Niacinamide 98-92-0 Manufacturer Exporter MEDIOCON INC

   Niacinamide  Manufactured by MEDIOCON INC    

 

·   Name : Niacinamide 

 

·   CAS No: 98-92-0

 

·   Molecular Weight: 122.12g/mol

 

·   Molecular formula: C₆H₆N₂O

·   Synonyms: Vitamin B3.

·    Chemical structure:

                                                                

                                        

                                                           

·   Appearance:  Nicotinamide is a white powder

 

·      Solubility: It is a powder of good water solubility

 

·        Use :

 

Physiological Functions

1. Energy production: Niacinamide  Manufactured by MEDIOCON INC     is necessary for the production of ATP (adenosine triphosphate), the primary energy currency of the body.

2. Nerve function: Niacinamide  Manufactured by MEDIOCON INC     is required for the synthesis of neurotransmitters, such as           acetylcholine,   which is essential for nerve function and transmission of nerve impulses.

   3. Heart function: Niacinamide  Manufactured by MEDIOCON INC     helps regulate heart function and is necessary for the production  

      of ATP in cardiac tissue.

 

Therapeutic Uses

1. Beriberi treatment: Niacinamide  Manufactured by MEDIOCON INC     is used to treat beriberi, a disease caused by Niacinamide  Manufactured by MEDIOCON INC     deficiency, characterized by nerve damage, muscle weakness, and heart failure.

2. Wernicke-Korsakoff syndrome treatment: Niacinamide  Manufactured by MEDIOCON INC     is used to treat Wernicke-Korsakoff syndrome, a brain disorder caused by Niacinamide  Manufactured by MEDIOCON INC     deficiency, characterized by confusion, memory loss, and difficulty with coordination and balance.

3. Alcohol withdrawal treatment: Niacinamide  Manufactured by MEDIOCON INC     is used to treat alcohol withdrawal symptoms, such as delirium tremens.

 

Dietary Supplement Uses

1. Vitamin B3 supplementation: Niacinamide  Manufactured by MEDIOCON INC     is used as a dietary supplement to prevent or treat Niacinamide  Manufactured by MEDIOCON INC     deficiency, particularly in individuals with inadequate diets or certain medical conditions.

2. Energy and endurance enhancement: Niacinamide  Manufactured by MEDIOCON INC     is sometimes used as a dietary supplement to enhance energy and endurance, although its effectiveness for this purpose is unclear.

 

Industrial Uses

1. Food fortification: Niacinamide  Manufactured by MEDIOCON INC     is used to fortify foods, such as cereals, bread, and pasta, to prevent Niacinamide  Manufactured by MEDIOCON INC     deficiency.

2. Animal feed supplementation: Niacinamide  Manufactured by MEDIOCON INC     is used as a supplement in animal feed to prevent Niacinamide  Manufactured by MEDIOCON INC     deficiency in livestock.

 

Other Uses

1. Cosmetic uses: Niacinamide  Manufactured by MEDIOCON INC     is sometimes used in cosmetic products, such as skin creams and hair care products, due to its potential antioxidant and anti-inflammatory properties.

2. Pharmaceutical applications: Niacinamide  Manufactured by MEDIOCON INC     is used as an excipients in some pharmaceutical products, such as tablets and capsules.

 

·      How is Niacinamide  Manufactured by MEDIOCON INC     Synthesized?

 

Chemical Synthesis

1. Wittig reaction: Niacinamide  Manufactured by MEDIOCON INC     can be synthesized using the Wittig reaction, which involves the reaction of a phosphonium ylide with a carbonyl compound.

2. Mannich reaction: Niacinamide  Manufactured by MEDIOCON INC     can be synthesized using the Mannich reaction, which involves the reaction of a carbonyl compound with an amine and a nucleophile.

3. Fischer indole synthesis: Niacinamide  Manufactured by MEDIOCON INC     can be synthesized using the Fischer indole synthesis, which involves the reaction of a phenylhydrazine with a carbonyl compound.

 

Fermentation

1. Microbial fermentation: Niacinamide  Manufactured by MEDIOCON INC     can be produced through microbial fermentation, using microorganisms such as bacteria or yeast.

2. Enzymatic conversion: Niacinamide  Manufactured by MEDIOCON INC     can be produced through enzymatic conversion of other compounds, such as pyridoxine (Vitamin B6).

 

Semi-Synthetic Methods

1. Partial synthesis: Niacinamide  Manufactured by MEDIOCON INC     can be synthesized through partial synthesis, which involves the modification of a naturally occurring compound.

2. Chemoenzymatic synthesis: Niacinamide  Manufactured by MEDIOCON INC     can be synthesized through chemo enzymatic synthesis, which involves the use of enzymes to catalyze specific reactions.

