Description

Alendronic Acid CAS NO 66376-36-1 is a nitrogen-containing bisphosphonate compound that serves as a key active pharmaceutical ingredient (API). It is a critical component in the formulation of medications used to treat and prevent osteoporosis and other bone disorders by inhibiting osteoclast-mediated bone resorption. This high-purity intermediate is essential for pharmaceutical manufacturers and research institutions developing treatments for metabolic bone diseases.

Application

• Pharmaceutical API: Primary use as the active ingredient in bisphosphonate drugs for osteoporosis (e.g., Alendronate Sodium).
• Bone Metabolism Research: Used in biochemical and pharmacological studies investigating bone resorption pathways.
• Reference Standard: Serves as a high-purity analytical standard for quality control in pharmaceutical production.
• Formulation Development: Utilized in R&D for developing new oral and injectable dosage forms.
• Generic Drug Manufacturing: Critical raw material for producing generic versions of alendronate-based medications.
• Veterinary Medicine: Potential application in treating bone disorders in animals.

Basic Information

Product Name	Alendronic Acid
CAS No.	66376-36-1
Molecular Formula	C4H13NO7P2
Molecular Weight	249.10 g/mol
Synonyms	Alendronate Acid; 4-Amino-1-hydroxybutylidene-1,1-bisphosphonic Acid; (4-Amino-1-hydroxy-1-phosphonobutyl)phosphonic Acid; AHBuBP; Alendronic Acid Monohydrate; Fosamax Impurity; Alendronate Acid (Free Acid Form)
EINECS	Contact for details

Quality Control

Our Alendronic Acid is manufactured under strict quality systems. It undergoes rigorous analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. Certificates of Analysis (COA) are provided with each batch, detailing parameters such as assay, related substances, and residual solvents. We can support compliance with ICH guidelines, USP/EP monographs, and customer-specific requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed after opening to minimize exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm

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