Lanthanum Carbonate Octahydrate is a hydrated lanthanum salt used as an active pharmaceutical ingredient in phosphate-binding formulations. It is primarily used to reduce elevated serum phosphate levels in patients with chronic kidney disease, particularly patients receiving dialysis.
Lanthanum Carbonate works as a non-calcium, non-aluminum phosphate binder. Following oral administration, lanthanum ions bind dietary phosphate within the gastrointestinal tract, forming insoluble lanthanum phosphate complexes that are eliminated in the feces. This reduces intestinal phosphate absorption and helps control serum phosphate concentrations.
Lanthanum Carbonate Octahydrate is the octahydrate form of lanthanum carbonate. Its molecular formula is La₂(CO₃)₃·8H₂O and its molecular weight is approximately 601.96 g/mol. The CAS Number commonly assigned to Lanthanum Carbonate Octahydrate is 6487-39-4.
The material is generally supplied as a white to off-white powder and is practically insoluble in water.
Lanthanum Carbonate dissociates in the acidic environment of the upper gastrointestinal tract, releasing lanthanum ions. These ions bind phosphate present in dietary contents to form highly insoluble lanthanum phosphate complexes.
Because phosphate binding occurs primarily within the gastrointestinal tract, systemic exposure to lanthanum is relatively low. The resulting reduction in phosphate absorption helps manage hyperphosphatemia.
Lanthanum Carbonate is used as a phosphate binder for the treatment of hyperphosphatemia associated with chronic kidney disease. It is particularly used in patients receiving dialysis, according to approved product indications and applicable clinical guidelines.
Lanthanum Carbonate Octahydrate API can be evaluated using validated analytical procedures for identification, assay, carbonate content, water/hydrate content, related substances, elemental impurities and other applicable quality attributes.
Suitable instrumental and chemical methods may be used for elemental identification, lanthanum content, carbonate determination and moisture/hydrate assessment. Acceptance criteria should be based on the applicable approved drug-substance specification and Certificate of Analysis.
Lanthanum Carbonate Octahydrate should be stored in a tightly closed pharmaceutical-grade container under controlled storage conditions. The material should be protected from excessive heat, moisture, direct light and contamination. Specific storage requirements should follow the applicable manufacturer's specification.
Lanthanum Carbonate Octahydrate 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 Octahydrate 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 |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |