Methylcobalamin 13422-55-4 MANUFACTURER EXPORTER MEDIOCON INC
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·
Name: Methylcobalamin
· CAS No: 13422-55-4
· Molecular Weight: 1344.38.
·
Molecular formula:
C63H91CoN13O14P
· Synonyms:
vitamin B12, Mecobalamin
· Chemical structure:
· Appearance:
Bright Red Crystals
· Solubility:
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
soluble in water and methanol, but less soluble in ethanol and other organic
solvents.
· Use :
1. Treat the deficiency
of vitamin B12
2. Related
neurological conditions, such as peripheral neuropathy.
3. Improve nerve
function and alleviate symptoms like numbness, tingling, and fatigue
· Dosage forms :
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc , a form of Vitamin B12, is available in
various dosage forms, including:
# Oral Dosage Forms
1. Tablets: Available in
strengths of 500 mcg, 1000 mcg, 2500 mcg, and 5000 mcg.
2. Capsules: Available
in strengths of 500 mcg, 1000 mcg, 2500 mcg, and 5000 mcg.
3. Lozenges: Available
in strengths of 500 mcg, 1000 mcg, and 2500 mcg, designed to dissolve in the
mouth.
4. Sublingual tablets:
Available in strengths of 500 mcg, 1000 mcg, and 2500 mcg, designed to dissolve
under the tongue.
# Parenteral Dosage Forms
1. Injectable solutions:
Available in strengths of 1000 mcg/ml and 5000 mcg/ml for intramuscular or
subcutaneous injection.
# Topical Dosage Forms
1. Creams: Available in
strengths of 0.1% and 0.5% for topical application.
2. Gels: Available in
strengths of 0.1% and 0.5% for topical application.
# Other Dosage Forms
1. Nasal sprays:
Available in strengths of 500 mcg/ spray and 1000 mcg/spray.
2. Lipotropic
injections: Available in combination with other ingredients like vitamin B
complex and amino acids for intramuscular injection.
· Side Effects:
Common Side Effects
1. Diarrhea: Loose
stools or diarrhea can occur, especially when taking high doses.
2. Nausea and vomiting:
Some people may experience nausea or vomiting, especially when taking
mecobalamin orally.
3. Headache: Mild to
moderate headaches can occur, possibly due to the increased energy and
alertness caused by mecobalamin.
4. Dizziness or
lightheadedness: Some individuals may experience dizziness or lightheadedness,
especially when standing up quickly.
5. Itching or rash:
Rarely, mecobalamin can cause itching or a rash, possibly due to an allergic
reaction.
Less Common Side Effects
1. Anxiety or
nervousness: High doses of mecobalamin can cause anxiety or nervousness in some
individuals.
2. Insomnia: Taking
mecobalamin too close to bedtime can disrupt sleep patterns and cause insomnia.
3. Fatigue:
Paradoxically, some people may experience fatigue or lethargy when taking
mecobalamin, possibly due to individual tolerance or interactions with other
medications.
4. Muscle weakness:
Rarely, mecobalamin can cause muscle weakness or cramps, possibly due to an
imbalance of electrolytes.
· Why we need to take dose of Manufactured by
Mediocon Inc ?
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc , a form of vitamin B12, plays a crucial
role in various bodily functions. Here are some of the needs and benefits of Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc in
human beings:
1. Energy Production
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
necessary for the production of energy from the food we consume. It helps
convert carbohydrates, fats, and proteins into ATP (adenosine triphosphate),
the primary energy currency of the body.
2. Nervous
System Function
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
required for the synthesis of myelin, the fatty substance that surrounds and
protects nerve fibers. It also plays a role in the transmission of nerve
impulses, ensuring proper communication between nerve cells.
3. Red Blood
Cell Formation
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
necessary for the production of red blood cells, which carry oxygen throughout
the body. A deficiency in Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can lead to anemia, fatigue, and weakness.
4. DNA Synthesis
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
required for the synthesis of DNA, the genetic material that contains the
instructions for the development and function of all living cells.
5. Homocysteine
Regulation
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc helps regulate Homocysteine levels in the
blood. Elevated Homocysteine levels are associated with an increased risk of
cardiovascular disease, stroke, and dementia.
6. Mood Regulation
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc plays a role in the synthesis of
neurotransmitters, such as serotonin and dopamine, which regulate mood,
motivation, and emotional response.
7. Detoxification
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
involved in the detoxification process, helping to remove toxins and heavy
metals from the body.
· How Methylcobalamin Manufactured by Mediocon
Inc is synthesizing?