 

Industrial Production

1. Chemical synthesis on a large scale: Niacinamide  Manufactured by MEDIOCON INC     is typically produced on a large scale through chemical synthesis, using methods such as the Wittig reaction or the Mannich reaction.

2. Fermentation on a large scale: Niacinamide  Manufactured by MEDIOCON INC     can also be produced on a large scale through microbial fermentation, using large-scale bioreactors.

 

Purification Methods

1. Crystallization: Niacinamide  Manufactured by MEDIOCON INC     can be purified through crystallization, which involves the formation of crystals from a solution.

2. Chromatography: Niacinamide  Manufactured by MEDIOCON INC     can be purified through chromatography, which involves the separation of compounds based on their interactions with a stationary phase.

3. Distillation: Niacinamide  Manufactured by MEDIOCON INC     can be purified through distillation, which involves the separation of compounds based on their boiling points.

 

 

·   What are the different dosage forms of Niacinamide?

 

Oral Dosage Forms

1. Tablets: Niacinamide  Manufactured by MEDIOCON INC     tablets are available in various strengths, ranging from 5-500 mg.

2. Capsules: Niacinamide  Manufactured by MEDIOCON INC     capsules are available in various strengths, ranging from 5-500 mg.

3. Syrup: Niacinamide  Manufactured by MEDIOCON INC     syrup is a liquid oral solution, often used for pediatric or geriatric patients.

4. Oral solution: Niacinamide  Manufactured by MEDIOCON INC     oral solution is a liquid concentrate that can be mixed with water or other liquids.

 

Parenteral Dosage Forms

1. Injectable solution: Niacinamide  Manufactured by MEDIOCON INC     injectable solution is used for intramuscular (IM) or intravenous (IV) administration.

2. Ampoules: Niacinamide  Manufactured by MEDIOCON INC     ampoules are small, single-dose containers used for IM or IV administration.

 

Topical Dosage Forms

1. Cream: Niacinamide  Manufactured by MEDIOCON INC     cream is used for topical application, often for skin conditions or wounds.

2. Ointment: Niacinamide  Manufactured by MEDIOCON INC     ointment is used for topical application, often for skin conditions or wounds.

 

Other Dosage Forms

1. Transdermal patches: Niacinamide  Manufactured by MEDIOCON INC     transdermal patches are used for slow, controlled release of Niacinamide  Manufactured by MEDIOCON INC     through the skin.

2. Lozenges: Niacinamide  Manufactured by MEDIOCON INC     lozenges are used for oral administration, often for patients with difficulty swallowing tablets or capsules.

3. Gummies: Niacinamide  Manufactured by MEDIOCON INC     gummies are chewable, fruit-flavored supplements used for oral administration.

 

Combination Products

1. Multivitamin tablets: Niacinamide  Manufactured by MEDIOCON INC     is often combined with other vitamins and minerals in multivitamin tablets.

2. B-complex tablets: Niacinamide  Manufactured by MEDIOCON INC     is often combined with other B vitamins in B-complex tablets.

3. Therapeutic combinations: Niacinamide  Manufactured by MEDIOCON INC     may be combined with other medications or nutrients for specific therapeutic uses, such as treating beriberi or Wernicke-Korsakoff syndrome.

 

·         How Niacinamide’s Dosage Forms are prepared

Niacinamide  Manufactured by MEDIOCON INC     dosage forms are prepared through various methods, depending on the specific dosage form and concentration:

Topical Dosage Forms

1. Creams: Niacinamide  Manufactured by MEDIOCON INC     creams are prepared by mixing Niacinamide  Manufactured by MEDIOCON INC     with a cream base, such as petrolatum, mineral oil, and waxes.

2. Gels: Niacinamide  Manufactured by MEDIOCON INC     gels are prepared by mixing Niacinamide  Manufactured by MEDIOCON INC     with a gel base, such as carbomer, and solvents, such as ethanol or propylene glycol.

3. Solutions: Niacinamide  Manufactured by MEDIOCON INC     solutions are prepared by dissolving Niacinamide  Manufactured by MEDIOCON INC     in a solvent, such as ethanol or propylene glycol.

4. Serums: Niacinamide  Manufactured by MEDIOCON INC     serums are prepared by mixing Niacinamide  Manufactured by MEDIOCON INC     with a serum base, such as glycerin, and solvents, such as ethanol or propylene glycol.

Oral Dosage Forms

1. Tablets: Niacinamide  Manufactured by MEDIOCON INC     tablets are prepared by compressing Niacinamide  Manufactured by MEDIOCON INC     powder with excipients, such as lactose, starch, and magnesium stearate.

