Potassium Sorbate 24634-61-5 Manufacturer Supplier Exporter, MEDIOCON INC

 

 

 

Potassium Sorbate Manufactured by MEDIOCON INC

 

   Name: Potassium Sorbate

CAS No: 24634-61-5

Molecular Weight: 150.22 g/mol

Molecular formula: C₆H₇KO₂

Synonyms:  Common synonyms for potassium sorbate include Sorbic acid potassium salt, E202, Potassium (E,E)-hexa-2,4-dienoate, 2,4-Hexadienoic acid, potassium salt, and trade names like Sorbistat-K or Sorbistat potassium.

Appearance : Potassium sorbate appears as a white to off-white crystalline powder or granules.

 Solubility : Potassium sorbate is highly soluble in water, dissolving readily at about 58.2% (58.2 g/100 mL) at room temperature (20°C).

Uses : Potassium sorbate is a widely used preservative in foods (like cheese, wine, baked goods, dried fruits) and personal care items (shampoos, lotions) to prevent mold, yeast, and bacteria growth.

 

 

  How Potassium Sorbate is manufactured by MEDIOCON INC Synthesized?

Potassium sorbate is produced industrially by neutralizing sorbic acid with potassium hydroxide

. Mediocon Inc. is a wholesaler and manufacturer of potassium sorbate, and the general manufacturing process involves this common chemical synthesis method. 

The synthesis typically involves the following main steps: 

1. Sorbic Acid Production: The key precursor, sorbic acid, is primarily synthesized through a two-step chemical process via the condensation reaction of ketene and crotonaldehyde:
• Ketene
• This polyester is then decomposed (depolymerized), often using hydrochloric acid, to produce crude sorbic acid.
• The crude sorbic acid is purified, typically through processes like distillation, activated carbon treatment, or recrystallization.
2. Neutralization: The purified sorbic acid is then reacted with an equimolar portion of potassium .
3. Purification and Finishing: The resulting potassium sorbate solution is treated to remove any remaining impurities, often with activated carbon filtration, to become a clear, colorless liquid.
• The solution is then dried, commonly using spray drying, to produce potassium sorbate powder.
• The powder is subsequently granulated to form uniform particles, followed by final drying and screening to obtain the finished product ready for packaging. 

 

 

What are the different  dosage forms of Potassium Sorbate Manufactured  by  MEDIOCON INC?

MEDIOCON INC is a supplier of pharmaceutical ingredients and general chemicals, and it offers Potassium Sorbate as a raw material in various industrial forms, but it is not typically listed as a manufacturer of finished pharmaceutical "dosage forms" (like specific pills, liquids, etc.) containing the ingredient. 

The company supplies Potassium Sorbate as a bulk chemical ingredient in the following industrial appearances: 

·       Noodle/Granular form

·       Powder

·       Pellet/Bead form 

Potassium sorbate is widely used as a preservative in various applications (food, cosmetics, pharmaceuticals), where it is incorporated into final products like solutions, creams, tablets, and capsules by formulators. MEDIOCON INC appears to supply the base ingredient to these formulators, rather than the final, ready-to-use dosage form itself. 

 

 

 How Potassium Sorbate Manufactured by MEDIOCON INC Dosage Forms are prepared?

Potassium sorbate manufactured by MEDIOCON INC is typically an ingredient in other formulations, and the final dosage forms are prepared by incorporating this ingredient into various pharmaceutical, cosmetic, or food products as a preservative. MEDIOCON INC is a manufacturer and wholesaler of pharmaceutical intermediates, not typically the end-product formulator. 

Manufacturing Process of Potassium Sorbate

Potassium sorbate is synthetically produced on an industrial scale by a two-step process: 

1.      Sorbic acid production: Crotonaldehyde and ketene undergo condensation to produce a polyester. The polyester is then depolymerized to obtain crude sorbic acid.

