Pyridoxine 58-56-0 Manufacturer Exporter Mediocon Inc

 

  Pyridoxine  manufacturer by Mediocon Inc

 

·   Name : Pyridoxine  manufacturer by Mediocon Inc

 

·   CAS No: 58-56-0

·   Molecular Weight: 169.18 g/mol

 

·   Molecular formula: C₈H₁₁NO₃

·   Synonyms: Vitamin B6.

 

·    Chemical structure:

                                                                

                                        

                                                           

·   Appearance: White powder

 

·   Solubility: Very soluble in water ,benzene , Ethyl ether.  

 

 

·        Use :

Pyridoxine, also known as Vitamin B6, is an essential nutrient that plays a crucial role in various bodily functions. Here are some of the main uses of pyridoxine:

Physiological Functions

1. Amino acid metabolism: Pyridoxine  manufacturer by Mediocon Inc is involved in the metabolism of amino acids, including the synthesis and breakdown of neurotransmitters.

2. Neurotransmitter synthesis: Pyridoxine  manufacturer by Mediocon Inc is necessary for the synthesis of neurotransmitters, such as serotonin, dopamine, and norepinephrine.

3. Red blood cell formation: Pyridoxine  manufacturer by Mediocon Inc is involved in the formation of red blood cells and helps maintain healthy red blood cell function.

4. Immune system function: Pyridoxine  manufacturer by Mediocon Inc is necessary for the proper functioning of the immune system.

Clinical Applications

1. Treatment of Pyridoxine  manufacturer by Mediocon Inc deficiency: Pyridoxine  manufacturer by Mediocon Inc is used to treat Pyridoxine  manufacturer by Mediocon Inc deficiency, which can cause a range of symptoms, including fatigue, weakness, and neurological problems.

2. Morning sickness: Pyridoxine  manufacturer by Mediocon Inc is used to treat morning sickness during pregnancy.

3. Prevention of homocysteine elevation: Pyridoxine, along with other B vitamins, is used to prevent the elevation of homocysteine levels in the blood, which is associated with an increased risk of cardiovascular disease.

4. Treatment of certain neurological disorders: Pyridoxine  manufacturer by Mediocon Inc is used to treat certain neurological disorders, such as pyridoxine-dependent epilepsy.

Dietary Supplement Uses

1. Energy metabolism: Pyridoxine  manufacturer by Mediocon Inc is used as a dietary supplement to support energy metabolism and reduce fatigue.

2. Mood support: Pyridoxine  manufacturer by Mediocon Inc is used as a dietary supplement to support mood and reduce stress.

3. Sleep support: Pyridoxine  manufacturer by Mediocon Inc is used as a dietary supplement to support sleep quality.

4. Skin and hair health: Pyridoxine  manufacturer by Mediocon Inc is used as a dietary supplement to support skin and hair health.

Pharmaceutical Applications

1. Tablets and capsules: Pyridoxine  manufacturer by Mediocon Inc is available in tablet and capsule form for the treatment of Pyridoxine  manufacturer by Mediocon Inc deficiency and other conditions.

2. Injectable solutions: Pyridoxine  manufacturer by Mediocon Inc is available as an injectable solution for the treatment of severe Pyridoxine  manufacturer by Mediocon Inc deficiency.

3. Topical creams and ointments: Pyridoxine  manufacturer by Mediocon Inc is used in topical creams and ointments to support skin health.

Other Uses

1. Food fortification: Pyridoxine  manufacturer by Mediocon Inc is used as a food fortificant to enrich foods, such as cereals and energy bars.

2. Animal feed: Pyridoxine  manufacturer by Mediocon Inc is used as an animal feed additive to support the health and well-being of animals.

 

 

 

·      How is Pyridoxine  manufacturer by Mediocon Inc synthesized?

 

Chemical Synthesis

1. Gryszkiewicz-Trochimowski method: This method involves the condensation of 4-pyridoxol with cyanoacetamide to form pyridoxine.

2. Heyl method: This method involves the reaction of 4-pyridoxol with β-chloropropionyl chloride to form pyridoxine.

 

Microbial Synthesis

1. Fermentation: Pyridoxine  manufacturer by Mediocon Inc can be produced through fermentation using microorganisms such as Escherichia coli, Saccharomyces cerevisiae, or Bacillus subtilis.