2. Capsules: Niacinamide  Manufactured by MEDIOCON INC     capsules are prepared by filling gelatin or vegetarian capsules with Niacinamide  Manufactured by MEDIOCON INC     powder.

3. Soft gels: Niacinamide  Manufactured by MEDIOCON INC     soft gels are prepared by filling gelatin or vegetarian soft gels with Niacinamide  Manufactured by MEDIOCON INC     oil.

Injectable Dosage Forms

1. Vials: Niacinamide  Manufactured by MEDIOCON INC     vials are prepared by filling sterile vials with Niacinamide  Manufactured by MEDIOCON INC     solution.

2. Ampoules: Niacinamide  Manufactured by MEDIOCON INC     ampoules are prepared by filling sterile ampoules with Niacinamide  Manufactured by MEDIOCON INC     solution.

Manufacturing Process

1. Weighing and mixing: Niacinamide  Manufactured by MEDIOCON INC     and excipients are weighed and mixed according to the formula.

2. Granulation: The mixture is granulated to improve flow ability and compressibility.

3. Compression: The granules are compressed into tablets or filled into capsules.

4. Filling and sealing: Vials or ampoules are filled with Niacinamide  Manufactured by MEDIOCON INC     solution and sealed.

5. Sterilization: Injectable dosage forms are sterilized by autoclaving or filtration.

6. Packaging: Dosage forms are packaged in suitable containers, such as bottles, tubes, or boxes.

Quality Control

1. Raw material testing: Niacinamide  Manufactured by MEDIOCON INC     and excipients are tested for purity, potency, and quality.

2. In-process testing: Dosage forms are tested during manufacturing for quality and purity.

3. Final product testing: Finished dosage forms are tested for quality, purity, and potency.

4. Stability testing: Dosage forms are tested for stability over time to ensure shelf-life.

Note: The specific manufacturing process may vary depending on the manufacturer and the specific dosage form being produced.

·         What are the appropriate Dosage forms of Niacinamide?

Niacinamide  Manufactured by MEDIOCON INC     dosage forms vary depending on the intended use, skin type, and concentration. Here are some common dosage forms:

Topical Dosage Forms

1. Creams: 0.025% to 0.1% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for dry or sensitive skin.

2. Gels: 0.025% to 0.1% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for oily skin or acne-prone skin.

3. Solutions: 0.05% to 0.1% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for normal to oily skin.

4. Serums: 0.05% to 0.1% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for normal to dry skin.

Oral Dosage Forms

1. Tablets: 10 mg to 50 mg Niacinamide  Manufactured by MEDIOCON INC     per tablet, suitable for treating Vitamin B3 deficiency or acne.

2. Capsules: 10 mg to 50 mg Niacinamide  Manufactured by MEDIOCON INC     per capsule, suitable for treating Vitamin B3 deficiency or acne.

3. Soft gels: 10 mg to 50 mg Niacinamide  Manufactured by MEDIOCON INC     per soft gel, suitable for treating Vitamin B3 deficiency or acne.

Injectable Dosage Forms

1. Vials: 0.1 ml to 1 ml Niacinamide  Manufactured by MEDIOCON INC     solution per vial, suitable for treating acne, fine lines, or skin discoloration.

2. Ampoules: 0.1 ml to 1 ml Niacinamide  Manufactured by MEDIOCON INC     solution per ampoule, suitable for treating acne, fine lines, or skin discoloration.

Concentrations

1. Low concentration: 0.025% to 0.05% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for sensitive skin or mild skin disorders.

2. Medium concentration: 0.05% to 0.1% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for moderate skin disorders.

3. High concentration: 0.1% to 0.3% Niacinamide  Manufactured by MEDIOCON INC     concentration, suitable for severe skin disorders or under medical supervision.

Frequency of Application

1. Once daily: Suitable for most skin types and concerns.

2. Every other day: Suitable for sensitive skin or mild skin disorders.

3. As needed: Suitable for specific skin concerns, such as acne or hyper pigmentation.

Note: The specific dosage form, concentration, and frequency of application may vary depending on the individual's skin type, concerns, and medical history. Always consult with a healthcare professional or a qualified expert before using Niacinamide  Manufactured by MEDIOCON INC     products.

 

·         When should Niacinamide  Manufactured by MEDIOCON INC     be taken?

Niacinamide  Manufactured by MEDIOCON INC     can be taken at different times depending on the specific product, skin type, and concerns. Here are some general guidelines:

Topical Niacinamide  Manufactured by MEDIOCON INC    

1. At night: Apply topical Niacinamide  Manufactured by MEDIOCON INC     products at night, as they can make the skin more sensitive to the sun.

