Active Pharmaceutical Ingredient

Paricalcitol — CAS 137000-91-6

Also known as: Zemplar (brand); 19-nor-1,25-dihydroxyvitamin D2; 19-nor-vitamin D2

GMP Certified IP / BP / USP Vitamin D Analog / Secondary Hyperparathyroidism Treatment Aurangabad, India
Paricalcitol API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Paricalcitol IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 137000-91-6

Product Overview

Paricalcitol is a synthetic vitamin D analog used in the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD). It selectively activates the vitamin D receptor (VDR) in the parathyroid glands and reduces PTH levels. Mediocon Inc manufactures this API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Prevention and treatment of secondary hyperparathyroidism in CKD patients
  • Management of elevated PTH levels in dialysis patients
  • Renal osteodystrophy treatment and bone disease prevention
  • Selective vitamin D receptor activation with reduced hypercalcemic effects

Technical Specifications

ParameterSpecification
CAS Number137000-91-6
Molecular FormulaC27H40O3
Molecular Weight412.61 g/mol
GradeIP / BP / USP
CategoryVitamin D Analog / Secondary Hyperparathyroidism Treatment
AppearanceWhite to off-white, crystalline powder
SolubilityPractically insoluble in water, freely soluble in ethanol and in methanol
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPCI/24032026
Mfg DateMAR 2026
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 / 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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