2. Biotechnological methods: Modern biotechnological methods, such as genetic engineering and enzyme engineering, can be used to improve the efficiency and yield of Pyridoxine  manufacturer by Mediocon Inc production.

 

Enzymatic Synthesis

1. Pyridoxal 5'-phosphate synthase: This enzyme catalyzes the conversion of pyridoxal 5'-phosphate to pyridoxine.

2. Pyridoxine  manufacturer by Mediocon Inc 5'-phosphate oxidase: This enzyme catalyzes the conversion of Pyridoxine  manufacturer by Mediocon Inc 5'-phosphate to pyridoxine.

 

Industrial Production

1. Chemical synthesis: Industrial production of Pyridoxine  manufacturer by Mediocon Inc typically involves chemical synthesis using the Gryszkiewicz-Trochimowski method or the Heyl method.

2. Purification: The synthesized Pyridoxine  manufacturer by Mediocon Inc is then purified using various methods, such as crystallization, distillation, or chromatography.

 

Quality Control

1. Assay: The purity and potency of Pyridoxine  manufacturer by Mediocon Inc are determined using various assay methods, such as HPLC or UV-Vis spectroscopy.

2. Impurity testing: The presence of impurities, such as pyridoxal or pyridoxamine, is tested using various methods, such as HPLC or GC-MS.

3. Stability testing: The stability of Pyridoxine  manufacturer by Mediocon Inc is tested under various conditions, such as temperature, humidity, and light exposure.

 

 

·   What are the different dosage forms of Pyridoxine?

Oral Dosage Forms

1. Tablets: Pyridoxine  manufacturer by Mediocon Inc tablets are available in various strengths, ranging from 10 mg to 500 mg.

2. Capsules: Pyridoxine  manufacturer by Mediocon Inc capsules are available in various strengths, ranging from 10 mg to 500 mg.

3. Softgels: Pyridoxine  manufacturer by Mediocon Inc softgels are available in various strengths, ranging from 10 mg to 500 mg.

4. Powders: Pyridoxine  manufacturer by Mediocon Inc powders are available for mixing with food or beverages.

5. Syrups: Pyridoxine  manufacturer by Mediocon Inc syrups are available for pediatric or geriatric use.

Parenteral Dosage Forms

1. Injectable solutions: Pyridoxine  manufacturer by Mediocon Inc injectable solutions are available for intramuscular or intravenous administration.

2. Ampoules: Pyridoxine  manufacturer by Mediocon Inc ampoules are available for intramuscular or intravenous administration.

Topical Dosage Forms

1. Creams: Pyridoxine  manufacturer by Mediocon Inc creams are available for topical application to support skin health.

2. Ointments: Pyridoxine  manufacturer by Mediocon Inc ointments are available for topical application to support skin health.

Combination Dosage Forms

1. Multivitamin tablets: Pyridoxine  manufacturer by Mediocon Inc is often combined with other vitamins and minerals in multivitamin tablets.

2. Vitamin B complex tablets: Pyridoxine  manufacturer by Mediocon Inc is often combined with other B vitamins in vitamin B complex tablets.

3. Prenatal vitamins: Pyridoxine  manufacturer by Mediocon Inc is often combined with other vitamins and minerals in prenatal vitamins.

Other Dosage Forms

1. Lozenges: Pyridoxine  manufacturer by Mediocon Inc lozenges are available for sucking to support oral health.

2. Gummies: Pyridoxine  manufacturer by Mediocon Inc gummies are available as a chewable dosage form.

3. Liquids: Pyridoxine  manufacturer by Mediocon Inc liquids are available for pediatric or geriatric use.

·         How Pyridoxine’s Dosage Forms are prepared?

Tablet Preparation

1. Weighing and mixing: Pyridoxine  manufacturer by Mediocon Inc powder is weighed and mixed with other ingredients, such as fillers, binders, and lubricants.

2. Granulation: The mixture is granulated to form a uniform powder.

3. Compression: The granulated powder is compressed into tablets using a tablet press.

4. Coating: The tablets may be coated with a thin layer of material, such as wax or shellac, to improve appearance and stability.

 

Capsule Preparation

1. Weighing and mixing: Pyridoxine  manufacturer by Mediocon Inc powder is weighed and mixed with other ingredients, such as fillers and lubricants.