2. Before bedtime: Apply topical Niacinamide  Manufactured by MEDIOCON INC     products 30 minutes to 1 hour before bedtime to allow the product to absorb into the skin.

Oral Niacinamide  Manufactured by MEDIOCON INC    

1. With meals: Take oral Niacinamide  Manufactured by MEDIOCON INC     supplements with meals to enhance absorption and reduce gastrointestinal side effects.

2. At bedtime: Take oral Niacinamide  Manufactured by MEDIOCON INC     supplements at bedtime, as they can cause drowsiness.

Specific Timing Considerations

1. Avoid peak sun hours: Avoid applying topical Niacinamide  Manufactured by MEDIOCON INC     products during peak sun hours (10am-4pm) to minimize photosensitivity.

2. Wait after exfoliating: Wait 24-48 hours after exfoliating or using harsh skincare products before applying topical Niacinamide  Manufactured by MEDIOCON INC     products.

3. Avoid using with other exfoliants: Avoid using topical Niacinamide  Manufactured by MEDIOCON INC     products with other exfoliants, such as alpha-hydroxy acids (AHAs) or beta-hydroxy acids (BHAs), as this can increase the risk of irritation.

Frequency of Application

1. Start with lower frequency: Start with a lower frequency of application (every other day) and gradually increase as your skin becomes more tolerant.

2. Adjust frequency based on skin response: Adjust the frequency of application based on your skin's response to the product.

Note: Always consult with a healthcare professional or a qualified expert before using Niacinamide  Manufactured by MEDIOCON INC     products, especially if you have sensitive skin or are prone to irritation.

·         What are the effects And Side effects of Niacinamide?

Positive Effects:

Topical Niacinamide  Manufactured by MEDIOCON INC    

1. Anti-aging: Reduces fine lines, wrinkles, and skin discoloration.

2. Acne treatment: Unclogs pores, reduces inflammation, and prevents future breakouts.

3. Skin brightening: Fades age spots, hyper pigmentation, and uneven skin tone.

4. Skin texture improvement: Enhances skin elasticity, firmness, and texture.

Oral Niacinamide  Manufactured by MEDIOCON INC    

1. Vitamin B3 deficiency treatment: Treats Vitamin B3 deficiency, which can cause night blindness, impaired immune function, and skin problems.

2. Acne treatment: Treats moderate to severe acne.

3. Psoriasis treatment: Treats psoriasis by reducing scaling, inflammation, and skin cell proliferation.

Common Side Effects:

Topical Niacinamide  Manufactured by MEDIOCON INC    

1. Redness: Temporary redness, especially in sensitive skin.

2. Irritation: Itching, stinging, or burning sensations.

3. Dryness: Dryness, flakiness, or peeling of the skin.

4. Sun sensitivity: Increased sensitivity to the sun, which can lead to sunburn.

Oral Niacinamide  Manufactured by MEDIOCON INC    

1. Headaches: Mild to severe headaches.

2. Dizziness: Dizziness or lightheadedness.

3. Nausea: Nausea or vomiting.

4. Diarrhea: Diarrhea or abdominal cramps.

Less Common Side Effects:

Topical Riboflavin

1. Skin discoloration: Temporary skin discoloration, such as post-inflammatory hyper pigmentation (PIH).

2. Eye irritation: Eye irritation, such as conjunctivitis or dry eyes.

3. Skin infections: Increased risk of skin infections, such as bacterial or fungal infections.

Oral

1. Liver damage: Elevated liver enzymes or liver damage.

2. Bone fractures: Increased risk of bone fractures, especially in older adults.

3. Birth defects: Increased risk of birth defects, especially when taken during pregnancy.

Rare but Serious Side Effects:

Topical Thiamine

1. Allergic reactions: Severe allergic reactions, such as anaphylaxis.

2. Skin necrosis: Skin necrosis or skin death.

Oral Thiamine

1. Pseudotum or cerebri: Increased intracranial pressure, which can lead to headaches, nausea, and vomiting.

2. Seizures: Seizures or convulsions.

[Note: Always consult with a healthcare professional or a qualified expert before using Niacinamide  Manufactured by MEDIOCON INC     products, especially if you have sensitive skin or are prone to irritation.]

·         How is Niacinamide  Manufactured by MEDIOCON INC     Tested Qualitatively?

Niacinamide  Manufactured by MEDIOCON INC     can be tested qualitatively using various methods to detect its presence and identify its structure:

Chemical Tests

1. Fluorescence test: Niacinamide  Manufactured by MEDIOCON INC     exhibits a characteristic blue fluorescence under UV light (365 nm) when treated with sodium hydroxide (NaOH) or potassium hydroxide (KOH).

