (e.g., with OPA), or advanced qNMR for purity, ensuring it meets pharmaceutical standards for identity and quality, often involving sample prep like hydrolysis and purification steps.

Here's a breakdown of common qualitative testing approaches:

1. Sodium Nitroprusside Test (Colorimetric)

· Principle: Detects free sulfhydryl (-SH) groups.

· Process:

o Prepare cysteine samples (or hydrolyzed/reduced forms).

o Adjust pH (e.g., to pH 9.2) and add Sodium Borohydride to ensure free -SH groups are available.

o Add Sodium Nitroprusside, which reacts with the -SH group to form a characteristic orange-red colored product.

o The color intensity (or presence/absence for qualitative) is assessed visually or using a smartphone/spectrophotometer.

2. Ninhydrin Test (Colorimetric/Spot Test)

· Principle: Reacts with amino acids, including cysteine, to produce a colored product (purple/blue).

· Process: Cysteine samples are reacted with ninhydrin reagent, and the resulting color indicates the presence of amino acids, confirming purity or reaction completion (e.g., after oxidation to cystine).

3. Iodine Titration (Okuda Method)

· Principle: Quantifies the free thiol (-SH) groups using iodine.

· Process: Cysteine is dissolved in acid, and iodine is used to titrate the reactive sulfur, indicating the amount of cysteine present.

4. UV-Vis Spectroscopy with Derivatization

· Principle: Cysteine itself has weak UV absorption; derivatization with reagents like OPA (ortho-phthalaldehyde) or Dansyl Chloride creates strongly fluorescent or UV-absorbing products.

· Process: Sample is derivatized, then analyzed via UV-Vis or HPLC with a detector, showing peaks for identification and purity.

5. Advanced Techniques (for Purity/Quantity)

· Quantitative NMR (qNMR): Highly sensitive for verifying the actual amount and purity against standards, often more reliable than older titrimetric methods, notes ScienceDirect.

Typical Steps for a Manufacturer (Qualitative)

1. Sample Prep: Dissolve/extract cysteine in appropriate solvent (e.g., 0.2N HCl).

2. Reaction: Apply one of the specific tests above (e.g., Nitroprusside, Ninhydrin).

3. Observation: Confirm the expected color change or signal, indicating positive identification of L-Cysteine.

4. Purity Checks: May involve checks for common impurities or related substances using chromatography or spectroscopy.

By employing these methods, manufacturers like Mediocon Inc. can ensure their L-Cysteine products meet required quality and identity standards.

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

The specific quality control tests performed on Cysteine acid (L-cysteine) by MEDIOCON INC would be detailed in the product's Certificate of Analysis (CoA) or technical data sheet, which are proprietary documents provided by the manufacturer to its customers.

In general, manufacturers of L-cysteine, especially for Active Pharmaceutical Ingredient (API) use, verify compliance with pharmacopeial specifications (e.g., USP or Ph. Eur. standards) and perform various tests to ensure product quality:

Common tests include:

· Assay/Purity: Quantitative analysis to determine the concentration and purity of the L-cysteine, often performed using techniques like high-performance liquid chromatography (HPLC).

· Identification: Specific tests, such as the lead acetate test (which detects the sulfur group and yields a black precipitate of lead sulfide), are used to confirm the presence of cysteine/cystine.

· Impurity Profiling: Control of sulfur-containing impurities and oxidative degradant levels is crucial.

· Heavy Metals/Aluminum levels: For products intended for injection or parenteral nutrition, careful control and testing for trace elements like aluminum are essential to prevent toxicity.

· Physical Characteristics: Tests for appearance, solubility, and specific rotation.

· Microbial Limits: Testing for the absence of harmful microorganisms.

For the exact tests and specifications for the product from MEDIOCON INC, you would need to consult their official product documentation or contact the company directly via their website or a B2B platform like PharmaCompass.

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

1. Raw Material Variability

· Bananas vary widely based on:

o Species/variety

o Ripeness stage

o Geographic origin

o Seasonal conditions

· This affects active phytochemical content (polyphenols, dopamine, flavonoids).

· Ensuring batch-to-batch consistency is a major challenge.

Impact: Difficult standardization of API strength.

2. Standardization of Active Constituents

· Banana extract contains multiple bioactive compounds.

· Identifying a marker compound (e.g., dopamine or total polyphenols) and maintaining a fixed concentration is complex.

· Natural degradation during processing further complicates standardization.

Impact: Regulatory compliance and reproducibility issues.

3. Extraction Process Optimization

· Selection of:

o Solvent (water, ethanol, hydro-alcoholic)

o Temperature

o Time

o Solvent-to-drug ratio

· Over-extraction may pull unwanted impurities.

· Under-extraction reduces potency.

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

Mediocon Inc is primarily a supplier and wholesaler of active pharmaceutical ingredients (APIs) and intermediates, rather than a manufacturer of its own branded, finished dosage forms of cysteine, acid. Cysteine, acid is a widely available amino acid, not a proprietary drug, so the manufacturing challenges are generic to the industry rather than specific to Mediocon Inc's products.

Key challenges in the general manufacturing and formulation of cysteine, acid and similar amino acids into dosage forms include:

· Stability and Degradation: Cysteine, acid and its derivatives (like the sweetener aspartame) are sensitive to external conditions such as temperature, moisture, and pH changes, which can lead to degradation during processing and storage. For example, aspartame decomposes at temperatures around 40°C.

