Tacrine API Manufacturer in India

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Tacrine API Manufacturer in India

Tacrine API

Tacrine is a centrally acting cholinesterase inhibitor belonging to the acridine class of compounds. Chemically, it is known as 1,2,3,4-tetrahydroacridin-9-amine and has the molecular formula C13H14N2 with a molecular weight of 198.26 g/mol. Tacrine is associated with inhibition of acetylcholinesterase and was historically developed for the management of symptoms associated with Alzheimer's disease.

Chemical and Pharmaceutical Profile

Tacrine is an aminoacridine derivative containing a tetrahydroacridine ring system with an amino substituent. The free-base API has CAS Number 321-64-2. Tacrine is also known as tetrahydroaminacrine and 1,2,3,4-tetrahydro-9-acridinamine.

CAS Number: 321-64-2
Molecular Formula: C13H14N2
Molecular Weight: 198.26 g/mol
IUPAC Name: 1,2,3,4-Tetrahydroacridin-9-amine

Tacrine should be distinguished from Tacrine Hydrochloride, which has CAS 1684-40-8 and molecular formula C13H15ClN2.

Mechanism of Action

Tacrine acts primarily as a reversible cholinesterase inhibitor. It inhibits acetylcholinesterase, reducing the enzymatic breakdown of acetylcholine and thereby increasing the availability of acetylcholine at cholinergic synapses.

The compound has also been investigated for activity against butyrylcholinesterase and other pharmacological targets. Its historical development was associated with the treatment of cognitive symptoms in Alzheimer's disease.

Pharmaceutical Applications

Tacrine is a centrally acting cholinesterase inhibitor with a historical pharmaceutical application in Alzheimer's disease. It has also been investigated in research involving cholinergic neurotransmission and acetylcholinesterase inhibition.

Tacrine has been discontinued from the United States market, so current pharmaceutical use and regulatory status should be evaluated according to the intended market and applicable regulatory requirements.

Quality and Analytical Testing

Quality evaluation of Tacrine API may include:

  • Identification by validated spectroscopic or chromatographic methods
  • Assay determination
  • Related substances and degradation products
  • Residual solvents
  • Water content
  • Residue on ignition, where applicable
  • Heavy-metal/elemental impurity controls
  • Melting-point characterization
  • Appearance
  • Solubility
  • Microbial quality where applicable

Final numerical acceptance criteria should be established against the applicable pharmacopoeial, customer, or validated manufacturer specification for the exact API form.

Tacrine API Manufacturer in India

Swapnroop Drugs and Pharmaceuticals provides pharmaceutical API manufacturing capabilities for international pharmaceutical markets. Tacrine is a specialized acridine-class pharmaceutical ingredient requiring controlled manufacturing, analytical characterization, impurity monitoring, and appropriate documentation.

For Tacrine API projects, the exact chemical form, applicable specification, analytical method, packaging requirements, and regulatory-market requirements should be established before commercial supply.

Packaging and Storage

Tacrine API should be packaged in suitable pharmaceutical-grade containers that protect the material from contamination, moisture, and environmental exposure.

Storage conditions should follow the validated product specification and stability data applicable to the supplied API. Packaging configuration and shelf-life should be confirmed through the applicable batch and quality documentation.

Documentation

Documentation for Tacrine API may include:

  • Certificate of Analysis (CoA)
  • Product specification
  • Analytical test report
  • Safety Data Sheet (SDS)
  • Batch documentation
  • Stability information, where applicable
  • Residual-solvent and impurity information
  • Regulatory support documentation, where applicable

Why Choose Tacrine API from Swapnroop?

  • Pharmaceutical API manufacturing expertise
  • WHO-GMP certified organization
  • Quality-focused manufacturing processes
  • Analytical and documentation support
  • International pharmaceutical market experience
  • Controlled packaging and handling
  • Focus on consistent pharmaceutical-grade quality

Conclusion

Tacrine is an aminoacridine-class cholinesterase inhibitor with the chemical identity C13H14N2 and CAS Number 321-64-2. Its pharmaceutical history is primarily associated with acetylcholinesterase inhibition and Alzheimer's disease therapy. Because Tacrine is distinct from its hydrochloride salt, API specifications should always identify the exact chemical form being manufactured and supplied.

Swapnroop Drugs and Pharmaceuticals supports pharmaceutical customers with quality-focused API manufacturing, analytical documentation, and controlled pharmaceutical material handling.

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 0.5%
Residue on Ignition NMT 0.1%
Melting Point Approximately 184–186°C
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