2. Thiochrome test: Niacinamide  Manufactured by MEDIOCON INC     reacts with potassium ferricyanide (K3[Fe(CN)6]) to form thiochrome, which exhibits a bright blue fluorescence under UV light.

3. Oxidation-reduction test: Niacinamide  Manufactured by MEDIOCON INC     can be oxidized to Niacinamide  Manufactured by MEDIOCON INC     disulfide using oxidizing agents like potassium permanganate (KMnO4) or ceric sulfate (Ce(SO4)2).

 

Microbiological Tests

1. Microbial growth inhibition test: Niacinamide  Manufactured by MEDIOCON INC     is essential for the growth of certain microorganisms, such as Saccharomyces cerevisiae (baker's yeast). The presence of Niacinamide  Manufactured by MEDIOCON INC     can be detected by measuring the growth inhibition of these microorganisms.

2. Niacinamide  Manufactured by MEDIOCON INC     -dependent enzyme assay: Niacinamide  Manufactured by MEDIOCON INC     is a cofactor for certain enzymes, such as pyruvate dehydrogenase. The presence of Niacinamide  Manufactured by MEDIOCON INC     can be detected by measuring the activity of these enzymes.

 

Physical Tests

1. Melting point determination: Niacinamide  Manufactured by MEDIOCON INC     has a characteristic melting point range of 248-250°C.

2. Solubility test: Niacinamide  Manufactured by MEDIOCON INC     is soluble in water and ethanol, but insoluble in non-polar solvents like chloroform or ether.

Chromatographic Tests

1. Thin-layer chromatography (TLC): Niacinamide  Manufactured by MEDIOCON INC     can be separated and identified using TLC on silica gel plates with a suitable mobile phase.

2. High-performance liquid chromatography (HPLC): Niacinamide  Manufactured by MEDIOCON INC     can be separated and identified using HPLC with a suitable column and mobile phase.

Spectroscopic Tests

1. UV-Vis spectroscopy: Niacinamide  Manufactured by MEDIOCON INC     exhibits a characteristic UV-Vis spectrum with absorption maxima at 235-240 nm and 270-275 nm.

2. Infrared (IR) spectroscopy: Niacinamide  Manufactured by MEDIOCON INC     exhibits a characteristic IR spectrum with absorption bands at specific wave numbers.

 

 

·         Which tests are performed on Niacinamide?

Physical Tests

1. Appearance: Visual inspection for color, clarity, and form.

2. Odor: Assessment of the characteristic odor of Niacinamide  Manufactured by MEDIOCON INC     .

3. Melting point: Determination of the melting point range (248-250°C).

4. Solubility: Testing for solubility in water, ethanol, and other solvents.

Chemical Tests

1. pH: Determination of the pH value of a Niacinamide  Manufactured by MEDIOCON INC     solution.

2. Assay: Quantitative determination of Niacinamide  Manufactured by MEDIOCON INC     content using techniques like HPLC or UV-Vis spectroscopy.

3. Impurities: Testing for impurities like Niacinamide  Manufactured by MEDIOCON INC     mono nitrate, Niacinamide  Manufactured by MEDIOCON INC     disulfide, or other related compounds.

4. Heavy metals: Testing for heavy metal contaminants like lead, mercury, or arsenic.

Microbiological Tests

1. Sterility: Testing for the absence of microorganisms.

2. Pyrogenicity: Testing for the presence of pyrogens (fever-inducing substances).

3. Endotoxin: Testing for the presence of endotoxins (lipopolysaccharides).

Spectroscopic Tests

1. UV-Vis spectroscopy: Verification of the characteristic UV-Vis spectrum.

2. Infrared (IR) spectroscopy: Verification of the characteristic IR spectrum.

3. Nuclear Magnetic Resonance (NMR) spectroscopy: Verification of the characteristic NMR spectrum.

Chromatographic Tests

1. Thin-layer chromatography (TLC): Separation and identification of Niacinamide  Manufactured by MEDIOCON INC     and its impurities.

2. High-performance liquid chromatography (HPLC): Quantitative determination of Niacinamide  Manufactured by MEDIOCON INC     content and impurities.

 

 

Stability Tests

1. Accelerated stability testing: Testing the stability of Niacinamide  Manufactured by MEDIOCON INC     under accelerated conditions (e.g., high temperature, humidity).

2. Long-term stability testing: Testing the stability of Niacinamide  Manufactured by MEDIOCON INC     over a longer period (e.g., 12-24 months).

 

·         What are the challenges in Manufacturing of Niacinamide  Manufactured by MEDIOCON INC     API?

The manufacturing of Niacinamide  Manufactured by MEDIOCON INC     API (Active Pharmaceutical Ingredient) poses several challenges:

Chemical Stability Challenges

1. Oxidation: Niacinamide  Manufactured by MEDIOCON INC     is prone to oxidation, which can lead to degradation and loss of potency.

