Vitamin B1 Manufactured Supplier Exporter by MEDIOCON INC

 

Vitamin B1 Manufactured by MEDIOCON INC     

Name: Vitamin B1

CAS No:  59-43-8 (for Thiamine free base)

or

67-03-8 (for Thiamine Hydrochloride, most common form).

Molecular Weight: - Thiamine (Free Base):

    - 265.36 g/mol

- Thiamine Hydrochloride (HCl, most common):

    - 337.27 g/mol

- Thiamine Mononitrate:

    - 327.36 g/mol

Molecular formula:   - Thiamine (Free Base):

    - C₁₂H₁₇N₄OS

- Thiamine Hydrochloride (HCl, most common):

    - C₁₂H₁₇ClN₄OS·HCl (or C₁₂H₁₈Cl₂N₄OS)

- Thiamine Mononitrate:

    - C₁₂H₁₇N₄OS·HNO₃ (or C₁₂H₁₈N₅O₄S)

Synonyms:  - Thiamine

- Thiamin

- Aneurine

- Vitamin B1 Hydrochloride (for HCl salt)

- Thiamine Mononitrate (for nitrate salt)

- 3-[(4-Amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylthiazolium chloride (chemical name) Appearance:  - Thiamine Hydrochloride (HCl):

    - White to off-white, crystalline powder.

    - Hygroscopic (absorbs moisture, handle carefully).

- Thiamine Mononitrate:

    - White to slightly yellowish, crystalline powder.

    - Less hygroscopic than HCl, more stable.

- Crystals:

    - Needle-like or prismatic.

- Solutions (e.g., oral/IV):

    - Clear, colorless liquid (pH-adjusted, preservative-free for injections).

 

Key Notes:

- Odor: Slight, characteristic (no strong smell).

- Taste: Bitter (HCl > Mononitrate).

- Packaging: Airtight drums, amber vials (light-sensitive).

- Compliance: Meets USP, EP standards.

 Solubility :  The Solubility of Vitamin B1 (Thiamine) varies by form:

- Thiamine Hydrochloride (HCl):

    - Highly soluble in water (~1 g/mL).

    - Sparingly soluble in ethanol (~0.03 g/mL).

    - Insoluble in ether, chloroform, benzene.

- Thiamine Mononitrate:

    - Moderately soluble in water (~0.1 g/mL, pH 6–7).

    - Slightly soluble in ethanol.

    - Insoluble in ether, oils.

- Thiamine (Free Base):

    - Less soluble in water (~0.05 g/mL, pH-dependent).

    - Soluble in dilute acids.

    - Insoluble in organic solvents.

Use :

The Uses of Vitamin B1 (Thiamine) manufactured by MEDIOCON INC include:

- Primary Uses:

    - Energy Metabolism: Supports carbohydrate breakdown → ATP (body’s fuel) ⚡.

    - Nervous System Health: Nerve function, prevents beriberi (deficiency disease) 🧠.

    - Heart Health: Supports cardiac muscle function.

- Clinical Uses:

    - Deficiency Treatment: Wernicke’s encephalopathy, beriberi (IM/IV urgent care) 💉.

    - Alcohol Use Disorder: Prevents/alleviates Wernicke-Korsakoff syndrome.

    - Diabetes Support: May improve nerve pain (neuropathy).

    - Pregnancy/Lactation: Supports maternal/fetal energy needs.

- Dietary Supplements:

    - Oral Tablets/Capsules: 1–100 mg/day (general health, stress).

    - Food Fortification: Mononitrate in cereals, flour (prevents deficiency) 🍞.

- Therapeutic Doses:

    - 50–100 mg/day (nerve pain, fatigue).

    - 100–300 mg IM/IV (acute deficiency, hospital use).

- Other Forms:

    - Injections: Emergencies (e.g., coma in Wernicke’s).

    - Syrups: Kids’ deficiency, easy intake 👶.

