Quick Facts
| CAS Number | 18016-24-5 |
|---|---|
| Molecular Formula | C12H22CaO14•H2O |
| Molecular Weight | 448.39 |
| Pharmacopoeia | USP, EP, FCC, CP |
| Packaging | 25 KG/BAG |
Product Overview
Calcium gluconate was first produced commercially in the 1920s as a safer alternative to calcium chloride for intravenous calcium therapy. Calcium chloride, while effective, caused severe venous irritation and tissue necrosis upon extravasation — a significant clinical hazard when IV access was less reliable than today. The calcium salt of gluconic acid, produced by fermenting glucose with Aspergillus niger and neutralizing with calcium carbonate or calcium hydroxide, proved to be much less irritating to veins and soft tissue while providing bioavailable elemental calcium. This tissue compatibility advantage made it the IV calcium of choice — a position it retains a century later.
Calcium gluconate is the calcium salt of gluconic acid, containing 9.3% elemental calcium by weight in the monohydrate form. While this is lower than calcium carbonate (40% elemental calcium), its clinical advantages are substantial: it dissolves readily in water (approximately 3.3 g/100 mL at 25 degrees Celsius), has a neutral to slightly sweet taste (making it ideal for oral liquid and chewable formulations), and is far less irritating to gastric mucosa than calcium carbonate or calcium chloride. The gluconate portion itself is a normal human metabolite — gluconic acid is produced endogenously via the pentose phosphate pathway and is also found naturally in fruits, honey, and wine.
In emergency medicine, calcium gluconate has unique, critical applications that no other calcium salt can fully substitute. It is the standard treatment for acute hydrofluoric acid (HF) burns — applied as a 2.5% topical gel or injected subcutaneously to bind fluoride ions and prevent the deep, progressive tissue destruction and potentially fatal systemic hypocalcemia that HF causes. It is also the preferred IV calcium salt for hyperkalemia with ECG changes, where it rapidly antagonizes the cardiac membrane-destabilizing effects of elevated potassium. These emergency applications alone make calcium gluconate an essential hospital medicine worldwide.
The global calcium gluconate market is served by multiple quality grades: pharmaceutical (USP/EP/BP/CP), food (FCC), and industrial/technical. China is the dominant global producer, with manufacturing integrated into large-scale glucose fermentation facilities. The pharmaceutical and food-grade markets are growing steadily, driven by aging populations with osteoporosis prevention needs, expanding calcium-fortified food and beverage categories, and rising parenteral nutrition requirements in hospital settings. KingWish supplies GMP-certified calcium gluconate meeting USP, EP, FCC, and CP standards for pharmaceutical, food, and nutritional applications.
Quality Specifications
| Assay (anhydrous, titration) | 98.0% - 102.0% (USP) |
|---|---|
| Elemental Calcium Content | 9.3% (theoretical, monohydrate) |
| pH (1 in 50 solution) | 6.0 - 8.2 |
| Chloride | ≤ 0.07% |
| Sulfate | ≤ 0.05% |
| Heavy Metals | ≤ 10 ppm; Arsenic ≤ 3 ppm |
| Reducing Substances | Compliant with USP (ensures gluconate integrity) |
| Bacterial Endotoxins (injectable) | Per USP <788> |
| Residual Solvents | Compliant with ICH Q3C |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
Applications
- Calcium deficiency treatment: Oral and IV calcium gluconate for hypocalcemia, tetany, and calcium depletion states. Standard 10% injectable solution provides 93 mg elemental Ca per 10 mL.
- Osteoporosis prevention: Calcium supplementation combined with vitamin D for bone density maintenance in postmenopausal women and elderly patients at fracture risk.
- Food fortification: FCC-grade calcium gluconate for calcium-fortified beverages, dairy products, nutritional bars, and infant formulas. Neutral taste ideal for fortification.
- Emergency cardiac care: IV 10% calcium gluconate for hyperkalemia with ECG changes and calcium channel blocker overdose. Rapid-onset cardiac membrane stabilization.
- Hydrofluoric acid burn treatment: 2.5% calcium gluconate gel applied topically and injected subcutaneously around HF burn sites. Binds fluoride ions to prevent tissue destruction and systemic toxicity.
Sourcing Calcium Gluconate: Key Checks
Documentation
Request CoA with assay by complexometric titration, heavy metals profile, chloride/sulfate limits, and reducing substances test. For injectable grade, request endotoxin certificate. For food grade, microbiological specifications and FCC compliance.
Red Flags
Positive reducing substances test indicates degraded gluconate. Elevated chloride or sulfate suggests incomplete purification. Poor water solubility or turbid solution indicates contamination or degradation. pH outside 6.0-8.2 range.
Packaging & Logistics
Standard: 25 KG/BAG with inner PE liner. Calcium gluconate is stable at room temperature but should be protected from moisture to prevent caking. Store at 15-25 degrees Celsius. Standard lead time 4-6 weeks. Custom packaging available.
Market Context
Global calcium gluconate market growing at ~5% CAGR, driven by aging populations, osteoporosis awareness, and expanding calcium-fortified food/drink markets. China dominates production. Multiple quality grades serve pharmaceutical, food, and industrial sectors.