2. Isomerization: Niacinamide  Manufactured by MEDIOCON INC     can undergo isomerization, which can affect its biological activity.

3. Photo degradation: Niacinamide  Manufactured by MEDIOCON INC     is sensitive to light, which can cause degradation and loss of potency.

Manufacturing Process Challenges

1. Synthesis complexity: The synthesis of Niacinamide  Manufactured by MEDIOCON INC     involves multiple steps, which can be challenging to optimize.

2. Purification difficulties: Niacinamide  Manufactured by MEDIOCON INC     requires careful purification to remove impurities and achieve the desired purity.

3. Scalability: Scaling up the manufacturing process can be challenging due to the sensitivity of Niacinamide  Manufactured by MEDIOCON INC     to temperature, light, and oxygen.

Quality Control Challenges

1. Assay and impurity testing: Accurate assay and impurity testing are crucial to ensure the quality of Niacinamide  Manufactured by MEDIOCON INC     API.

2. Stability testing: Stability testing is essential to ensure the shelf-life of Niacinamide  Manufactured by MEDIOCON INC     API.

3. Regulatory compliance: Compliance with regulatory requirements, such as ICH guidelines, is essential.

Handling and Storage Challenges

1. Light protection: Niacinamide  Manufactured by MEDIOCON INC     API requires protection from light to prevent photodegradation.

2. Temperature control: Niacinamide  Manufactured by MEDIOCON INC     API requires careful temperature control to prevent degradation.

3. Humidity control: Niacinamide  Manufactured by MEDIOCON INC     API requires careful humidity control to prevent degradation.

Cost and Yield Challenges

1. High production costs: The manufacturing of Niacinamide  Manufactured by MEDIOCON INC     API can be costly due to the complexity of the synthesis and purification processes.

2. Low yields: The yields of Niacinamide  Manufactured by MEDIOCON INC     API can be low due to the sensitivity of the molecule to degradation.

3. Raw material costs: The cost of raw materials, such as beta-carotene, can be high.

Environmental Challenges

1. Solvent usage: The manufacturing of Niacinamide  Manufactured by MEDIOCON INC      API requires the use of solvents, which can be hazardous to the environment.

2. Waste generation: The manufacturing of Niacinamide  Manufactured by MEDIOCON INC     can generate waste, which requires careful disposal.

3. Energy consumption: The manufacturing of Niacinamide  Manufactured by MEDIOCON INC     requires energy, which can contribute to greenhouse gas emissions.

[Note: The specific tests performed on Niacinamide  Manufactured by MEDIOCON INC     may vary depending on the manufacturer, regulatory requirements, and intended use.]

·         What are the challenges in manufacturing of Niacinamide  Manufactured by MEDIOCON INC     Dosage forms ?

Topical Dosage Forms Challenges

1. Stability: Niacinamide  Manufactured by MEDIOCON INC     is unstable in aqueous environments, making it challenging to formulate stable topical products.

2. Solubility: Niacinamide  Manufactured by MEDIOCON INC     has poor solubility in water, requiring the use of solvents or co-solvents.

3. Penetration: Niacinamide  Manufactured by MEDIOCON INC     has difficulty penetrating the skin, requiring the use of penetration enhancers.

4. Photo stability: Niacinamide  Manufactured by MEDIOCON INC     is sensitive to light, requiring the use of photo stabilizers or protective packaging.

Oral Dosage Forms Challenges

1. Bioavailability: Niacinamide  Manufactured by MEDIOCON INC     has poor bioavailability due to its lipophilic nature and susceptibility to degradation.

2. Stability: Niacinamide  Manufactured by MEDIOCON INC     is unstable in the presence of oxygen, moisture, and heat, requiring careful formulation and packaging.

3. Taste and odor: Niacinamide  Manufactured by MEDIOCON INC     has a strong, unpleasant taste and odor, requiring the use of flavorings and odor-masking agents.

4. Gastrointestinal side effects: Niacinamide  Manufactured by MEDIOCON INC     can cause gastrointestinal side effects, such as nausea and diarrhea, requiring careful formulation to minimize these effects.

Injectable Dosage Forms Challenges

1. Stability: Niacinamide  Manufactured by MEDIOCON INC     is unstable in aqueous environments, making it challenging to formulate stable Injectable products.

2. Solubility: Niacinamide  Manufactured by MEDIOCON INC     has poor solubility in water, requiring the use of solvents or co-solvents.

3. Sterility: Injectable products require strict sterility testing and control to prevent contamination.

4. Pyrogenicity: Injectable products require testing for Pyrogenicity to prevent fever-inducing contaminants.

General Challenges

1. Cost: Niacinamide  Manufactured by MEDIOCON INC     is a costly ingredient, making it challenging to formulate affordable products.

