Iron 7439-89-6 Manufacturer Exporter MEDIOCON INC

 

Iron

 

·   Name: Iron

 

·   CAS No: 7439-89-6

 

 

·   Molecular Weight: 55.845 u

 

·   Molecular formula: Fe

 

·   Synonyms:  Elemental iron (Fe) itself is not soluble in water, certain forms of iron, like ferrous iron      

                     (Fe2+) and  ferric iron (Fe3+), can dissolve in water, particularly in their ionic forms. 

                                                        

·   Appearance:  It is a slightly brittle metal at room temperature and has a shiny-greyish appearance when                 

                           Oxidation is removed.

 

·   Solubility:  elemental iron (Fe) itself is not soluble in water, certain forms of iron, like ferrous iron            

                    (Fe2+) and ferric iron (Fe3+), can dissolve in water, particularly in their ionic forms.   

·   Use :

 

Biological Functions:

1. Oxygen transport: Iron is a key component of hemoglobin, which carries oxygen from the lungs to the body's tissues.

2. Energy production: Iron is necessary for the production of ATP (adenosine triphosphate), the energy currency of the body.

3. Immune system function: Iron is required for the proper functioning of the immune system, including the production of white blood cells.

4. Cognitive function: Iron is involved in the synthesis of neurotransmitters, such as dopamine and serotonin, which are essential for cognitive function.

 

Medical Uses:

1. Treatment of iron deficiency anemia: Iron supplements are used to treat iron deficiency anemia, a condition characterized by low red blood cell count and hemoglobin levels.

2. Treatment of chronic diseases: Iron is used to treat chronic diseases, such as chronic kidney disease, heart failure, and cancer.

3. Pregnancy and lactation: Iron is essential for pregnant and breastfeeding women, as it supports the growth and development of the fetus and baby.

 

Industrial Uses:

1. Steel production: Iron is a key component of steel, which is used in construction, transportation, and consumer goods.

2. Machinery and equipment: Iron is used in the manufacture of machinery and equipment, such as engines, gears, and bearings.

3. Electronics: Iron is used in the production of electronic components, such as transformers, motors, and generators.

 

Food and Beverage Uses:

1. Fortification of foods: Iron is added to foods, such as cereals, bread, and pasta, to prevent iron deficiency.

2. Cooking and food preparation: Iron cookware and utensils are used for cooking and food preparation.

3. Beverages: Iron is added to some beverages, such as energy drinks and supplements, to support energy production and overall health.

 

Other Uses:

1. Cosmetics: Iron is used in some cosmetics and skincare products, such as face creams and serums.

2. Pharmaceuticals: Iron is used as an excipient in some pharmaceutical products, such as tablets and capsules.

3. Veterinary medicine: Iron is used in veterinary medicine to treat iron deficiency anemia in animals.

 

 

·      How is Iron Synthesized?

 

Extraction from Iron Ore:

1. Blast furnace method: Iron ore is extracted from the earth and then smelted in a blast furnace with coke and limestone to produce pig iron.

2. Direct reduction method: Iron ore is extracted and then reduced to iron using natural gas or coal.

 

Refining and Purification:

1. Steel production: Pig iron is further refined and purified to produce steel, which is a alloy of iron and carbon.

2. Electrolysis: Iron is refined and purified through electrolysis, which involves passing an electric current through a bath of molten iron.

3. Vacuum distillation: Iron is refined and purified through vacuum distillation, which involves heating the iron in a vacuum to remove impurities.

 

Chemical Synthesis:

1. Carbonyl process: Iron is synthesized through the carbonyl process, which involves reacting iron oxide with carbon monoxide to produce iron pentacarbonyl.

2. Hydrogen reduction: Iron is synthesized through hydrogen reduction, which involves reacting iron oxide with hydrogen to produce iron.

 

Biological Synthesis:

1. Microbial reduction: Iron is synthesized through microbial reduction, which involves using microorganisms to reduce iron oxide to iron.