2.      Neutralization: The resulting sorbic acid is neutralized with potassium hydroxide or potassium carbonate to produce an aqueous potassium sorbate solution.

3.      Purification and drying: The solution is treated with activated carbon to remove impurities, filtered, and then spray-dried to yield a white powder.

4.      Granulation (optional): The powder may then be granulated using a granulator or tablet press, often with the addition of a small amount of potassium sorbate solution as a binder, followed by a final drying stage (e.g., fluidized bed drying) and screening to form a stable, storable, crystalline product. 

Preparation of Dosage Forms

MEDIOCON INC supplies the potassium sorbate (powder or granules) to other manufacturers who then incorporate it into their final products to inhibit microbial growth: 

·       Liquid preparations: In many pharmaceutical and cosmetic liquid preparations (solutions, syrups, lotions, shampoos), the potassium sorbate powder is dissolved in the aqueous phase during the formulation process, typically at concentrations between 0.1% and 0.3%, to act as a preservative.

·       Solid dosage forms: In tablets, such as certain paracetamol tablets, potassium sorbate solution can be used as a binding agent during the wet granulation process, before drying and tabletting with other excipients.

·       Other applications: It can also be incorporated into edible films for food packaging or pectin-based gummies as a preservative for nutraceuticals. 

The effectiveness of potassium sorbate as an antimicrobial agent is highly dependent on the pH of the final product, working best in acidic matrices (pH 2-6.5). 

 

 

What are the appropriate Dosage forms of Potassium Sorbate Manufactured  by  MEDIOCON   INC?

MEDIOCON INC is a manufacturer and wholesaler of pharmaceutical ingredients and intermediates, and generally supplies Potassium Sorbate as a raw material in powder or granular form. It does not manufacture finished, specific dosage forms for direct patient use containing only potassium sorbate. 

Potassium sorbate itself is widely used as an excipient or preservative in a variety of other final product dosage forms and applications, including: 

·       Oral Liquids: Used as a preservative in solutions, syrups, and suspensions.

·       Topical Formulations: Incorporated into ointments, creams, and gels.

·       Gummies: Used in pectin-based chewable nutraceutical and pharmaceutical gummies.

·       Cosmetics: Functions as a preservative in various cosmetic formulations. 

For information on the specific products MEDIOCON INC supplies, you would need to consult their official product list or contact them directly, as the search results primarily identify them as a supplier of bulk ingredients and intermediates, not a producer of final, over-the-counter medicines. 

 

When should Potassium Sorbate Manufactured by MEDIOCON INC be taken?

Potassium sorbate manufactured by MEDIOCON INC is an industrial chemical widely used as a preservative in the food, beverage, cosmetic, and pharmaceutical industries, not a medication to be "taken" on a schedule. It is added to various products during the manufacturing or production process to extend their shelf life and prevent microbial growth. 

It is not a direct consumption product with instructions on "when" to take it in the way a medicine would have. Instead, the "timing" of its use refers to when it is incorporated into other products: 

·       In Food/Beverage Production: It is typically added during the post-fermentation stage in items like wine and fruit juices to prevent further yeast activity, or mixed into wet ingredients (water, milk, eggs) when making items like baked goods, cheeses, and sauces.

·       In Cosmetics/Pharmaceuticals: It is included as an ingredient in the product formulation phase to ensure the final product remains stable and free from microbial contamination over time. 

For specific dosage and application instructions regarding a particular product, you must refer to the manufacturer's guidelines or the ingredient list on the final consumer product. 

 

 

 

 What are the effects And Side effects of Potassium Sorbate Manufactured by MEDIOCON INC?

The effects and side effects of potassium sorbate from any manufacturer, including MEDIOCON INC, are consistent with the general properties of the chemical as an approved, low-toxicity preservative. The effects are primarily related to food preservation, while side effects are rare and usually limited to allergic reactions in sensitive individuals. 

