Histidine, 71-00-1 Manufacturer, exporter, supplier by MEDIOCON INC

 

 

 

              Histidine,  Manufactured by MEDIOCON INC

 

 Name:   Histidine

CAS No  : 71-00-1

Molecular Weight :155.15 g/mol

Molecular formula :C₆H₉N₃O₂

Synonyms  :L-2-Amino-3-(4-imidazolyl)propionic acid, His, H, Glyoxaline-5-alanine

Appearance : White crystals or crystalline powder; odorless

 Solubility:  Soluble in water (approx. 41.6 g/L at 25 °C); very slightly soluble in ethanol

Uses :Histidine has various applications across different fields: 

·       Nutritional Supplement It is used as a fortifier and an important component in amino acid infusions and compound amino acid preparations.

·       Medical Applications It is used as a drug to treat conditions such as gastric ulcers, rheumatoid arthritis, anemia, and certain heart diseases. It is also a precursor for vital metabolites including histamine, carnosine, and anserine, which affect renal function, neurotransmission, and the immune system.

·       Biochemical Research & Cell Culture Histidine is a standard component in many cell culture media and is widely used for general biochemical research.

·       Food Industry In the food industry, it serves as a flavor enhancer, contributing to the perception of umami taste.

·       Cosmetics It functions as a skin-conditioning agent, antistatic agent, and humectant in cosmetic products. 

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

 Information regarding the specific histidine product ("Histidine, acid") manufactured by MEDIOCON INC and its available dosage forms is not available in the search results. The search results primarily identify MEDIOCON INC as a manufacturer and wholesaler, but do not list their specific product catalog or drug labels. 

Generally, histidine supplements and combination products are available in several common dosage forms: 

·       Tablets

·       Capsules

·       Oral powders

·       Solutions/Liquids (for oral or intravenous use, often in combination with other amino acids)

·       Creams/Gels/Ointments (for topical application) 

To find the exact dosage form of the product in question, it is recommended to contact the manufacturer directly using the contact information that might be available on the MEDIOCON INC official website or product packaging. 

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

Histidine is generally available in common dosage forms such as tablets, capsules, oral powders, and intravenous solutions. It is also used as an active pharmaceutical ingredient (API) and excipient in various protein-based biopharmaceutical formulations. 

Mediocon Inc. is a supplier of pharmaceutical ingredients, including amino acids, and offers L-Histidine in the form of a powder for further manufacturing and compounding. 

Available Forms of Histidine

·       Powder: Histidine as an API or a nutraceutical ingredient is commonly supplied in powder form (e.g., L-Histidine HCl powder, L-Histidine base powder) for use by other manufacturers to create final dosage products.

·       Tablets/Capsules: Histidine supplements for oral consumption are widely available as over-the-counter tablets or capsules.

·       Oral Solutions/Suspensions: It can be formulated into oral powders that are mixed with liquid, or as pre-made solutions.

·       Intravenous (IV) Solutions: Histidine is a common component in parenteral nutrition formulations (amino acid injections) administered intravenously in clinical settings.

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

Mediocon Inc., like other pharmaceutical manufacturers, likely employs both classical wet chemistry qualitative tests and modern chromatographic techniques to ensure the quality and identity of its Histidine (L-histidine) product. The specific tests used often follow established pharmacopeial standards (e.g., USP or EP). 

Standard Qualitative Tests for Histidine

Classical qualitative tests rely on specific chemical reactions that produce a visible color change in the presence of histidine's unique imidazole functional group. 

·       Pauly's Diazo Test: This is a specific test for amino acids with an imidazole or phenol group (histidine and tyrosine). The histidine sample is reacted with diazotized sulfanilic acid in an alkaline medium to form a characteristic red-colored azo dye.

·       Knoop-Histidine Test: The sample is treated with 5% bromine in 33% acetic acid, followed by neutralization with excess ammonium carbonate solution. Heating the alkaline solution produces a distinct blue or violet coloration if histidine is present.

