KAMAT PHARMATECH

Services / Quality Testing

Quality Testing involves developing a Quality Management System of your drug substance and drug product.

Kamat Pharmatech can demonstrate quality of effective systems to be used in pre-clinical and clinic studies as well as manufacturing by verifying such protocols written. Kamat Pharmatech provides clients with studies related to ICH 10 "Pharmaceutical Quality Systems" which can provide important data when filing.

Developing a QMS for you product is very important when it comes to commercialization, thus studying and preparing this system can start during initial stages. Even though during initial stages the product is still developing, understanding such Quality Aspects early can help tremendously when it comes to final stages.

Relevant Instruments

Densitometer	METTLER TOLEDO	Densito 30PX
Differential Scanning Calorimeter	PerkinElmer	DSC4000
Freeze Drying Microscope	Linkam	Olympus BX51
HPLC-CAD System	Peak Scientific Instruments Ltd.	Corona Nitrogen 1010
HPLC-RID	SHIMADZU	RID-20A
HPLC-UV System	SHIMADZU	LC-2010AHT
HPLC-UV System	SHIMADZU	LC-2010AHT
Karl-Fischer Coulometer	Metrohm	831 KF Coulometer
Osmometer	ADVANCED INSTRUMENTS INC.	Model 3320
Oxygen Meter	PreSens	Microx 4
Particle Size Distribution Analyzer	Shimadzu	SALD-2300
Polarimeter	Azzota Corporation	AP-45
Rheometer	TA Instruments	Discovery HR-2
Texture Analyzer	Stable Micro Systems	TA.XT plus Texture Analyzer
Type IV Dissolution Apparatus	SOTAX	CE7 smart
UV-Vis Spectrophotometer	Azzota Corporation	SM1000 UV-Vis Spectrophotometer
Viscometer	RHEOSENSE, INC.	uVISC
Zeta Potential Meter	Microtrac	ZETA-check PMX 500