Effects

Potassium sorbate (E202) is widely used as a preservative in food, beverages, cosmetics, and pharmaceuticals. 

·       Antimicrobial Action: Its primary effect is to inhibit the growth of molds, yeasts, and some bacteria, thus extending the shelf life of products and preventing spoilage.

·       Mechanism: In an acidic environment, it forms sorbic acid, which penetrates microbial cell membranes and disrupts enzyme activity related to energy production, leading to the inhibition of microbial metabolism.

·       Flavor/Odor Neutrality: It is generally odorless and tasteless at the concentrations used in food products, so it does not alter the flavor profile of the items it preserves.

·       Metabolism: When consumed in typical food additive amounts, it is metabolized harmlessly in the body into water and carbon dioxide and does not accumulate in the system. 

Side Effects

Potassium sorbate is generally recognized as safe (GRAS) by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Food Safety Authority (EFSA) when used within approved limits. The acceptable daily intake (ADI) is set at 25 mg per kilogram of body weight. 

Potential side effects are typically rare and often linked to high concentrations or individual sensitivity: 

·       Allergic Reactions: Rare allergic reactions are the most commonly reported side effect in sensitive individuals. Symptoms can include skin irritation, rashes, redness, itching, and in very rare cases, more severe reactions like hives, mouth tingling, or swelling.

·       Skin and Eye Irritation: In its pure or highly concentrated form (e.g., as an ingredient for industrial use), it can be an irritant to the skin, eyes, and respiratory system.

·       Gastrointestinal Issues: Ingestion of extremely large quantities might lead to minor, temporary issues like nausea, vomiting, or diarrhea.

·       Potential for Long-Term Effects (Research-based): Some recent in vitro (lab cell studies) and animal research at very high doses, far exceeding normal dietary intake, suggest potential health risks, including oxidative stress, genotoxicity (damage to DNA), and potential liver or kidney effects, or links to cancer-related pathways. These findings indicate a need for more research but do not change the current regulatory consensus for safe consumption at approved levels. 

 

 

 How is Potassium Sorbate Manufactured by MEDIOCON  INC  Tested Qualitatively?

MEDIOCON INC, like other reputable suppliers, employs rigorous quality control measures and standard industry testing protocols to ensure the purity and quality of its potassium sorbate. Qualitative testing is typically part of a comprehensive quality assurance program that also includes quantitative analysis and purity checks. 

Specific qualitative tests for potassium sorbate production and quality control, based on standard pharmacopeial and food additive requirements (e.g., from the FAO or USP), include: 

·       Appearance and Odor Check: The final product should be white or almost white crystals/powder and odorless.

·       Solubility Test: The substance should be very soluble in water and slightly soluble in ethanol.

·       Flame Test for Potassium: Dissolving the sample in water and performing a flame test confirms the presence of the potassium ion, which produces a characteristic color.

·       Bromine Color Discharge Test (Test for Unsaturation): A solution of the sample is tested with bromine solution. The rapid disappearance of the bromine color confirms the presence of the carbon-carbon double bonds characteristic of the sorbate structure.

·       Melting Point of Precipitated Sorbic Acid: Acidifying an aqueous solution precipitates sorbic acid, which can be collected, dried, and its melting point determined (expected range: 132°C to 136°C) as a confirmation of identity.

·       Infrared (IR) Absorption Spectrophotometry: The infrared spectrum of the sample is compared to a certified standard (Potassium Sorbate CRS) to ensure the molecular structure matches.

·       Aldehyde Content Test: This is a purity test that involves comparing the color produced by the sample after reacting with Schiff's reagent to a standard control solution, ensuring aldehyde impurities do not exceed specified limits.

·       Acidity or Alkalinity Test: This test involves dissolving the sample in water and using indicators (like phenolphthalein) and titration to ensure the solution's pH falls within the required narrow range, indicating proper chemical balance and the absence of excessive acidic or basic impurities. 

