Description

n-Desmethyl Ibandronate Sodium is a high-purity pharmaceutical intermediate and reference standard, specifically the N-desmethyl metabolite of the bisphosphonate drug Ibandronate. This compound is of critical importance for research and development, analytical method validation, and metabolic studies within the pharmaceutical industry. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories focused on bone metabolism therapeutics and drug impurity profiling.

Application

• Pharmaceutical Reference Standard: Used for the identification, assay, and impurity quantification of Ibandronate Sodium and related drug substances in compliance with pharmacopeial methods (e.g., USP, EP).
• Metabolite Studies: Serves as a critical analytical standard in pharmacokinetic and pharmacodynamic research to study the metabolism and clearance of Ibandronate.
• Impurity Profiling: Essential for the development and validation of analytical methods (HPLC, LC-MS) to control and quantify process-related impurities in active pharmaceutical ingredient (API) batches.
• Research & Development: Employed in preclinical and clinical research to understand the structure-activity relationship and metabolic pathways of bisphosphonate compounds.
• Quality Control Laboratories: Used as a certified reference material to ensure the accuracy and reliability of in-house testing for Ibandronate Sodium API and finished dosage forms.

Basic Information

Product Name	n-Desmethyl Ibandronate Sodium
CAS No.	953805-81-7
Molecular Formula	C8H21NNaO7P2
Molecular Weight	343.19 g/mol
Synonyms	N-Desmethyl Ibandronate Sodium; 1-Hydroxy-3-(methylpentylamino)propane-1,1-diyldiphosphonic Acid Sodium Salt; Ibandronate N-Desmethyl Metabolite Sodium Salt; Sodium {1-hydroxy-3-[methyl(pentyl)amino]-1-phosphonopropyl}phosphonate
EINECS	Contact for details

Quality Control

Our n-Desmethyl Ibandronate Sodium is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification (IR, NMR), assay (HPLC), and rigorous impurity profiling to ensure it meets the high-purity standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.5%

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