 How is  Vitamin B1 manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC manufactures Vitamin B1 (Thiamine) typically through chemical synthesis, here’s a quick breakdown:

- Key Steps:

    1. Starting Materials:

    - 2-Methyl-5-ethoxymethylpyrimidine (Pyrimidine part).

    - 4-Methyl-5-(2-hydroxyethyl)thiazole (Thiazole part).

    2. Synthesis:

    - Pyrimidine Synthesis: React acetamidine + malononitrile → form pyrimidine ring.

    - Thiazole Synthesis: React acetoacetic ester + chloroacetone + thiourea → form thiazole ring.

    - Coupling: Combine both rings using quaternization (with a linker like CNCH2CH2OH) → Thiamine.

    3. Purification:

    - Crystallization (water/ethanol), filtration, drying → 99%+ pure Thiamine HCl/Mononitrate.

- Common Salts:

    - Thiamine Hydrochloride (HCl): Most common, water-soluble.

    - Thiamine Mononitrate: More stable (heat/moisture), used in foods.

- Why This Process?

    - Scalable, Cost-Effective.

    - Meets USP/EP standards.

- Challenges:

    - Yield Optimization: Minimize impurities (e.g., thiazole dimers).

    - Green Shift: Exploring biocatalysis (enzymes) to reduce solvents.

- MEDIOCON INC Focus:

    - cGMP Compliance.

    - HPLC testing for purity, no heavy metals.

What are the different  dosage forms  Vitamin B1 Manufactured  by  MEDIOCON INC?

MEDIOCON INC’s Vitamin B1 (Thiamine) comes in these dosage forms:

- Oral Solids:

    - Tablets: 3 mg, 5 mg, 10 mg, 50 mg, 100 mg – plain or film-coated.

    - Capsules: 50 mg, 100 mg – gelatin/vegetarian shells.

- Powder:

    - Sachets: 1 g, 3 g – mix in water/juice, food fortification 💧.

- Liquids:

    - Oral Solution: 5 mg/5 mL – pediatric, flavors 👶.

    - Injections (IM/IV):

        - Ampoules (1 mL/2 mL): 50 mg/mL, 100 mg/mL – sterile, for emergencies.

- Food/Feed Additives:

    - Thiamine HCl/Mononitrate Powder: Bulk (25 kg drums), fortified foods.

 

Key Highlights:

- Strengths: 3–100 mg (oral), 50–100 mg/mL (injectable).

- Excipients:

    - No preservatives (orally), buffers (injections), flavors (syrup).

- Packaging:

    - Airtight, light-resistant (see 👈).

    - Ampoules in cartons (clinical use).

 

 When should Vitamin B1 Manufactured by MEDIOCON INC be taken?

 MEDIOCON INC’s Vitamin B1 (Thiamine)—here’s when to take it for best results 😊:

- Best Time:

    - With Meals: Boosts absorption, reduces stomach upset. 🍴

    - Morning/Afternoon: Supports energy metabolism; avoid night if you’re sensitive (rare).

- Specific Needs:

    - Deficiency (e.g., Wernicke’s): 50–100 mg IM/IV (doctor-guided, urgent).

    - Supplements (dietary): 1–5 mg daily (RDA: 1.1–1.2 mg for adults).

    - Nerve Pain/Stress: 50–100 mg/day (split doses, consult doc).

    - Alcohol Use/Diabetes: Talk to doc—may need higher doses.

- Dosage Forms:

    - Oral Tablets/Capsules: With food, swallow whole.

    - Liquid (Syrup): Shake, measure, kids-friendly 👶.

    - Injection (IM/IV): Clinical setting only, doctor-administered 💉.

- Avoid:

    - Empty stomach → nausea risk.

    - High doses (>500 mg/day) without doc → no extra benefit, waste.

- Key Notes:

    - Water-soluble → take with water, no food interactions.

    - Pregnant/Breastfeeding? → 1.4–1.5 mg/day (RDA), check doc.

    - Store cool, dry—no special timing but track expiry.

