Description

Sodium Risedronate is the sodium salt form of risedronate, a third-generation bisphosphonate compound. This high-purity active pharmaceutical ingredient (API) is critical for the formulation of effective osteoporosis treatments and other bone metabolism disorders. It is primarily utilized by pharmaceutical manufacturers in the development and production of solid oral dosage forms. Our supply ensures consistent quality and reliable material for global pharmaceutical applications.

Application

• Pharmaceutical API: Primary active ingredient in prescription 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 (osteitis deformans) to regulate bone turnover.
• Oral Tablet Manufacturing: Key component in the production of delayed-release and immediate-release tablet formulations.
• Osteoporosis Prevention: Incorporated into therapeutic regimens to increase bone mineral density and reduce fracture risk.
• Research & Development: Serves as a reference standard and raw material in preclinical and clinical pharmaceutical research.
• Generic Drug Production: Essential for manufacturers developing bioequivalent generic versions of branded bisphosphonate drugs.

Basic Information

Product Name	Sodium Risedronate
CAS No.	115436-72-1
Molecular Formula	C7H10NNaO7P2
Molecular Weight	305.10 g/mol
Synonyms	Risedronate Sodium; Sodium [1-hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonate; NE-58095; Sodium 1-Hydroxy-2-(3-pyridinyl)ethylidene-1,1-bisphosphonate; Actonel (as the active component); (1-Hydroxy-2-(3-pyridinyl)ethylidene)bisphosphonic Acid Monosodium Salt; 2-(3-Pyridinyl)-1-hydroxyethylidene-1,1-bisphosphonic Acid Sodium Salt
EINECS	Contact for details

Quality Control

Our Sodium Risedronate is manufactured under strict quality systems suitable for pharmaceutical use. Quality is assured through comprehensive analytical testing against stringent in-house specifications, which align with major pharmacopeial standards. A Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure traceability and compliance.

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 container must be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
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 Ph. Eur. 2.6.12/2.6.13

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