Description

Ibandronate Sodium is a highly potent nitrogen-containing bisphosphonate salt, widely recognized for its role in inhibiting osteoclast-mediated bone resorption. This active pharmaceutical ingredient (API) is critical for the development and production of effective treatments for bone-related disorders, offering significant therapeutic value. It is primarily required by pharmaceutical manufacturers and research institutions focused on osteoporosis and metastatic bone disease therapies. Consistent quality and reliable supply are paramount for ensuring the efficacy and safety of the final medicinal products.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for the treatment and prevention of osteoporosis in postmenopausal women.
• Oncological Formulations: Used in the management of skeletal-related events (SREs), such as bone pain and fractures, associated with metastatic bone cancer.
• Injectable Drug Products: Formulated into sterile intravenous (IV) solutions for clinical administration.
• Oral Solid Dosage Forms: Incorporated into tablets for oral therapy regimens.
• Research & Development: Serves as a key reference standard and intermediate in pharmacological studies and new drug development for bone metabolism.
• Generic Drug Manufacturing: Essential for the production of bioequivalent generic versions of branded bisphosphonate drugs.

Basic Information

Product Name	Ibandronate Sodium
CAS No.	138844-81-2
Molecular Formula	C9H22NNaO7P2
Molecular Weight	359.21 g/mol
Synonyms	Ibandronate Sodium Salt; Ibandronic Acid Sodium Salt; Sodium Ibandronate; Ibandronate Monosodium Salt; Bonviva (brand name related); Bondronat (brand name related); (1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic Acid Monosodium Salt; BN-21
EINECS	Contact for details

Quality Control

Our Ibandronate Sodium is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopoeial standards (e.g., USP, EP). Every batch undergoes comprehensive analytical testing including identification, assay, impurity profiling, and residual solvent analysis to ensure it meets stringent specifications for pharmaceutical use. A Certificate of Analysis (COA) documenting all test results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to almost white powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
pH (1% Solution)	6.0 - 8.0

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.