L-Carnitine 541-15-1 MANUFACTURER Exporter MEDIOCON INC
L-Carnitine MANUFACTURED BY MEDIOCON
INC
·
Name: L-Carnitine
·
CAS No: 541-15-1
·
Molecular Weight: 161.2g/mol
·
Molecular formula: C7H15NO3
·
Synonyms: Levocarnitine
·
Appearance: white
crystals to crystalline powder
·
Solubility:
L-Carnitine Manufactured by MEDIOCON INC is highly soluble in water.
·
Use :
Medical Uses:
1. Cardiovascular
health:L-Carnitine Manufactured by MEDIOCON INC may help reduce blood pressure,
improve lipid profiles, and prevent cardiovascular disease.
2. Neuroprotection:L-Carnitine
Manufactured by MEDIOCON INC may have neuroprotective effects, potentially
helping with neurodegenerative diseases such as Alzheimer's and Parkinson's.
3. Muscle disorders:L-Carnitine
Manufactured by MEDIOCON INC may help alleviate symptoms of muscle disorders,
including muscular dystrophy and myasthenia gravis.
4. Kidney disease:L-Carnitine
Manufactured by MEDIOCON INC may help reduce the risk of kidney disease and improve
kidney function.
Performance Enhancement:
1. Exercise performance:L-Carnitine
Manufactured by MEDIOCON INC may improve exercise performance by increasing
energy production, reducing fatigue, and enhancing endurance.
2. Weight loss:L-Carnitine
Manufactured by MEDIOCON INC may aid in weight loss by increasing fat burning
and improving insulin sensitivity.
3. Muscle recovery:L-Carnitine
Manufactured by MEDIOCON INC may help reduce muscle soreness and improve
recovery after exercise.
Nutritional Supplements:
1. Energy and endurance:L-Carnitine
Manufactured by MEDIOCON INC is often used in energy drinks and supplements to
enhance endurance and reduce fatigue.
2. Weight management:L-Carnitine
Manufactured by MEDIOCON INC is used in weight loss supplements to aid in fat
burning and weight management.
3. Antioxidant support:L-Carnitine
Manufactured by MEDIOCON INC has antioxidant properties, making it a popular
ingredient in antioxidant supplements.
Pharmaceutical
Applications:
1. Injectable solutions:L-Carnitine
Manufactured by MEDIOCON INC is used in injectable solutions for the treatment
of carnitine deficiency and other medical conditions.
2. Tablets and capsules:L-Carnitine
Manufactured by MEDIOCON INC is used in oral tablets and capsules for various
medical conditions, including cardiovascular disease and muscle disorders.
Food and Beverage:
1. Energy drinks:L-Carnitine
Manufactured by MEDIOCON INC is often added to energy drinks to enhance
endurance and reduce fatigue.
2. Sports nutrition:L-Carnitine
Manufactured by MEDIOCON INC is used in sports nutrition products, such as
protein powders and bars, to aid in muscle recovery and performance.
3. Functional foods:L-Carnitine
Manufactured by MEDIOCON INC is added to functional foods, such as energy bars
and beverages, to provide potential health benefits.
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How isL-Carnitine Manufactured by MEDIOCON INC synthesized?
Microbial Fermentation:
1. Bacterial strains: Bacterial
strains such as E. coli, Bacillus subtilis, and Pseudomonas aeruginosa are used
forL-Carnitine Manufactured by MEDIOCON INC production.
2. Fermentation conditions:
Fermentation conditions such as temperature, pH, and nutrient supply are
optimized forL-Carnitine Manufactured by MEDIOCON INC production.
3. Downstream processing: The
fermented broth is processed to isolate and purify L-Carnitine.
Chemical Synthesis:
1. Starting materials: Starting
materials such as 3-hydroxypropionic acid, glycine, and trimethylamine are used
forL-Carnitine Manufactured by MEDIOCON INC synthesis.
