Active Pharmaceutical Ingredient

Sertraline Hydrochloride — CAS 7446-34-6

Also known as: Zoloft / Lustral API

GMP Certified IP / BP / EP / USP Antidepressant / SSRI Aurangabad, India
Sertraline Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sertraline Hydrochloride IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 7446-34-6

Product Overview

Sertraline Hydrochloride is the HCl salt form of the widely prescribed SSRI antidepressant Sertraline. As the commercially available form (Zoloft, Lustral), it provides superior water solubility for oral formulations. It selectively inhibits serotonin reuptake with high potency and minimal affinity for adrenergic, cholinergic, or histaminergic receptors. Mediocon Inc manufactures pharmacopoeial-grade Sertraline HCl API meeting IP/BP/EP/USP specifications.

Therapeutic Applications
  • Major Depressive Disorder
  • OCD, PTSD, Panic Disorder
  • PMDD treatment
  • Oral tablet/capsule formulations

Technical Specifications

ParameterSpecification
CAS Number7446-34-6
Molecular FormulaC₁₇H₁₇Cl₂N·HCl
Molecular Weight342.69 g/mol
GradeIP / BP / EP / USP
CategoryAntidepressant / SSRI
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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