Sodium Chloride 7647-14-5 Manufacturer Supplier Exporter, MEDIOCON INC

                                    

                                Sodium Chloride Manufactured by MEDIOCON INC

 

   Name: Sodium Chloride

CAS No: 7647-14-5

Molecular Weight:  58.44 g/mol

Molecular formula:  NaCl

Synonyms:    Salt

  Table salt

  Common salt

  Halite (its natural mineral form)

  NaCl (chemical formula)

  Rock salt (less refined form)

  Sea salt

 

Appearance : Sodium chloride (table salt) appears as a white, crystalline solid, often as powder, granules, or distinct colorless crystals, sometimes described as pearls, with a characteristic salty taste and no odor. 

 Solubility : Sodium chloride (NaCl) solubility in water is about 36 grams per 100 mL (or 100 g) of water at room temperature (25°C), increasing slightly with temperature to around 39 g at 100°C, but it's known for its relatively stable solubility across temperatures, unlike many salts. It dissolves well in polar solvents like water, forming a neutral solution, but poorly in nonpolar solvents like oil.  

Uses : Medical & Health

·       Electrolyte Replacement: Replaces sodium lost through sweat or illness to prevent cramps and dehydration.

·       Saline Solutions: Used for IV drips, wound cleaning, nasal irrigation, and as a diluent for medicines. 

Industrial & Manufacturing

·       Chemical Production: Raw material for making soda ash (for glass, detergents), chlorine, caustic soda, and hydrochloric acid.

·       De-icing: Lowers ice's melting point to clear roads and sidewalks in winter.

·       Water Treatment: Used in water softeners to remove hardness minerals.

·       Other Industries: Process aid in textiles, paper, leather tanning, and rubber manufacturing; component in oil/gas drilling fluids. 

Household & Other Uses

·       Cleaning: Helps remove grease and stains from pots and pans.

·       Cosmetics: Found in shampoos, toothpaste, and cleansers.

·       Science: Common compound in labs for experiments and demonstrations

 

 

 

  How Sodium Chloride is manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC is a wholesaler and manufacturer that uses the standard industry method of microbial fermentation to produce Sodium Chloride (HA), which is then processed into the final product. This is the predominant method in modern manufacturing due to safety, purity, and ethical concerns associated with animal extraction. 

The general process involves the following stages:

·       Fermentation Specific, often genetically modified, bacterial strains such as Streptococcus zooepidemicus or Bacillus subtilis are grown in a nutrient-rich culture medium within large fermenters. The bacteria metabolically produce and secrete the high-molecular-weight HA polymer into the medium.

·       Purification The resulting viscous broth undergoes extensive downstream processing to separate the HA from the bacterial cells, proteins, and potential endotoxins. This typically involves a sequence of steps:

o   Filtration and Centrifugation The solid bacterial biomass and large impurities are removed from the liquid culture medium.

o   Precipitation Organic solvents, commonly ethanol or isopropanol, are added to the solution, causing the crude HA to precipitate out as a solid.

o   Washing and Dialysis The precipitate is redissolved and subjected to repeated washing and dialysis using specific solutions to remove residual solvents, salts, and other low-molecular-weight contaminants to achieve the required purity (e.g., cosmetic or medical grade).

·       Processing and Sterilization The purified HA is typically obtained as a white powder after drying. For specific applications like dermal fillers, this powder is dissolved, cross-linked using agents like 1,4-Butanediol Diglycidyl Ether (BDDE) to enhance longevity and viscosity, and then filled into syringes. The final product then undergoes a terminal sterilization process, usually autoclaving, to ensure safety. 

 

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

MEDIOCON INC is a manufacturer and supplier of Sodium Chloride as a cosmetic raw material (API/fine chemical) in powder or bulk form. The company does not manufacture finished, specific dosage form products like creams, serums, or injections under its own brand name. 

Instead, other companies use the raw Sodium Chloride powder as an ingredient to create their own final products in various dosage forms, such as: 

·       Gels

·       Creams and lotions

·       Serums

·       Injectable solutions (for medical and cosmetic procedures)

·       Oral forms like tablets, soft capsules, liquids, and powders, which are available in the wider market but not specifically manufactured as a finished product by MEDIOCON INC. 

