Calcium Gluconate Monohydrate Manufactured Supplier Exporter by MEDIOCON INC

 

Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC     

Name: Calcium Gluconate Monohydrate

CAS No:  299-28-5

Molecular Weight: 448.39 g/mol

Molecular formula:   C12H22CaO14 · H2O

Synonyms - Calcium D-gluconate monohydrate

- Gluconic acid, calcium salt (2:1), monohydrate

- Calcium gluconate hydrate

Appearance:  - White crystalline powder

- Odorless, with a slightly sweet taste.

 Solubility :  - - Lentinan: Soluble in water, slightly soluble in ethanol

- Eritadenine: Soluble in water, methanol, and ethanol.

Use :

- - Immune system support: Boosts immunity and overall health

- Antioxidant properties: Protects against oxidative stress

- Cardiovascular health: Supports heart health and cholesterol management

- Cancer prevention and treatment: Lentinan has anti-tumor properties

 

 How is  Calcium Gluconate Monohydrate  manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC’s Calcium Gluconate Monohydrate synthesis typically follows this process:

- Raw Materials:

    - Calcium Carbonate (CaCO₃) or Calcium Hydroxide (Ca(OH)₂).

    - Gluconic Acid (from glucose fermentation, Aspergillus niger).

- Neutralization Reaction:

    - CaCO₃/Ca(OH)₂ + 2 C₆H₁₂O₇ (Gluconic Acid) → Ca(C₆H₁₁O₇)₂ · H₂O + CO₂/H₂O.

    - Maintains pH 6.0–7.0, 60–80°C, stirred.

- Filtration:

    - Removes impurities, activated carbon may decolorize.

- Crystallization:

    - Solution concentrated (vacuum evaporation), cooled (20–25°C) → crystals form.

    - Seed crystals boost yield.

- Drying:

    - Centrifuged, washed (water/ethanol), dried (50–60°C) to <1% moisture.

- Milling & Packaging:

    - Fine powder, sieved (≤150 μm), packed in HDPE drums (food/pharma grade).

 

Key Controls:

- Purity: Meets USP/BP standards.

- Assay: 98.0–102.0% Ca(C₆H₁₁O₇)₂·H₂O.

- Tests: Heavy metals, microbiology, particle size.

What are the different  dosage forms  Calcium Gluconate Monohydrate Manufactured  by  MEDIOCON INC?

MEDIOCON INC’s Calcium Gluconate Monohydrate dosage forms are prepared as follows:

 

- Oral Tablets:

    - Process:

        - Mix powder with excipients (starch, MCC, Mg stearate).

        - Compress into tablets (500 mg or 1 g).

        - Coat (optional): Film/sugar coat for taste masking.

    - Packaging: Blisters (10/30 tablets) or HDPE bottles.

    - Use: Swallow with water, chewable option.

 

- Powder / Sachets:

    - Process:

        - Mill to fine powder (≤150 μm).

        - Fill into sachets (1 g, 5 g).

    - Packaging: Moisture-resistant sachets (10/20 count).

    - Use: Mix in 100–200 mL water/juice.

 

- Injectable Solution (10% w/v):

    - Process:

        - Dissolve in WFI (100 mg/mL), 80°C, stir.

        - Filter (0.22 µm), fill ampoules (10 mL).

        - Sterilize (autoclave, 121°C, 15 min).

    - Packaging: Glass ampoules, sealed, labeled.

    - Use: Slow IV push/IM, hospital use.

 

- Syrup (Oral Liquid):

    - Process:

        - Dissolve in water (90–100 mg/mL).

        - Add flavors, sweeteners (sorbitol), preservatives (parabens).

        - Filter, fill PET bottles (100/200 mL).

    - Packaging: Child-resistant cap, measuring cup.

    - Use: Shake, dose via spoon/cup.

 

Key Steps:

1. API Standardization: 98–102% purity (USP/BP).

2. Sterility (Injectables): Endotoxin <0.5 EU/mg.

3. Testing: HPLC, microbial limits, pH (syrup: ~6.0).

 

 How Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC   Dosage Forms are prepared?

