Tiludronic Acid API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Tiludronic Acid API Manufacturer in India

Swapnroop Drugs & Pharmaceuticals offers Tiludronic Acid as a pharmaceutical active ingredient for applications related to bone metabolism and bisphosphonate drug development. Tiludronic Acid, also known as Tiludronate, is a synthetic bisphosphonate compound belonging to the class of drugs that affect bone structure and mineralization.

Tiludronic Acid is associated with the treatment of bone disorders, particularly Paget's disease of bone. It acts primarily by inhibiting osteoclast-mediated bone resorption, thereby reducing excessive breakdown of mineralized bone tissue.

The compound is chemically identified as [(4-chlorophenyl)sulfanyl-phosphonomethyl]phosphonic acid and contains two phosphonic acid groups. PubChem lists Tiludronic Acid under CAS No. 89987-06-4 with molecular formula C7H9ClO6P2S and molecular weight 318.61 g/mol.

About Tiludronic Acid API

Tiludronic Acid is a nitrogen-free bisphosphonate. Unlike nitrogen-containing bisphosphonates, its molecular structure contains a chlorophenylthio substituent attached to a methylene bisphosphonate group.

Tiludronic Acid is also known as Tiludronate and has been assigned ATC code M05BA05. The compound is classified within the bisphosphonate group of medicines affecting bone structure and mineralization.

Chemical and Pharmaceutical Profile

ParameterDetails
Product NameTiludronic Acid
SynonymsTiludronate, Tiludronic Acid
CAS No.89987-06-4
Molecular FormulaC7H9ClO6P2S
Molecular Weight318.61 g/mol
IUPAC Name[(4-chlorophenyl)sulfanyl-phosphonomethyl]phosphonic acid
Chemical ClassBisphosphonate
Drug ClassBone metabolism / Bisphosphonate
ATC CodeM05BA05
PubChem CID60937
AppearanceWhite to off-white powder
Physical FormPowder
ChiralityAchiral
Target/ActionInhibition of osteoclast-mediated bone resorption

The chemical identity, formula, molecular weight, CAS number and PubChem CID are documented by PubChem.

Pharmaceutical Applications

Tiludronic Acid is a bisphosphonate used in pharmaceutical applications involving disorders of bone remodeling. Its established therapeutic association is with Paget's disease of bone (osteitis deformans).

Its pharmacological activity is primarily associated with suppression of osteoclastic bone resorption. By reducing excessive osteoclast activity, bisphosphonates such as tiludronate can help reduce abnormal bone turnover.

Mechanism of Action

Tiludronic Acid acts primarily on bone tissue and inhibits osteoclastic activity. This reduces the processes responsible for resorption of the mineralized bone matrix.

As a non-nitrogen-containing bisphosphonate, Tiludronic Acid differs structurally and mechanistically from later-generation nitrogen-containing bisphosphonates.

Quality and Analytical Testing

As a small-molecule bisphosphonate, Tiludronic Acid can be characterized using conventional pharmaceutical analytical techniques.

Typical quality-control testing may include:

  • Identification by IR and/or other suitable spectroscopic techniques
  • Assay by an appropriately validated chromatographic or titrimetric method
  • Related substances/organic impurities
  • Water content or loss on drying
  • Residue on ignition/sulfated ash where applicable
  • Elemental/ionic impurity controls where required
  • pH of specified solution where applicable
  • Melting/decomposition characteristics
  • Solubility
  • Residual solvents
  • Microbiological quality where applicable

The applicable release specifications should be established according to the manufacturer's approved specification, customer requirements and the applicable regulatory standard.

A UK veterinary regulatory assessment notes that disodium tiludronate is an established active substance but is not described in a pharmacopoeial monograph in that context; the active-substance specification was therefore controlled through an Active Substance Master File (ASMF).

Tiludronic Acid API Manufacturer in India

Swapnroop Drugs & Pharmaceuticals focuses on pharmaceutical active ingredients with emphasis on quality, analytical characterization, documentation and controlled manufacturing practices.

Tiludronic Acid can be supplied for pharmaceutical development and manufacturing applications according to agreed product specifications and applicable quality requirements.

Packaging and Storage

Tiludronic Acid should be packaged in suitable, tightly closed pharmaceutical-grade containers that protect the material from moisture and contamination.

Recommended storage conditions should follow the approved product specification and stability data. Published chemical data describe Tiludronic Acid as a powder and report room-temperature storage conditions; specific commercial storage requirements should be confirmed against the applicable batch specification.

Documentation

Depending on the grade and customer requirements, documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Certificate of Conformance (CoC)
  • Safety Data Sheet (SDS)
  • Batch/Lot information
  • Analytical test report
  • Manufacturing documentation
  • Stability information, where applicable
  • Residual solvent information, where applicable
  • Elemental impurity information, where applicable
  • Regulatory documentation
  • BSE/TSE statement, where applicable
  • GMO statement, where applicable

Why Choose Swapnroop for Tiludronic Acid?

  • Pharmaceutical API-focused product portfolio
  • Quality-oriented manufacturing practices
  • Batch-specific analytical documentation
  • Controlled raw-material and production processes
  • Analytical testing according to approved specifications
  • Regulatory-oriented documentation
  • Pharmaceutical development and manufacturing support
  • Focus on consistency, traceability and quality

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.10%
Heavy Metals NMT 20 ppm
pH (1% Solution) 6.0–8.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 5.0%
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