 

 

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

Information on the specific manufacturing process used by MEDIOCON INC for their sodium chloride products is not publicly available in the provided search results. The company is identified as a manufacturer and wholesaler, potentially of active pharmaceutical ingredients (APIs) and other products, but specific product details and manufacturing methods are proprietary. 

However, the general pharmaceutical industry standards for preparing sodium chloride dosage forms, particularly injections (sterile liquid formulations), follow specific, highly controlled processes to ensure purity and sterility. 

General Manufacturing Process for Sodium Chloride Injections

The standard preparation of pharmaceutical-grade sodium chloride injection (e.g., 0.9% Normal Saline) typically involves the following general steps: 

1.      Preparation of Pharmaceutical Grade Salt: Highly pure sodium chloride (NaCl) is used as the starting material, complying with pharmacopoeia standards like USP or Ph. Eur. This salt is generally obtained through the purification of natural sources (seawater evaporation or mining rock salt) followed by crystallization and filtration processes to remove impurities.

2.      Dissolution: The pure sodium chloride is dissolved in sterile water for injection in a precise proportion to achieve the desired concentration (e.g., 9 g of NaCl per liter for a 0.9% solution).

3.      Filtration: The resulting solution is filtered to remove any particulate matter and minimize bacterial contamination.

4.      Filling: The filtered solution is accurately dispensed into appropriate containers, such as ampoules, infusion bottles, or pre-filled syringes, and the containers are sealed.

5.      Sterilization: The sealed containers undergo a terminal sterilization process to ensure the final product is sterile and non-pyrogenic (free of fever-inducing substances). This often involves autoclaving or high-temperature moist heat sterilization, although some modern methods may use radiation sterilization to maintain clarity and stability.

6.      Quality Control: The final product is subjected to rigorous quality control testing to verify its concentration, pH (typically 4.5 to 7.0), clarity, and sterility, ensuring it meets all regulatory requirements. 

Dosage Forms

Sodium chloride is available in various dosage forms, primarily as solutions: 

·       Injections: Sterile solutions in various concentrations (e.g., 0.9%, 3%, 23.4%) for intravenous administration, used for hydration, electrolyte balance, or as a diluent for other drugs.

·       Oral forms: Tablets used to prepare an isotonic solution or taken directly as directed by a healthcare professional.

·       Other solutions: Used in hemodialysis, oral rehydration salts (ORS), and as a basic excipient in many other pharmaceutical products. 

For specific details regarding MEDIOCON INC's proprietary processes, you would need to consult their official product documentation or contact the company directly.

 

 

 

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

Mediocon Inc primarily functions as a manufacturer and exporter of pharmaceutical raw materials, including active pharmaceutical ingredients (APIs), intermediates, and excipients. They do not appear to manufacture finished sodium chloride drug products in specific dosage forms for direct patient use. 

The company provides high-purity sodium chloride as a pharmaceutical chemical (likely a raw material or excipient) to other manufacturers, who then use it to formulate various dosage forms. Common final dosage forms of sodium chloride manufactured by other pharmaceutical companies typically include: 

·       Solutions for injection/infusion: These are sterile liquid formulations administered intravenously, intramuscularly, or subcutaneously in various concentrations (e.g., 0.45%, 0.9%, 3%, 5%).

·       Oral tablets: Used as an electrolyte replenisher to help prevent heat cramps.

·       Inhalation solutions: Solutions for nebulization to help with respiratory conditions.

·       Ophthalmic solutions (eye washes): Used in eye care products.

·       Nasal sprays: Used in various nasal saline products. 

When should Sodium Chloride Manufactured by MEDIOCON INC be taken?

Sodium chloride manufactured by MEDIOCON INC should be taken exactly as directed by a healthcare provider to treat specific conditions like sodium deficiency, dehydration, or as a diluent for other medications. The timing and dosage depend entirely on the specific medical problem being addressed and the form of the medication. 

General Guidelines

·       Always follow your doctor's instructions or the directions on the product label if using an over-the-counter version.

·       The form of the product matters: Sodium chloride comes as tablets, oral solutions, injections, and nasal products, each with different usage instructions.

·       Do not take more of it, more often, or for a longer time than prescribed. 

Before using any medication, including sodium chloride manufactured by MEDIOCON INC, it is important to understand that information provided here is for general knowledge and should not be taken as medical advice. Always consult with a healthcare provider for diagnosis, treatment, and before starting any new medication or supplement.

