Description

Alendronate Sodium is the sodium salt form of alendronic acid, a potent bisphosphonate compound. It is a critical active pharmaceutical ingredient (API) primarily valued for its ability to inhibit osteoclast-mediated bone resorption. This makes it an essential raw material for the global pharmaceutical industry, specifically for the formulation of osteoporosis treatments. Manufacturers of solid oral dosage forms, such as tablets, rely on high-purity Alendronate Sodium CAS NO 129318-43-0 to ensure drug efficacy and patient safety.

Application

• Pharmaceutical API: Primary use as the active ingredient in medications for the treatment and prevention of osteoporosis in postmenopausal women and men.
• Bone Disorder Therapeutics: Used in formulations targeting Paget's disease of bone and other conditions involving excessive bone turnover.
• Generic Drug Manufacturing: Serves as a key starting material for producers of generic bisphosphonate medications.
• Clinical Research: Employed in preclinical and clinical studies for developing new bone-targeting therapeutic agents.
• Veterinary Medicine: Potential application in the treatment of bone-related disorders in animals.

Basic Information

Product Name	Alendronate Sodium
CAS No.	129318-43-0
Molecular Formula	C4H12NNaO7P2 • xH2O
Molecular Weight	Anhydrous: 249.10 g/mol
Synonyms	Alendronate Sodium Trihydrate; Sodium Alendronate; Alendronic Acid Sodium Salt; 4-Amino-1-hydroxybutylidene-1,1-bisphosphonic Acid Sodium Salt; MK-217 Sodium Salt; Fosamax™ API; Adronat; ONO-5920
EINECS	Contact for details

Quality Control

Our Alendronate Sodium is manufactured under strict quality systems. It undergoes comprehensive analytical testing to meet stringent pharmaceutical-grade specifications, including identification, purity assay, and control of related substances and residual solvents. We provide full traceability and support regulatory filings. Certificates of Analysis (COA) compliant with current pharmacopeial standards (USP/EP) are available for every batch upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water (KF Titration)	10.0% - 16.0% (for trihydrate)
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Microbial Enumeration	Complies with EP/USP requirements

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