Description

Ibandronate Sodium Impurity 6 is a designated impurity reference standard used in the pharmaceutical development and quality control of Ibandronate Sodium, a bisphosphonate drug. This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and batch release testing.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Ibandronate Sodium API.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Used in stability studies to monitor impurity profiles and degradation pathways of Ibandronate Sodium formulations.
• Critical for regulatory compliance and filing, supporting documentation for agencies like the FDA, EMA, and PMDA.
• Supports research and development of Ibandronate Sodium, including process chemistry optimization and impurity synthesis studies.
• Employed in pharmacopoeial testing to ensure batches meet the stringent purity criteria of USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Ibandronate Sodium Impurity 6
CAS No.	77223-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ibandronic Acid Impurity 6; Ibandronate Related Compound 6; Ibandronate Sodium EP Impurity 6; Ibandronate Sodium USP Impurity 6; 1-Hydroxy-3-(methylpentylamino)propylidene-1,1-bisphosphonic Acid Impurity; BN 17355 Impurity; Bonviva Impurity; Bondronat Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibandronate Sodium Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods and purity determination by chromatographic techniques. Certificates of Analysis (COA) with detailed chromatographic data (HPLC/UPLC) are provided and available upon request to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation. For long-term storage, consider conditions under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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