Active Pharmaceutical Ingredient

Alendronate

Also known as: Fosamax

CAS: 121268-17-5 Bisphosphonate / Bone Health USP / BP Bulk Supply Available
Alendronate API Manufacturer India | Mediocon Inc
Alendronate — Pharmaceutical Grade API

Product Overview

CAS No: 121268-17-5  |  MF: C₄H₁₃NO₇P₂  |  MW: 325.12 g/mol

Alendronate (Alendronic acid) is a bisphosphonate used for the treatment and prevention of osteoporosis in postmenopausal women and men. It inhibits osteoclast-mediated bone resorption. Mediocon Inc supplies pharmaceutical-grade Alendronate sodium meeting USP and BP standards.

Key Features

  • Potent bisphosphonate antiresorptive
  • USP/BP compliant quality
  • Inhibits osteoclast activity
  • Suitable for weekly tablet formulations

Applications

  • Postmenopausal osteoporosis tablets
  • Glucocorticoid-induced osteoporosis
  • Paget's disease of bone treatment
  • Male osteoporosis management

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameAlendronate
Also Known AsFosamax
CAS Number121268-17-5
Molecular FormulaC₄H₁₃NO₇P₂
Molecular Weight325.12 g/mol
CategoryBisphosphonate / Anti-osteoporotic
AppearanceWhite Crystalline Powder
GradeUSP / BP

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.0%
Loss on DryingNMT 1.0%
Melting PointN/A
Heavy MetalsNMT 10 ppm
pH4.0 – 5.0 (1% solution)
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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