2. Reaction conditions: Reaction
conditions such as temperature, pressure, and catalysts are optimized forL-Carnitine
Manufactured by MEDIOCON INC synthesis.
3. Purification: The synthesizedL-Carnitine
Manufactured by MEDIOCON INC is purified using techniques such as
crystallization, distillation, and chromatography.
Enzymatic Synthesis:
1. Enzyme selection: Enzymes such as
carnitine dehydrogenase and carnitine transferase are used forL-Carnitine
Manufactured by MEDIOCON INC synthesis.
2. Substrate selection: Substrates
such as 3-hydroxypropionic acid and glycine are used forL-Carnitine
Manufactured by MEDIOCON INC synthesis.
3. Reaction conditions: Reaction
conditions such as temperature, pH, and enzyme concentration are optimized forL-Carnitine
Manufactured by MEDIOCON INC synthesis.
Semi-Synthetic Methods:
1. Starting materials: Starting
materials such as L-lysine and 3-hydroxypropionic acid are used forL-Carnitine
Manufactured by MEDIOCON INC synthesis.
2. Chemical transformations: Chemical
transformations such as alkylation, hydrolysis, and oxidation are used to
synthesize L-Carnitine.
3. Purification: The synthesizedL-Carnitine
Manufactured by MEDIOCON INC is purified using techniques such as
crystallization, distillation, and chromatography.
Biotechnological Methods:
1. Genetic engineering: Genetic
engineering techniques are used to develop microorganisms that produce
L-Carnitine.
2. Fermentation: Fermentation
conditions are optimized forL-Carnitine Manufactured by MEDIOCON INC production.
3. Downstream processing: The
fermented broth is processed to isolate and purify L-Carnitine.
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What are the different dosages Forms of L-Carnitine?
Oral Dosage Forms:
1. Tablets:L-Carnitine Manufactured by
MEDIOCON INC tablets are available in various strengths, ranging from 250 mg to
1000 mg.
2. Capsules:L-Carnitine Manufactured
by MEDIOCON INC capsules are available in various strengths, ranging from 250
mg to 1000 mg.
3. Powder:L-Carnitine Manufactured by
MEDIOCON INC powder is available in bulk or sachet forms, allowing for flexible
dosing.
4. Liquid:L-Carnitine Manufactured by
MEDIOCON INC liquid is available in various flavors and strengths, ranging from
250 mg to 1000 mg per serving.
Parenteral Dosage Forms:
1. Injectable solutions:L-Carnitine
Manufactured by MEDIOCON INC injectable solutions are available for intravenous
or intramuscular administration.
2. Ampoules:L-Carnitine Manufactured
by MEDIOCON INC ampoules are available for intravenous or intramuscular
administration.
Topical Dosage Forms:
1. Creams:L-Carnitine Manufactured by
MEDIOCON INC creams are available for topical application, often used for skin
care and wound healing.
2. Gels:L-Carnitine Manufactured by
MEDIOCON INC gels are available for topical application, often used for skin
care and wound healing.
3. Ointments:L-Carnitine Manufactured
by MEDIOCON INC ointments are available for topical application, often used for
skin care and wound healing.
Other Dosage Forms:
1. Effervescent tablets:L-Carnitine
Manufactured by MEDIOCON INC effervescent tablets are available, which dissolve
in water to create a fizzy drink.
2. Chewable tablets:L-Carnitine
Manufactured by MEDIOCON INC chewable tablets are available, which can be
chewed and swallowed.
3. Lozenges:L-Carnitine Manufactured
by MEDIOCON INC lozenges are available, which dissolve in the mouth to provide
a quick dose.
Combination Products:
1. Multivitamin supplements:L-Carnitine
Manufactured by MEDIOCON INC is often combined with other vitamins and minerals
in multivitamin supplements.
2. Energy drinks:L-Carnitine
Manufactured by MEDIOCON INC is often combined with other ingredients, such as
caffeine and taurine, in energy drinks.
3. Sports nutrition products:L-Carnitine
Manufactured by MEDIOCON INC is often combined with other ingredients, such as
protein and creatine, in sports nutrition products.
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How L-Carnitine’s Dosage Forms are prepared?
Tablet Preparation:
1. Weighing and mixing:L-Carnitine
Manufactured by MEDIOCON INC powder is weighed and mixed with other ingredients,
such as fillers, binders, and lubricants.
2. Granulation: The
mixture is granulated to improve flow and compressibility.
3. Compression: The
granules are 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:L-Carnitine
Manufactured 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, which are then sealed.
3. Polishing: The
capsules may be polished to improve appearance.
Powder Preparation:
1. Weighing and mixing:L-Carnitine
Manufactured by MEDIOCON INC powder is weighed and mixed with other
ingredients, such as fillers and flavorings.
2. Sifting: The mixture
is sifted to improve flow and uniformity.
3. Packaging: The powder
is packaged in containers, such as bottles or sachets.
Liquid Preparation:
1. Weighing and mixing:L-Carnitine
Manufactured by MEDIOCON INC powder is weighed and mixed with other
ingredients, such as water, flavorings, and preservatives.
2. Dissolution: The
mixture is dissolved to create a uniform solution.
3. Filtration: The
solution may be filtered to improve clarity and stability.
4. Packaging: The liquid
is packaged in containers, such as bottles or ampoules.
Injectable Preparation:
1. Weighing and mixing:L-Carnitine
Manufactured by MEDIOCON INC powder is weighed and mixed with other
ingredients, such as water and preservatives.
2. Dissolution: The
mixture is dissolved to create a uniform solution.
3. Filtration: The
solution may be filtered to improve clarity and stability.
4. Sterilization: The
solution is sterilized using techniques, such as autoclaving or filtration.
5. Packaging: The
injectable solution is packaged in containers, such as vials or ampoules.
Topical Preparation:
1. Weighing and mixing:L-Carnitine
Manufactured by MEDIOCON INC powder is weighed and mixed with other
ingredients, such as creams, gels, or ointments.
2. Dissolution: The
mixture is dissolved to create a uniform solution.
3. Filtration: The
solution may be filtered to improve clarity and stability.
4. Packaging: The
topical solution is packaged in containers, such as tubes or jars.
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What are the appropriate Dosage forms of L-Carnitine?
Oral Dosage Forms:
1. Tablets: Suitable for adults and children, 250-1000 mg
per tablet.
2. Capsules: Suitable for adults and children, 250-1000 mg
per capsule.
3. Powder: Suitable for adults and children, 1-5 grams per
serving.
4. Liquid: Suitable for adults and children, 1-5 grams per
serving.
Parenteral Dosage Forms:
1. Injectable solutions: Suitable for hospital use, 1-3
grams per vial.
2. Ampoules: Suitable for hospital use, 1-3 grams per
ampoule.
Topical Dosage Forms:
1. Creams: Suitable for skin care and wound healing, 1-5%L-Carnitine
Manufactured by MEDIOCON INC concentration.
2. Gels: Suitable for skin care and wound healing, 1-5%L-Carnitine
Manufactured by MEDIOCON INC concentration.
3. Ointments: Suitable for skin care and wound healing,
1-5%L-Carnitine Manufactured by MEDIOCON INC concentration.
Other Dosage Forms:
1. Effervescent tablets: Suitable for adults and children,
250-1000 mg per tablet.
2. Chewable tablets: Suitable for adults and children,
250-1000 mg per tablet.
3. Lozenges: Suitable for adults and children, 250-1000 mg
per lozenge.
Considerations:
1. Age: Pediatric and geriatric patients may require
different dosage forms and strengths.
2. Route of administration: Oral, parenteral, and topical
routes require different dosage forms.
3. Disease state: Patients with certain disease states,
such as kidney or liver disease, may require different dosage forms and
strengths.
4. Patient compliance:
Dosage forms should be designed to improve patient compliance, such as
easy-to-swallow tablets or flavored liquids..