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
synthesized through a multi-step process involving microbial fermentation and
chemical modification. Here's an overview of the synthesis process
Microbial Fermentation
1. Microorganism
selection: Microorganisms such as Pseudomonas denitrificans, Propionibacterium
shermanii, or Bacillus megaterium are selected for their ability to produce cobalamin.
2. Fermentation: The
selected microorganisms are grown in a nutrient-rich medium, and the
fermentation process is optimized to
produce high yields of cobalamin.
3. Cobalamin production:
The microorganisms produce cobalamin, which is then extracted and purified.
Chemical Modification
1. Conversion to
Cyanocobalamin: The extracted cobalamin is converted to Cyanocobalamin through
a chemical reaction involving cyanide.
2. Reduction to
cob(II)alamin: Cyanocobalamin is reduced to cob(II)alamin using a reducing
agent such as sodium borohydride.
3. Methylation:
Cob(II)alamin is then methylated using methyl iodide or another methylating
agent to produce Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc .
Purification and Crystallization
1. Purification: The
synthesized Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc is purified using techniques such as
chromatography, crystallization, or distillation.
2. Crystallization: The
purified Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc is crystallized to produce a highly pure and
stable form of the vitamin.
Final
Product
The resulting Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is a
highly pure and bioavailable form of vitamin B12, suitable for use in
pharmaceuticals, dietary supplements, and food fortification.
· How to Identify Manufactured by Mediocon Inc Qualitatively?
Qualitative
identification of Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc involves various chemical and physical tests
to confirm its presence. Here are some methods:
Chemical
Tests
1. Dragendorff's test: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc gives a positive reaction with Dragendorff's
reagent, producing a reddish-brown precipitate.
2. Potassium cyanide
test: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc reacts with potassium cyanide to form Cyanocobalamin,
which gives a characteristic red color.
3. Nitrous acid test: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc reacts with nitrous acid to form a
yellow-colored compound.
Spectroscopic
Tests
1. UV-Visible
spectroscopy: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc exhibits a characteristic absorption spectrum
with peaks at 361 nm, 550 nm, and 582 nm.
2. Infrared
spectroscopy: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc shows characteristic IR absorption bands at
1600-1700 cm-1, 1500-1600 cm-1, and 1300-1400 cm-1.
Chromatographic
Tests
1. Thin-layer
chromatography (TLC): Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can be separated and identified using TLC,
with a characteristic Rf value.
2. High-performance
liquid chromatography (HPLC): Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can be identified and quantified using HPLC,
with a characteristic retention time.
These tests can be used
individually or in combination to qualitatively identify Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc .
· What are the different Methylcobalamin Manufactured
by Mediocon Inc different dosage forms
and how it is prepared?
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
available in various dosage forms, each with its own preparation method. Here
are some of the most common dosage forms:
1.
Tablets
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is mixed with excipients like lactose,
microcrystalline cellulose, and magnesium stearate. The mixture is then
compressed into tablets.
- Strengths: 500 mcg,
1000 mcg, 2500 mcg, and 5000 mcg.
- Route of
administration: Oral.
2.
Capsules
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is filled into capsules made of gelatin
or vegetarian alternatives.
- Strengths: 500 mcg,
1000 mcg, 2500 mcg, and 5000 mcg.
- Route of
administration: Oral.
3.
Injectable Solutions
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is dissolved in a sterile solution,
typically containing sodium chloride and water for injection.
- Strengths: 1000 mcg/
ml. and 5000 mcg/ ml.
- Route of
administration: Intramuscular (IM) or subcutaneous (SC) injection.
4.
Lozenges
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is mixed with excipients like sugar,
cornstarch, and magnesium stearate. The mixture is then compressed into
lozenges.
- Strengths: 500 mcg,
1000 mcg, and 2500 mcg.
- Route of
administration: Sublingual (under the tongue).
5.
Sublingual Tablets
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is mixed with excipients like lactose,
microcrystalline cellulose, and magnesium stearate. The mixture is then
compressed into tablets.
- Strengths: 500 mcg,
1000 mcg, and 2500 mcg.
- Route of
administration: Sublingual (under the tongue).
6.
Nasal Sprays
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is dissolved in a sterile solution,
typically containing water and a preservative. The solution is then filled into
nasal spray bottles.
- Strengths: 500
mcg/spray and 1000 mcg/spray.
- Route of
administration: Intranasal.
7.
Topical Creams and Gels
- Preparation: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc powder is mixed with excipients like glycerin,
water, and a preservative. The mixture is then filled into tubes or jars.
- Strengths: 0.1% and
0.5% w/w.