· Formulation Complexities:

o Excipient Compatibility: Selecting compatible excipients is critical to maintain the stability, safety, and efficacy of the final product. Inappropriate choices can lead to unwanted interactions or reduced shelf life.

o Physical Properties: Challenges exist in managing the physical properties of the powder, such as flowability and compressibility, which are vital for creating uniform tablets or capsules, especially when dealing with unrefined or natural ingredients.

o Solubility Issues: The aqueous solubility and hydrophilicity of amino acids can present challenges in developing certain dosage forms, such as fast-dissolving tablets, and may require specific formulation techniques like lyophilization (freeze-drying).

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

Mediocon Inc supplies L-Cysteine (acid) in various forms, typically packed in bulk for industrial use, like 25 kg bags or drums for large quantities (food/pharma grade), but also smaller lab packs (grams) from other suppliers, indicating packaging depends on grade and buyer's need, often with options like HDPE bags, cartons, or poly-lined drums, as it's an amino acid used as a dough conditioner, flavor enhancer, or pharmaceutical ingredient.

Typical Packaging Options (General for L-Cysteine):

· Bulk Industrial: 25 kg HDPE woven bags, 25 kg drums, or large cartons, often with inner poly bags for protection.

· Laboratory/Research: Smaller pack sizes like 100g, 500g, or 25g bottles or containers.

· Custom: Options for customized packaging are often available from manufacturers and distributors.

Key Takeaway:
Since Mediocon Inc. offers a range of nutraceutical and pharmaceutical ingredients, their L-Cysteine (acid) is likely available in standard industrial packaging (like 25kg bags/drums) for bulk orders, but you should contact them directly for specific pack sizes, grades (food, pharma), and current availability.

What is shelf life Of Cysteine, acid, Manufactured by MEDIOCON INC?

For L-Cysteine Hydrochloride (acid form), the typical shelf life is 24 months (2 years) when stored sealed at room temperature, though specific products, like from Mediocon Inc., should have an exact expiration date or retest date on their Certificate of Analysis (COA) or product label, as stability can vary slightly by grade and formulation, with some showing 12-24 months or even just 1 year if stored improperly.

Key Factors Affecting Shelf Life:

· Form: L-Cysteine hydrochloride is generally stable, but moisture and air can cause degradation.

· Purity/Grade: Pharmaceutical or medicine grade often has specific stability data.

· Storage: Keeping it in its original, sealed container away from heat and light is crucial.

· Manufacturer's Data: The most reliable source is the manufacturer's label or COA, which confirms the specific batch's stability.

To Find the Exact Shelf Life:

1. Check the Product Label: Look for a "Best By" or expiration date.

2. Consult the Certificate of Analysis (COA): This document, often provided with the product, will list the retest or expiration date.

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

For a label claiming "Cysteine, acid, Manufactured by MEDIOCON INC," you need to include the full chemical name (likely L-Cysteine Hydrochloride Monohydrate or similar), purity/grade (USP, Food Grade), manufacturer details (MEDIOCON INC, Address), batch/lot number, net weight, storage conditions, warnings (e.g., skin/eye irritant, respiratory), and potentially usage instructions or safety data sheet (SDS) reference, adhering to regulations like GMP/FDA for its intended use (e.g., dietary supplement, food additive, pharmaceutical).

Here's a breakdown of essential label claims:

Product Identification:

Product Name: L-Cysteine Hydrochloride Monohydrate (or similar precise name).
Chemical Formula:

$cap C sub 3 cap H sub 7 cap N cap O sub 2 cap S center dot cap H cap C l center dot cap H sub 2 cap O$

3𝐻7𝑁𝑂2𝑆⋅𝐻𝐶𝑙⋅𝐻2𝑂

(for L-Cysteine HCl Monohydrate).

CAS Number: 7048-04-6 (for L-Cysteine HCl Monohydrate).
Manufacturer: MEDIOCON INC.
Country of Origin: (If required by regulations).

Quality & Purity:

Grade: USP, Food Grade, Pharmaceutical Grade, etc..
Purity/Assay: (e.g.,

$is greater than or equal to 98.5 %$

Complies with: USP, EP, FCC standards.
Lot/Batch Number: Essential for traceability.
Certificate of Analysis (CoA) Available: Sigma-Aldrich website.

Usage & Safety:

Intended Use: Dietary Supplement Ingredient, Flavoring Agent, Pharmaceutical API, etc.
Storage: Store in a cool, dry place, protected from light/moisture (e.g., 2-30°C).
Warnings: "May cause skin/eye irritation," "Avoid inhalation," NIH website.
Safety Data Sheet (SDS): "Refer to SDS for complete safety information."
Net Weight/Quantity: (e.g., 25 kg, 1 lb).

Regulatory & Company Info:

Distributor/Company Address: MEDIOCON INC, City, Country.
Contact Info: Phone/Website.
GMP Certified: (If applicable).

Example Label Snippet:
L-Cysteine Hydrochloride Monohydrate | Pharmaceutical grade website
Purity:

$is greater than or equal to 99.0 %$

Always check specific regional regulations (FDA, EFSA, etc.) for the final product's intended market.

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

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

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

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