·
When shouldL-Carnitine Manufactured by MEDIOCON INC be
taken?
General Guidelines:
1. Morning: TakingL-Carnitine
Manufactured by MEDIOCON INC in the morning may help support energy production
and mental clarity throughout the day.
2. Before exercise: TakingL-Carnitine
Manufactured by MEDIOCON INC 30-60 minutes before exercise may help improve
exercise performance, reduce fatigue, and enhance recovery.
3. With meals: TakingL-Carnitine
Manufactured by MEDIOCON INC with meals may help improve absorption and reduce
gastrointestinal side effects.
4. At bedtime: TakingL-Carnitine
Manufactured by MEDIOCON INC at bedtime may help support muscle recovery and
relaxation during sleep.
Specific Timing Considerations:
1. For weight loss: TakingL-Carnitine
Manufactured by MEDIOCON INC 30-60 minutes before exercise may help enhance fat
burning and weight loss.
2. For exercise performance: TakingL-Carnitine
Manufactured by MEDIOCON INC 30-60 minutes before exercise may help improve
exercise performance, reduce fatigue, and enhance recovery.
3. For muscle recovery: TakingL-Carnitine
Manufactured by MEDIOCON INC within 30-60 minutes after exercise may help
support muscle recovery and reduce muscle soreness.
4. For cognitive function: TakingL-Carnitine
Manufactured by MEDIOCON INC in the morning may help support cognitive
function, memory, and mood throughout the day.
Individual Considerations:
1. Start with a low dose: Begin with a
low dose (500-1000 mg) and gradually increase as needed and tolerated.
2. Listen to your body: Pay attention
to how your body responds toL-Carnitine Manufactured by MEDIOCON INC and adjust
the timing and dosage accordingly.
3. Consult a healthcare professional:
If you have specific health concerns or questions, consult a healthcare
professional for personalized guidance.
·
What are the effects And Side effects of L-Carnitine?
General Guidelines:
1. Morning: TakingL-Carnitine Manufactured by MEDIOCON INC in the morning
may help support energy production and mental clarity throughout the day.
2. Before exercise: TakingL-Carnitine Manufactured by MEDIOCON INC 30-60
minutes before exercise may help improve exercise performance, reduce fatigue,
and enhance recovery.
3. With meals: TakingL-Carnitine Manufactured by MEDIOCON INC with meals
may help improve absorption and reduce gastrointestinal side effects.
4. At bedtime: TakingL-Carnitine Manufactured by MEDIOCON INC at bedtime
may help support muscle recovery and relaxation during sleep.
Specific Timing Considerations:
1. For weight loss: TakingL-Carnitine Manufactured by MEDIOCON INC 30-60
minutes before exercise may help enhance fat burning and weight loss.
2. For exercise performance: TakingL-Carnitine Manufactured by MEDIOCON
INC 30-60 minutes before exercise may help improve exercise performance, reduce
fatigue, and enhance recovery.
3. For muscle recovery: TakingL-Carnitine Manufactured by MEDIOCON INC within
30-60 minutes after exercise may help support muscle recovery and reduce muscle
soreness.
4. For cognitive function: TakingL-Carnitine Manufactured by MEDIOCON INC in
the morning may help support cognitive function, memory, and mood throughout
the day.
Individual Considerations:
1. Start with a low dose: Begin with a low dose (500-1000 mg) and
gradually increase as needed and tolerated.
2. Listen to your body: Pay attention to how your body responds toL-Carnitine
Manufactured by MEDIOCON INC and adjust the timing and dosage accordingly.
3. Consult a healthcare professional: If you have specific health concerns
or questions, consult a healthcare professional for personalized guidance.
·
How isL-Carnitine Manufactured by MEDIOCON INC Tested
Qualitatively?
Chemical Tests:
1. Ninhydrin test:L-Carnitine Manufactured
by MEDIOCON INC reacts with ninhydrin to form a purple-colored compound,
indicating the presence of an amino group.
