Sodium Benzoate 532-32-1 Manufacturer Supplier Exporter, MEDIOCON INC

 

 

                             

Sodium Benzoate Manufactured by MEDIOCON INC

 

   Name: Sodium Benzoate 

CAS No: 532-32-1

Molecular Weight: 144.11 g/mol

Molecular formula:  C₇H₅NaO₂

Synonyms : Synonyms for Sodium Benzoate (C₇H₅NaO₂) include Benzoic Acid Sodium Salt, Benzoate of Soda, E 211 (in food), Natrium benzoicum, Sobenate, and various chemical names like Benzenecarboxylic Acid Sodium Salt, often identified by its CAS number 532-32-1. 

Appearance : Sodium benzoate typically appears as a white crystalline powder or granules, often described as odorless or almost odorless, and can also come in flake form, with some forms being slightly hygroscopic (absorbing moisture). 

  

 Solubility : Sodium benzoate is highly soluble in water, with amounts varying slightly by temperature (e.g., ~56.5 g/100mL at 25°C or ~630 g/L at 30°C) and is also soluble in polar solvents like ethanol but less so in nonpolar ones, making it an effective preservative in acidic foods and beverages where it converts to its active form, benzoic acid, notes Wikipedia, ChemicalBook, Sigma-Aldrich, and Tokyo Chemical Industry Co., Ltd. 

 

Uses : Sodium benzoate is a widely used preservative that prevents microbial growth (mold, yeast, bacteria) in acidic foods like sodas, juices, jams, pickles, and salad dressings, extending their shelf life. It's also used in cosmetics (shampoos, lotions), pharmaceuticals (cough syrups, tablet lubricants, treatments for high ammonia levels), and industrially as a corrosion inhibitor in coolants, acting as the sodium salt of benzoic acid, which is more water-soluble.  

 

  How Sodium Benzoate  is manufactured by MEDIOCON INC Synthesized?

Sodium benzoate is a widely used preservative that prevents microbial growth (mold, yeast, bacteria) in acidic foods like sodas, juices, jams, pickles, and salad dressings, extending their shelf life. It's also used in cosmetics (shampoos, lotions), pharmaceuticals (cough syrups, tablet lubricants, treatments for high ammonia levels), and industrially as a corrosion inhibitor in coolants, acting as the sodium salt of benzoic acid, which is more water-soluble.  

Food & Beverages

·       Carbonated Drinks: Prevents spoilage in sodas and flavored waters.

·       Fruit Products: Used in juices, jams, jellies, and fruit syrups.

·       Condiments: Found in pickles, salad dressings, ketchup, and soy sauce. 

Cosmetics & Personal Care

·       Water-Based Products: Prevents microbial growth in lotions, face cleansers, shampoos, and toothpaste. 

·       Other Products: Used in baby wipes and mouthwash. 

Pharmaceuticals & Medicine

·       Preservative: Stabilizes liquid medications like cough syrups.

·       Excipient: Acts as a lubricant in pill manufacturing.

·       Therapeutic Use: Prescribed in high doses to treat dangerously high blood ammonia levels (hyperammonemia). 

Industrial & Other Uses

·       Corrosion Inhibitor: Protects engine coolants from rusting.

·       Paints & Coatings: Used as an additive.

·       Fire Retardant: Added to some plastics. 

 

 

 

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

MEDIOCON INC primarily acts as a manufacturer and supplier of pharmaceutical raw materials (APIs, intermediates, and excipients) and generally provides Sodium Benzoate in bulk form as a powder. 

It is typically used as an ingredient by other companies to manufacture final medicinal products. Sodium benzoate is a common excipient available for use in various final dosage forms, including: 

·       Liquid Oral solutions

·       Solid Oral forms (tablets, capsules)

·       Topical preparations

·       Parenteral (injectable) solutions 

 

 

 

 How Sodium Benzoate  Manufactured by MEDIOCON INC Dosage Forms are prepared?

MEDIOCON INC primarily acts as a supplier and wholesaler of chemical ingredients, including sodium benzoate, rather than a manufacturer of specific finished dosage forms. They supply sodium benzoate in bulk powder or granular form to other companies (pharmaceutical, food, cosmetic) who then incorporate it into their own final products. 

