Regulatory-driven analytical services for drug development

We provide regulatory-driven analytical services for drug development including monitoring and quality control for APIs, intermediates, raw materials and finished products.

Our services encompass:

  • method development and validation, 
  • characterization of reference materials, 
  • stability testing, routine sample analysis, 
  • GLP batch release testing and other special studies. 

Our experienced scientists readily make efficient and productive solutions tailored to your projects. Our diversified and best-in-class analytical instruments enable us to provide optimized services for your individual needs.

In supporting CMC programs, pre-formulation, formulation and product release, our laboratories are equipped with advanced and qualified instruments. All written procedures and SOPs (standard operating procedure) are strictly followed so that data integrity is maintained with complete and accurate results and traceable records.

WuXi AppTec’s record of successful on-site inspections for a number of domestic and international projects shows our readiness to extend these services to support the development of your products.

Instruments in labs

API or Drug Product

Description

In Process Control

Reference Standardization

Method development validation

Compound release

Stability study

HPLC


Equipped with all kinda of detectors include UV, PDA, CLND, ELSD, CAD, FLD

HPLC/MS

Equipped with all kinds of MS detectors including single quadrupole, triple quadrupole, TOF, Orbitrap Elite

GC

Both headspace and direct injection mode available.

GC/MS

Both headspace and direct injection mode available.

NMR

500MHz or 400MHz, BBFO, smart probe, cold probe available

X-Ray Powder Diffraction

Nondestructive technique for the identification of crystalline phases in powdered solid samples

Elemental Analysis

Quantitative elemental composition

ICPMS

Performed on solid or liquid samples. They can determine a range of metals and several non-metals. Trace unknowns can also be detected and identified

IR

Both KBr pellet and ATR mode available

TGA DSC

More than one brand of high sensitive equipment available

Dissolution

Polarimeter

6 wavelengths are available: 589nm, 546nm, 365nm, 405nm, 436nm, 633nm

stability and photostability chamber

With all ICH conditions

Green: Often Used | Blue: Sometimes Used