2. Biuret test:L-Carnitine
Manufactured by MEDIOCON INC reacts with biuret reagent to form a
purple-colored compound, indicating the presence of a peptide bond.
3. Dragendorff's test:L-Carnitine
Manufactured by MEDIOCON INC reacts with Dragendorff's reagent to form a
orange-colored precipitate, indicating the presence of a tertiary amine group.
Chromatographic Tests:
1. Thin Layer Chromatography (TLC):L-Carnitine
Manufactured by MEDIOCON INC can be separated and identified using TLC, which
involves spotting a sample on a silica gel plate and developing it with a
solvent system.
2. High Performance Liquid
Chromatography (HPLC):L-Carnitine Manufactured by MEDIOCON INC can be separated
and identified using HPLC, which involves injecting a sample into a column and
detecting it with a UV or MS detector.
Spectroscopic Tests:
1. Infrared (IR) spectroscopy:L-Carnitine
Manufactured by MEDIOCON INC can be identified using IR spectroscopy, which
involves measuring the absorption of infrared radiation by the molecule.
2. Nuclear Magnetic Resonance (NMR)
spectroscopy:L-Carnitine Manufactured by MEDIOCON INC can be identified using
NMR spectroscopy, which involves measuring the absorption of radiofrequency
energy by the molecule.
Enzymatic Tests:
1. Carnitine palmitoyltransferase
(CPT) assay:L-Carnitine Manufactured by MEDIOCON INC can be measured using a
CPT assay, which involves measuring the transfer of a palmitoyl group from CoA
to L-Carnitine.
2. Carnitine dehydrogenase (CDH)
assay:L-Carnitine Manufactured by MEDIOCON INC can be measured using a CDH
assay, which involves measuring the oxidation ofL-Carnitine Manufactured by
MEDIOCON INC toL-Carnitine Manufactured by MEDIOCON INC aldehyde.
·
Which tests are performed on L-Carnitine?
Physical Tests:
1. Appearance: Visual inspection for
color, clarity, and form.
2. Odor: Olfactory evaluation for
characteristic smell.
3. Taste: Gustatory evaluation for
characteristic taste.
4. Melting point: Measurement of
melting point to confirm identity.
5. Specific rotation: Measurement of
optical rotation to confirm chirality.
Chemical Tests:
1. Assay: Quantitative measurement ofL-Carnitine
Manufactured by MEDIOCON INC content using HPLC or other chromatographic
methods.
2. Impurities: Detection and
quantification of impurities, such as D-Carnitine, using HPLC or other
chromatographic methods.
3. Heavy metals: Testing for presence
of heavy metals, such as lead, mercury, and arsenic.
4. Residual solvents: Testing for
presence of residual solvents, such as methanol, ethanol, and acetone.
Microbiological Tests:
1. Total bacterial count: Testing for
presence of bacteria, such as E. coli and Salmonella.
2. Total yeast and mold count: Testing
for presence of yeast and mold.
3. Sterility testing: Testing for
presence of microorganisms in sterile products.
Chromatographic Tests:
1. Thin Layer Chromatography (TLC):
Qualitative identification ofL-Carnitine Manufactured by MEDIOCON INC using
TLC.
2. High Performance Liquid
Chromatography (HPLC): Quantitative measurement ofL-Carnitine Manufactured by
MEDIOCON INC content and impurities using HPLC.
3. Gas Chromatography (GC):
Quantitative measurement ofL-Carnitine Manufactured by MEDIOCON INC content and
impurities using GC.
Spectroscopic Tests:
1. Infrared (IR) spectroscopy:
Qualitative identification ofL-Carnitine Manufactured by MEDIOCON INC using IR
spectroscopy.
2. Nuclear Magnetic Resonance (NMR) spectroscopy:
Qualitative identification ofL-Carnitine Manufactured by MEDIOCON INC using NMR
spectroscopy.