2. Enzymatic synthesis: Iron is synthesized through enzymatic synthesis, which involves using enzymes to catalyze the reduction of iron oxide to iron.

 

Other Methods:

1. Sol-gel method: Iron is synthesized through the sol-gel method, which involves reacting iron salts with a gel-like substance to produce iron oxide.

2. Hydrothermal method: Iron is synthesized through the hydrothermal method, which involves reacting iron salts with water at high temperature and pressure to produce iron oxide.

 

 ·   What are the different dosage forms of Iron?

 

Oral Dosage Forms:

1. Tablets: Iron tablets are available in various strengths, including ferrous sulfate, ferrous gluconate, and ferrous fumarate.

2. Capsules: Iron capsules are available in various strengths, including ferrous sulfate, ferrous gluconate, and ferrous fumarate.

3. Syrups: Iron syrups are available in various strengths, including ferrous sulfate and ferrous gluconate.

4. Suspensions: Iron suspensions are available in various strengths, including ferrous sulfate and ferrous gluconate.

5. Powders: Iron powders are available in various strengths, including ferrous sulfate and ferrous gluconate.

 

Parenteral Dosage Forms:

1. Injectable solutions: Iron injectable solutions are available in various strengths, including iron dextran and iron sucrose.

2. Intravenous solutions: Iron intravenous solutions are available in various strengths, including iron dextran and iron sucrose.

 

Topical Dosage Forms:

1. Creams: Iron creams are available for topical application, often used to treat iron deficiency-related skin conditions.

2. Ointments: Iron ointments are available for topical application, often used to treat iron deficiency-related skin conditions.

 

Other Dosage Forms:

1. Gummies: Iron gummies are available in various strengths, including ferrous sulfate and ferrous gluconate.

2. Lozenges: Iron lozenges are available in various strengths, including ferrous sulfate and ferrous gluconate.

3. Sprays: Iron sprays are available in various strengths, including ferrous sulfate and ferrous gluconate.

 

Considerations:

1. Bioavailability: The bioavailability of iron varies depending on the dosage form and strength.

2. Tolerability: The tolerability of iron varies depending on the dosage form and strength.

3. Interactions: Iron can interact with other medications, including antacids, proton pump inhibitors, and blood thinners.

 

·         How Iron  ’s Dosage Forms are prepared?

Oral Dosage Forms:

1. Tablets:

 - Weighing and mixing of iron salts (e.g., ferrous sulfate, ferrous gluconate) with excipients (e.g., binders, fillers).

 - Granulation or direct compression to form tablets.

 - Coating with a thin layer of material (e.g., wax, shellac) to improve appearance and stability.

2. Capsules:

    - Weighing and mixing of iron salts with excipients (e.g., fillers, lubricants).

    - Filling of iron mixture into capsule shells (e.g., gelatin, vegetarian capsules).

    - Sealing of capsules to prevent leakage.

3. Syrups and Suspensions:

    - Weighing and mixing of iron salts with excipients (e.g., sweeteners, flavorings).

    - Dissolution of iron salts in a solvent (e.g., water, glycerin).

    - Filtration and packaging of the final product.

Parenteral Dosage Forms:

1. Injectable Solutions:

 - Weighing and mixing of iron salts (e.g., iron dextran, iron sucrose) with excipients (e.g., buffers, preservatives).

- Dissolution of iron salts in a solvent (e.g., water, saline).

 - Filtration and sterilization of the solution.

2. Intravenous Solutions:

   - Weighing and mixing of iron salts with excipients.

   - Dissolution of iron salts in a solvent.

   - Filtration and sterilization of the solution.

Topical Dosage Forms:

1. Creams and Ointments:

    - Weighing and mixing of iron salts (e.g., iron oxide, iron sulfate) with excipients (e.g., emollients, humectants).