Which tests are performed on Vitamin B1 Manufactured by  MEDIOCON INC ?

MEDIOCON INC’s Vitamin B1 (Thiamine) undergoes these key tests to ensure quality:

- *1. *Identification 🔍

    - IR Spectroscopy: Matches standard thiamine spectrum.

    - HPLC Retention Time: Confirms peak alignment.

- *2. *Assay (Purity) 🧪

    - HPLC (UV Detection): 98.0–102.0% of label claim (HCl/Mononitrate).

    - Titration (Potentiometric): Acid-base for HCl salt.

- *3. *Impurities ⚖️

    - Related Substances (HPLC): <1.0% (e.g., thiazole, pyrimidine).

    - Heavy Metals: <10 ppm (Pb, Cd, Hg, As).

    - Residue on Ignition: <0.1%.

- *4. *Physical Tests 🌟

    - Appearance: White to off-white, crystalline powder.

    - Solubility:

        - HCl Salt: ~1 g/mL (water), sparing in ethanol.

        - Mononitrate: ~0.1 g/mL (water), pH 6–7.

    - pH (1% Solution): 2.7–3.3 (HCl), 6.0–7.0 (Mononitrate).

- *5. *Microbial Limits 🦠

    - Total Aerobic Count: <1,000 CFU/g.

    - E. coli, Salmonella, Yeast/Mold: Absent.

- *6. *Loss on Drying 💧

    - <5.0% (105°C, 2 hrs).

- *7. *Particle Size (API) 🔬

    - D90 < 150 µm (flowability check).

- *8. *Specific Tests (Dosage Forms) 💊

    - Dissolution (Tablets): >75% in 45 mins (pH 4.5 buffer).

    - Uniformity (Tabs/Capsules): ±10% of label.

    - Sterility (Injections): USP <71> compliant.

- *9. *Stability Studies 📆

    - Real-Time/Accelerated (25°C/40°C, 6–12 months): Assay, impurities.

 

Key Notes:

- Complies with USP, EP, IP.

- Batch Certificate includes COA (assay, impurities, microbiology).

- Storage: Cool (<25°C), dry, light-protected.

What are the challenges in Manufacturing of Vitamin B1 Manufactured by MEDIOCON   INC API?

MEDIOCON INC’s Vitamin B1 (Thiamine) API manufacturing faces these key challenges:

- *1. *Complex Chemical Synthesis 🔬

    - Issue: Multi-step process (pyrimidine + thiazole → coupling) → low yields, impurities.

    - Fix: Optimize reaction temps, solvents (e.g., DMF), catalysts. Explore biocatalysis (greener).

- *2. *Stability & Degradation 🌟

    - Issue: Heat, moisture, pH > 6 → breaks down (thiazole + pyrimidine).

    - Fix: Dry processing, cool storage (<25°C), acidic stabilizers.

- *3. *Purity & Impurities 🧪

    - Issue: Related substances (e.g., thiazole dimers) → strict HPLC tests.

    - Fix: Recrystallization (water/ethanol), optimize coupling step.

- *4. *Cost & Scalability 💲

    - Issue: 6–8 steps, solvents (DMF) → expensive, waste.

    - Trend: Streamline synthesis, biotech routes (enzymes) → cheaper, greener.

- *5. *Hygroscopic Nature (HCl Salt) 💧

    - Issue: Absorbs moisture → caking, handling issues.

    - Fix: Mononitrate salt (more stable), desiccants, airtight drums.

- *6. *Regulatory Compliance 📜

    - Issue: cGMP, ICH Q7 → docs, validation, no heavy metals.

    - Fix: Batch tracking, HPLC/ICP-MS tests, audits.

- *7. *Environmental Impact 🌎

    - Issue: Solvents (DMF, acetonitrile) → waste, toxicity.

    - Fix: Green solvents, recycling, enzyme catalysis R&D.

- *8. *Crystallization Control 🔮

    - Issue: Particle size → flow, dissolution variability.

