Etidronic Acid is a synthetic bisphosphonate active pharmaceutical ingredient (API) used for its ability to regulate bone mineral metabolism and inhibit abnormal calcification. It is also known as etidronate and belongs to the first generation of bisphosphonate compounds.
Etidronic Acid has applications in pharmaceutical formulations for certain disorders involving bone resorption and ectopic calcification.
Etidronic Acid is a phosphorus-containing bisphosphonate structurally related to pyrophosphate. It has a strong affinity for hydroxyapatite in bone and can influence bone mineralization and osteoclast-mediated bone resorption.
CAS Number: 2809-21-4
Molecular Formula: C₂H₈O₇P₂
Molecular Weight: 206.03 g/mol
Etidronic Acid binds to hydroxyapatite crystals in bone and affects bone mineral metabolism. At therapeutic concentrations, bisphosphonates can inhibit osteoclast-mediated bone resorption.
Its pharmacological effects include:
At higher concentrations, etidronate can also interfere with normal bone mineralization, making dose and formulation important considerations.
Etidronic Acid has been used in pharmaceutical formulations for:
The exact therapeutic application depends on the formulation, country and applicable regulatory labeling.
Etidronic Acid is a bisphosphonate pharmaceutical ingredient with defined chemical and physicochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances and other quality attributes.
Typical quality evaluation may include:
Pharmaceutical-grade Etidronic Acid should comply with the applicable approved specification, pharmacopoeial requirements where applicable, and relevant regulatory standards.
A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.
Store Etidronic Acid in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability 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 20 ppm |
| pH (1% Solution) | 5.5 – 6.5 |