    - Heating and mixing of the iron mixture with a lipid phase (e.g., oils, waxes).

    - Cooling and pouring of the cream or ointment into containers.

Other Dosage Forms:

1. Gummies and Lozenges:

    - Weighing and mixing of iron salts with excipients (e.g., gelling agents, sweeteners).

    - Heating and mixing of the iron mixture with a gelling agent.

    - Pouring of the gummy or lozenge mixture into molds and cooling.

2. Sprays:

    - Weighing and mixing of iron salts with excipients (e.g., propellants, solvents).

    - Filling of the iron mixture into spray containers.

    - Sealing of containers and testing of the final product.

·         What are the appropriate Dosage forms of Iron ?

 

Oral Dosage Forms:

1. Ferrous sulfate tablets: 65 mg of elemental iron per tablet, suitable for adults and children over 12 years.

2. Ferrous gluconate tablets: 35-40 mg of elemental iron per tablet, suitable for adults and children over 12 years.

3. Ferrous fumarate tablets: 65-100 mg of elemental iron per tablet, suitable for adults and children over 12 years.

4. Iron polysaccharide complexes: 50-100 mg of elemental iron per capsule or tablet, suitable for adults and children over 12 years.

 

Liquid Dosage Forms:

1. Ferrous sulfate drops: 15-20 mg of elemental iron per mL, suitable for infants and children under 12 years.

2. Ferrous gluconate syrup: 10-20 mg of elemental iron per mL, suitable for infants and children under 12 years.

 

Parenteral Dosage Forms:

1. Iron dextran injection: 50 mg of elemental iron per mL, suitable for adults and children over 12 years.

2. Iron sucrose injection: 20 mg of elemental iron per mL, suitable for adults and children over 12 years.

 

Topical Dosage Forms:

1. Iron oxide cream: 2-5% iron oxide, suitable for topical application in adults and children over 12 years.

 

Other Dosage Forms:

1. Iron-fortified foods: Cereals, bread, and other foods fortified with iron, suitable for adults and children over 12 years.

2. Iron supplements: Various forms of iron supplements, including capsules, tablets, and powders, suitable for adults and children over 12 years.

 

Considerations:

1. Age and weight: Dosage forms and strengths may vary depending on age and weight.

2. Dietary restrictions: Vegetarian or vegan individuals may require alternative dosage forms.

3. Medical conditions: Certain medical conditions, such as kidney disease or gastrointestinal disorders, may require specialized dosage forms.

4. Pregnancy and lactation: Pregnant or breastfeeding women may require higher doses of iron or specialized dosage forms.

 

 ·         When should Iron be taken?

Best Time to Take Iron:

1. On an empty stomach: Iron is best absorbed on an empty stomach, so taking it 1-2 hours before meals or 2-3 hours after meals is recommended.

2. With vitamin C: Taking iron with vitamin C (e.g., orange juice, citrus fruits) can enhance absorption.

3. Avoid taking with antacids or milk: Antacids and milk can inhibit iron absorption.

 

Timing Considerations:

1. Morning: Taking iron in the morning can help increase energy levels throughout the day.

2. Before bedtime: Avoid taking iron before bedtime, as it can cause stomach upset and interfere with sleep.

3. With meals: If taking iron on an empty stomach causes stomach upset, taking it with meals can help alleviate symptoms.

 

Special Considerations:

1. Pregnancy: Pregnant women should take iron supplements as directed by their healthcare provider, usually starting at 12-16 weeks of gestation.

2. Menstruation: Women with heavy menstrual bleeding may need to take iron supplements during their period to replenish lost iron.

3. Chronic diseases: Individuals with chronic diseases, such as kidney disease or gastrointestinal disorders, may need to take iron supplements at specific times or with certain foods to enhance absorption.

 

Important Reminders:

1. Consult a healthcare professional: Before taking iron supplements, consult with a healthcare professional to determine the best timing and dosage for individual needs.