MEDIOCON INC’s Calcium Gluconate Monohydrate dosage forms are prepared as follows:

 

- Oral Tablets:

    - Process:

        - Mix powder with excipients (starch, MCC, Mg stearate).

        - Compress into tablets (500 mg or 1 g).

        - Coat (optional): Film/sugar coat for taste masking.

    - Packaging: Blisters (10/30 tablets) or HDPE bottles.

    - Use: Swallow with water, chewable option.

 

- Powder / Sachets:

    - Process:

        - Mill to fine powder (≤150 μm).

        - Fill into sachets (1 g, 5 g).

    - Packaging: Moisture-resistant sachets (10/20 count).

    - Use: Mix in 100–200 mL water/juice.

 

- Injectable Solution (10% w/v):

    - Process:

        - Dissolve in WFI (100 mg/mL), 80°C, stir.

        - Filter (0.22 µm), fill ampoules (10 mL).

        - Sterilize (autoclave, 121°C, 15 min).

    - Packaging: Glass ampoules, sealed, labeled.

    - Use: Slow IV push/IM, hospital use.

 

- Syrup (Oral Liquid):

    - Process:

        - Dissolve in water (90–100 mg/mL).

        - Add flavors, sweeteners (sorbitol), preservatives (parabens).

        - Filter, fill PET bottles (100/200 mL).

    - Packaging: Child-resistant cap, measuring cup.

    - Use: Shake, dose via spoon/cup.

 

Key Steps:

1. API Standardization: 98–102% purity (USP/BP).

2. Sterility (Injectables): Endotoxin <0.5 EU/mg.

3. Testing: HPLC, microbial limits, pH (syrup: ~6.0).

 When should Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC be taken?

 MEDIOCON INC’s Calcium Gluconate Monohydrate is best taken as follows:

- Oral Tablets/Powder/Syrup:

    - With Meals: Boosts absorption (especially with vitamin D). 🍴

    - 1–3 g/day (elemental calcium: ~90 mg/g):

        - Adults: 1–2 tablets (500 mg–1 g) 2–3× daily.

        - Children: 0.5–1 g/day (syrup for ease), consult pediatrician.

    - Avoid with:

        - High-fiber foods, iron supplements (space by 2 hours).

        - Caffeine/alcohol (reduces absorption).

 

- Injectable (IV/IM):

    - Emergency Use Only (hospitals):

        - Hypocalcemia, cardiac arrest: 1–2 g (10–20 mL of 10%) slow IV.

        - Monitor ECG, calcium levels.

    - No self-administration.

 

Key Notes:

- Osteoporosis Prevention: Evening dose aids bone remodeling.

- Pregnancy/Lactation: 1–1.5 g/day, consult doctor.

- Kidney Issues: Monitor calcium levels; avoid high doses.

Which tests are performed on Calcium Gluconate Monohydrate Manufactured by  MEDIOCON INC ?

MEDIOCON INC’s Calcium Gluconate Monohydrate typically undergoes these tests (as per USP/BP standards):

- Identification:

    - IR Spectroscopy: Matches reference spectrum.

    - Calcium Test: Positive with ammonium oxalate (precipitate).

- Assay:

    - Complexometry (EDTA Titration): 98.0–102.0% purity (anhydrous basis).

    - Elemental Calcium: ~9% w/w.

- Purity & Impurities:

    - HPLC: Gluconic acid, related substances (<1%).

    - Chloride, Sulfate: Within limits (<0.05%, <0.1%).

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

- Physical Tests:

    - Appearance: White crystalline powder.

    - Solubility: Soluble in water (3–4 g/100 mL, 20°C).

    - Loss on Drying: 5.0–8.0% (105°C, 2 hours).

    - pH (5% Solution): 6.0–8.0.

- Microbiological Tests:

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

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

- Injectable-Specific (if parenteral):

    - Sterility Test: Complies (membrane filtration).

    - Endotoxins (LAL): <0.5 EU/mg.

    - Particulates: Meets USP <788>.

- Additional:

    - Particle Size: ≤150 μm (powder/tablets).

    - Label Claim: Confirms dosage (mg/tablet or mL).

 

Certifications Often Checked:

- cGMP, USP/BP Compliance, ISO 22000 (food/pharma).

- Non-GMO, Halal, Kosher (if specified).

