Ibandronate Sodium is a nitrogen-containing bisphosphonate active pharmaceutical ingredient (API) used primarily to inhibit bone resorption. It is the sodium salt of ibandronic acid and belongs to the bisphosphonate class of medicines used in the management of bone-related disorders.
Ibandronate Sodium is available in different hydrated forms. The commonly referenced monohydrate has the molecular formula C9H22NNaO9P2·H2O and a molecular weight of approximately 377.22 g/mol. The anhydrous form has a molecular weight of approximately 359.23 g/mol. The CAS number commonly associated with Ibandronate Sodium is 138844-81-6.
Ibandronate Sodium is a synthetic nitrogen-containing bisphosphonate structurally related to pyrophosphate. It has a high affinity for hydroxyapatite in bone and acts primarily by inhibiting osteoclast-mediated bone resorption.
The compound is used in pharmaceutical development for products intended for the management of osteoporosis and other conditions involving excessive bone resorption.
Ibandronate is taken up by osteoclasts during bone resorption and inhibits farnesyl pyrophosphate synthase (FPPS) within the mevalonate pathway.
Inhibition of this enzyme interferes with protein prenylation and osteoclast function, ultimately reducing osteoclast activity and bone resorption.
Ibandronate Sodium API is used in the development and manufacture of:
Ibandronate Sodium is manufactured through controlled chemical synthesis followed by purification, salt formation and, where applicable, controlled hydration/crystallization.
Quality control may include identification, assay, related substances, water content, phosphorus content, sodium content, residual solvents and elemental impurities according to the applicable approved specification.
Ibandronate Sodium is generally supplied as a white or almost white crystalline powder. It is highly polar because of its phosphonate groups and is soluble in water.
The exact molecular weight and water content depend on whether the API is supplied as the anhydrous form or a specific hydrate, so the commercial specification should clearly state the form supplied.
Ibandronate Sodium should be stored in a tightly closed container, protected from excessive moisture, heat and direct light. Storage conditions should follow the manufacturer's current CoA, SDS and validated stability requirements.
Depending on the intended pharmaceutical application, documentation may include:
Ibandronate Sodium is an established nitrogen-containing bisphosphonate API that reduces osteoclast-mediated bone resorption through inhibition of the mevalonate pathway. Its pharmaceutical applications are primarily associated with osteoporosis and other bone-resorption-related formulations.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.5% |
| pH (1% Solution) | 3.5 – 5.5 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 2.0% |