Description

Ibandronate Impurity is a high-purity reference standard used for the analytical control and qualification of the active pharmaceutical ingredient Ibandronate Sodium. This compound is critical for ensuring the quality, safety, and efficacy of bisphosphonate-based osteoporosis treatments by enabling precise identification and quantification of related substances. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory compliance teams focused on impurity profiling and method validation.

Application

• Primary use as a certified reference standard for analytical method development and validation in pharmaceutical quality control.
• Identification and quantification of related substances during stability studies and release testing of Ibandronate Sodium API and finished drug products.
• Critical component in impurity profiling to meet stringent regulatory requirements (e.g., ICH Q3A/B) for new drug applications and generic filings.
• Used in pharmacopoeial testing to verify compliance with monographs from USP, EP, or other international standards.
• Supporting research in degradation pathway studies to understand the stability and shelf-life of bisphosphonate formulations.
• Calibration of analytical instruments such as HPLC, UPLC, and LC-MS systems for precise impurity analysis.

Basic Information

Product Name	Ibandronate Impurity
CAS No.	919491-64-8
Molecular Formula	C9H23NO7P2
Molecular Weight	319.23 g/mol
Synonyms	Ibandronate Related Compound; Ibandronic Acid Impurity; (1-Hydroxy-3-(methylpentylamino)propylidene)bisphosphonic Acid; 3-(N-Methyl-N-pentyl)amino-1-hydroxypropane-1,1-diphosphonic Acid; Ibandronate Process Impurity; Ibandronate Sodium Impurity; BN-1 Impurity; BN 52111 Impurity
EINECS	Contact for details

Quality Control

Every batch of our Ibandronate Impurity is manufactured and tested under strict quality management systems. The material is characterized using advanced spectroscopic and chromatographic techniques to ensure identity, purity, and batch-to-batch consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. Our quality commitment aligns with cGMP principles to support regulatory submissions and pharmaceutical manufacturing.

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 under inert conditions or in a desiccator after opening to prevent degradation. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%

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