Description

Strontium Ranelate Hydrate CAS NO 674773-07-0 is a pharmaceutical-grade active ingredient, a strontium salt of ranelic acid. This compound is of significant commercial interest for its specific biological activity and role in advanced therapeutic research and development. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development of treatments for metabolic bone disorders.

Application

• Pharmaceutical Active Ingredient (API): Serves as the key therapeutic component in the formulation of prescription medications for osteoporosis and other bone-related conditions.
• Biomedical Research: Used as a reference standard and investigational compound in preclinical and clinical studies focusing on bone metabolism, osteoblast function, and bone density.
• Analytical Reference Standard: Employed in quality control laboratories for the identification and quantification of strontium ranelate in drug products using techniques like HPLC and mass spectrometry.
• Formulation Development: Critical for R&D teams developing solid oral dosage forms, such as tablets or granules, requiring precise and consistent API quality.
• Regulatory Submissions: Supplied to support drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) with certified quality data.

Basic Information

Product Name	Strontium Ranelate Hydrate
CAS No.	674773-07-0
Molecular Formula	C12H6N2O8SSr2·xH2O
Molecular Weight	513.49 g/mol (Anhydrous basis)
Synonyms	Strontium ranelate; Distrontium 5-[bis(2-oxido-2-oxoethyl)amino]-4-cyano-3-(2-oxido-2-oxoethyl)thiophene-2-carboxylate hydrate; Protelos (Brand Name); Protos; Osseor; Strontium 5-[bis(carboxymethyl)amino]-4-cyano-3-(carboxymethyl)thiophene-2-carboxylate hydrate; S12911
EINECS	Contact for details

Quality Control

Our Strontium Ranelate Hydrate is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, suitable for pharmaceutical applications. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and heavy metals is provided with every shipment to ensure full traceability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (Strontium)	Positive
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	As per batch COA
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.