The process for preparing dosage forms using sodium benzoate, generally speaking, involves incorporating it as an excipient or preservative into the final product formulation. 

General Manufacturing Process for Sodium Benzoate as an Ingredient 

Sodium benzoate is typically produced via a chemical synthesis process, not a dosage form preparation process by the supplier. 

1.      Neutralization: Benzoic acid is neutralized with sodium hydroxide (caustic soda) or sodium bicarbonate in a reaction tank to produce a solution of sodium benzoate.

2.      Purification: The crude solution is decolorized using activated carbon and then filtered to obtain a clean sodium benzoate solution.

3.      Drying and Solidification: The purified solution is then concentrated and dried using various methods (e.g., spray drying, drum slicing, or wet extrusion) to form the desired solid form (powder, flakes, or granules/columns).

4.      Packaging: The final solid product is screened and packaged, often in 25 kg bags or drums, for distribution to other manufacturers. 

Incorporation into Dosage Forms (by client companies)

The client companies of MEDIOCON INC use the supplied sodium benzoate in specific applications: 

·       Liquid Medications (Oral Solutions, Syrups, Suspensions): Sodium benzoate is dissolved in the liquid formulation as a preservative to prevent microbial growth. This process requires careful pH control for maximum effectiveness, as its optimal function is below pH 4.5.

·       Topical Formulations (Creams, Ointments): It is incorporated into semi-solid preparations as an antimicrobial agent.

·       Solid Dosage Forms: It may also be used as a lubricant in some tablet manufacturing processes. 

The specific final preparation method for a given dosage form depends on the client company's formulation and manufacturing process, not on the initial bulk production method employed by MEDIOCON INC. 

 

 

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

MEDIOCON INC primarily manufactures Active Pharmaceutical Ingredients (APIs) intermediates and does not appear to produce finished dosage forms of Sodium Benzoate for direct patient use. Instead, the company supplies Sodium Benzoate as a raw material (excipient) in a white or almost white powder form to other manufacturers. 

Sodium benzoate, in general, is a versatile excipient used by pharmaceutical companies to create a variety of finished products. The common dosage forms that utilize sodium benzoate as a preservative or an active ingredient (for specific conditions like urea cycle disorders) include: 

·       Oral solutions and syrups

·       Pediatric drops

·       Topical formulations (ointments, creams, and gels)

·       Oral Powders (for compounding)

·       Tablets (as a lubricant or excipient)

·       Capsules (as an excipient) 

 

 

 

When should Sodium Benzoate  Manufactured by MEDIOCON INC be taken?

Sodium Benzoate (SB) manufactured by MEDIOCON INC isn't a typical over-the-counter supplement; it's used as a preservative in many medicines or prescribed for specific conditions like high ammonia levels (hyperammonemia), often alongside phenylbutyrate, or for urea cycle disorders, so when you take it depends entirely on your doctor's prescription and the underlying medical need, not a general guideline.. Always follow your healthcare provider's specific instructions, as SB can interact with other drugs and is only given in controlled doses. 

 

 

 What are the effects And Side effects of Sodium Benzoate  Manufactured by MEDIOCON INC?

The effects and side effects of sodium benzoate manufactured by MEDIOCON INC are the same as those for sodium benzoate produced by any other manufacturer, as they relate to the chemical compound itself. 

MEDIOCON INC is a manufacturer of pharmaceutical intermediates and active pharmaceutical ingredients located in Aurangabad, India. While they list potassium benzoate among their products, generic information regarding their specific sodium benzoate product is not available in the search results. 

Common Effects and Uses

Sodium benzoate is widely used as a preservative due to its antifungal and antibacterial properties. 

·       Preservative: It inhibits the growth of mold, yeast, and bacteria in various products, particularly in acidic foods and beverages (e.g., sodas, pickles, fruit juices, and sauces), as well as in cosmetics and liquid medicines like cough syrups.

·       Medical Use: In larger, prescription doses, it is used as a therapeutic agent to treat high blood levels of ammonia, which can occur with liver disease or inherited urea cycle disorders.

