Phenylalanine 3-91-2, Manufacturer, supplier, exporter by MEDIOCON INC

 

 

 

              Phenylalanine, Manufactured by MEDIOCON INC

 

 Name:   Phenylalanine

CAS no:3-91-2 (for L-phenylalanine; DL-phenylalanine is 150-30-1).

Molecular Weight : 165.19 g/mol.

·       Molecular formula: : C₉H₁₁NO₂.

·        Synonyms: L-Phe, Phe, (S)-Alpha-Amino-Benzenepropanoic Acid, 3-Phenylalanine

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

·       Solubility: Soluble in water (e.g., 14.11 g/L at 25 °C), and dilute mineral acid and alkali hydroxide solutions. It is slightly soluble in ethanol.

o   Uses : Nutrition and Supplements: As an essential amino acid, it is used in nutritional supplements and fortified foods.

o   Pharmaceuticals: It serves as a building block for drug synthesis and is used in the treatment of vitiligo, stress, and depression. It may also help boost pain tolerance for migraines and PMS.

o   Food Industry: It is a common ingredient in some artificial sweeteners (like aspartame), and as a food additive/flavor enhancer.

o   Industrial/Biochemistry: Used in industrial manufacturing and for biochemistry research purposes. 

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

Mediocon Inc. manufactures L-Asparagine in powder form, but the specific phenylalanine product lines offered by the company are intermediates for other drugs, not final dosage forms of phenylalanine. 

Generally, phenylalanine supplements are available in various dosage forms, including: 

·       Capsules

·       Oral powders

·       Tablets 

For more specific information on the products manufactured by Mediocon Inc., you can visit their official website or use the contact information available through business directories like IndiaMART. 

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

Information on the specific qualitative testing methods used by MEDIOCON INC to manufacture phenylalanine is not publicly available in the provided search results. However, general qualitative and quantitative methods for testing phenylalanine in a laboratory setting include the following, which pharmaceutical manufacturers typically adapt for their own quality control: 

Common Qualitative and Quantitative Testing Methods for Phenylalanine

• Phenylalanine Agar Test (for bacterial differentiation): This is a microbiology test, not for product quality, that detects the presence of the enzyme phenylalanine deaminase in bacteria. A positive test is indicated by the formation of a green color after adding a 10% ferric chloride solution, which reacts with the resulting phenylpyruvic acid.
• Guthrie Test: An older newborn screening test where a blood sample on filter paper is placed on an agar medium with bacteria and a growth inhibitor. Bacterial growth indicates high phenylalanine levels.
• Paper Chromatography: An older method used to separate amino acids. Phenylalanine produces a deep blue spot when sprayed with ninhydrin and treated with an alkaline solution, allowing for its identification.
• High-Performance Liquid Chromatography (HPLC): This is a widely used method in pharmaceutical analysis for both qualitative identification (based on retention time) and quantitative determination. Phenylalanine's natural fluorescence allows for detection using fluorescence detectors without complex derivatization in some methods.
• Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS): Considered a "gold standard" in modern analysis, this highly sensitive and specific method is used for accurate identification and quantification of phenylalanine in various samples, including dried blood spots for patient monitoring.
• Enzymatic Assays: These involve a coupled enzyme reaction where phenylalanine deamination produces NADH, which then reacts with a probe to yield a fluorescent product proportional to the amount of phenylalanine present. 
•  

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

The tests performed on Phenylalanine acid manufactured by MEDIOCON INC would be standard quality control and analytical tests as per pharmaceutical and chemical industry regulations (e.g., Ph. Eur., JP, USP), focusing on purity, identity, and safety. 

The specific tests include:

·       Identity testing: Verifies that the product is indeed Phenylalanine, often using techniques like High-Performance Liquid Chromatography (HPLC), Nuclear Magnetic Resonance (NMR), or mass spectrometry.

·       Purity and Assay: Determines the concentration of Phenylalanine and checks for impurities using methods such as:

o   HPLC analysis: Measures the total amino acid content and identifies related substances or impurities.

o   Loss on Drying: Measures the amount of volatile matter, typically water, in the sample.

o   Ash content: Determines the inorganic residue remaining after ignition.

·       Physical Property Analysis:

o   pH measurement: Checks the acidity/alkalinity of a solution of the product.

o   Solubility: Ensures it dissolves as expected in specified solvents like water or various acids.

o   Melting point/Decomposition range: Used as an indicator of purity.

o   Specific Rotation: Measures the optical activity, as L-phenylalanine is the biologically active form.

·       Safety and Quality Assurance:

o   Microbial Load/Endotoxin testing: Ensures the product is suitable for its intended use, especially if used in parenterals or cell culture media.

o   Heavy metals testing: Checks for potentially toxic metal impurities. 