3. Mass spectrometry (MS): Qualitative
identification ofL-Carnitine Manufactured by MEDIOCON INC using MS.
Stability Tests:
1. Accelerated stability testing:
Testing the stability ofL-Carnitine Manufactured by MEDIOCON INC under
accelerated conditions, such as high temperature and humidity.
2. Long-term stability testing:
Testing the stability ofL-Carnitine Manufactured by MEDIOCON INC over a longer period,
such as 12-24 months.
·
What are the challenges in Manufacturing ofL-Carnitine
Manufactured by MEDIOCON INC API?
Raw Material Challenges:
1. Availability and quality of raw materials: The
availability and quality of raw materials, such as 3-hydroxypropionic acid and
glycine, can impact the production of L-Carnitine.
2. Purity and consistency of raw materials: The purity and
consistency of raw materials can affect the yield and quality of L-Carnitine.
Process Challenges:
1. Complexity of synthesis: The synthesis ofL-Carnitine
Manufactured by MEDIOCON INC involves multiple steps, including fermentation,
extraction, and purification, which can be challenging to control.
2. Optimization of reaction conditions: The reaction
conditions, such as temperature, pH, and pressure, need to be optimized to
achieve high yields and purity of L-Carnitine.
3. Scalability of process: The process needs to be scalable
to meet commercial demands, which can be challenging due to the complexity of
the synthesis.
Purification Challenges:
1. Separation ofL-Carnitine Manufactured by MEDIOCON INC from
impurities: The separation ofL-Carnitine Manufactured by MEDIOCON INC from
impurities, such as D-Carnitine, can be challenging due to their similar
properties.
2. Removal of residual solvents: The removal of residual
solvents, such as methanol and ethanol, can be challenging due to their
volatility and potential impact on product quality.
Regulatory Challenges:
1. Compliance with regulatory requirements: The manufacturing
process needs to comply with regulatory requirements, such as cGMP and ICH
guidelines, which can be challenging due to the complexity of the synthesis.
2. Documentation and record-keeping: The documentation and
record-keeping requirements for the manufacturing process can be challenging
due to the need for detailed records and traceability.
Quality Control Challenges:
1. Assay and impurity testing: The assay and impurity
testing ofL-Carnitine Manufactured by MEDIOCON INC can be challenging due to
the need for accurate and precise methods.
2. Stability testing: The stability testing ofL-Carnitine
Manufactured by MEDIOCON INC can be challenging due to the need for accelerated
and long-term stability studies.
Cost and Yield Challenges:
1. High production costs: The production costs ofL-Carnitine
Manufactured by MEDIOCON INC can be high due to the complexity of the synthesis
and the need for high-quality raw materials.
2. Low yields: The
yields ofL-Carnitine Manufactured by MEDIOCON INC can be low due to the
complexity of the synthesis and the need for optimization of reaction
conditions.
·
What are the challenges in manufacturing ofL-Carnitine
Manufactured by MEDIOCON INC Dosage forms?
Tablet Manufacturing Challenges:
1. Flow and compressibility:L-Carnitine
Manufactured by MEDIOCON INC powder can be difficult to flow and compress,
making tablet manufacturing challenging.
2. Tablet hardness and friability:
Achieving optimal tablet hardness and friability can be difficult due to the
hygroscopic nature of L-Carnitine.
3. Disintegration and dissolution:
Ensuring proper disintegration and dissolution ofL-Carnitine Manufactured by
MEDIOCON INC tablets can be challenging due to the hydrophilic nature of the
active ingredient.
Capsule Manufacturing Challenges:
1. Fill weight and uniformity:
Achieving accurate fill weights and uniformity can be difficult due to the
hygroscopic nature of L-Carnitine.
2. Capsule shell integrity: Ensuring
the integrity of the capsule shell can be challenging due to the moisture-sensitive
nature of L-Carnitine.