Administration by Use

Specific administration timing often relates to the condition being treated:

·       For Hyponatremia (low blood sodium levels): It may be administered on a schedule determined by a healthcare professional.

·       For Prevention of Heat Cramps: Oral use for this purpose is typically administered as directed.

·       With Food: Oral forms can often be taken with or without food; however, taking with food may help mitigate stomach upset.

·       As a Diluent/Vehicle: For injections, it is used to dilute or dissolve other drugs immediately prior to administration by a healthcare professional. 

Important Precautions

·       Missed Dose: If a dose is missed, take it as soon as possible. If it is close to the time for the next dose, it is generally advised to skip the missed dose and return to the normal schedule. Avoid taking double doses.

·       Low-Salt Diet: Individuals on a low-salt diet should consult a doctor before taking sodium chloride supplements.

·       Seek Guidance: Dosing for children should be determined by a doctor. Pregnant or breastfeeding individuals should consult a healthcare provider before use. 

Since specific product details for the MEDIOCON INC brand are not available in the search results, it is crucial to follow the precise instructions provided with the medicine or by a pharmacist or doctor.

 

 

 

 

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

The effects and side effects of sodium chloride manufactured by Mediocon Inc. are the same as those for any other manufacturer, as the active ingredient is identical across all products. Sodium chloride is an essential electrolyte used to replenish fluids and prevent dehydration. 

Possible side effects typically depend on the concentration and method of administration (e.g., oral, intravenous, inhalation) and can range from mild injection site reactions to more severe issues from fluid or sodium overload, especially in vulnerable patients. 

Effects of Sodium Chloride

Sodium chloride (salt) is a crucial component for normal bodily functions. Its medical effects include: 

·       Fluid and Electrolyte Balance: Helps maintain the water balance in the body and keeps it hydrated.

·       Essential Functioning: Plays a role in nerve impulses, muscle contractions, and the regulation of blood pressure.

·       Replenishment: Used to treat or prevent sodium loss caused by excessive sweating, dehydration, diarrhea, or other conditions.

·       Vehicle for Other Medications: Often used as a diluent or a base solution for administering other medicines intravenously or for cleaning wounds. 

Potential Side Effects

Side effects typically occur with excessive administration, in patients with pre-existing conditions (e.g., heart or kidney disease), or due to an allergic reaction. 

Common and Minor Side Effects

·       Nausea and vomiting

·       Stomach cramps or pain

·       Headache and dizziness

·       Fatigue or weakness

·       Runny nose or cough (if used as an inhalation solution)

·       Injection or infusion site reactions (redness, pain, burning sensation) 

Serious Side Effects (Require immediate medical attention)

·       Allergic reactions: Hives, rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing.

·       Fluid overload (Hypervolemia): Swelling in the hands, feet, or ankles; rapid weight gain; pulmonary edema (fluid in the lungs), leading to trouble breathing.

·       High sodium levels (Hypernatremia): Confusion, extreme thirst, muscle weakness, muscle twitching, irritability, and in severe cases, seizures or coma.

·       Heart issues: Fast heartbeat or heart failure.

·       Neurological complications: Risk of serious neurologic complications, such as hyponatremic encephalopathy, associated with rapid changes in sodium levels. 

Important: Always consult with a healthcare professional before using any medication to ensure it is safe for your specific health condition and to understand the correct dosage and administration. 

 

 

 How is Sodium Chloride Manufactured by MEDIOCON  INC  Tested Qualitatively?

To test Sodium Chloride (NaCl) qualitatively, manufacturers like those supplying the medical/food industry (such as implied by "MEDIOCON") use tests for identity (e.g., XRF, visual), chloride/sodium ions (silver nitrate for Cl⁻, flame test for Na⁺), and purity (pH, appearance, melting point, <</loss on drying, <</impurities like sulfates) using techniques like titration (Mohr's, Volhard), spectroscopy, and standard pharmacopeial methods to ensure it's pure NaCl and meets specifications. 