·       Ninhydrin Test: Like most alpha-amino acids, histidine will react with ninhydrin reagent to produce a purple color (Ruhemann's purple). This test confirms the presence of an amino acid but is not specific to histidine alone. 

Modern Analytical Methods

For a high degree of specificity and to detect impurities, pharmaceutical companies typically use modern instrumental methods. 

·       High-Performance Liquid Chromatography (HPLC): This is a primary method for both qualitative identification (by retention time) and quantitative analysis of histidine and its potential impurities.

o   HPLC with Post-Column Derivatization (PCD): The sample is separated on a cation-exchange or HILIC column and then reacted online with a reagent, such as o-phthalaldehyde (OPA) or ninhydrin, before detection. This method is highly specific and sensitive.

o   HPLC with UV or Mass Spectrometry (MS) Detection: The compound can be detected using UV light at a specific wavelength (e.g., 210 nm or 200 nm) or via mass spectrometry for a more definitive identification based on molecular weight and fragmentation pattern. 

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

The specific tests performed on Histidine acid (likely L-histidine monohydrochloride monohydrate) manufactured by MEDIOCON INC would be detailed in the product's Certificate of Analysis (CoA) or technical data sheet. Generally, the quality control for a pharmaceutical or high-grade amino acid product includes a standard set of tests to ensure purity, identity, and safety. 

Typical tests and analyses for a high-purity Histidine product generally include:

·       Assay (Purity): Quantification of the L-histidine content, typically achieving a minimum purity of 98% or 99%. This is commonly performed using methods such as High-Performance Liquid Chromatography (HPLC).

·       Appearance: Visual inspection to confirm physical form and color, usually a white or almost white powder.

·       Solubility: Testing to ensure it dissolves correctly in specified solvents (e.g., freely soluble in water).

·       Identity: Confirmation that the substance is indeed histidine through specific chemical reactions or instrumental analysis like Mass Spectrometry (MS) or Fourier-transform infrared (FTIR) spectroscopy.

·       pH: Measurement of the pH of a standard solution (e.g., a 1% solution), which typically falls within a range of 5.0 to 8.0 depending on the specific salt form.

·       Moisture/Water Content: Determination of residual water content to meet specified limits.

·       Specific Optical Rotation: Measuring the compound's optical activity to confirm the presence of the correct L-enantiomer.

·       Heavy Metals/Impurities: Testing for the presence of trace elements and other impurities to ensure safety standards are met.

·       Microbiological Tests: Ensuring the product meets hygienic standards, especially if produced by fermentation. 

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

Information regarding the specific manufacturing challenges for Histidine API by MEDIOCON INC is not publicly available in the search results. However, the general challenges in Active Pharmaceutical Ingredient (API) manufacturing include regulatory compliance, complex chemistry, and supply chain management. 

General Challenges in API Manufacturing

Common difficulties in the production of APIs across the industry include:

·       Regulatory Compliance: Adhering to stringent regulations from agencies like the FDA and EMA and maintaining Good Manufacturing Practices (GMP) is a major challenge.

·       Complex Chemistry: The synthesis process for many APIs can be complex, and scaling up from the lab to industrial production can introduce new, unexpected impurities that require careful control and monitoring.

·       Supply Chain Management: Disruptions in the raw material supply chain, reliance on specific source countries, and managing the logistics network can impact production timelines and product quality.

·       Quality Control and Assurance: Ensuring consistent quality requires rigorous testing, monitoring, and documentation of all parameters, including purity, potency, and stability.

·       Environmental Sustainability: The industry faces pressure to adopt "green chemistry" principles to minimize the environmental impact of chemical use and energy-intensive processes. 

Tests Performed on Histidine API 

While specific tests performed by MEDIOCON INC are proprietary, the general tests performed on Histidine as an API would align with pharmacopeial standards and general quality control (QC) practices for amino acids. 