3. Content uniformity: Ensuring
content uniformity ofL-Carnitine Manufactured by MEDIOCON INC capsules can be
challenging due to the potential for segregation or uneven distribution of the
active ingredient.
Liquid Manufacturing Challenges:
1. Solubility and stability: Ensuring
the solubility and stability ofL-Carnitine Manufactured by MEDIOCON INC in
liquid formulations can be challenging due to its hydrophilic nature.
2. Preservation and antimicrobial
efficacy: Ensuring the preservation and antimicrobial efficacy ofL-Carnitine
Manufactured by MEDIOCON INC liquids can be challenging due to the potential
for microbial growth.
3. Flavor and odor masking: Masking
the flavor and odor ofL-Carnitine Manufactured by MEDIOCON INC can be
challenging due to its characteristic taste and smell.
Semi-Solid Manufacturing Challenges:
1. Texture and consistency: Achieving
optimal texture and consistency ofL-Carnitine Manufactured by MEDIOCON INC semi-solids
can be challenging due to the hygroscopic nature of the active ingredient.
2. Stability and preservation:
Ensuring the stability and preservation ofL-Carnitine Manufactured by MEDIOCON
INC semi-solids can be challenging due to the potential for microbial growth.
3. Packaging and storage: Ensuring
proper packaging and storage ofL-Carnitine Manufactured by MEDIOCON INC semi-solids
can be challenging due to the moisture-sensitive nature of the active
ingredient.
Quality Control Challenges:
1. Assay and impurity testing:
Ensuring accurate assay and impurity testing ofL-Carnitine Manufactured by
MEDIOCON INC dosage forms can be challenging due to the need for precise and
accurate methods.
2. Content uniformity testing:
Ensuring content uniformity ofL-Carnitine Manufactured by MEDIOCON INC dosage
forms can be challenging due to the potential for segregation or uneven
distribution of the active ingredient.
3. Stability testing: Ensuring the
stability ofL-Carnitine Manufactured by MEDIOCON INC dosage forms can be
challenging due to the need for accelerated and long-term stability studies.
·
What is the Packing for L-Carnitine?
Solid Dosage Forms (Tablets/Capsules):
1. Bottles: HDPE (High-Density
Polyethylene) or PET (Polyethylene Terephthalate) bottles with screw caps or
child-resistant closures.
2. Blister packs: PVC (Polyvinyl
Chloride) or PVDC (Polyvinylidene Chloride) blister packs with aluminum or
paper backing.
3. Strip packs: Paper or foil strip
packs with individual tablets or capsules.
Powder Dosage Forms:
1. Bottles: HDPE or PET bottles with
screw caps or child-resistant closures.
2. Canisters: Plastic or metal
canisters with screw caps or snap-fit lids.
3. Pouches: Stand-up pouches or flat
pouches made of paper, foil, or plastic.
Liquid Dosage Forms:
1. Bottles: HDPE or PET bottles with
screw caps or child-resistant closures.
2. Vials: Glass or plastic vials with
rubber stoppers and aluminum or plastic caps.
3. Ampoules: Glass ampoules with
rubber stoppers and aluminum or plastic caps.
Semi-Solid Dosage Forms:
1. Tubes: Plastic or metal tubes with
screw caps or snap-fit lids.
2. Jars: Plastic or glass jars with
screw caps or snap-fit lids.
3. Pouches: Stand-up pouches or flat
pouches made of paper, foil, or plastic.
Packaging Materials:
1. Paper: Used for labels, inserts, and
packaging materials.
2. Plastic: Used for bottles,
canisters, pouches, and other packaging components.
3. Foil: Used for blister packs, strip
packs, and pouches.
4. Glass: Used for vials and ampoules.
5. Rubber: Used for stoppers and
seals.
6. Aluminum: Used for caps, closures,
and blister pack backing.
Packaging Requirements:
1. Child-resistance: Packaging must be
child-resistant to prevent accidental ingestion.
2. Tamper-evidence: Packaging must be
tamper-evident to prevent unauthorized access.
