Description

Ibandronate Impurity 3 (Ibandronate EP Impurity C) is a designated impurity standard used in the analytical profiling and quality control of Ibandronate Sodium, a bisphosphonate drug. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and regulatory compliance of the active pharmaceutical ingredient (API). It is primarily required by professionals in pharmaceutical R&D, quality assurance (QA), and quality control (QC) for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Ibandronate EP Impurity C in Ibandronate Sodium API and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles throughout the drug's shelf life.
• Quality Control & Batch Release: Used in routine QC testing to confirm that impurity levels in commercial API batches are within the limits specified by pharmacopeial monographs (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data and specifications for drug master files (DMFs).
• Stability Studies: Employed as a marker to track the formation of this specific degradation product under various stress conditions (e.g., heat, humidity, light).
• Research on Degradation Pathways: Aids in research to understand the chemical degradation mechanisms of Ibandronate, supporting formulation optimization.

Basic Information

Product Name	Ibandronate Impurity 3 (Ibandronate EP Impurity C)
CAS No.	905808-25-5
Molecular Formula	C9H22NO7P2
Molecular Weight	333.22 g/mol
Synonyms	Ibandronate Related Compound C; (3-(Methylpentylamino)-1-hydroxypropane-1,1-diyl)bis(phosphonic acid); 1-Hydroxy-3-(methylpentylamino)propylidene-1,1-bisphosphonic Acid; Ibandronic Acid Impurity C; Ibandronate Sodium Impurity C; EP Impurity C of Ibandronate; Ibandronate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Ibandronate Impurity 3 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive). The container should be kept in a dry environment and allowed to reach room temperature before opening to prevent condensation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay (by HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Specific Impurities (HPLC)	Individually ≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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