Services and Solutions

品质至臻引领非凡追求卓越使命必达

Our Discovery Services covers the entire spectrum of early-stage research from target identification to delivery of drug candidates for further development. We have experienced team of medicinal chemistry and organic chemistry experts to support our customers’ need for hit identification, lead generation lead optimization programs.
Hit identification Hit-to-lead discovery Lead generation Lead optimization SAR development Libraries synthesis for Lead compounds Patent application preparation Project management

As an experienced commercial manufacturer, LinkChem can provide one-stop outsourcing intermediates services of process route development and verification, analysis method development and verification, process improvement and application registration to help customers with investigational to commercial-scales developments. The development services include a large number of raw materials, registered starting materials and GMP advanced intermediates throughout the entire drug development process.

With our strong and diverse infrastructure, LinkChem facilities are multipurpose and flexible and allow a rapid response to meet customer requirements. LinkChem have the advantage in the field of Heterocyclic Chemistry, chiral drugs, Carbohydrate chemistry, Nucleoside chemistry, Peptide Chemistry and Antibody Drug Conjugation (ADC).

LinkChem’s factory workshop has good versatility, flexible capacity of rapid switch and project management mode to ensure that the production and operation system can quickly and high-quality delivery of products and services required by customers.

Relying on the international standard quality system and large-scale commercialized GMP product production experience, we can provide customers with high quality commercialized API and GMP intermediate products at the optimal cost, and provide customers with a series of additional services such as secondary process development and optimization. LinkChem has different types and different sizes of plants, which can achieve the perfect combination of laboratory scale to commercial production scale and ensure the stability of supply.

: Development and optimization of innovative process routes; Production of API/intermediates; Synthesis and manufacture of building blocks; Development and process optimization of preclinical candidate compounds

: Process optimization of designated routes; Production of Special chemicals; GMP/Non-GMP production of intermediates; Synthesis of high-quality kg scale samples

Service Platform: XFlow Chemistry is committed to building the flow chemistry platform using the industrial continuous flow reaction technology, adhering to the concept of green and safe production, providing customers with continuous flow process design, process optimization, laboratory testing, feasibility study, equipment improvement, process development as well as fully integrated solutions to better meet the needs of customers in large-scale, sustainable production.

Reaction Types for Flow Chemistry Applications: Nitration reaction (concentrated sulfuric acid, dichloroethane); Sulfonation reaction; Chlorination reaction (photocatalytic, thermocatalytic); Amination/Reductive amination reaction; High-temperature and high-pressure reaction; Metal reagent reaction (butyl lithium, Grignard reagent, DIBAL-H, etc.); Diazotization reaction, diazonium salt hydrolysis; Oxidation reaction (hydrogen peroxide/Swern/peroxycarboxylic acid/ozone/air/nitric acid); Esterification reaction; Azide reaction; Gas-liquid reaction

Continuous Production Technology Development: Regular products + Continuous flow process; Complete line (multi-step reaction) of continuous technology process; Continuous reaction - extraction and washing - evaporation and crystallization - distillation and concentration

New Catalyst Technology + New Reactor Technology: Application of new technologies such as solid super acids, ionic liquids + Continuous flow technology; New process + New equipment; Reduce overall costs and achieve intrinsic safety

Feasibility Assessment of Continuous Reactions: Process development and optimization; Validation and scale-up; Generation of technology packages; Technology transfer to production; Continuous process improvement; Process optimization at laboratory, kilogram and commercial production scale

LinkChem has a highly experienced regulatory affairs team which provides CMC services at all research stages of Investigational New Drug application (IND) and its clinical trial phases (P1, P2, P3), New Drug Applications (NDA), Abbreviated New Drug Application (ANDA), and post-approval regulatory services including product change, annual report and re-registration service. LinkChem establishes standardized management system to ensure the authenticity and professionalism of the data, to assist the drug regulatory department verification. With profound professional knowledge in synthesis, QC, QA, domestic and foreign policies and regulations, registration and rich industry resources, we provide domestic and foreign customers with high efficiency and high quality drug registration and declaration services in accordance with the requirements of laws and regulations.