2. Filling: The mixture is filled into empty capsules using a capsule filling machine.

3. Sealing: The capsules are sealed using a capsule sealing machine.

Liquid Preparation

1. Weighing and mixing: Pyridoxine  manufacturer by Mediocon Inc powder is weighed and mixed with other ingredients, such as water, glycerin, and flavorings.

2. Dissolution: The mixture is dissolved in water or another solvent to form a uniform solution.

3. Filtration: The solution is filtered to remove any impurities.

4. Packaging: The solution is packaged in bottles or other containers.

Injectable Preparation

1. Weighing and mixing: Pyridoxine  manufacturer by Mediocon Inc powder is weighed and mixed with other ingredients, such as water, saline, and preservatives.

2. Dissolution: The mixture is dissolved in water or another solvent to form a uniform solution.

3. Filtration: The solution is filtered to remove any impurities.

4. Sterilization: The solution is sterilized using a method such as autoclaving or filtration.

5. Packaging: The solution is packaged in vials or ampoules.

Topical Preparation

1. Weighing and mixing: Pyridoxine  manufacturer by Mediocon Inc powder is weighed and mixed with other ingredients, such as creams, ointments, and gels.

2. Blending: The mixture is blended to form a uniform paste or cream.

3. Packaging: The paste or cream is packaged in tubes or jars.

Quality Control

1. Assay: The final product is tested for Pyridoxine  manufacturer by Mediocon Inc content using a method such as HPLC or UV-Vis spectroscopy.

2. Impurity testing: The final product is tested for impurities using a method such as HPLC or GC-MS.

3. Stability testing: The final product is tested for stability using a method such as accelerated stability testing or long-term stability testing.

 

·         What are the appropriate Dosage forms of Pyridoxine?

Oral Dosage Forms

1. Tablets: 10-500 mg per tablet, suitable for adults and children.

2. Capsules: 10-500 mg per capsule, suitable for adults and children.

3. Softgels: 10-500 mg per softgel, suitable for adults and children.

4. Powders: 10-100 mg per scoop, suitable for pediatric or geriatric use.

5. Syrups: 5-20 mg per 5 mL, suitable for pediatric use.

Parenteral Dosage Forms

1. Injectable solutions: 10-100 mg per mL, suitable for intramuscular or intravenous administration.

2. Ampoules: 10-100 mg per ampoule, suitable for intramuscular or intravenous administration.

Topical Dosage Forms

1. Creams: 1-5% pyridoxine, suitable for topical application to support skin health.

2. Ointments: 1-5% pyridoxine, suitable for topical application to support skin health.

Combination Dosage Forms

1. Multivitamin tablets: Pyridoxine  manufacturer by Mediocon Inc is often combined with other vitamins and minerals in multivitamin tablets.

2. Vitamin B complex tablets: Pyridoxine  manufacturer by Mediocon Inc is often combined with other B vitamins in vitamin B complex tablets.

3. Prenatal vitamins: Pyridoxine  manufacturer by Mediocon Inc is often combined with other vitamins and minerals in prenatal vitamins.

Pediatric Dosage Forms

1. Drops: 5-20 mg per mL, suitable for pediatric use.

2. Syrups: 5-20 mg per 5 mL, suitable for pediatric use.

3. Chewable tablets: 10-50 mg per tablet, suitable for pediatric use.

 

Geriatric Dosage Forms

1. Tablets: 10-50 mg per tablet, suitable for geriatric use.

2. Capsules: 10-50 mg per capsule, suitable for geriatric use.

3. Liquid formulations: 5-20 mg per 5 mL, suitable for geriatric use.

·         When should Pyridoxine  manufacturer by Mediocon Inc be taken?

Best Time to Take Pyridoxine

1. Morning: Taking Pyridoxine  manufacturer by Mediocon Inc in the morning can help support energy production and mental performance throughout the day.

2. With meals: Taking Pyridoxine  manufacturer by Mediocon Inc with meals can help improve absorption and reduce gastrointestinal side effects.

3. Before bedtime: Taking Pyridoxine  manufacturer by Mediocon Inc before bedtime may help support sleep quality and duration.

Specific Timing for Different Needs

1. Pregnancy and lactation: Pyridoxine  manufacturer by Mediocon Inc can be taken at any time of day, but it's recommended to take it with breakfast to help support fetal development during pregnancy.

2. Athletes and individuals with high physical activity: Pyridoxine  manufacturer by Mediocon Inc can be taken 30-60 minutes before exercise to help support energy production and reduce muscle cramps.

