ISOTEC

Introduction

Services Overview

Facilities

SAFC Bangalore

Specialized Technologies

Manufacturing Sites
	ISOTEC™ Miamisburg, OH USA

ISOTEC™ has the most experienced team of stable isotope custom synthesis chemists in the industry, led by an impressive group of Ph.D.s, each one an expert in his field. ISOTEC routinely engages in the multiple-step syntheses of complex isotope labeled and natural abundance molecules including, metabolites and steroids. ISOTEC™ is proud to be the first isotope specialty company to successfully meet the US FDA manufacturing requirements for the production of stable isotope labeled and natural abundance drug substances.

Overview
Miamisburg Manufacturing Overview
	Over 20 years experience in complex, multi-step organic synthesis
	Custom synthesis , process development, and process validation
	Process dedicated laboratories and equipment
	Independent HVAC systems for each laboratory providing class 100,000 air quality
	Validated 5-gallon stainless steel pressure reactor
	USP water system
	Capacity ranging from milligrams to kilograms
	Registered with the FDA for manufacture of APIs
Special Technologies
	Stable isotope chemistry
	Chemical and Biochemical synthesis
	Separation and purification
	High temperature & high pressure technology
	High Purity Distillation (Gas and Liquid)
Analytical Capabilities
	Provides method development and method validation
	High-Field NMR's
	GC-MS
	HPLCs
	HPLC-MS
	ICs

Manufacturing Sites