3. Light protection: Packaging must
protect the contents from light to prevent degradation.
4. Moisture protection: Packaging must
protect the contents from moisture to prevent degradation.
5. Labeling and instructions:
Packaging must include clear labeling and instructions for use.
·
What is shelf life Of L-Carnitine?
Solid Dosage Forms (Tablets/Capsules):
1. Unopened: 2-3 years from the date of manufacture when
stored in a cool, dry place.
2. Opened: 6-12 months from the date of opening when stored
in a cool, dry place.
Powder Dosage Forms:
1. Unopened: 2-3 years from the date of manufacture when
stored in a cool, dry place.
2. Opened: 3-6 months from the date of opening when stored
in a cool, dry place.
Liquid Dosage Forms:
1. Unopened: 1-2 years from the date of manufacture when
stored in a cool, dry place.
2. Opened: 1-3 months from the date of opening when stored
in a cool, dry place.
Semi-Solid Dosage Forms:
1. Unopened: 1-2 years from the date of manufacture when
stored in a cool, dry place.
2. Opened: 1-3 months from the date of opening when stored
in a cool, dry place.
Factors Affecting Shelf Life:
1. Temperature: High temperatures can affect the stability
and shelf life of L-Carnitine.
2. Humidity: High humidity can affect the stability and
shelf life of L-Carnitine.
3. Light: Exposure to light can affect the stability and
shelf life of L-Carnitine.
4. Packaging: The type and quality of packaging can affect
the shelf life of L-Carnitine.
5. Storage conditions: Storage conditions, such as
temperature, humidity, and light, can affect the shelf life of L-Carnitine.
Expiration Date:
The expiration date ofL-Carnitine
Manufactured by MEDIOCON INC is typically indicated on the packaging and is
determined by the manufacturer based on stability studies and other factors.
·
What should the label claim include for L- Carnitine?
Mandatory Information:
1. Product name: The name of the product, including the
words "L-Carnitine" or "L-Carnitine Tartrate".
2. Net quantity: The net quantity ofL-Carnitine
Manufactured by MEDIOCON INC in the container, expressed in grams or
milligrams.
3. Serving size: The serving size of L-Carnitine, expressed
in grams or milligrams.
4. Servings per container: The number of servings per
container.
5. Ingredients: A list of ingredients, including
L-Carnitine, and any other inactive ingredients.
6. Directions for use: Instructions for how to take the
product, including the recommended dosage and frequency.
7. Caution statement: A caution statement warning of potential
side effects, interactions, or contraindications.
8. Storage instructions: Instructions for how to store the
product, including temperature, humidity, and light exposure.
Optional Information:
1. Benefits: A statement describing the potential benefits
of L-Carnitine, such as "Supports energy production" or "Helps
with weight management".
2. Clinical studies: A reference to clinical studies that
support the efficacy of L-Carnitine.
3. Patent information: A statement indicating that the
product is patented or patent-pending.
4. Manufacturing information: A statement indicating that
the product is manufactured in a cGMP-compliant facility.
5. Third-party certifications: A logo or statement
indicating that the product has been certified by a third-party organization,
such as NSF International or the National Science Foundation.
Label Claim Examples:
1. "L-Carnitine 500mg per serving"
2. "Supports energy production and weight
management"
3. "Clinically tested to improve exercise
performance"
4. "Manufactured in a cGMP-compliant facility"
5. "Third-party
certified for purity and potency"
·
Where canL-Carnitine Manufactured by MEDIOCON INC are
procured?
L-Carnitine 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 findL-Carnitine Manufactured by MEDIOCON
INC products on online marketplaces like
Amazon or e-commerce websites specializing in
pharmaceuticals or skincare products.
- Local Pharmacies or Skincare Stores: You can also check with local
pharmacies or skincare stores in your area for Guggal Extract product
Remember to ensure the quality and authenticity of theL-Carnitine
Manufactured by MEDIOCON INC product,
regardless of the procurement source.
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