3. Individuals with certain medical conditions: Pyridoxine  manufacturer by Mediocon Inc may need to be taken at specific times of day to manage conditions such as homocystinuria, sideroblastic anemia, or pyridoxine-dependent epilepsy.

Factors to Consider

1. Food interactions: Pyridoxine  manufacturer by Mediocon Inc can interact with certain foods, such as coffee, tea, and chocolate, which may reduce its absorption.

2. Medication interactions: Pyridoxine  manufacturer by Mediocon Inc can interact with certain medications, such as anticonvulsants, antidepressants, and blood thinners, which may affect its efficacy or increase the risk of side effects.

3. Individual tolerance: Some individuals may experience gastrointestinal side effects, such as nausea or diarrhea, when taking pyridoxine, which may require adjusting the timing or dose.

Consult a Healthcare Professional

1. Before taking pyridoxine: Consult a healthcare professional before taking pyridoxine, especially if you have a medical condition, take medications, or are pregnant or breastfeeding.

2. To determine the best timing: Consult a healthcare professional to determine the best timing for taking Pyridoxine  manufacturer by Mediocon Inc based on your individual needs and health status.

 

·         What are the effects And Side effects of Pyridoxine?

 

Effects of Pyridoxine:

1. Energy production: Pyridoxine  manufacturer by Mediocon Inc plays a crucial role in energy production, particularly in the metabolism of carbohydrates, fats, and proteins.

2. Neurotransmitter synthesis: Pyridoxine  manufacturer by Mediocon Inc is involved in the synthesis of neurotransmitters, such as serotonin, dopamine, and norepinephrine, which regulate mood, appetite, and sleep.

3. Immune system function: Pyridoxine  manufacturer by Mediocon Inc is necessary for the proper functioning of the immune system, including the production of antibodies and the activation of immune cells.

4. Heart health: Pyridoxine  manufacturer by Mediocon Inc may help lower homocysteine levels, which is associated with a reduced risk of cardiovascular disease.

Side Effects of Pyridoxine:

1. Gastrointestinal side effects: Nausea, vomiting, diarrhea, stomach cramps, and abdominal pain may occur, especially when taking high doses.

2. Neurological side effects: Headaches, dizziness, fatigue, and numbness or tingling in the hands and feet may occur, especially when taking high doses.

3. Allergic reactions: Rarely, Pyridoxine  manufacturer by Mediocon Inc can cause allergic reactions, such as hives, itching, and difficulty breathing.

4. Interactions with medications: Pyridoxine  manufacturer by Mediocon Inc may interact with certain medications, such as anticonvulsants, antidepressants, and blood thinners, which may affect its efficacy or increase the risk of side effects.

Rare but Serious Side Effects:

1. Sensory neuropathy: High doses of Pyridoxine  manufacturer by Mediocon Inc (exceeding 200 mg/day) may cause sensory neuropathy, a condition characterized by numbness, tingling, and pain in the hands and feet.

2. Seizures: Rarely, Pyridoxine  manufacturer by Mediocon Inc can cause seizures, especially in individuals with a history of seizure disorders.

Precautions and Contraindications:

1. Pregnancy and breastfeeding: Pyridoxine  manufacturer by Mediocon Inc is generally considered safe during pregnancy and breastfeeding, but high doses may cause adverse effects.

2. Kidney or liver disease: Individuals with kidney or liver disease should consult their healthcare provider before taking pyridoxine.

3. Surgery: Pyridoxine  manufacturer by Mediocon Inc may increase the risk of bleeding during surgery; individuals should inform their healthcare provider about Pyridoxine  manufacturer by Mediocon Inc supplementation before undergoing surgery.

 

·         How is Pyridoxine  manufacturer by Mediocon Inc tested qualitatively?

Chemical Tests

1. Fluorescence test: Pyridoxine  manufacturer by Mediocon Inc exhibits a characteristic fluorescence under UV light, which can be used to detect its presence.

2. Colorimetric test: Pyridoxine  manufacturer by Mediocon Inc reacts with certain reagents, such as ferric chloride, to produce a characteristic color change.

3. Precipitation test: Pyridoxine  manufacturer by Mediocon Inc can be precipitated out of solution using reagents like silver nitrate or lead acetate.