Common quality control tests for an amino acid API like Histidine include:

·       Appearance: Visual inspection to ensure the physical form (e.g., white or almost white powder) meets specifications.

·       Assay: A test to determine the potency or concentration of the active ingredient, typically a minimum percentage on a dry basis.

·       Moisture Content: Testing for acceptable levels of water using methods like loss on drying.

·       pH: Measuring the pH of a solution of the API to ensure it falls within a specified range.

·       Solubility: Verifying that the API dissolves as expected in a given solvent (e.g., freely soluble in water).

·       Identification of Impurities: Advanced analytical techniques such as High-Performance Liquid Chromatography (HPLC) and mass spectrometry are used to detect and quantify trace impurities, including residual solvents and heavy metals, to ensure safety and efficacy.

·       Microbial Limits Testing: Ensuring the product is within acceptable limits for microbial contamination.

·       Specific Rotation: A test often used for chiral compounds like amino acids to confirm the correct stereoisomer is present. 

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

 

Typical Packaging for L-Histidine:

·       Bulk: 25 kg drums (Fiber or HDPE) are common for large industrial orders, as seen with other suppliers.

·       Intermediate Sizes: 1 kg, 5 kg, 10 kg in HDPE drums or multi-layered bags.

·       Smaller Quantities: For research or smaller-scale use, it can come in 1g, 5g, 25g bottles. 

How to Find Mediocon's Specific Packaging:

1.    Check Mediocon's Website: Visit Mediocon Inc and look for their specific L-Histidine product page or contact them directly.

2.    Contact Mediocon: Reach out to their sales or customer service for precise packaging details for the Histidine you need (e.g., L-Histidine Base or L-Histidine HCl).

3.    Check Distributor Listings: Look at IndiaMART or similar platforms where Mediocon lists their products, as they often specify packaging sizes like 1kg, 5kg, 10kg, 25kg in HDPE drums. 

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

For a Histidine product by MEDIOCON INC, the label should include its identity (Histidine, Aminoacetic Acid), manufacturer (MEDIOCON INC), purity (e.g., 99%+ or Pharma Grade), physical form (white crystalline powder), chemical properties (formula C2H5NO2, smallest amino acid), intended use (cell culture, buffer, precursor), and compliance info (USP/EP tested if applicable), plus batch/expiry dates, storage, and directions, ensuring it meets regulatory standards for its specific application (food, pharma, lab). 

Essential Label Claims:

1.    Product Name: Histidine.

2.    Chemical Name: Aminoacetic Acid / Aminoethanoic Acid.

3.    Manufacturer: Manufactured by MEDIOCON INC.

4.    Purity/Grade: E.g., 99%+; Pharma Grade; Tested to USP/EP standards (if applicable).

5.    Chemical Formula: C2H5NO2.

6.    Net Weight/Quantity: (e.g., 100g, 1kg).

7.    Appearance: White crystalline powder.

8.    Intended Use/Application:

1. "For laboratory, research, or cell culture use" (if not for human consumption).

2.    "Buffering agent," "Protein synthesis," "Neurotransmitter precursor" (functional claims).

9.    Storage Conditions: "Store in a cool, dry place," "Keep container tightly closed".

10. Batch Number & Expiry Date: Essential for traceability.

11. Safety/Handling: Appropriate hazard warnings (though generally safe, good practice).

12. Regulatory Info: FDA/ECHA registration if relevant to market. 

Example Layout:

·       MEDIOCON INC

·       Histidine (Aminoacetic Acid)

·       Purity: 99% min. (Pharma Grade)

·       Formula: C2H5NO2 | MW: 75.07 g/mol

·       Appearance: White powder

·       Use: Cell Culture, Buffer, Synthesis.

·       Batch: [Batch No.] | Expiry: [MM/YYYY]

·       Storage: Cool, dry place. 

This covers the core requirements, but specific regulations depend on whether it's for a food additive, pharmaceutical excipient, or lab chemical. 

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

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

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