2. Follow the recommended dosage: Take iron supplements as directed, and do not exceed the recommended dosage without consulting a healthcare professional.

3. Monitor iron levels: Regularly monitor iron levels to ensure they are within a healthy range.

 

 

·         What are the effects And Side effects of Iron?

Beneficial Effects:

1. Increased energy: Iron helps transport oxygen to cells, increasing energy levels.

2. Improved cognitive function: Iron is essential for brain function and development.

3. Healthy skin, hair, and nails: Iron helps maintain healthy skin, hair, and nails.

4. Supports immune system: Iron is necessary for the production of white blood cells.

5. Prevents anemia: Iron supplements can help prevent and treat iron deficiency anemia.

 

Common Side Effects:

1. Nausea and vomiting: High doses of iron can cause stomach upset.

2. Diarrhea: Iron supplements can cause diarrhea, especially when taken in high doses.

3. Constipation: Some people may experience constipation when taking iron supplements.

4. Abdominal pain: Iron supplements can cause stomach cramps and abdominal pain.

5. Dark stools: Iron supplements can cause stools to turn dark or black.

 

Less Common Side Effects:

1. Headaches: Some people may experience headaches when taking iron supplements.

2. Dizziness: High doses of iron can cause dizziness and lightheadedness.

3. Fatigue: Iron supplements can cause fatigue, especially when taken in high doses.

4. Joint pain: Some people may experience joint pain when taking iron supplements.

5. Skin rash: Rarely, iron supplements can cause a skin rash or itching.

 

Serious Side Effects:

1. Iron overload: Taking too much iron can lead to iron overload, which can cause liver damage, heart problems, and other serious health issues.

2. Gastrointestinal bleeding: High doses of iron can cause gastrointestinal bleeding.

3. Anaphylaxis: Rarely, iron supplements can cause anaphylaxis, a severe and life-threatening allergic reaction.

 

Interactions:

1. Antacids: Antacids can interfere with iron absorption.

2. Tetracyclines: Tetracyclines can interact with iron supplements.

3. Blood thinners: Iron supplements can interact with blood thinners.

4. Thyroid medications: Iron supplements can interact with thyroid medications.

 

·         How is Iron Tested Qualitatively?

Chemical Tests:

1. Ferroin Test: A few drops of ferroin solution (1,10-phenanthroline) are added to the sample. A red color indicates the presence of iron(II) ions.

2. Potassium Ferrocyanide Test: A few drops of potassium ferrocyanide solution are added to the sample. A blue precipitate indicates the presence of iron(III) ions.

3. Ammonium Thiocyanate Test: A few drops of ammonium thiocyanate solution are added to the sample. A red color indicates the presence of iron(III) ions.

 

Spectroscopic Tests:

1. Atomic Absorption Spectroscopy (AAS): AAS is used to detect and quantify iron in a sample.

2. Inductively Coupled Plasma Mass Spectrometry (ICP-MS): ICP-MS is used to detect and quantify iron in a sample.

 

Colorimetric Tests:

1. Orthophenanthroline Test: A few drops of orthophenanthroline solution are added to the sample. A red color indicates the presence of iron(II) ions.

2. Bathophenanthroline Test: A few drops of bathophenanthroline solution are added to the sample. A red color indicates the presence of iron(II) ions.

 

Spot Tests:

1. Iron(III) Chloride Test: A few drops of iron(III) chloride solution are added to the sample. A yellow or brown color indicates the presence of iron(III) ions.

2. Iron(II) Sulfate Test: A few drops of iron(II) sulfate solution are added to the sample. A green or blue color indicates the presence of iron(II) ions.

Other Tests:

1. Magnetic Test: Iron is attracted to a magnet, indicating its presence.

2. X-Ray Fluorescence (XRF): XRF is used to detect and quantify iron in a sample.

·         Which tests are performed on Iron ?