 

   Which tests are performed on Potassium Sorbate Manufactured by  MEDIOCON INC ?

MEDIOCON INC is a manufacturer of pharmaceutical intermediates, and information regarding the specific quality control tests they perform on their potassium sorbate product line is not publicly available in the search results. 

However, the quality control of potassium sorbate is generally governed by standard pharmaceutical and food-grade specifications, such as the USP (United States Pharmacopeia), EP (European Pharmacopoeia), BP (British Pharmacopoeia), and FCC (Food Chemicals Codex). Manufacturers like MEDIOCON INC would likely perform the following standard tests to ensure their product meets these international benchmarks: 

Standard Quality Control Tests

·       Identification Tests: These confirm the substance is indeed potassium sorbate.

o   Potassium test: Typically a flame test.

o   Double bond test: Using a chemical reaction, such as adding a few drops of bromine solution and observing the color disappear.

o   Spectrophotometry: Using Ultraviolet (UV) or Infrared (IR) absorption to match the spectral characteristics of the sample to a known standard.

·       Assay: This determines the purity and concentration of the potassium sorbate, typically required to be between 98.0% and 101.0% on a dried basis. This is often performed using titration with 0.1 M perchloric acid.

·       Physical Appearance: Visual inspection to ensure the product is a white or off-white powder or granules with a slight characteristic odor.

·       Solubility: Testing that the product dissolves correctly in water and ethanol.

·       Loss on Drying (LOD): Measures the moisture content to ensure it is below a specified maximum limit (e.g., maximum 1.0%).

·       Acidity or Alkalinity: A pH test using phenolphthalein solution to ensure the acidity or alkalinity is within the set limits.

·       Impurities and Heavy Metals:

o   Aldehydes: Testing for the presence of aldehydes, which should be below a maximum percentage (e.g., 0.15%).

o   Heavy metals: Testing for trace amounts of metals like lead (Pb), arsenic (As), and mercury (Hg), usually with strict maximum limits (e.g., <10 ppm for heavy metals as Pb).

·       Heat Stability: Testing to ensure no change in color after heating for a set period. 

To get the exact list of tests performed by MEDIOCON INC, you would need to obtain their specific product specification sheet or Certificate of Analysis (CoA) directly from the company. 

 

 

 

What are the challenges in manufacturing of Potassium Sorbate Manufactured by MEDIOCON  INC ’s Dosage forms?

Information on specific manufacturing challenges of potassium sorbate dosage forms by a company named MEDIOCON INC is not available in the provided sources. The general manufacturing and formulation challenges of potassium sorbate in pharmaceutical and food applications are related to its stability, pH dependency, and potential interactions with other ingredients and packaging materials. 

General Manufacturing Challenges with Potassium Sorbate

The general challenges in manufacturing dosage forms containing potassium sorbate include:

·       pH Dependency: Potassium sorbate is most effective as an antimicrobial agent in acidic conditions, typically at a pH of 3.0-5.5. Its efficacy significantly decreases at higher pH levels (above 6.0), which requires careful pH control during formulation to ensure product safety and shelf life.

·       Stability Issues: It can degrade under certain conditions, such as exposure to high temperatures (above 160 °C), light, oxygen, or specific metal ions. Degradation can reduce its potency and potentially lead to the formation of other compounds, sometimes causing color changes (browning).

·       Compatibility with other Ingredients: Potassium sorbate may react with other components in a formulation, such as certain iron salts or ascorbic acid, which can lead to stability problems or the formation of potentially toxic compounds at high concentrations.

·       Formulation Challenges in Solid Forms: While widely used in liquid and semi-solid formulations (creams, lotions, syrups), incorporating it into solid dosage forms like tablets or capsules as an active ingredient can present challenges related to uniform distribution, adhesion, and controlled release, sometimes requiring specialized techniques like encapsulation.