·       Potential Therapeutic Effects (Under Research): Studies suggest potential benefits as an add-on therapy for certain neurological and psychiatric conditions, including schizophrenia, depression, and some neurodegenerative diseases. 

Potential Side Effects and Health Concerns

While the FDA has classified sodium benzoate as "Generally Recognized As Safe" (GRAS) when used within approved limits (up to 0.1% in food), research has identified potential side effects and health concerns. 

·       Benzene Formation: When combined with vitamin C (ascorbic acid) and exposed to heat or light, sodium benzoate can form benzene, a known carcinogen.

·       Hyperactivity (ADHD): Some studies have linked the consumption of beverages containing sodium benzoate (and some artificial food colorings) to increased hyperactivity and ADHD symptoms in children.

·       Inflammation and Oxidative Stress: Studies, mostly in animals and test-tubes, suggest that sodium benzoate can promote inflammation and increase free radicals in the body, which may increase the risk of chronic diseases.

·       Allergic Reactions: A small percentage of individuals may be hypersensitive and experience allergic reactions such as skin rashes, itching, swelling, or asthma-like symptoms.

·       Organ Function: Animal studies have indicated potential negative effects on liver and kidney parameters in high doses.

·       Reproductive/Hormonal Effects: Some animal studies suggest potential negative impacts on hormone levels and fertility. 

For medicinal products, a doctor should closely monitor a patient for potential side effects such as nausea, vomiting, abdominal pain, or neurological symptoms. 

 

 

 

 How is Sodium Benzoate  Manufactured by MEDIOCON  INC  Tested Qualitatively?

To test sodium benzoate qualitatively, manufacturers like MEDIOCON use methods such as colorimetric tests (e.g., with copper sulfate for benzoates), TLC (Thin-Layer Chromatography) for separation, non-aqueous titrations for purity, and spectroscopic techniques (HPLC, AAS) to confirm identity and detect impurities, ensuring it meets pharmacopoeial standards for food or pharma use. 

Key Qualitative Tests

1.      Colorimetric Test (Copper Sulfate Test):

·       Procedure: Mix the sodium benzoate sample with sodium hydroxide and copper sulfate solution.

·       Observation: A distinct blue precipitate (copper benzoate) forms, confirming the presence of benzoate ions.

2.      TLC (Thin-Layer Chromatography):

·       Purpose: To separate sodium benzoate from potential impurities.

·       Procedure: Dissolve the sample and apply to a TLC plate; develop with a specific solvent system (e.g., water/methanol) and visualize spots.

3.      Acidity/Alkalinity Test:

·       Purpose: To check for free benzoic acid or excess alkali.

·       Procedure: Test with pH indicators or titrate to determine if the solution is neutral or slightly alkaline.

4.      Spectroscopic Methods (HPLC/UV):

·       Purpose: For precise identification and quantification (though the question asks for qualitative, HPLC also confirms identity).

·       Procedure: Uses specific mobile phases (like buffer/acetonitrile) and C18 columns to generate unique retention times, matching known standards.

5.      Heavy Metals & Sulfite Tests:

·       Purpose: To ensure safety by checking for harmful contaminants like lead or sulfites. 

How MEDIOCON Likely Tests

·       For raw material intake and final product release, MEDIOCON would perform standard tests outlined in pharmacopoeias (USP, BP, IP) or food standards (FCC).

·       They would use a combination of classical wet chemistry (titration, precipitation) and instrumental methods (HPLC, AAS) for comprehensive quality control. 

In essence, testing ensures the sodium benzoate is pure (not contaminated) and chemically identical to the standard, meeting safety regulations for its intended application (food, pharma)

 

 

 

   Which tests are performed on Sodium Benzoate  Manufactured by  MEDIOCON INC ?

While specific tests for MEDIOCON INC.'s Sodium Benzoate aren't listed, manufacturers follow pharmacopeial standards (USP/BP/EP) for identity, purity, and strength, including Titration (assay), HPLC (purity/impurities), Heavy Metals testing, Loss on Drying, pH, and Clarity/Color tests, ensuring quality for pharmaceutical and food use by checking for impurities like chlorides, sulfates, arsenic, and microbial load. 