Chromatographic Tests

1. Thin-layer chromatography (TLC): TLC can be used to separate and identify Pyridoxine  manufacturer by Mediocon Inc from other compounds based on its retention factor (Rf) value.

2. High-performance liquid chromatography (HPLC): HPLC can be used to separate and identify Pyridoxine  manufacturer by Mediocon Inc from other compounds based on its retention time and UV-Vis spectrum.

3. Gas chromatography (GC): GC can be used to separate and identify Pyridoxine  manufacturer by Mediocon Inc from other compounds based on its retention time and mass spectrum.

Spectroscopic Tests

1. UV-Vis spectroscopy: Pyridoxine  manufacturer by Mediocon Inc exhibits a characteristic UV-Vis spectrum with absorption maxima at 290-300 nm.

2. Infrared (IR) spectroscopy: Pyridoxine  manufacturer by Mediocon Inc exhibits a characteristic IR spectrum with absorption peaks at specific wavenumbers.

3. Nuclear magnetic resonance (NMR) spectroscopy: Pyridoxine  manufacturer by Mediocon Inc exhibits a characteristic NMR spectrum with specific chemical shifts and coupling patterns.

Enzymatic Tests

1. Enzyme-linked immunosorbent assay (ELISA): ELISA can be used to detect Pyridoxine  manufacturer by Mediocon Inc using specific antibodies.

2. Enzymatic assays: Enzymatic assays can be used to detect Pyridoxine  manufacturer by Mediocon Inc based on its ability to act as a coenzyme for specific enzymes.

Other Tests

1. Melting point determination: Pyridoxine  manufacturer by Mediocon Inc has a characteristic melting point, which can be used to identify its presence.

2. Solubility testing: Pyridoxine  manufacturer by Mediocon Inc has specific solubility characteristics, which can be used to identify its presence.

·         Which tests are performed on Pyridoxine?

Physical Tests

1. Appearance: Visual inspection to check for color, clarity, and presence of impurities.

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

3. Melting point: Determination of the melting point to verify the identity and purity of pyridoxine.

4. Solubility: Testing of solubility in various solvents to verify the identity and purity of pyridoxine.

Chemical Tests

1. Assay: Quantitative determination of Pyridoxine  manufacturer by Mediocon Inc content using techniques like HPLC, GC, or UV-Vis spectroscopy.

2. Impurity testing: Detection and quantification of impurities like pyridoxal, pyridoxamine, and other related compounds.

3. Heavy metal testing: Detection and quantification of heavy metals like lead, mercury, and arsenic.

4. pH testing: Determination of the pH of Pyridoxine  manufacturer by Mediocon Inc solutions to verify their stability and compatibility.

Chromatographic Tests

1. Thin-layer chromatography (TLC): Separation and identification of Pyridoxine  manufacturer by Mediocon Inc and its impurities using TLC.

2. High-performance liquid chromatography (HPLC): Separation and quantification of Pyridoxine  manufacturer by Mediocon Inc and its impurities using HPLC.

3. Gas chromatography (GC): Separation and quantification of Pyridoxine  manufacturer by Mediocon Inc and its impurities using GC.

Spectroscopic Tests

1. UV-Vis spectroscopy: Determination of the UV-Vis spectrum of Pyridoxine  manufacturer by Mediocon Inc to verify its identity and purity.

2. Infrared (IR) spectroscopy: Determination of the IR spectrum of Pyridoxine  manufacturer by Mediocon Inc to verify its identity and purity.

3. Nuclear magnetic resonance (NMR) spectroscopy: Determination of the NMR spectrum of Pyridoxine  manufacturer by Mediocon Inc to verify its identity and purity.

Microbiological Tests

1. Sterility testing: Testing for the presence of microorganisms like bacteria, yeast, and mold.

2. Endotoxin testing: Testing for the presence of endotoxins, which are bacterial toxins.

Stability Testing

1. Accelerated stability testing: Testing the stability of Pyridoxine  manufacturer by Mediocon Inc under accelerated conditions like high temperature and humidity.

2. Long-term stability testing: Testing the stability of Pyridoxine  manufacturer by Mediocon Inc over a longer period under normal storage conditions.

·         What are the challenges in Manufacturing of Pyridoxine  manufacturer by Mediocon Inc API?