·       Organoleptic Properties: At high concentrations, potassium sorbate can impart minor off-flavors, such as bitterness, which can affect patient compliance for oral dosage forms (e.g., syrups or chewable tablets).

·       Regulatory Limits: Strict monitoring and adherence to regulatory limits (e.g., maximum acceptable daily intake) are necessary due to potential health risks at excessively high doses (though generally considered safe at approved levels). Ensuring concentrations are within permissible limits requires precise manufacturing and quality control. 

Manufacturers often address these challenges through careful formulation design, advanced preservation techniques (e.g., modified atmosphere packaging, combination with other preservatives), and the use of high-purity, food-grade materials to ensure product quality and stability. 

 

 

                                                                 

What is shelf life Of Potassium Sorbate Manufactured by MEDIOCON INC?

The standard shelf life for potassium sorbate from MEDIOCON INC is typically 24 months (2 years) from the date of manufacture, provided it is stored in a cool, dry place away from direct sunlight in its original, tightly sealed packaging. 

Some sources indicate a potential shelf life of up to 3 years under ideal storage conditions, such as the Conflate product which is protected from sunlight, kept dry and at ambient temperature (max 30°C). 

For the most accurate and product-specific information regarding the batch you have, you should consult the product label or the manufacturer's official documentation. You can also contact MEDIOCON INC directly via their official email or website: 

·       Email: sales@mediocon.com

·       Website: www.mediocon.com 

 

 

 

What should the label claim for Potassium Sorbate Manufactured by MEDIOCON INC   Include?

Required Label Information

·       Product Identifier: The name of the product, clearly stated as "Potassium Sorbate". It may also include the E number "E202" (used in the EU but helpful for global trade) or "Sorbistat-K" as other names.

·       Intended Use Statement: A statement indicating its purpose, such as "For Food Use" or "Preservative". This assures safe use in accordance with food additive regulations.

·       Manufacturer Information: The name and address of the manufacturer, packager, or distributor (MEDIOCON INC).

·       Net Quantity: The accurate weight, volume, or count of the contents.

·       Batch or Lot Number: A mark identifying the specific batch or lot for traceability.

·       Date of Minimum Durability or Use-by Date: The expiration or "best by" date.

·       Instructions for Use: Clear directions for proper use, including recommended levels (e.g., typical usage levels are 0.025%–0.1% in foods) to ensure compliance with regulations and prevent misuse.

·       Storage Conditions: Specific instructions for storage, such as "Store in a cool, dry, well-ventilated place" and "Keep container tightly closed to prevent moisture uptake", as the substance is sensitive to moisture and light.

·       Safety and Handling Information: This may include GHS (Globally Harmonized System) labeling elements, particularly if it's in pure, bulk form:

o   Signal Word: Warning.

o   Hazard Statement: H319: Causes serious eye irritation.

o   Precautionary Statements: P280 (Wear protective gloves/eye protection) and P305+P351+P338 (IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing).

o   First Aid Measures: Basic first-aid information in case of exposure.

·       Quality/Compliance Standards (optional but recommended): Mentions of compliance with standards like FCC (Food Chemicals Codex), USP (U.S. Pharmacopeia), ISO, Kosher, or Halal, if certified, to assure quality for global trade.

·       Chemical Identifiers (optional but recommended for bulk/industrial packaging): CAS Number (24634-61-5) and chemical formula (C₆H₇KO₂). 

Prohibited Claims

·       Claims suggesting the product is an explicit source of dietary "potassium" that provides significant daily value, as it is primarily an additive used in small quantities, and high concentrations require specific warnings if in supplement form over 99mg.

·       Claims that are false, misleading, or would cause the final food product to be misbranded.

 

 

 

Where can Potassium Sorbate Manufactured by MEDIOCON INC are procured?

Potassium Sorbate 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 Potassium Sorbate 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 Potassium Sorbate Manufactured by MEDIOCON INC products.

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