Active Pharmaceutical Ingredient

Sirolimus — CAS 53123-88-9

Also known as: Rapamycin; Rapamune

GMP Certified IP / BP / EP / USP mTOR Inhibitor / Immunosuppressant Aurangabad, India
Sirolimus API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sirolimus IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 53123-88-9

Product Overview

Sirolimus (Rapamycin) is a macrolide immunosuppressant produced by Streptomyces hygroscopicus that inhibits the mechanistic target of rapamycin (mTOR). Used extensively in solid organ transplantation and for certain oncological indications. Mediocon Inc manufactures pharmaceutical-grade Sirolimus API at its GMP-certified Aurangabad facility.

Therapeutic Applications
  • Organ transplant rejection prevention
  • mTOR pathway inhibition
  • Oncology (TSC, RCC)
  • Immunosuppressant formulations

Technical Specifications

ParameterSpecification
CAS Number53123-88-9
Molecular FormulaC₅₁H₇₉NO₁₃
Molecular Weight914.17 g/mol
GradeIP / BP / EP / USP
CategorymTOR Inhibitor / Immunosuppressant
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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