Raw Material Sourcing

1. Quality and purity: Ensuring the quality and purity of raw materials, such as 4-pyridoxol, can be challenging.

2. Supply chain reliability: Securing a reliable supply chain for raw materials can be difficult.

Synthesis and Purification

1. Complex synthesis: Pyridoxine  manufacturer by Mediocon Inc synthesis involves multiple steps, including condensation, hydrolysis, and crystallization, which can be challenging to control.

2. Purification difficulties: Purifying Pyridoxine  manufacturer by Mediocon Inc to meet pharmaceutical standards can be difficult due to its hygroscopic nature and tendency to form impurities.

3. Yield optimization: Optimizing the yield of Pyridoxine  manufacturer by Mediocon Inc while minimizing impurities can be challenging.

Quality Control and Assurance

1. Impurity control: Controlling impurities, such as pyridoxal and pyridoxamine, can be challenging.

2. Stability testing: Ensuring the stability of Pyridoxine  manufacturer by Mediocon Inc API over time can be difficult.

3. Regulatory compliance: Meeting regulatory requirements, such as those set by the FDA or EMA, can be challenging.

Manufacturing Process Challenges

1. Scalability: Scaling up the manufacturing process while maintaining quality and yield can be challenging.

2. Equipment design: Designing equipment that can handle the hygroscopic nature of Pyridoxine  manufacturer by Mediocon Inc can be difficult.

3. Operator safety: Ensuring operator safety when handling pyridoxine, which can be hazardous in large quantities, can be challenging.

Environmental and Waste Management Challenges

1. Waste disposal: Disposing of waste generated during the manufacturing process can be challenging.

2. Environmental impact: Minimizing the environmental impact of the manufacturing process can be difficult.

3. Regulatory compliance: Meeting regulatory requirements related to environmental protection and waste management can be challenging.

Cost and Economic Challenges

1. Raw material costs: Managing raw material costs, which can fluctuate, can be challenging.

2. Manufacturing costs: Controlling manufacturing costs, including labor and equipment expenses, can be difficult.

3. Market competition: Competing with other manufacturers in the market can be challenging.

 

·         What are the challenges in manufacturing of Pyridoxine  manufacturer by Mediocon Inc Dosage forms?

Tablet Manufacturing Challenges

1. Flowability and compressibility: Pyridoxine  manufacturer by Mediocon Inc hydrochloride is a hygroscopic powder, which can make it difficult to achieve good flowability and compressibility.

2. Tablet hardness and friability: Controlling tablet hardness and friability can be challenging due to the hygroscopic nature of pyridoxine.

3. Disintegration and dissolution: Ensuring that the tablets disintegrate and dissolve properly can be difficult.

Capsule Manufacturing Challenges

1. Fill weight and fill volume: Ensuring accurate fill weight and fill volume can be challenging due to the hygroscopic nature of pyridoxine.

2. Capsule shell compatibility: Ensuring compatibility between the capsule shell and the Pyridoxine  manufacturer by Mediocon Inc fill material can be difficult.

3. Moisture control: Controlling moisture levels during capsule manufacturing can be challenging.

Liquid Manufacturing Challenges

1. Solubility and stability: Ensuring the solubility and stability of Pyridoxine  manufacturer by Mediocon Inc in liquid formulations can be challenging.

2. pH control: Controlling the pH of liquid formulations can be difficult.

3. Preservative efficacy: Ensuring the efficacy of preservatives in liquid formulations can be challenging.

Semi-Solid Manufacturing Challenges

1. Consistency and texture: Ensuring the consistency and texture of semi-solid formulations can be challenging.

2. Stability and shelf-life: Ensuring the stability and shelf-life of semi-solid formulations can be difficult.

3. Moisture control: Controlling moisture levels during semi-solid manufacturing can be challenging.

Packaging Challenges

1. Moisture protection: Ensuring that the packaging protects the Pyridoxine  manufacturer by Mediocon Inc dosage form from moisture can be challenging.

2. Light protection: Ensuring that the packaging protects the Pyridoxine  manufacturer by Mediocon Inc dosage form from light can be difficult.

3. Child-resistance and senior-friendliness: Ensuring that the packaging is child-resistant and senior-friendly can be challenging.

Regulatory Challenges

1. Compliance with cGMP: Ensuring compliance with current Good Manufacturing Practice (cGMP) regulations can be challenging.