Physical Tests:

1. Appearance: Visual inspection to check for color, texture, and physical form.

2. Odor: Olfactory inspection to check for any unusual or unpleasant odors.

3. Melting Point: Measurement of the temperature at which iron melts.

4. Density: Measurement of the mass per unit volume of iron.

 

Chemical Tests:

1. Assay: Determination of the percentage of iron present in the sample.

2. Impurities: Detection and quantification of impurities such as carbon, silicon, manganese, and phosphorus.

3. pH: Measurement of the acidity or alkalinity of iron solutions.

4. Solubility: Determination of the solubility of iron in various solvents.

 

Spectroscopic Tests:

1. Atomic Absorption Spectroscopy (AAS): Quantification of iron and impurities using AAS.

2. Inductively Coupled Plasma Mass Spectrometry (ICP-MS): Quantification of iron and impurities using ICP-MS.

3. X-Ray Fluorescence (XRF): Non-destructive analysis of iron and impurities using XRF.

 

Microbiological Tests:

1. Total Aerobic Microbial Count: Determination of the number of aerobic microorganisms present in the sample.

2. Total Yeast and Mold Count: Determination of the number of yeast and mold present in the sample.

3. Escherichia coli (E. coli): Detection and quantification of E. coli in the sample.

 

Toxicity Tests:

1. Acute Toxicity: Determination of the lethal dose of iron that causes death in a short period.

2. Chronic Toxicity: Determination of the effects of long-term exposure to iron.

3. Genotoxicity: Determination of the potential of iron to cause genetic damage.

 

Other Tests:

1. Heavy Metal Testing: Detection and quantification of heavy metals such as lead, mercury, and arsenic.

2. Particle Size Distribution: Determination of the size distribution of iron particles.

3. Moisture Content: Determination of the moisture content of iron.

·         What are the challenges in Manufacturing of Iron API?

Raw Material Challenges:

1. Quality of iron ore: The quality of iron ore can vary significantly, affecting the final product's purity and quality.

2. Impurities: Iron ore often contains impurities like carbon, silicon, manganese, and phosphorus, which must be removed during processing.

3. Supply chain disruptions: Disruptions in the supply chain can impact the availability and quality of raw materials.

 

Process Challenges:

1. Extraction and purification: Iron extraction and purification processes can be complex and require specialized equipment.

2. Control of particle size: Controlling particle size is crucial to ensure uniformity and stability of the final product.

3. Temperature and humidity control: Iron is sensitive to temperature and humidity, requiring careful control during processing and storage.

 

Equipment Challenges:

1. Corrosion: Iron can corrode equipment, requiring specialized materials and coatings.

2. Equipment maintenance: Regular maintenance is necessary to prevent equipment failure and ensure consistent product quality.

3. Scalability: Equipment must be scalable to accommodate varying batch sizes and production demands.

 

Regulatory Challenges:

1. Compliance with cGMP: Manufacturers must comply with current Good Manufacturing Practice (cGMP) regulations to ensure product quality and safety.

2. Regulatory inspections: Manufacturers must be prepared for regulatory inspections and audits to ensure compliance.

3. Documentation and record-keeping: Accurate documentation and record-keeping are essential to demonstrate compliance and ensure product quality.

 

Quality Control Challenges:

1. Testing and validation: Manufacturers must develop and validate testing methods to ensure product quality and purity.

2. Stability testing: Stability testing is necessary to ensure the product remains stable and effective throughout its shelf life.

3. Contamination control: Manufacturers must implement controls to prevent contamination and ensure product quality.

 

Cost and Yield Challenges:

1. Raw material costs: Fluctuations in raw material costs can impact profitability.

2. Yield optimization: Manufacturers must optimize yields to minimize waste and reduce costs.

3. Energy and resource efficiency: Manufacturers must balance production costs with energy and resource efficiency.

 

·         What are the challenges in manufacturing of Iron’s Dosage forms?