Route Screening &process optimization of APIs

Study of complete impurities of APIs

Polymorph, salt and co-crystal screening of APIs

Crystallization processes of API and intermediate for scale-up, control of polymorph and particle size

Technical pack of intermediates support

On-site audit

IND/NDA/ANDA regular filling support

Since 2015, LinkChem has formed its new functional materials business through continuous technology development and accumulation, including lithium battery materials, functional optoelectronic materials, semiconductor materials, PI monomer and other products. All the products have entered the stage in technology research and development, key process optimization, finished product quality control, commercial production and sales. A number of products have passed sample testing, and some products have entered the supply stage of large tonnage.

Service advantages

Technical advantages: The company has the national CNAS recognized laboratory, obtained CNAS certificate and CMA certificate.

Team advantages: The team has been deeply engaged in the material industry for decades, with strong independent research and development technology capabilities.

Capacity advantages: Jiangxi, Shandong and other industrial bases with annual tonnage level production capacity.

Management advantages: The company has perfect quality management system, also has a wealth of industrial mass production experience.

Service scope

Customized development

服务范围

Process research and analysis

服务范围

Commercial production services

Product list

Photoresist monomer, PI monomer, PSPI, Lithium battery additive, etc.

No.	Scope	Product
1	Photoresist monomer	4-tert-Butoxystyrene VPBO [95418-58-9]
2		4-(Ethoxyethoxy)styrene VPEO [157057-20-0]
3		4-Acetoxystyrene VPAC [2628-16-2]
4	PI monomer - Acid Anhydride	4,4'-(Hexafluoroisopropylidene)diphthalic anhydride 6FDA [1107-00-2]
5		3,3',4,4'-Benzophenonetetracarboxylic dianhydride BTDA [2421-28-5]
6		3,3',4,4'-Biphenyltetracarboxylic dianhydride BPDA [2420-87-3]
7		4,4'-Oxydiphthalic anhydride ODPA [1823-59-2]
8	PI monomer - Diamine	2,2'-Bis(trifluoromethyl)benzidine TFMB [341-58-2]
9		4,4'-Oxydianiline ODA [101-80-4]
10		2,2'-Dimethyl-[1,1'-biphenyl] -4,4'-Diamine mTD [84-67-3]
11		9,10-Anthracenedione, 2,4,5,7-tetraamino-1,8-dihydroxy- NADA [2716984-43-7]
12	LCD Photoresist PSPI	2,2-Bis(3-amino-4-hydroxyphenyl)hexafluoropropane 6FAP [83558-87-6]
13		3,3'-Diamino-4,4'-dihydroxydiphenyl sulfone BAS [7545-50-8]
14		3,3'-Dihydroxybenzidine HAB [2373-98-0]
15		2,2-Bis(3-amino-4-hydroxyphenyl)propane BAP [1220-78-6]
16		Phenol, 4,4'-cyclohexylidenebis[2-amino-CBAP [30817-90-4]
17		Phenol, 4,4'-oxybis[2-amino-OBAP [6423-17-2]
14	Lithium battery electrolyte additive	Vinylene carbonate VC [872-36-6]
15		Lithium Bis(fluorosulfonyl)imide LiFSl [171611-11-3]
16		Lithium bis(oxalate)borate LiBOB [244761-29-3]
17		Lithium difluoro(oxalato)borate(1-) LiODFB [409071-16-5]

: Quick analysis for new drug substance; Analytical support for process research; In process control and release test; Analytical method development, method validation and qualification; Elemental analysis and method development; Genotoxic impurity method development and validatio; Residual solvent method development and validation; Reference standard characterization and qualification; Impurity isolation, identification and characterization; Stability studies for drug substance