Alendronate sodium NEW

‌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.