- Route of
administration: Topical application.
These
dosage forms can be prepared using various manufacturing processes, including:
1. Wet granulation: A
process where the active ingredient is mixed with excipients and a liquid
binder to form a granule.
2. Dry granulation: A
process where the active ingredient is mixed with excipients and compressed
into a granule.
3. Direct compression: A
process where the active ingredient is mixed with excipients and compressed
directly into a tablet.
4. Sterile filtration: A
process where the solution is filtered to remove impurities and ensure
sterility.
The specific
manufacturing process used depends on the dosage form and the equipment
available.
·
What
are the problems raised in manufacturing of dosage formulations?
Manufacturing dosage
formulations of Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can raise several problems, including:
1.
Stability Issues
1. Light sensitivity: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
sensitive to light, which can cause degradation and loss of potency.
2. Temperature
sensitivity: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can degrade at high temperatures, affecting
its stability and shelf life.
3. Moisture sensitivity:
Methylcobalamin Manufactured by Mediocon Inc
Manufactured by Mediocon Inc can
absorb moisture, leading to degradation and loss of potency.
2.
Solubility and Bioavailability Issues
1. Poor solubility: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc has
poor solubility in water, which can affect its bioavailability and absorption.
2. Variable bioavailability:
The bioavailability of Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can vary depending on the dosage form, route
of administration, and individual factors.
3.
Formulation Challenges
1. Taste and odor
masking: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc has a strong, unpleasant taste and odor, which
can be challenging to mask in oral dosage forms.
2. Tablet compression: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc can
be difficult to compress into tablets due to its poor flow ability and
compressibility.
3. Capsule filling: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc can
be challenging to fill into capsules due to its poor flow
ability and density.
4.
Analytical Challenges
1. Assay and purity
determination: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc can be challenging to assay and determine its
purity due to its complex chemical structure and instability.
2. Impurity profiling: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc can
contain impurities, such as cobalt oxide, which can be challenging to detect
and quantify.
5.
Regulatory Challenges
1. Compliance with regulatory
requirements: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc dosage formulations must comply with
regulatory requirements, such as those related to stability, bioavailability,
and purity.
2. Labeling and
packaging requirements: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc dosage formulations must meet labeling and
packaging requirements, such as those related to storage, handling, and
disposal.
6.
Scale-up and Manufacturing Challenges
1. Scale-up challenges: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc dosage formulations can be challenging to
scale up from laboratory to commercial production.
2. Manufacturing process
optimization: The manufacturing process for Methylcobalamin Manufactured by
Mediocon Inc Manufactured by Mediocon
Inc dosage formulations requires
optimization to ensure consistent quality, stability, and bioavailability.
3. Equipment and
facility requirements: Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc dosage formulations require specialized
equipment and facilities to ensure proper manufacturing, packaging, and
storage.
What
is storage condition of Methylcobalamin Manufactured by Mediocon Inc & its dosage forms ?
·
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc and
its dosage forms require specific storage conditions to maintain their stability,
potency, and quality. Here are some general guidelines:
Storage
Conditions for Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc Bulk Material
1. Temperature: Store at
a temperature range of 2-8°C (36-46°F).
2. Humidity: Store in a
dry place, protected from moisture.
3. Light: Protect from
direct sunlight and intense artificial light.
4. Container: Store in a
tightly sealed, light-resistant container.
Storage Conditions for Methylcobalamin
Manufactured by Mediocon Inc Manufactured
by Mediocon Inc Dosage Forms
1.
Tablets and Capsules:
- Store at a temperature range of 15-30°C (59-86°F).
- Protect from moisture and humidity.
- Store in a tightly sealed container.
2.
Injectable Solutions:
- Store at a temperature range of 2-8°C
(36-46°F).
- Protect from light and freezing
temperatures.
- Store in a tightly sealed,
light-resistant container.
3.
Lozenges and Sublingual Tablets:
- Store at a temperature range of 15-30°C
(59-86°F).
- Protect from moisture and humidity.
- Store in a tightly sealed container.
4.
Nasal Sprays:
- Store at a temperature range of 15-30°C
(59-86°F).
- Protect from light and freezing
temperatures.
- Store in a tightly sealed,
light-resistant container.
Special
Precautions
1. Avoid exposure to
extreme temperatures: Avoid exposing Methylcobalamin Manufactured by Mediocon
Inc Manufactured by Mediocon Inc and its dosage forms to extreme temperatures
(above 40°C/104°F or below -20°C/-4°F).
2. Protect from light:
Protect Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc and its dosage forms from direct sunlight and
intense artificial light.