Tablet Manufacturing Challenges:

1. Iron oxidation: Iron can oxidize during tablet manufacturing, leading to discoloration and degradation.

2. Tablet hardness and friability: Iron tablets can be prone to hardness and friability issues, affecting their stability and dissolution.

3. Disintegration and dissolution: Iron tablets must disintegrate and dissolve properly to ensure bioavailability.

 

Capsule Manufacturing Challenges:

1. Iron powder flowability: Iron powder can be difficult to handle due to its poor flowability, affecting capsule filling and weight uniformity.

2. Capsule stability: Iron capsules can be prone to stability issues, such as moisture absorption and degradation.

3. Zinc content uniformity: Ensuring uniformity of iron content within capsules can be challenging.

 

Liquid Dosage Form Challenges:

1. Iron solubility and stability: Iron can be difficult to solubilize and stabilize in liquid dosage forms, affecting its bioavailability.

2. pH control: Maintaining the optimal pH range for iron stability and bioavailability can be challenging.

3. Preservation and antimicrobial control: Liquid iron dosage forms require effective preservation and antimicrobial control to prevent contamination.

 

Topical Dosage Form Challenges:

1. Iron oxide dispersion and stability: Iron oxide can be challenging to disperse and stabilize in topical dosage forms, affecting its bioavailability.

2. Skin penetration and permeation: Ensuring optimal skin penetration and permeation of iron from topical dosage forms can be challenging.

3. Moisturizing and skin feel: Topical iron dosage forms must provide a pleasant skin feel and moisturizing properties.

 

Parenteral Dosage Form Challenges:

1. Iron solubility and stability: Iron can be difficult to solubilize and stabilize in parenteral dosage forms, affecting its bioavailability.

2. Sterility and pyrogenicity: Ensuring the sterility and pyrogenicity of parenteral iron dosage forms is crucial.

3. Injectability and syringeability: Parenteral iron dosage forms must be injectable and syringeable, with minimal pain and discomfort.

 

Other Challenges:

1. Regulatory compliance: Manufacturers must comply with regulatory requirements, such as cGMP and USP guidelines.

2. Scalability and manufacturing efficiency: Manufacturers must balance production costs with scalability and manufacturing efficiency.

3. Quality control and testing: Manufacturers must implement robust quality control and testing procedures to ensure product quality and purity.

·         What is the Packing for Iron ?

Primary Packaging:

1. HDPE (High-Density Polyethylene) drums: HDPE drums are commonly used for packing iron powder or granules.

2. Polypropylene (PP) containers: PP containers are used for packing iron tablets, capsules, or other solid dosage forms.

3. Glass bottles: Glass bottles are used for packing iron liquids or solutions.

 

Secondary Packaging:

1. Corrugated cardboard boxes: Corrugated cardboard boxes are used for packing and shipping iron containers.

2. Paper bags or sacks: Paper bags or sacks are used for packing iron powder or granules.

3. Plastic bags or pouches: Plastic bags or pouches are used for packing iron tablets, capsules, or other solid dosage forms.

 

Tertiary Packaging:

1. Pallets: Pallets are used for stacking and shipping iron containers.

2. Shrink wrapping: Shrink wrapping is used to secure iron containers to pallets.

3. Stretch wrapping: Stretch wrapping is used to secure iron containers to pallets.

 

Specialized Packaging:

1. Moisture-resistant packaging: Moisture-resistant packaging is used for packing iron to prevent moisture absorption.

2. Light-resistant packaging: Light-resistant packaging is used for packing iron to prevent light-induced degradation.

3. Tamper-evident packaging: Tamper-evident packaging is used for packing iron to prevent tampering or contamination.

 

Labeling and Marking:

1. Product labels: Product labels are attached to iron containers to provide product information.

2. Batch numbers and expiration dates: Batch numbers and expiration dates are printed on iron containers to ensure traceability and quality control.

