Description
Sodium Bicarbonate Tablets USP (1 gm)
Healthy Inc is a specialized global supplier and exporter of advanced nephrological, metabolic, and critical-care therapeutics. We provide ultra-high-purity, pharmacopeially validated Sodium Bicarbonate Tablets USP (1 gm / 1000 mg), manufactured in WHO–GMP certified, highly climate-controlled oral solid dosage facilities. This “Systemic Alkalinizing Agent” is a massive-volume, life-sustaining export to nephrology centers, dialysis clinics, urology networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated intervention for metabolic acidosis in Chronic Kidney Disease (CKD).
Product Overview
This formulation contains a massive, clinical dose of Sodium Bicarbonate, a highly potent systemic and urinary alkalinizer that acts as the body’s primary buffering agent to maintain strict physiological pH.
The “Metabolic Acidosis & Nephrology” Specialist:
- Mechanism 1 (The Systemic Buffer – CKD Shield): In Chronic Kidney Disease (CKD), the failing kidneys lose their ability to excrete daily dietary acid, leading to a dangerous buildup of hydrogen ions in the blood (Metabolic Acidosis). This acidic blood literally dissolves the patient’s bones to steal calcium for buffering, and destroys muscle tissue. The 1 gm Sodium Bicarbonate tablet floods the bloodstream with bicarbonate ions (HCO3-). These ions aggressively bind to the toxic hydrogen ions, converting them into water and carbon dioxide, instantly restoring a safe blood pH.
- Delaying Dialysis: Global nephrology guidelines mandate aggressive bicarbonate therapy for CKD patients because maintaining normal serum bicarbonate levels physically slows the decline of kidney function, delaying the traumatic and expensive transition to end-stage renal dialysis.
- Mechanism 2 (Urinary Alkalinization): By excreting excess bicarbonate into the urine, this medication drastically raises urinary pH. This prevents the crystallization of uric acid, serving as a highly effective prophylactic treatment against uric acid kidney stones.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated or Uncoated Tablet, packed in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE bottles to prevent the highly reactive API from absorbing ambient humidity and effervescing.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Sodium Bicarbonate USP/Ph.Eur. | 1 gm (1000 mg) | Clinical Nephrology Standard: High-dose systemic alkalinization for the management of metabolic acidosis. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Stearic Acid / Magnesium Stearate | Diluent / Superdisintegrant / Lubricant (Engineered for immediate dissolution without premature effervescence) |
*Pack Sizes: Bottles of 100 or 10×10 Alu-Alu Blisters (Optimized specifically for strict, high-volume chronic nephrology regimens where patients consume multiple grams daily).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Nephrology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antacids/Alkalinizers) |
| CAS Number | 144-55-8 |
| Dosage Form | Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters or Moisture-Barrier HDPE Bottles (STRICTLY MANDATORY). Sodium Bicarbonate is extremely sensitive to moisture and will rapidly degrade (off-gassing CO2) if exposed to humidity. Strict barrier packaging guarantees multi-year shelf life across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Keep containers tightly closed. Protect from moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Ultra-Low Humidity Compression: Manufacturing a 1000 mg dose of pure Sodium Bicarbonate presents a massive structural challenge. If the relative humidity (RH) on the manufacturing floor is too high, the powder will absorb water, stick to the tooling, and begin chemically reacting before compression. Our facilities utilize strictly controlled, ultra-low humidity environmental suites and advanced dry-granulation/direct-compression techniques to guarantee absolute tablet integrity, structural hardness, and exact USP assay compliance.
Therapeutic Indications (Human Use)
Indicated for the targeted correction of severe acid-base imbalances:
- Chronic Kidney Disease (CKD): Management of metabolic acidosis in patients with renal failure to slow disease progression and prevent bone demineralization.
- Urinary Alkalinization: Prophylaxis against uric acid and cystine kidney stones, and to enhance the renal excretion of certain acidic drugs during overdose/toxicity (e.g., Aspirin/Salicylates or Phenobarbital).
- Severe Dyspepsia: Symptomatic relief of severe acid indigestion and heartburn (though 1g is generally reserved for systemic clinical use).
Dosage & Administration
Recommended Dosage (Strictly as per Nephrologist/Physician Guidelines):
- Standard Adult Dosing (Metabolic Acidosis): Dosing is highly individualized based on regular serum bicarbonate blood tests. A typical starting dose is 1 to 2 grams (1 to 2 tablets) taken 2 to 3 times a day.
- Administration (THE WATER RULE): Tablets MUST be taken with a full glass of water (at least 8 ounces). If taken without enough water, the rapid release of carbon dioxide gas in the stomach can cause severe gastric distention.
- Timing: Should be taken 1 to 2 hours after meals to prevent the neutralization of stomach acid required for normal digestion.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Sodium Overload (Edema & Heart Failure Risk): Each 1 gm tablet contains approximately 274 mg of elemental sodium (11.9 mEq). In CKD patients, who already struggle to excrete fluid, this massive sodium load can trigger severe fluid retention, worsening hypertension, pulmonary edema, and congestive heart failure. Volume status must be heavily monitored.
- Metabolic Alkalosis: Overdosing can swing the blood pH too far the other way, causing metabolic alkalosis. This is characterized by severe muscle twitching, irritability, tetany (muscle cramps), and dangerous cardiac arrhythmias.
- Hypokalemia Risk: Rapid correction of acidosis forces potassium to shift from the blood into the cells, potentially causing severe, life-threatening hypokalemia (low potassium). Serum electrolytes must be monitored closely during initiation.
- Drug Interactions (Gastric pH Alteration): By neutralizing stomach acid, Sodium Bicarbonate prevents the absorption of drugs that require an acidic environment (like Ketoconazole or Iron supplements). It must be separated from other medications by at least 2 hours.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Nephrological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for dialysis networks in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.








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