Qingdao TaiHongDa Chemical Co.,Ltd  
Product catalogue
Boronic acids
Other series
Chemical & Analytical Development  

Analytical Development (ARD) is to support Chemical Process Development and Formulation Development during the pharmaceutical development. ARD offers GMP compliant Analytical and Microbiological testing services to the pharmaceutical and biotech companies. We are equipped with state-of-the-art analytical instruments. We deliver fast and reliable results and help our clients to achieve their goals of registration.THAIHONGDA CHEMICAL CO.,LTD  ARD team offers a wealth of experience and expertise in every aspect of analytical support ranging from method development to regulatory submissions. Our team also has experience with SFDA filing to get Clinical Trial Approval in China.

Key Services


Method development and validation for starting material, intermediates, API, and dosage forms
Residual solvent
Content uniformity
Chiral methods
Cleaning methods
Method transfer
Stability program design and testing
Reference standard qualification
Impurity/degradant isolation, identification and characterization
Clinical materials release and stability to support clinical program
CMC document preparation (IND, NDA, SFDA clinical trial permit, DMF)
Microbiological tests

ARD Instrumentation


HPLC, LC-MS, GC, GC-MS, NMR (300, 400 MHz), Prep-LC, dissolution bath, UV and more.
All Sundia instruments employed for analytical method validation, product release and stability testings are qualified and calibrated per cGMP requirements

Stability Program




Stability chambers fully qualified and calibrated
Continuous electronic monitoring and daily check
Equipped with alarm, automated call -out
Full UPS back-up
Back-up chambers
Standard chamber conditions that can support global registration:



Study and protocol design
Long-term stability testing
Accelerated stability testing
Drug substance stability testing
Drug product stability testing
Photostability testing
Forced degradation studies
Evaluate product storage and derive shelf life
Strict documentation of stability sample tracking
Timely results and timely notification of OOS and OOT results
Customized interim and final stability reports

Impurity/Degradant Isolation, Identification and Characterization


Isolation of impurities from mg to multi-gram level
Fraction collection via analytical- to preparative-scale chromatography
Multiple identification tools on site: LC/MS/MS, LC/DAD, NMR, etc
Synthesis of authentic materials for reference to isolated impurities

Microbiological Equipment/services


Microbial Limits
Antimicrobial Effectiveness
Antibiotic Assay
Particulate Matter (Light Obscuration and Optical Microscopy)
Water Testing
Environmental Monitoring

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