What are the challenges in Manufacturing of Calcium Gluconate Monohydrate  Manufactured by MEDIOCON   INC API?

The challenges in manufacturing Calcium Gluconate Monohydrate API by MEDIOCON INC (or generally) include:

- Raw Material Variability:

    - Gluconic Acid Source: Fermentation (e.g., Aspergillus niger) yield depends on pH, glucose purity, microbes. 🍄

    - Calcium Salt Purity: CaCO₃/Ca(OH)₂ impurities affect assay.

- Crystallization Control:

    - Crystal Size & Purity: Slow cooling needed to avoid fines, optimize yield. High moisture → caking.

    - Polymorph Risk: Unwanted forms impact solubility/bioavailability.

- Solubility & Drying:

    - Low Water Solubility (3–4 g/100 mL): Needs hot water, careful evaporation.

    - Moisture Sensitivity: Drying (50–60°C) must hit <1% H₂O without degradation.

- Purity & Impurities:

    - Heavy Metals (Pb, Cd): Strict control in reactants, testing.

    - Oxalates/Related Substances: HPLC monitoring; fermentation by-products.

- Sterility (Injectables):

    - Endotoxin Control: <0.5 EU/mg → costly LAL tests, aseptic filling.

    - Particulates: 0.22 µm filtration, cleanrooms.

- Scale-Up & Cost:

    - Batch Consistency: Mixing, heat transfer issues in large reactors.

    - Yield Loss: Optimizing Ca-gluconate recovery vs. effluent handling.

- Regulatory Compliance:

    - cGMP, USP/BP Standards: Docs, validation, audits → time/cost.

    - Stability Testing: Light, moisture protection (packaging).

 

Mitigations:

- In-process HPLC checks, PAT (Process Analytical Tech).

- Optimized reactors, spray drying for powder flow.

- ICH Q7 guidelines, supplier audits.

What is the Packing for Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC?

The packing for Calcium Gluconate Monohydrate manufactured by MEDIOCON INC typically includes:

- Primary Packaging:

    - HDPE Drums (25 kg, 50 kg):

        - For bulk API: Food/pharma-grade, moisture-resistant, sealed with liners.

    - Glass Bottles (for injectables, 10 mL/20 mL ampoules):

        - For 10% w/v solution: Amber, sterile, break-seal or flip-top.

    - Sachets (1 g, 5 g for oral powder):

        - For food/supplements: Multi-layer (PET/Alu/PE), heat-sealed.

    - Blisters (tablets):

        - For oral tablets: PVC/Alu, 10/30 tablets per strip.

 

- Secondary Packaging:

    - Cartons (export-grade):

        - Labelled with batch no., expiry, storage (25°C, <60% RH).

        - For injectables: "Sterile, Do Not Shake" warnings.

    - Pallets (for drums):

        - Shrink-wrapped, labelled per shipping norms (e.g., UN, IATA).

 

- Label Details:

    - Product Name, Strength (e.g., 1 g/tablet), Lot No., Expiry.

    - Storage: "Tightly sealed, protect from moisture/light."

    - Regulatory Marks: cGMP, ISO, USP/BP compliance.

 

What is shelf life Of Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC? 

The shelf life of Calcium Gluconate Monohydrate manufactured by MEDIOCON INC is typically:

- 24 months (2 years) from the date of manufacture when stored properly:

    - Conditions:

        - Temperature: 15–25°C (avoid heat).

        - Humidity: <60% RH (moisture-sensitive).

        - Packaging: Sealed, airtight containers (HDPE drums, glass ampoules).

        - Light Protection: Keep in original packaging, avoid direct sunlight.

 

- Specifics:

    - API (Bulk Powder): 24 months in HDPE drums with desiccant.

    - Tablets/Sachets: 18–24 months, check label for exact date.

    - Injectable Solution (10% w/v): 12–18 months (sterile ampoules, avoid freezing).

    - Post-Opening: Use within 3 months (tablets/powder) or immediately (injectables).

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 Calcium Gluconate Monohydrate 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 Calcium Gluconate Monohydrate  manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of Calcium Gluconate Monohydrate Manufactured by MEDIOCON INC product, regardless of the procurement source.