Key Qualitative Tests for Sodium Chloride 

1. Identification Tests (Identity & Purity)
• Visual Inspection: Check for a white, crystalline powder appearance, confirming it's not visibly contaminated.
• X-Ray Fluorescence (XRF): A quick, non-destructive method to verify the elemental composition (Na and Cl) and authenticate the salt's identity.
• Melting Point/Boiling Point: Pure NaCl has a specific melting point (801°C); deviations can indicate impurities.
• pH Test: A 10% solution should fall within a specific pH range (e.g., 8.2-10.0), ensuring proper function and indicating no significant acidic/basic contaminants.
2. Chloride Ion (

−

) Detection

• Silver Nitrate Test: Adding dilute nitric acid followed by silver nitrate (

3

) to the sample solution produces a white precipitate (silver chloride,

), confirming the presence of chloride ions.

3. Sodium Ion (

+

) Detection

• Flame Test: Dissolve NaCl in water and introduce it to a flame; a characteristic bright yellow/orange flame confirms the presence of sodium.
3. Purity/Impurity Tests
• Titration Methods (e.g., Mohr's/Volhard): Used to quantify the chloride content (assay) or check for other ions like sulfate, ensuring high purity (e.g., >99%).
• Loss on Drying (LOD): Measures residual water content, which should be below a certain limit (e.g., <5%).
• Impurity Screening: Testing for specific contaminants like sulfates, calcium, magnesium, or potassium, which should be below strict limits for pharmaceutical/analytical grades. 

 

 

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

To test Sodium Chloride (NaCl) qualitatively, manufacturers like those supplying the medical/food industry (such as implied by "MEDIOCON") use tests for identity (e.g., XRF, visual), chloride/sodium ions (silver nitrate for Cl⁻, flame test for Na⁺), and purity (pH, appearance, melting point, <</loss on drying, <</impurities like sulfates) using techniques like titration (Mohr's, Volhard), spectroscopy, and standard pharmacopeial methods to ensure it's pure NaCl and meets specifications. 

Key Qualitative Tests for Sodium Chloride 

1. Identification Tests (Identity & Purity)
• Visual Inspection: Check for a white, crystalline powder appearance, confirming it's not visibly contaminated.
• X-Ray Fluorescence (XRF): A quick, non-destructive method to verify the elemental composition (Na and Cl) and authenticate the salt's identity.
• Melting Point/Boiling Point: Pure NaCl has a specific melting point (801°C); deviations can indicate impurities.
• pH Test: A 10% solution should fall within a specific pH range (e.g., 8.2-10.0), ensuring proper function and indicating no significant acidic/basic contaminants.
2. Chloride Ion (

−

) Detection

• Silver Nitrate Test: Adding dilute nitric acid followed by silver nitrate (

3

) to the sample solution produces a white precipitate (silver chloride,

), confirming the presence of chloride ions.

3. Sodium Ion (

+

) Detection

• Flame Test: Dissolve NaCl in water and introduce it to a flame; a characteristic bright yellow/orange flame confirms the presence of sodium.
3. Purity/Impurity Tests
• Titration Methods (e.g., Mohr's/Volhard): Used to quantify the chloride content (assay) or check for other ions like sulfate, ensuring high purity (e.g., >99%).
• Loss on Drying (LOD): Measures residual water content, which should be below a certain limit (e.g., <5%).
• Impurity Screening: Testing for specific contaminants like sulfates, calcium, magnesium, or potassium, which should be below strict limits for pharmaceutical/analytical grades. 

 

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

MEDIOCON INC primarily manufactures pharmaceutical intermediates and fine chemicals, and information regarding specific challenges in its own manufacturing of sodium chloride (NaCl) dosage forms is not publicly available. However, the general pharmaceutical industry faces several common challenges in manufacturing high-purity sodium chloride for various dosage forms (injections, oral rehydration salts, etc.). 

General Manufacturing Challenges for Pharmaceutical Sodium Chloride

The primary challenges relate to achieving the stringent purity requirements and maintaining regulatory compliance. 

·       Purity and Impurity Removal: Raw solar or rock salt cannot be used directly due to insufficient purity and high microbial content. The manufacturing process, often involving crystallization of vacuum salt from brine, must effectively remove undesirable ions (calcium, magnesium, sulfate, bromide, potassium) to meet pharmacopeial standards (USP, Ph.Eur., etc.).

