Vitamin B1 59-43-8 Manufacturer Supplier Exporter 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 :

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