ExtRx Corporation provides onsite technical consultation as well follow-up laboratory work in pharmaceutical related polymers.

Areas of Consultation:

Polymer synthesis:

All aspects of condensation polymerization and addition polymerization. Extensive knowledge in the synthesis of homo polymers and copolymers of polyethylene oxide including ethoxylated fatty acids and alcohols, polyoxazolines, and acrylonitrile based polymers.

Polymer Characterization:

Polymer characterization using GPC, viscosity, GC, GC/MS, NMR, and other routine analysis such as pH, heavy metals etc.

Polymer Purification:

Purification of polymers using preparative GPC, supercritical fluid extraction/chromatography, and other routinely used processes such as solvent extraction, vacuum distillation etc.

CMC related activities for cGMP manufacturing and stability studies:

Planning, executing, project management on various CMC related activities for drug substance and drug compound for FDA filing of IND, ANDA, and NDA.

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Outsourcing and Technology Transfer:

Assist with vendor identification, screening and recommendation. Project specification development, planning and execution at vendor site.

Patents and documentation:

Assist with applying new patents and extension of existing patents. Work with patent attorneys to identify experimental data for new patents and extension of existing patents. Plan and execute appropriate experiments and write reports for patent attorneys.

Laboratory Facility:

ExtRx Corporation laboratory is equipped with the following equipments for synthesis, characterization and purification of polymers and related compounds. In addition to the major equipments listed, the labs are equipped with laboratory accessories such as centrifuges, freezers, water bath circulators, oil baths with controllers, ovens, vacuum pumps, pH meter, SS pressure filter units, magnetic stirrers, rotary evaporator,

Polymer Synthesis:

Equipment	Manufacturer	Specifications
2- Gal High Pressure SS Reactor with Magna drive	PARR Instrument Company	2 Gal with controller and data logging - cGMP version
2 Liter High Pressure SS Reactors with Magna drive (4 each)	PARR Instrument Company	2 Liter with controller and data logging
600 ml High Pressure SS Reactor with Magna drive	PARR Instrument Company	600 ml with controller and data logging
450 ml High Pressure SS Reactor with Magna drive	PARR Instrument Company	450 ml with controller and data logging
Several glass reactors		ranging from 5 ml to 5 L capacity
High vacuum line		capable of as low as 50 microns of Hg

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Polymer Characterization:

Equipment	Manufacturer	Specifications
GPC/HPLC - pump, autosampler, detector and software	Waters Corporation	with RI and Fluorescence detector
HPLC - pump, autosampler, detector and software	Waters Corporation	with RI and Fluorescence detector
GC with liquid autosampler and headspace auto sampler	Hewlett Packard	5890 series II GC with HP 7673 and HP 7694 auto samplers & controller
HP 5989A Mass Spectrometer	Hewlett Packard	Mass Detector for HP GC
GCD series Gas Chromatograph	Hewlett Packard	Electron ionization mass detector
Preparative LC System	Waters Corporation	Model 500 A
Cloud Point Apparatus
Multi Angle Light Scattering Detector	Wyatt Instruments	for GPC system
Various Balances	Mettler & Denver	Four analytical and 6 other
Microscopes	B & L	Stereo and Fluorescence

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Polymer Purification:

Equipment	Manufacturer	Specifications
Small scale high pressure extractor		from 10 ml to 100 ml extractors
Large scale high pressure extractor with co-solvent pump	Thar Designs	with 1 Gal stirred SS extractor and 1 Gal non-stirred SS reactor with solvent recovery system and data logging - cGMP version
Large scale high pressure extractor		with 1 Gal stirred SS extractor and 1 Gal non-stirred SS reactor with solvent recovery system
Wiped film vacuum still	Pope Scientific	2" still with controller
Several solvent extractors		capacity from 100 ml to 1 L