Description

Alendronic Acid Dimeric Anhydride (Impurity) is a key chemical reference standard used in the pharmaceutical development and quality control of bisphosphonate drugs. This compound is of critical importance for ensuring the purity, safety, and efficacy of active pharmaceutical ingredients (APIs) like alendronate sodium. It is primarily required by analytical laboratories and pharmaceutical manufacturers engaged in research, method validation, and regulatory compliance testing for osteoporosis treatments.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Alendronic Acid and Alendronate Sodium API batches.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for impurity profiling in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability over the shelf life.
• Regulatory Submissions: Essential for preparing impurity data packages required for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this dimeric anhydride impurity during API manufacturing.

Basic Information

Product Name	Alendronic Acid Dimeric Anhydride (Impurity)
CAS No.	165043-20-9
Molecular Formula	C8H14N2O10P4
Molecular Weight	464.10 g/mol
Synonyms	Alendronate Dimeric Anhydride; Alendronic Acid Anhydride Impurity; Fosamax Impurity; (4-Amino-1-hydroxybutylidene)bis(phosphonic acid) Anhydride; 1-Hydroxy-4-aminobutylidenediphosphonic Acid Dimeric Anhydride; Alendronic Acid Related Compound; Bisphosphonate Dimer Anhydride; Alendronate Impurity A (in some literature)
EINECS	Contact for details

Quality Control

Every batch of Alendronic Acid Dimeric Anhydride (Impurity) is manufactured and tested under strict quality management systems. We provide comprehensive analytical data, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the exacting standards for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is supplied with each shipment, supporting compliance with cGMP and relevant pharmacopeial guidelines.

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 in a desiccated environment to maintain stability and purity. Handle with appropriate precautions in a well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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