2. Labeling and packaging compliance: Ensuring compliance with labeling and packaging regulations can be difficult.

3. Stability testing and shelf-life determination: Ensuring that stability testing and shelf-life determination meet regulatory requirements can be challenging.

 

·         What are the storage conditions of Pyridoxine?

General Storage Conditions

1. Temperature: Store Pyridoxine  manufacturer by Mediocon Inc in a cool, dry place at a temperature between 15°C to 30°C (59°F to 86°F).

2. Humidity: Store Pyridoxine  manufacturer by Mediocon Inc in a dry place with a relative humidity of 60% or less.

3. Light: Protect Pyridoxine  manufacturer by Mediocon Inc from direct sunlight and intense artificial lighting.

Specific Storage Conditions

1. Pyridoxine  manufacturer by Mediocon Inc hydrochloride: Store Pyridoxine  manufacturer by Mediocon Inc hydrochloride in a tightly closed container, protected from light and moisture.

2. Pyridoxine  manufacturer by Mediocon Inc tablets or capsules: Store Pyridoxine  manufacturer by Mediocon Inc tablets or capsules in a tightly closed container, protected from light and moisture.

3. Pyridoxine  manufacturer by Mediocon Inc injection: Store Pyridoxine  manufacturer by Mediocon Inc injection in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F).

4. Pyridoxine  manufacturer by Mediocon Inc powder: Store Pyridoxine  manufacturer by Mediocon Inc powder in a tightly closed container, protected from light and moisture.

Handling Precautions

1. Handle with care: Handle Pyridoxine  manufacturer by Mediocon Inc with care to avoid damage to the packaging or the product itself.

2. Avoid contamination: Avoid contaminating Pyridoxine  manufacturer by Mediocon Inc with other substances, such as moisture, dust, or other chemicals.

3. Use clean equipment: Use clean equipment and utensils when handling Pyridoxine  manufacturer by Mediocon Inc to avoid contamination.

Shelf-Life

1. Pyridoxine  manufacturer by Mediocon Inc hydrochloride: The shelf-life of Pyridoxine  manufacturer by Mediocon Inc hydrochloride is typically 2-3 years from the date of manufacture.

2. Pyridoxine  manufacturer by Mediocon Inc tablets or capsules: The shelf-life of Pyridoxine  manufacturer by Mediocon Inc tablets or capsules is typically 1-2 years from the date of manufacture.

3. Pyridoxine  manufacturer by Mediocon Inc injection: The shelf-life of Pyridoxine  manufacturer by Mediocon Inc injection is typically 1-2 years from the date of manufacture.

Note: The storage conditions and shelf-life of Pyridoxine  manufacturer by Mediocon Inc may vary depending on the specific product and manufacturer. It's essential to follow the storage instructions provided by the manufacturer and to check the expiration date or shelf-life of the product.

·         What is the Packing for Pyridoxine?

Pyridoxine, also known as Vitamin B6, is typically packaged in various forms to protect it from light, moisture, and other environmental factors that can affect its stability and potency. Here are some common packaging options for pyridoxine:

 

Solid Dosage Forms

1. Bottles: Pyridoxine  manufacturer by Mediocon Inc tablets or capsules are often packaged in HDPE (high-density polyethylene) or PET (polyethylene terephthalate) bottles with tight-fitting caps.

2. Blister packs: Pyridoxine  manufacturer by Mediocon Inc tablets or capsules may be packaged in blister packs made of PVC (polyvinyl chloride) or aluminum.

3. Strip packs: Pyridoxine  manufacturer by Mediocon Inc tablets or capsules may be packaged in strip packs made of paper or foil.

Liquid Dosage Forms

1. Amber glass bottles: Pyridoxine  manufacturer by Mediocon Inc liquid formulations are often packaged in amber glass bottles with tight-fitting caps to protect them from light.

2. HDPE bottles: Pyridoxine  manufacturer by Mediocon Inc liquid formulations may be packaged in HDPE bottles with tight-fitting caps.

3. Pouches: Pyridoxine  manufacturer by Mediocon Inc liquid formulations may be packaged in pouches made of flexible materials like plastic or foil.

Parenteral Dosage Forms

1. Glass vials: Pyridoxine  manufacturer by Mediocon Inc injectable formulations are often packaged in glass vials with rubber stoppers and aluminum caps.

2. Prefilled syringes: Pyridoxine  manufacturer by Mediocon Inc injectable formulations may be packaged in prefilled syringes made of glass or plastic.

