Description

Strontium Ranelate is a synthetic organic strontium salt with the CAS registry number 135459-87-9. This compound is of significant commercial and research interest primarily due to its established role in bone metabolism. It is a critical active pharmaceutical ingredient (API) for the development and manufacture of treatments targeting bone-related disorders. The material is essential for pharmaceutical manufacturers, research institutions, and developers of advanced therapeutic formulations.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription medications for osteoporosis and other bone density conditions.
• Clinical Research: Used in preclinical and clinical studies investigating bone formation, resorption, and the treatment of metabolic bone diseases.
• Formulation Development: Serves as a key component in the R&D of solid oral dosage forms, such as tablets and capsules.
• Reference Standard: Employed as a high-purity analytical standard in quality control laboratories for method development and validation.
• Biomedical Research: Utilized in biochemical studies to understand the mechanism of action of strontium ions on osteoblast and osteoclast activity.

Basic Information

Product Name	Strontium Ranelate
CAS No.	135459-87-9
Molecular Formula	C₁₂H₆N₂O₈SSr₂
Molecular Weight	513.49 g/mol
Synonyms	Strontium 5-[bis(2-carboxyethyl)carbamoyl]-2-carboxy-3-cyanothiophen-4-olate; Distrontium 5-[bis(2-carboxyethyl)carbamoyl]-4-cyano-3-thiophencarboxylate; Protelos; Protos; Osseor; Strontium ranelate hydrate; Ranelic acid strontium salt
EINECS	Contact for details

Quality Control

Our Strontium Ranelate is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines for pharmaceutical ingredients. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting results for assay, related substances, residual solvents, and heavy metals.

Storage

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

Specification

Item	Specification
Appearance	White to almost white 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)	≤ 5.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Sulfated Ash	Contact for details

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