?Alendronate Sodium Trihydrate (CAS 121268-17-5)?
Google Keywords: Alendronate Sodium Trihydrate, CAS 121268-17-5, Osteoporosis Drug Synthesis, Bisphosphonate API Manufacturing, GMP Pharmaceutical Intermediates

?? ?Product Overview?

?Alendronate Sodium Trihydrate? (CAS 121268-17-5) is a high-purity trihydrate form of alendronate sodium, a bisphosphonate class drug widely used to treat ?osteoporosis? and ?bone disorders? by inhibiting osteoclast-mediated bone resorption. This intermediate ensures reliable and scalable production of alendronate-based APIs, adhering to strict pharmaceutical quality standards.

• ?Primary Function?: Critical intermediate in synthesizing alendronate sodium API, ensuring bioavailability and therapeutic efficacy.

• ?Applications?: Osteoporosis therapy development, bone metabolism research, and pharmaceutical formulation optimization.

? ?Key Advantages?

?? ?Ultra-High Purity? | ≥99.0% (HPLC/GC verified) | Complies with ICH Q11 guidelines for intermediates.
?? ?Enhanced Stability? | Trihydrate form ensures superior stability under storage, minimizing degradation risks.
?? ?Regulatory Compliance? | Fully characterized by NMR, FTIR, and XRPD to support FDA/EMA submissions and GMP compliance.

?? ?Applications?

1. ?API Production?: Enables efficient synthesis of alendronate sodium for osteoporosis treatments.

2. ?Formulation Development?: Used in tablets and oral solutions to enhance bioavailability and patient compliance.

3. ?Research & Development?: Supports preclinical studies on bone density improvement and fracture prevention.

?? ?Quality Assurance?

• ?Testing Methods?: HPLC, GC, NMR, FTIR, and X-ray powder diffraction (XRPD) for structural confirmation and purity analysis.

• ?Standards?: Meets USP <1086>, EP 10.0, and ISO 9001:2015 certified manufacturing protocols.

?? ?Market Trends?

The ?global osteoporosis treatment market? is projected to reach ?$18.9 billion by 2030? (CAGR 4.5%), driven by aging populations and rising demand for cost-effective bisphosphonate therapies. Alendronate remains a cornerstone treatment, with intermediates like this trihydrate form accelerating generic and novel drug production.

Empower your osteoporosis drug pipeline with Alendronate Sodium Trihydrate – engineered for purity, stability, and regulatory excellence.