    - Fix: Seed crystals, controlled cooling, milling.

 

Quick Notes:

- No fermentation (vs. some B vitamins).

- Salt Choice:

    - HCl: Cheaper, water-soluble → tablets.

    - Mononitrate: More stable → food fortification.

- Tests: HPLC assay (99–101%), heavy metals <10 ppm.

What are the challenges in manufacturing of Vitamin B1 Manufactured by MEDIOCON  INC ’s Dosage forms?

MEDIOCON INC’s Vitamin B1 (Thiamine) dosage forms face these key manufacturing challenges:

- *1. *Stability Issues 🌟

    - Issue: Heat, moisture, pH > 6 → degradation (thiamine → thiazole + pyrimidine).

    - Fix:

        - Desiccants, airtight packaging.

        - Acidic pH (3–4) in liquids, avoid metal containers.

        - Coating tablets (film/sugar) for protection.

- *2. *Solubility & Taste 💧

    - Issue: HCl salt is hygroscopic, bitter taste.

    - Fix:

        - Mononitrate (food-grade, less bitter).

        - Flavor-masking (syrups), effervescent tablets.

- *3. *Sterility (Injectables) 💉

    - Issue: Aseptic filling, no preservatives.

    - Fix:

        - 0.22 µm filtration, autoclave vials/ampoules.

        - Nitrogen flush (oxygen-free).

- *4. *Uniformity (Tablets/Capsules) 🧩

    - Issue: Low-dose (3–5 mg) → blending challenges.

    - Fix:

        - Wet granulation, direct compression with diluents.

        - HPLC checks (content uniformity).

- *5. *pH Control (Liquids) ⚖️

    - Issue: pH < 3 → irritation, >6 → degradation.

    - Fix: Citrate/phosphate buffers, pH 3.5–4.5.

- *6. *Cost & Scalability 💲

    - Issue: Multi-step synthesis → yield losses.

    - Trend: Optimize coupling step, explore biocatalysis.

- *7. *Regulatory Compliance 📜

    - Issue: cGMP, sterility (injectables), no heavy metals.

    - Fix:

        - Batch docs, validation, HPLC/ICP-MS tests.

        - Particle size control (powders).

- *8. *Packaging Compatibility 📦

    - Issue: Glass interactions (injections), moisture ingress.

What is shelf life Of Vitamin B1 Manufactured by MEDIOCON INC? 

MEDIOCON INC’s Vitamin B1 (Thiamine) typically has this shelf life, depending on the form:

- API (Thiamine HCl/Mononitrate):

    - 36 months (unopened, <25°C, 60% RH, airtight drums).

    - Re-test after 6 months open, keep desiccated.

- Tablets/Capsules:

    - 24–36 months (unopened, <25°C, dry).

    - Open: Use within 1 year, keep airtight.

- Oral Solution/Syrup:

    - 12–18 months (unopened, 2–8°C ⬇️).

    - Open: 1 month (refrigerate), check clarity before use.

- Injections (IM/IV):

    - 18–24 months (sealed ampoules, <25°C, dark).

    - Use immediately post-open, discard if cloudy/particulate.

- Powder (Sachets/Food Grade):

    - 18–24 months (sealed, <25°C, dry).

    - Open: 1 month, reseal tightly.

- Mononitrate (Food Fortification):

    - 36 months (bulk, <25°C, airtight), more stable than HCl.

 

Key Factors Affecting:

- Moisture → caking, degradation.

- Heat/pH > 6 → loss of potency.

- Light exposure → yellowish tint.

- Storage:

    - Airtight, cool (<25°C), dark.

    - No freezing (liquids).

- Tests:

    - HPLC assay (98–102% at expiry).

    - Re-test if >6 months open.

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

For Dosage Forms :

- Online Marketplaces: You can find Vitamin B1 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 Vitamin B1 manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity Vitamin B1 Manufactured by MEDIOCON INC product, regardless of the procurement source.