Description

Ibandronate Sodium Monohydrate CAS NO 138926-19-9 is a high-purity bisphosphonate active pharmaceutical ingredient (API) used in the formulation of osteoporosis treatments. Its primary value lies in its potent and selective inhibition of osteoclast-mediated bone resorption, offering a critical therapeutic effect for bone-related disorders. This compound is essential for pharmaceutical manufacturers and research institutions developing injectable and oral medications targeting postmenopausal osteoporosis and other metabolic bone diseases.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of ibandronic acid-based medications for osteoporosis.
• Injectable Formulations: Used in the production of ready-to-use intravenous (IV) solutions for clinical administration.
• Oral Solid Dosage Forms: Key component in the development of film-coated tablets, such as Bonviva®/Boniva®.
• Oncology Supportive Care: Applied in formulations to manage skeletal-related events (SREs) like hypercalcemia of malignancy and bone metastases.
• Research & Development: Serves as a reference standard and building block in pharmacological studies of bone metabolism.
• Generic Drug Manufacturing: Critical for companies producing bioequivalent versions of branded bisphosphonate therapies.

Basic Information

Product Name	Ibandronate Sodium Monohydrate
CAS No.	138926-19-9
Molecular Formula	C9H22NNaO7P2 • H2O
Molecular Weight	359.23 g/mol (Monohydrate)
Synonyms	Ibandronate Sodium; Ibandronic Acid Sodium Salt Monohydrate; Sodium Ibandronate Monohydrate; Ibandros Sodium; BN-21; Bonviva (trade name); Boniva (trade name); 3-(N-Methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid monosodium salt monohydrate
EINECS	Contact for details

Quality Control

Our Ibandronate Sodium Monohydrate is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and relevant pharmacopoeial standards (e.g., USP, EP). Each batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to ensure full traceability and regulatory support for your projects.

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 product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment. For long-term stability, consider storage under an inert atmosphere.

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.5% - 5.5%
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Heavy Metals	NMT 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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