Active Pharmaceutical Ingredient

Sirolimus

Also known as: Rapamycin; Rapamune; Fyarro

CAS: 53123-88-9 mTOR Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Sirolimus API — Mediocon Inc
Sirolimus — Pharmaceutical Grade API

Product Overview

CAS No: 53123-88-9  |  MF: C₅₁H₇₉NO₁₃  |  MW: 914.17 g/mol

Sirolimus (Rapamycin) is a macrolide compound with potent immunosuppressant and antiproliferative properties used as an active pharmaceutical ingredient. Mediocon Inc supplies high-purity Sirolimus API conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Sirolimus inhibits the mammalian target of rapamycin (mTOR), a key protein kinase involved in cell proliferation and immune activation. It is used to prevent organ rejection in transplant patients and in the treatment of certain cancers and rare diseases.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Organ transplant rejection prophylaxis
  • Renal cell carcinoma treatment
  • Lymphangioleiomyomatosis (LAM)
  • Drug-eluting coronary stent coating

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 NameSirolimus
Also Known AsRapamycin; Rapamune; Fyarro
CAS Number53123-88-9
Molecular FormulaC₅₁H₇₉NO₁₃
Molecular Weight914.17 g/mol
CategorymTOR Inhibitor — Immunosuppressant
AppearanceWhite to off-white powder
SolubilityInsoluble in water; freely soluble in ethanol and methanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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