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Innovative R&D

Innovation direction

Technology platform

Patent certificate

Precision instrument platform

1、Precision instrument platform instrument introduction

Instrument name	Test item	Instructions
ICP-MS (Inductively Coupled Plasma Mass Spectrometer)	Full sweep of trace element impurities (semi-quantitative)	Only trace analysis is performed, and ion chromatography or other methods are recommended for major ion impurities
	Quantitative detection of trace element impurities (R&D or GMP),
	Method development
	Method validation (R&D or GMP)
LC-MS (Single lever LMS)	Organic impurity characterization (R & D), provide mass spectrometry (mass-charge ratio)	The M/Z range is 50-1200
LC-MS (Single lever LMS)		Sample preparation and mobile phase have special requirements
LCMSMS (Triple quadrupole LMS)	Development of trace impurity methods	Sample preparation and mobile phase have special requirements
	Method validation (R&D or GMP)
	Quantitative testing (R&D or GMP)
GCMSMS (Triple four-bar GC)	Development of trace impurity methods	EI source only
	Method validation (R&D or GMP)
	Quantitative testing (R&D or GMP)
	Full sweep
X-ray diffraction (XRD)	Crystal phase analysis (qualitative, quantitative)	If you want to do quantification, you need to do method development first to confirm whether the limit of quantification，can meet the requirements
DSC (Differential Scanning Calorimeter)	The glass transition temperature, cold crystallization, melting, phase transition, enthalpy change and product stability of the sample were detected.	The test temperature range is -80℃-500℃
TGA (Thermogravimetric Analyzer)	Study the thermal stability of substances.	Test temperature range: 30℃-500℃
Particle size analyzer	Test the particle size and particle size distribution of the sample	Dry method and wet method
Particle size analyzer	Development and validation of particle size detection methods	Dry method and wet method
BET (Nitrogen adsorption Desorption Apparatus)	Test the specific surface area and pore size of solid drugs	/
DVS (Dynamic Water Vapor Adsorption Instrument)	Studies on sample moisture-inducing and vapor-induced phase transformation	/
Preparation	Impurity preparation	/

2、External delegation detects business processes

　　(1)Consulting related business

　　Consult in advance for special projects and uncertain contents

　　(2)Determine the test items and instruments,fill in the application form for CMC precision instrument platform R&D sample testing(if there is a method or other requirements,add it in the remarks)

　　Note:No special requirements or previously tested can skip the consultation step.

　　(3)Follow the approval process of OA Rising Quality Center technical service commissioning

　　(Attached is the CMC precision instrument platform R&D sample testing application form)

　　(4)The sample and paper application form shall be sent to Wuhan Ruisheng Pharmaceutical,and the recipient shall be Zhu Lanlan

　　Note:If special circumstances require business communication,the corresponding person in charge of the instrument can be contacted.

3、Platform planning

　　1.The precision instrument platform has 10 instruments.According to the business characteristics,we will consider undertaking R&D sample testing commissioned by external enterprises in the future to fully improve the utilization rate of instruments.

　　2.The precision instrument platform will carry out laboratory and document system construction in accordance with GMP requirements.

　　3.Precision instrument platform has high technical requirements,more than 60%of the personnel are graduate students,and the follow-up will strengthen the personnel's instrument operation and principle training;Enable personnel to meet multiple development.