Description

Tiludronate Disodium Hemihydrate is a bisphosphonate compound that acts as a potent inhibitor of bone resorption. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily utilized by pharmaceutical manufacturers in the development and production of treatments for metabolic bone disorders such as Paget's disease and osteoporosis.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for bone resorption disorders.
• Osteoporosis Treatment: Formulated into tablets or other dosage forms to increase bone mineral density and reduce fracture risk.
• Paget's Disease Therapy: Used in medications to manage the symptoms and progression of Paget's disease of bone.
• Veterinary Medicine: Potential application in treating bone disorders in companion and large animals.
• Research & Development: Serves as a reference standard and key intermediate in pharmacological and clinical research.
• Formulation Development: Used in pre-formulation and stability studies for new drug delivery systems.

Basic Information

Product Name	Tiludronate Disodium Hemihydrate
CAS No.	155453-10-4
Molecular Formula	C7H7Cl2Na2O6P2S · 0.5H2O
Molecular Weight	401.0 g/mol (anhydrous basis)
Synonyms	Tiludronic Acid Disodium Salt Hemihydrate; (4-Chlorophenyl)thio-methylene-1,1-bisphosphonic Acid Disodium Salt Hemihydrate; Tiludronate Sodium; SR 41319B; CAS 149845-07-8 (anhydrous); Skelid (Brand Name); Tiludronate Disodium
EINECS	Contact for details

Quality Control

Our Tiludronate Disodium Hemihydrate is manufactured under strict quality systems to meet the rigorous standards required for pharmaceutical actives. Each batch is tested against comprehensive specifications to ensure identity, purity, strength, and composition. A Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. Production can be aligned with cGMP guidelines for pharmaceutical applications.

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 dry environment to prevent degradation. The original container should be kept tightly sealed after each use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 4.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Meets Ph. Eur. / USP criteria

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