Analysis and testing platform/chemical process testing platform of Medicilon

2020-06-22

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Platform Introduction

Shanghai Medicilon chemical analysis and testing platform is a shared platform that provides analysis and testing services.

The platform has a professional and refined scientific research service team. There are more than 80 devices including NMR, SFC, UPCC, ICP-MS, IC, LC-MS/MS, Prep-HPLC, DSC, TGA, etc. The classification registration sample management system is implemented, which implements automatic management and clear charging, and mainly serves the fields of chemistry, medicine, and chemical industry. At present, the platform has established long-term cooperative relations with many companies, providing strong support for the scientific research work of each company.

Cooperation model

(1) Test class
Sign an annual agreement, monthly payment or quarterly payment;

(2) Project category
Sign a single project, you can sign an annual framework agreement.

Undertake business:

(1) Can undertake business-test category:

Serial number	Instrument/Type	Instrument model
1	Nuclear magnetic resonance NMR	Bruker 400 MHz
2	LC-MS	Shimadzu LC-MS 2020
		Waters UPLC-Qda
		Agilent 6120
3	GC-MS	Agilent 7890B;
3	GC-MS	Shimadzu GC-MS 2020
4	High performance liquid chromatography HPLC	Agilent 1200；
4	High performance liquid chromatography HPLC	Shimadzu 20AD
5	Chiral sample analysis UPCC/HPLC	Waters UPCC
5	Chiral sample analysis UPCC/HPLC	Shimadzu 20AD
6	Residual solvent analysis GC-HS	Agilent GC-HS 7890B
6	Residual solvent analysis GC-HS	Shimadzu GC-2010 plus
7	Ion content analysis IC	Thermo IC 5500
8	Metal element analysis ICP-MS	PE NexION 1000
9	UV spectrum UV	PE LAMBDA 365

10	Infrared spectrum IR	PE Spectrum Two
11	Optical rotation test OR	Anto Paar MCP5300
12	Differential Thermal Analysis DSC	METTLER DSC 3
13	Thermogravimetric analysis TGA	METTLER TGA 2
14	Moisture test KF	METTLER V30S
14	Moisture test KF	METTLER C30SX
15	Ignition residue test ROI	Muffle
16	Loss on drying test LOD	Oven
16	Loss on drying test LOD	METTLER HX 204
17	Melting point test MP	METTLER MP 70
18	Solution Clarity Analysis	Clarifier
19	Solubility test	Visual method
20	Microbial limit test	Pharmacopoeia Standard Test

(2) Can undertake business-analysis projects:

Serial number	project	Use the instrument
1	diQ-NMR	NMR
2	Structural confirmation	NMR
3	Impurity standardization (declaration)	HPLC, GC-HS, moisture meter, ROI
4	API standardization (declaration)	HPLC, GC-HS, moisture analyzer, ROI, titrator
5	Compound main peak preparation	Pre-HPLC
6	Impurity preparation	Pre-HPLC
7	Chiral method screening and splitting	SFC
8	Stability test	Stability box, HPLC, GC-HS and physical and chemical instruments
9	GC-HS methodology development and validation	GC-HS

10	GC-MS methodology development and validation	GC-MS
11	HPLC methodology development and validation	HPLC
12	ICP-MS method development and verification	ICP-MS
13	IC method development and verification	IC
14	LC-MS-MS method development and verification	LC-MS-MS
15	Microbial limit method development and verification	Microbiology laboratory

Main large instruments:

(1)

Nuclear Magnetic Resonance Spectrometer NMR

model:
Bruker Avance Ⅲ HD 400 MHz

Main functions: suitable for molecular structure analysis, content determination, known structure confirmation and unknown structure speculation and reaction mechanism research in chemistry, medicine, chemical industry, etc. It can test the NMR spectrum of various cores such as H, C, F, P, B and so on; equipped with PABBO SP probe, it can be used for 1H, 13C, DEPT, NOESY, COSY, HMBC, HSQC and other 1D and 2D homonuclear and heteronuclear Related experiments and variable temperature experiments.

(2)

Inductively coupled plasma mass spectrometer ICP-MS

model:

PE NexION 1000

Main function : suitable for the research of metal elements in chemistry, biology, medicine, clinical and so on. It can measure more than 80 elements at the same time, with high sensitivity, simultaneous multi-element rapid analysis, suitable for trace or ultra-trace element analysis of complex systems (10-9~10-12g/L). Such as research techniques for the control and analysis methodology of elemental impurities.

(3)

Ion Chromatography IC

model:

Thermofish ICS5000+ (conductivity and amperometric detector)

Main functions: Widely used in the analysis and methodological studies of anions, cations, organic acids, organic amines, cyanide, sulfur ions, iodide ions, sugars and amino acids in samples from industries such as environment, materials, chemicals, food, biology, and medicine .

(4)

Triple quadrupole mass spectrometer LC-MS-MS

model:

Agilent 6410

Main functions: suitable for molecular weight determination in chemical, pharmaceutical, chemical and other aspects, detection and methodological study of trace PGI impurities from ppm to ppb levels.

(5)

Chiral sample analysis

model:

Waters UPC2/8 column screening

Chiral sample analysis

model:

Shimadzu 20AD/12 column screening

Main functions:suitable for screening and development of chiral compounds in chemistry, medicine, chemical industry, etc., ee value, chiral purity determination, etc. Provide a powerful method for the resolution of chiral compounds.

(6)

Chiral split SFC

model:

SFC80/SFC150

Main function: suitable for the resolution of chiral compounds from mg to 100g in chemistry, medicine, chemical industry, etc.

(7)

Gas chromatography-mass spectrometer GCMS

model:

Agilent 5977A

Gas chromatography-mass spectrometry GCMS

Model: Shimadzu GC-MS 2020

Main function: Suitable for environment, food, petrochemical industry, biomedicine, flavor and fragrance, forensic poison, tobacco and other industries. It can qualitatively and quantitatively detect and analyze small molecular organic compounds with low boiling point and good thermal stability, especially suitable for low boiling point Methodological studies on trace impurities such as potentially genotoxic impurities.

(8)

Pre-LC

model:

Waters 2545-QDa150ml/min

Preparative chromatography

model:

Gilson 306 50ml/min

Main functions: suitable for separation and purification of organic synthesis products of compounds in chemistry, medicine, chemical industry, etc., preparation and separation of trace impurities in raw materials and preparations.

Other instruments

	infrared spectrometer model: PE Spectrum TWO
	UV spectrometer model: PE Lambda 365
	Polarimeter model: Anton Paar MCP5300
	Moisture Analyzer: model: METTLER TOLEDO V30S
	Moisture Analyzer: model: METTLER TOLEDO V30S
	Potentiometric titrator: model: METTLER TOLEDO T50