Description

Alendronate Sodium CAS NO 121268-17-5 is a highly potent bisphosphonate compound used as an active pharmaceutical ingredient (API). It is a critical therapeutic agent for the treatment and prevention of osteoporosis and other bone metabolism disorders. This API is essential for pharmaceutical manufacturers developing solid oral dosage forms, particularly tablets, targeting bone density improvement and fracture risk reduction.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for osteoporosis treatment (e.g., Fosamax®).
• Osteoporosis Therapy: Formulated into tablets for increasing bone mineral density and reducing fracture risk in postmenopausal women and men.
• Paget's Disease Treatment: Used in medications to treat Paget's disease of bone, which causes enlarged and misshapen bones.
• Glucocorticoid-Induced Osteoporosis Prevention: Key component in therapies for patients on long-term corticosteroid treatment.
• Bone Metastasis Management: Investigated for use in managing skeletal complications associated with bone metastases.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for producing cost-effective alternatives to branded bisphosphonate drugs.

Basic Information

Product Name	Alendronate Sodium
CAS No.	121268-17-5
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; Fosamax (Brand Name API); Adronat; Alendros; ONO-5920
EINECS	Contact for details

Quality Control

Our Alendronate Sodium is manufactured under strict quality systems to meet the rigorous standards of the global pharmaceutical industry. Production adheres to current Good Manufacturing Practices (cGMP) guidelines. Each batch is subjected to comprehensive analytical testing, including identification, assay, impurity profiling, and residual solvent analysis, to ensure compliance with pharmacopeial monographs (USP/EP). A Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 12.0% (for trihydrate)
pH (1% Solution)	Contact for details
Related Substances (HPLC)	Individual Impurity: ≤ 0.5% Total Impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with USP <61>

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