Common Quality Control Tests for Sodium Benzoate:

·       Identification: Tests like Infrared Spectroscopy (IR) or chemical reactions to confirm it's sodium benzoate.

·       Assay (Purity): Titration (acid-base) with HCl or perchloric acid to determine the percentage of sodium benzoate.

·       Related Substances/Impurities: HPLC (High-Performance Liquid Chromatography) to detect and quantify impurities.

·       Heavy Metals: Atomic Absorption Spectrometry (AAS) or other methods to check for toxic metals.

·       Loss on Drying: To measure moisture content.

·       pH: Of an aqueous solution, ensuring it's within specified limits.

·       Clarity and Color of Solution: Visual inspection of its dissolved state.

·       Chloride & Sulfate Content: Tests for specific inorganic impurities.

·       Microbial Limits: Testing for bacteria and fungi, especially for pharmaceutical grades. 

 

 

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

MEDIOCON INC is a manufacturer of pharmaceutical intermediates, not a known producer of finished sodium benzoate dosage forms. The challenges in manufacturing sodium benzoate dosage forms generally involve formulation stability, taste masking, and navigating stringent regulatory and market demands. 

General Challenges in Sodium Benzoate Dosage Form Manufacturing

While there is no public information regarding "MEDIOCON INC"'s specific dosage forms, the general challenges in the industry for manufacturing sodium benzoate products include: 

·       Regulatory Compliance and Health Concerns: Manufacturers must adhere to strict regulatory limits, typically up to 0.1% concentration in liquid pharmaceutical formulations, as higher doses or interactions with other ingredients (like vitamin C) can lead to the formation of carcinogenic benzene. Navigating these regulations and addressing consumer health concerns is a significant hurdle.

·       Formulation Stability and pH Control: Sodium benzoate is only an effective preservative in acidic conditions (optimal below pH 4.5). Maintaining the specific pH range throughout the product's shelf life is critical to ensure its efficacy and prevent degradation or loss of function of other active ingredients.

·       Taste Masking for Palatability: Sodium benzoate has a bad taste, which has led to formulation failures in preliminary investigations of oral liquid forms, especially for pediatric use. Developing advanced taste-masking technologies, such as coated granules or microcapsules with saliva-resistant coatings, is necessary to ensure patient acceptance and adherence to medication.

·       Physical Properties and Handling: Traditional powdered or granular sodium benzoate can present manufacturing challenges such as poor fluidity, caking, dust generation during handling, and electrostatic reactions. These issues can affect manufacturing efficiency, safety, and product consistency, leading some manufacturers to explore alternative physical forms like columnar solids.

·       Market Demands and Competition: There is a growing consumer preference for natural, "clean-label" preservatives, which challenges the demand for synthetic options like sodium benzoate. Manufacturers must either invest in innovative, natural alternatives or use advanced technology to produce high-purity, cost-effective sodium benzoate that meets evolving market standard

 

                                                                 

What is shelf life Of Sodium Benzoate  by MEDIOCON INC?

While specific data for MEDIOCON INC. isn't public, sodium benzoate generally has a shelf life of 1 to 2 years (12-24 months) when stored properly (cool, dry, sealed) and is stable, but its preservative power can diminish over time, requiring checking the Certificate of Analysis (COA) for exact dates. 

 

 

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

For MEDIOCON INC's Sodium Benzoate, label claims should highlight its function as a preservative (antifungal/antibacterial), its GRAS status (Generally Recognized As Safe by the FDA, if for food use), its identification as E211 (Europe), its use in foods/drinks (jams, soft drinks, syrups, pickles), and its pharma applications (syrups, oral solutions) as an excipient, with specific concentration limits (e.g., under 0.1%) depending on application, ensuring compliance with FDA (USA), FSSAI (India), and USDA (Organic) guidelines. 

 

 

Where can Sodium Benzoate  Manufactured by MEDIOCON INC are procured?

Sodium Benzoate  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 Sodium Benzoate  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 Sodium Benzoate  Manufactured by MEDIOCON INC products.

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