2. Regulatory compliance: Niacinamide  Manufactured by MEDIOCON INC     products must comply with regulatory requirements, such as FDA guidelines, which can be challenging.

3. Scalability: Scaling up the manufacturing process can be challenging due to the sensitivity of Niacinamide  Manufactured by MEDIOCON INC     to temperature, light, and oxygen.

4. Quality control: Ensuring the quality of Niacinamide  Manufactured by MEDIOCON INC     products can be challenging due to the complexity of the manufacturing process and the sensitivity of the ingredient.

·         What are the storage conditions of Riboflavin?

General Storage Conditions

1. Cool, dry place: Store Niacinamide  Manufactured by MEDIOCON INC     in a cool, dry place, away from direct sunlight and heat sources.

2. Temperature control: Store Niacinamide  Manufactured by MEDIOCON INC     at a temperature between 15°C and 30°C (59°F to 86°F).

3. Humidity control: Store Niacinamide  Manufactured by MEDIOCON INC     in a humidity-controlled environment, with a relative humidity of 60% or less.

Specific Storage Conditions

1. Light protection: Store Niacinamide  Manufactured by MEDIOCON INC     in a light-protective container, such as a amber-colored glass bottle or a container with a UV-blocking coating.

2. Moisture protection: Store Niacinamide  Manufactured by MEDIOCON INC     in a moisture-protective container, such as a desiccant-controlled container or a container with a moisture-absorbing packet.

3. Oxygen protection: Store Niacinamide  Manufactured by MEDIOCON INC     in an oxygen-free environment, such as a nitrogen-purged container or a container with an oxygen-absorbing packet.

Storage Conditions for Specific Dosage Forms

1. Tablets and capsules: Store Niacinamide  Manufactured by MEDIOCON INC     tablets and capsules in a cool, dry place, away from direct sunlight and heat sources.

2. Injectable solutions: Store Niacinamide  Manufactured by MEDIOCON INC     Injectable solutions in a refrigerator at a temperature between 2°C and 8°C (36°F to 46°F).

3. Topical creams and ointments: Store Niacinamide  Manufactured by MEDIOCON INC     topical creams and ointments in a cool, dry place, away from direct sunlight and heat sources.

Shelf-Life

1. Typical shelf-life: The typical shelf-life of Niacinamide  Manufactured by MEDIOCON INC     is 2-3 years from the date of manufacture.

2. Expiration date: Check the expiration date on the label and discard any expired products.

Handling Precautions

1. Handle with care: Handle Niacinamide  Manufactured by MEDIOCON INC     with care to avoid damage to the packaging or the product.

2. Avoid contamination: Avoid contaminating Niacinamide  Manufactured by MEDIOCON INC     with other substances or products.

3. Follow proper disposal procedures: Follow proper disposal procedures for expired or damaged Niacinamide  Manufactured by MEDIOCON INC     products.

 

·         What is the Packing for Niacinamide?

Primary Packaging

1. Amber-colored glass bottles: Protects Niacinamide  Manufactured by MEDIOCON INC     from light and UV radiation.

2. Dark-colored plastic bottles: Protects Niacinamide  Manufactured by MEDIOCON INC     from light and UV radiation.

3. Aluminum or tin tubes: Protects Niacinamide  Manufactured by MEDIOCON INC     from light, UV radiation, and moisture.

4. Glass or plastic ampoules: Protects Niacinamide  Manufactured by MEDIOCON INC     from light, UV radiation, and moisture.

Secondary Packaging

1. Cartons: Protects primary packaging from light, moisture, and physical damage.

2. Boxes: Protects primary packaging from light, moisture, and physical damage.

3. Pouches: Protects primary packaging from light, moisture, and physical damage.

Tertiary Packaging

1. Shipping containers: Protects secondary packaging from physical damage during transportation.

2. Pallets: Protects shipping containers from physical damage during transportation.

Specialized Packaging

1. Nitrogen-flushed packaging: Removes oxygen from the packaging to prevent degradation.

2. Desiccant-controlled packaging: Controls moisture levels to prevent degradation.

3. UV-blocking packaging: Blocks UV radiation to prevent degradation.

4. Temperature-controlled packaging: Maintains a specific temperature range to prevent degradation.

Labeling and Marking

1. Product label: Includes product name, concentration, and instructions for use.

2. Expiration date: Includes expiration date or shelf-life information.

3. Storage instructions: Includes storage instructions to maintain product stability.

4. Warning labels: Includes warning labels for potential side effects or interactions.

Note: The specific packaging requirements for Niacinamide  Manufactured by MEDIOCON INC     may vary depending on the manufacturer, product form, and regulatory requirements.