·       Quality Control and Sterility: Sodium chloride intended for parenteral (injectable) dosage forms must meet strict requirements for bacterial endotoxins and sterility. This necessitates rigorous quality control measures, validated sterilization processes (e.g., heat sterilization for aqueous solutions), and sterile manufacturing environments to prevent contamination.

·       Regulatory Compliance and Audits: Manufacturers must adhere to rigorous Good Manufacturing Practice (GMP) standards enforced by agencies like the FDA and EMA. This involves extensive documentation, compliance reporting, product traceability, and frequent inspections, which increase operational complexity and costs, particularly for smaller or newer companies.

·       Physical Properties and Formulation Stability:

o   Caking Prevention: Since pharmaceutical-grade salt cannot use anti-caking agents, special measures are required during production and packaging to prevent the salt from caking, which affects its handling and flow properties.

o   Formulation Compatibility: In solid dosage forms (like tablets), incorporating sodium chloride as an excipient can raise stability concerns, as high concentrations can influence the structural integrity (e.g., causing a collapse of porous matrices in some formulations) or lead to salt dissociation.

·       Supply Chain and Environmental Concerns: Ensuring a steady, high-quality supply of raw materials amid global supply chain disruptions is a challenge. Additionally, the energy consumption and waste generation associated with large-scale salt purification processes raise environmental concerns and pressure for sustainable practices. 

What is shelf life Of Sodium Chloride Manufactured by MEDIOCON INC?

The shelf life of Sodium Chloride (NaCl) depends heavily on its form (pure salt vs. solution) and intended use; pure NaCl has a virtually indefinite shelf life if kept dry, while sterile solutions like IV saline typically last 18 to 36 months (1.5 to 3 years), with the specific expiry date printed on the product's packaging, as indicated by suppliers like ICU Medical or SAHPRA for similar products, and it's crucial to follow MediCon's specific product label for exact dates and storage conditions. 

 

 

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

For Sodium Chloride (NaCl) manufactured by MEDIOCON INC, especially for medical use, the label must include its name, strength (e.g., 0.9%), composition (NaCl in Water for Injection), osmolarity, electrolyte content (mEq/L Na+ & Cl-), pH, sterility, isotonicity, lack of antimicrobials, usage directions (hydration, diluent), single-use warnings, and storage, adhering to USP standards for parenteral solutions, as seen in FDA label examples. 

Here's a breakdown of essential claims and information:

Product Identification

·       Product Name: Sodium Chloride Injection, USP (or appropriate grade).

·       Manufacturer: MEDIOCON INC.

·       Chemical Formula: NaCl. 

Composition & Strength

·       Strength: e.g., "0.9% Sodium Chloride" or "9 g/L".

·       Ingredients: "Sodium Chloride in Water for Injection".

·       Electrolytes: "Contains 154 mEq/L sodium and 154 mEq/L chloride".

·       pH: Nominal pH (e.g., 5.5) and range (e.g., 4.5 to 7.0).

·       Osmolarity: Approx. 308 mOsmol/L (calculated). 

Usage & Safety

·       Indication: For hydration, electrolyte replenishment, diluent for compatible drugs (for intravenous use).

·       Sterility: Sterile, nonpyrogenic.

·       Isotonic: Isotonic.

·       No Preservatives: "Contains no bacteriostatic antimicrobial agents or added buffer".

·       Single Use: For single-dose injection; discard unused portion.

·       Warnings: Cautious use in heart failure, renal impairment; risk of fluid overload/electrolyte imbalance if rapidly administered. 

Regulatory & Supply Info

·       USP/FDA Compliance: Must meet USP (United States Pharmacopeia) standards.

·       Storage: Proper storage conditions.

·       Package Details: NDC numbers, fill volume, etc. (specific to MEDIOCON's product). 

Example Snippet from a Similar Product Label:
"0.9% Sodium Chloride Injection, USP is sterile, nonpyrogenic, isotonic. Each 100 mL contains 900 mg sodium chloride in water for injection. Electrolytes: 154 mEq/L Na+, 154 mEq/L Cl-. Osmolarity: 308 mOsmol/L (calc.). pH: 5.6 (4.5-7.0). No bacteriostat. For IV use as a source of electrolytes and water

 

 

Where can Sodium Chloride Manufactured by MEDIOCON INC are procured?

Sodium Chloride 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 Chloride 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 Chloride Manufactured by MEDIOCON INC products.

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