Description

Alendronic Acid Related Impurity 2 is a high-purity chemical reference standard, specifically identified as a known impurity of the active pharmaceutical ingredient Alendronic Acid. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Alendronic Acid and related drug substances.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical standard for developing, optimizing, and validating chromatographic methods to detect and quantify this specific impurity.
• Quality Control (QC) & Stability Testing: Employed in routine QC testing of bulk drug substances and finished dosage forms to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control.
• Research & Development: Used in R&D laboratories to study the degradation pathways and stability profile of Alendronic Acid.
• Calibration Standard: Acts as a precise calibration standard for ensuring the accuracy and reproducibility of analytical instrumentation.

Basic Information

Product Name	Alendronic Acid Related Impurity 2
CAS No.	165043-19-6
Molecular Formula	C4H12NO7P2+ • X-
Molecular Weight	Contact for details
Synonyms	Alendronate Impurity 2; Fosamax Impurity 2; (4-Amino-1-hydroxybutylidene)bisphosphonic Acid Impurity 2; Alendronic Acid EP Impurity B; Alendronic Acid Related Compound B; 1-Hydroxy-4-aminobutylidene-1,1-bisphosphonic Acid Related Substance 2; 4-Amino-1-hydroxybutylidene-1,1-bisphosphonate Impurity 2
EINECS	Contact for details

Quality Control

Our Alendronic Acid Related Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

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. Handle and store under inert atmosphere if specified.

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)	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.