·         What is shelf life Of Niacinamide? 

Typical Shelf Life

1. Topical Niacinamide  Manufactured by MEDIOCON INC     products: 2-3 years from the date of manufacture, when stored in a cool, dry place, away from direct sunlight and heat sources.

2. Oral Niacinamide  Manufactured by MEDIOCON INC     supplements: 2-3 years from the date of manufacture, when stored in a cool, dry place, away from direct sunlight and heat sources.

3. Injectable Niacinamide  Manufactured by MEDIOCON INC     solutions: 1-2 years from the date of manufacture, when stored in a refrigerator at a temperature between 2°C and 8°C (36°F to 46°F).

Factors Affecting Shelf Life

1. Storage conditions: Temperature, humidity, and light exposure can affect the shelf life.

2. Packaging: The type of packaging, such as glass or plastic, can affect the shelf life  .

3. Concentration: Higher concentrations of Niacinamide  Manufactured by MEDIOCON INC     may have a shorter shelf life due to increased instability.

4. Formulation: The presence of other ingredients, such as antioxidants or stabilizers, can affect the shelf life .

Signs of Degradation

1. Color change: A change in color, such as darkening or yellowing, may indicate degradation.

2. Odor change: A change in odor, such as a strong or unpleasant smell, may indicate degradation.

3. Texture change: A change in texture, such as thickening or thinning, may indicate degradation.

4. Loss of potency: A decrease in potency or effectiveness may indicate degradation.

Expiration Date

1. Manufacturers' expiration date: Check the expiration date on the label, which is typically set by the manufacturer.

2. Regulatory requirements: Check regulatory requirements, such as FDA guidelines, for expiration date labeling.

Note: Always follow the specific storage and handling instructions provided by the manufacturer, and check the expiration date on the label to ensure the product is used within its shelf life.

 

·         What should the label claim for Niacinamide  Manufactured by MEDIOCON INC     Include?

The label claim for Niacinamide  Manufactured by MEDIOCON INC     should include the following information:

Mandatory Label Claims

1. Product name: The name of the product, including the strength and form of Niacinamide  Manufactured by MEDIOCON INC     (e.g., "Niacinamide  Manufactured by MEDIOCON INC     0.25% Cream").

2. Active ingredient: The active ingredient, retinol, should be listed, along with its concentration (e.g., "Niacinamide  Manufactured by MEDIOCON INC     0.25%").

3. Indications: The intended use of the product, such as "For the treatment of acne" or "For anti-aging".

4. Directions for use: Clear instructions on how to use the product, including frequency and duration of use.

5. Warnings: Any warnings or precautions, such as "Avoid use during pregnancy or breastfeeding" or "May cause skin irritation".

6. Side effects: A list of potential side effects, such as "Redness, itching, or dryness".

7. Storage instructions: Instructions on how to store the product, such as "Store in a cool, dry place".

Optional Label Claims

1. Benefits: Claims about the benefits of retinol, such as "Reduces fine lines and wrinkles" or "Improves skin texture".

2. Clinical studies: References to clinical studies that support the efficacy of the product.

3. Comparisons: Comparisons to other products or treatments, such as "More effective than vitamin C".

Regulatory Requirements

1. FDA compliance: Compliance with FDA regulations, such as labeling requirements and good manufacturing practices (GMPs).

2. EU compliance: Compliance with EU regulations, such as labeling requirements and GMPs.

3. Other regulatory compliance: Compliance with other regulatory requirements, such as those in Canada, Australia, or Japan.

Label Claim Examples

1. " Niacinamide  Manufactured by MEDIOCON INC     0.25% Cream: For the treatment of acne and anti-aging. Reduces fine lines and wrinkles, improves skin texture, and fades age spots."

2. " Niacinamide  Manufactured by MEDIOCON INC     1.0% Serum: Clinically proven to reduce wrinkles and fine lines. Improves skin elasticity and firmness."

3. " Niacinamide  Manufactured by MEDIOCON INC     0.5% Moisturizer: For sensitive skin. Soothes and hydrates the skin while reducing the appearance of fine lines and wrinkles."

Note: Label claims should be supported by scientific evidence and complies with regulatory requirements.

 

·         Where can Niacinamide  Manufactured by MEDIOCON INC     are procured?

Niacinamide  Manufactured by MEDIOCON INC     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 Niacinamide  Manufactured by MEDIOCON INC     products on online market places 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 Niacinamide  Manufactured by MEDIOCON INC     products.

        Remember to ensure the quality and authenticity of the Niacinamide  Manufactured by MEDIOCON INC     product, regardless of                

        The procurement source.