Labeling and Packaging Requirements

1. Labeling: Pyridoxine  manufacturer by Mediocon Inc packaging must be labeled with the product name, strength, dosage form, and expiration date.

2. Child-resistant packaging: Pyridoxine  manufacturer by Mediocon Inc packaging must be child-resistant to prevent accidental ingestion.

3. Tamper-evident packaging: Pyridoxine  manufacturer by Mediocon Inc packaging must be tamper-evident to prevent contamination or adulteration.

Regulatory Requirements

1. cGMP compliance: Pyridoxine  manufacturer by Mediocon Inc packaging must comply with current Good Manufacturing Practice (cGMP) regulations.

2. FDA compliance: Pyridoxine  manufacturer by Mediocon Inc packaging must comply with FDA regulations, including labeling and packaging requirements.

3. EU compliance: Pyridoxine  manufacturer by Mediocon Inc packaging must comply with EU regulations, including labeling and packaging requirements.

 

 

·         What is shelf life Of Pyridoxine? 

Solid Dosage Forms

1. Tablets: 24-36 months (2-3 years) from the date of manufacture.

2. Capsules: 24-36 months (2-3 years) from the date of manufacture.

3. Powder: 24-36 months (2-3 years) from the date of manufacture.

Liquid Dosage Forms

1. Solutions: 12-24 months (1-2 years) from the date of manufacture.

2. Suspensions: 12-24 months (1-2 years) from the date of manufacture.

Parenteral Dosage Forms

1. Injectable solutions: 12-24 months (1-2 years) from the date of manufacture.

2. Injectable suspensions: 12-24 months (1-2 years) from the date of manufacture.

Storage Conditions

1. Temperature: Store at 15-30°C (59-86°F).

2. Humidity: Store at 60% relative humidity or less.

3. Light: Protect from direct sunlight and intense artificial lighting.

Note

1. Expiration date: The expiration date or shelf life of Pyridoxine  manufacturer by Mediocon Inc must be labeled on the packaging.

2. Stability testing: Stability testing must be performed to confirm the shelf life of Pyridoxine.

3. Regulatory compliance: The shelf life of Pyridoxine  manufacturer by Mediocon Inc must comply with regulatory requirements.

·         What should the label claim for Pyridoxine  manufacturer by Mediocon Inc Include?

Mandatory Information

1. Product name: The name of the product, including the strength and dosage form (e.g., "Pyridoxine  manufacturer by Mediocon Inc Hydrochloride Tablets, 100 mg").

2. Active ingredient: The name and amount of Pyridoxine  manufacturer by Mediocon Inc per serving (e.g., "Pyridoxine  manufacturer by Mediocon Inc Hydrochloride, 100 mg").

3. Indications: The intended use of the product (e.g., "Dietary supplement to support heart health").

4. Directions for use: Instructions on how to take the product, including the recommended dosage and frequency (e.g., "Take one tablet daily with food").

5. Warning and precautions: Any warnings or precautions related to the product, such as interactions with other medications or potential side effects (e.g., "Consult with a healthcare professional before taking this product if you have any medical conditions").

6. Storage and handling: Instructions on how to store and handle the product (e.g., "Store in a cool, dry place").

7. Expiration date or shelf life: The expiration date or shelf life of the product (e.g., "Best by 02/2025").

8. Manufacturer's information: The name and address of the manufacturer, as well as any relevant contact information.

Optional Information

1. Nutrition facts: A nutrition facts panel that provides information on the product's nutritional content, including calories, fat, carbohydrates, and protein.

2. Other ingredients: A list of other ingredients in the product, such as excipients, fillers, or flavorings.

3. Clinical studies: Information on any clinical studies that support the product's claims or efficacy.

4. Third-party certifications: Logos or statements indicating that the product has been certified by a third-party organization, such as NSF International or the National Science Foundation.

5. Label claims: Additional label claims that are supported by scientific evidence, such as " Supports heart health" or "May help reduce homocysteine levels".

 

·         Where can Pyridoxine  manufacturer by Mediocon Inc are procured?

Pyridoxine  manufacturer 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 Pyridoxine  manufacturer 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 Pyridoxine  manufacturer by Mediocon Inc products.

        Remember to ensure the quality and authenticity of the Pyridoxine  manufacturer by Mediocon Inc product, regardless  

       of the procurement source.