The "phenylalanine deaminase test" and "xanthoproteic test" found in the search results are typically biochemical identification tests for bacteria in a laboratory setting, not quality control tests for

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

Manufacturing banana extract as an API involves challenges like securing consistent, quality raw material (bananas/peels), optimizing extraction for high yield/purity (especially removing impurities during scale-up), managing costs (substrate, operations, downstream processing), ensuring regulatory compliance (CPCB, CDSCO), and developing sustainable practices to handle biomass waste while meeting API quality targets like purity and particle size. 

Here are the key challenges:

Raw Material & Supply Chain:

·       Consistent Supply: Ensuring a steady, year-round source of high-quality banana biomass (peels, pseudostems, etc.) for uninterrupted production.

·       Biomass Variability: Natural variations in banana composition due to climate, soil, and pathogens can affect extract quality. 

Extraction & Purification (Downstream Processing):

·       Yield & Purity: Developing efficient, cost-effective methods to isolate target compounds (like flavonoids, phenolics) while removing unwanted substances.

·       Scale-Up Issues: Impurities present in small batches might become major issues during large-scale manufacturing, requiring process adjustments.

·       Separation Technologies: Effectively separating the API from the biomass using advanced techniques (e.g., continuous crystallization, liquid-liquid extraction) is complex. 

Quality & Regulatory Compliance:

·       Critical Quality Attributes (CQAs): Controlling parameters like purity, impurity profiles, water content, and particle size to meet API standards.

·       Regulatory Adherence: Meeting strict guidelines from bodies like CPCB, CDSCO, and adhering to environmental regulations (EMS, green chemistry). 

Process & Sustainability:

·       Cost-Effectiveness: Balancing high production, operation, and purification costs with market demands.

·       Waste Management: Handling large volumes of banana biomass waste sustainably to prevent environmental contamination.

·       Green Chemistry: Implementing eco-friendly solvents and catalysts (like ionic liquids) to reduce the environmental footprint. 

Company-Specific (MEDIOCON INC):

·       Specific challenges for MEDIOCON INC would involve applying these general API manufacturing hurdles to their unique banana extract process, focusing on their chosen extraction methods and target compounds, potentially utilizing patents for specific compounds like elemicin or salicylate derivatives

 

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

 

Mediocon Inc supplies Phenylalanine, typically packed in 25 kg fiber drums, as a white crystalline powder for pharma/nutraceutical use, though exact packaging can vary by grade (L or DL) and supplier, often using robust, sealed containers to protect against moisture and spoilage, as seen with similar suppliers like Fengchen Group. 

Standard Packaging Details

·       Weight: Commonly 25 kilograms (25 Kg) per unit.

·       Container: Fiber drums are a common choice.

·       Material: Chemical-proof packaging is used to prevent moisture and contamination.

·       Form: A white to off-white crystalline powder. 

To get precise packaging for your order, it's best to contact Mediocon Inc, as they can confirm details for the specific Phenylalanine grade (L-Phenylalanine or DL-Phenylalanine) you require.

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

Amino Acid (Phenylalanine), list its purity/concentration, specify the form (e.g., L-Phenylalanine), state it's manufactured by MEDIOCON INC, and crucially, include a warning for Phenylketonuria (PKU), stating "Contains Phenylalanine," as this essential amino acid can be harmful to individuals with this genetic disorder. 

Key Labeling Components:

1.    Product Name: Phenylalanine (or L-Phenylalanine/DL-Phenylalanine, depending on isomer)

2.    Product Type: Amino Acid / Essential Amino Acid

3.    Manufacturer: Manufactured by MEDIOCON INC

4.    Purity/Concentration: e.g., 99% Pure, 500mg per serving

5.    Warning (Mandatory for PKU):

1.             "PHENYLKETONURICS: CONTAINS PHENYLALANINE" (This is a standard FDA requirement for products with aspartame, but applies generally where phenylalanine is present for safety).

6.    Uses: Briefly state its function (e.g., "For nutritional support," "Dietary Supplement").

7.    Ingredients: List Phenylalanine as the active ingredient.

8.    Storage & Handling: Standard directions (cool, dry place).

9.    Net Quantity: Weight or volume of the product. 

Why the PKU Warning is Critical:
People with the rare genetic disorder Phenylketonuria (PKU) cannot properly metabolize phenylalanine, leading to dangerous buildup. The warning ensures they avoid products containing it, including artificial sweeteners like aspartame and protein-rich foods. 

By including these details, the label serves both nutritional transparency and critical health safety for consumers, especially those with PKU. 

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

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

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