3. Maintain humidity
control: Maintain a relative humidity of 60-70% to prevent moisture absorption.
4. Use a desiccant: Use
a desiccant, such as silica gel, to maintain a dry environment.
By following these
storage conditions and precautions, you can help maintain the stability,
potency, and quality of Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc and its dosage forms.
· What will be the Label for Methylcobalamin Manufactured by Mediocon
Inc ?
Here's a sample label for Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc :
Label
Information
1. Product Name: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc Tablets/Capsules/Injectable Solution
2. Active Ingredient: Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc
3. Strength: 500 mcg,
1000 mcg, 2500 mcg, or 5000 mcg (depending on the product)
4. Dosage Form: Tablet,
Capsule, or Injectable Solution
5. Route of
Administration: Oral, Sublingual, or Intramuscular/Intravenous (depending on
the product)
6. Indications: For the
treatment of vitamin B12 deficiency, megaloblastic anemia, and other conditions
related to vitamin B12 deficiency.
7. Contraindications:
Hypersensitivity to Methylcobalamin Manufactured by Mediocon Inc Manufactured by Mediocon Inc or any other ingredient in the product.
8. Warnings and
Precautions: Allergic reactions, anaphylaxis, and other adverse reactions may
occur.
9. Dosage and
Administration: Follow the recommended dosage and administration instructions.
10. Storage: Store at a
temperature range of 15-30°C (59-86°F), protect from moisture and humidity, and
store in a tightly sealed container.
11. Expiration Date:
[Insert expiration date]
12. Manufactured By:
[Insert manufacturer's name and address]
13. Distributed By:
[Insert distributor's name and address]
14. NDC Number: [Insert
NDC number]
15. Rx Only: [Insert
"Rx Only" symbol, if applicable]
Additional
Labeling Requirements
1. Child-resistant
packaging: If the product is intended for oral use, the packaging must be
child-resistant.
2. Tamper-evident
packaging: The packaging must be tamper-evident to ensure the product's
integrity.
3. Barcoding: The label
must include a barcode that contains the NDC number and other relevant
information.
4. Serial numbering: The
label must include a unique serial number to facilitate tracking and tracing.
[Note:
The specific labeling requirements may vary depending on the country, region,
or regulatory agency. It's essential to consult with regulatory authorities and
follow the applicable guidelines to ensure compliance.]
· What are the packing available?
Methylcobalamin
Manufactured by Mediocon Inc
Manufactured by Mediocon Inc is
available in various packaging options:
Oral Dosage Forms
1. Bottles: 30, 60, 90,
120, 180, 240, 360 tablets/capsules
2. Blister packs: 10,
20, 30, 60, 90 tablets/capsules
3. Strip packs: 10, 20,
30, 60 tablets/capsules
4. Unit-dose packaging: Single-dose
packets or containers
Injectable
Dosage Forms
1. Vials: 1 ml, 2 ml, 5 ml,
10 ml
2. Cartridges: 1 ml, 2
ml, 5 ml
3. Prefilled syringes: 1
ml, 2 ml, 5 ml
Liquid
Dosage Forms
1. Bottles: 10 ml, 20
ml, 30 ml, 60 ml
2. Dropper bottles: 10
ml, 20 ml, 30 ml
Other
Packaging Options
1. Single-dose cups:
Oral liquids
2. Dose packs: Oral
solids
3. Travel packs: Oral
solids and liquid
4. Sample packs:
Promotional packs
Specialized
Packaging
1. Child-resistant
packaging: Oral solids and liquids
2. Tamper-evident
packaging: Oral solids and liquids
3. Light-resistant
packaging: Photosensitive products
4. Refrigerated
packaging: Temperature-sensitive products
· Availability of Products
1. For API
a.
MEDIOCON
INC
Regd. Add: B-2, Arch Sarthak, G-1, N-7
CIDCO,
Jalgaon Road,
Aurangabad-431003, Maharashtra, India
Factory Address: Plot No 11,
Shendra MIDC, Aurangabad-431154, Maharashtra, India
Website: www.mediocon.com
Email id:info@mediocon.com
Whats app/Cell: +91 7249455639
GST No: 27DHUPM2366D1ZZ
b.
SWAPNROOP DRUGS & PHARMACEUTICALS.
Plot No.D-187/16, five
star shendra MIDC, shendra
Aurangabad- 431154, Maharashtra, India.
Tel: + 91-7387999183, +91-240-2994158
Website: www.swapnroopdrugs.com
Email: Swapnroop@gmail.com
2. For Dosage Forms :
Any Local Medicinal Store.
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