3. Warning labels: Warning labels are attached to iron containers to alert users of potential hazards or precautions.

 

·         What is shelf life Of Iron ? 

Iron  Metal:

1. Iron  metal ingots: 2-5 years when stored in a dry, cool place.

2. Iron  metal powder: 1-3 years when stored in a dry, cool place, away from moisture and air.

 

Iron  Compounds:

1. Iron  oxide: 2-5 years when stored in a dry, cool place, away from moisture and air.

2. Iron  sulfate: 2-5 years when stored in a dry, cool place, away from moisture and air.

3. Iron  gluconate: 2-5 years when stored in a dry, cool place, away from moisture and air.

 

Iron  Dosage Forms:

1. Iron  tablets: 2-5 years when stored in a dry, cool place, away from moisture and air.

2. Iron  capsules: 2-5 years when stored in a dry, cool place, away from moisture and air.

3. Iron  liquids: 1-3 years when stored in a dry, cool place, away from moisture and air.

 

Factors Affecting Shelf Life:

1. Temperature: High temperatures can accelerate degradation and reduce shelf life.

2. Humidity: High humidity can cause Iron  to oxidize and degrade.

3. Light: Exposure to light can cause Iron  to degrade and lose potency.

4. Contamination: Contamination with air, moisture, or other substances can reduce shelf life.

5. Packaging: Poor packaging can expose Iron  to environmental factors and reduce shelf life.

 

Storage Recommendations:

1. Store in a dry, cool place: Away from direct sunlight, moisture, and air.

2. Use airtight containers: To prevent contamination and exposure to air and moisture.

3. Keep away from strong-smelling substances: To prevent contamination and absorption of odors.

4. Check expiration dates: Regularly check expiration dates and rotate stock to ensure oldest products are used first.

·         What should the label claim for Iron Include?

Mandatory Label Claims:

1. Product Name: The name of the product, including the word "Iron" or the specific type of iron (e.g., Ferrous Sulfate, Ferrous Gluconate).

2. Quantity: The quantity of iron in the product, expressed in milligrams (mg) or grams (g) per serving.

3. Serving Size: The serving size of the product, expressed in units (e.g., tablets, capsules, teaspoons).

4. Daily Value (DV): The percentage of the Daily Value (DV) for iron per serving.

5. Warning Statement: A warning statement indicating that iron can be toxic in high doses and that accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.

 

Optional Label Claims:

1. Benefit Statements: Statements describing the benefits of iron, such as "Helps maintain healthy red blood cells" or "Supports immune system function".

2. Targeted Health Claims: Claims targeting specific health conditions, such as "Helps reduce the risk of iron deficiency anemia" or "Supports healthy pregnancy".

3. Structure/Function Claims: Claims describing the role of iron in maintaining healthy bodily functions, such as "Essential for healthy red blood cell production" or "Supports energy metabolism".

4. Nutrient Content Claims: Claims highlighting the nutrient content of the product, such as "High in iron" or "Rich in essential nutrients".

5. Other Ingredients: A list of other ingredients present in the product, such as excipients, fillers, or binders.

 

Regulatory Requirements:

1. Compliance with FDA regulations: Label claims must comply with FDA regulations, including 21 CFR Part 101 (Food Labeling) and 21 CFR Part 201 (Labeling Requirements for Prescription Drugs).

2. Compliance with USP guidelines: Label claims must comply with USP guidelines for dietary supplements and pharmaceuticals.

3. Truthful and non-misleading labeling: Label claims must be truthful and non-misleading, avoiding exaggerated or unsubstantiated claims.

·         Where can Iron are procured?

Iron  can be procured from various sources, depending on your location and requirements. Here are some options:

1.      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

 

2.      For Dosage Forms :

     - Online Marketplaces: You can find Iron  e 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 Iron  e products.

       Remember to ensure the quality and authenticity of the Iron  e product, regardless of the          

        procurement source.