Lanthanum Carbonate Tetrahydrate is a hydrated form of lanthanum carbonate used as a pharmaceutical active ingredient with phosphate-binding properties. It is a non-calcium, non-aluminum phosphate binder designed to bind dietary phosphate within the gastrointestinal tract and reduce phosphate absorption.
Lanthanum Carbonate Tetrahydrate contains lanthanum ions that interact with dietary phosphate under gastrointestinal conditions, forming poorly soluble lanthanum phosphate complexes. This mechanism makes lanthanum carbonate suitable for pharmaceutical formulations intended for the management of elevated serum phosphate levels associated with chronic kidney disease.
Lanthanum Carbonate Tetrahydrate is a hydrated inorganic lanthanum salt with the molecular formula La₂(CO₃)₃·4H₂O and a molecular weight of approximately 529.90 g/mol. The commonly referenced CAS Number for Lanthanum Carbonate Tetrahydrate is 6487-38-3.
It is generally supplied as a white to off-white powder or crystalline solid and has very low solubility in water.
After oral administration, lanthanum carbonate interacts with phosphate in the gastrointestinal tract. Lanthanum ions bind phosphate to form insoluble lanthanum phosphate complexes, thereby decreasing the amount of phosphate available for intestinal absorption.
This gastrointestinal phosphate-binding activity helps reduce serum phosphate concentrations in patients with impaired renal phosphate excretion.
Lanthanum Carbonate is primarily used as a phosphate-binding agent for the management of hyperphosphatemia associated with chronic kidney disease, particularly in patients receiving dialysis, according to applicable approved indications.
The tetrahydrate form may be relevant as a defined pharmaceutical raw-material or API hydration state where specified by the manufacturer or applicable specification.
Lanthanum Carbonate Tetrahydrate can be evaluated using validated analytical procedures for identity, lanthanum content, carbonate content, hydration/water content, related substances, elemental impurities and other applicable quality attributes.
Analytical techniques may include elemental analysis, suitable spectroscopic methods and validated chemical or chromatographic procedures. Hydration state is an important quality attribute for a tetrahydrate material and should be controlled according to the approved specification.
Acceptance criteria should be based on the applicable manufacturer's drug-substance specification, Certificate of Analysis and relevant regulatory requirements.
Lanthanum Carbonate Tetrahydrate should be stored in a tightly closed pharmaceutical-grade container under controlled conditions. Because the material is a defined hydrate, it should be protected from environmental conditions that could alter its hydration state. Excessive heat, moisture and contamination should be avoided.
Lanthanum Carbonate Tetrahydrate API may be supplied for qualified pharmaceutical manufacturing, formulation development, research and analytical applications. Product specifications, Certificate of Analysis, packaging details and regulatory documentation should be confirmed according to the intended application.
Lanthanum Carbonate Tetrahydrate API is available for pharmaceutical development and manufacturing requirements subject to applicable quality and regulatory requirements. Customers can request product specifications, analytical documentation, Certificate of Analysis, packaging information and commercial details for their specific requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Water Content | NMT 2.0% |