Solutions
Analytical Services

Overview 

The pharmaceutical analysis team includes Analytical R & D (ARD) department and  QC department. The ARD team has nearly 40 analysts, all of which have a bachelor's degree or above (75% have a master's degree or higher). The QC Department has nearly 20 people, all of which have a bachelor's degree or above, of which nearly 40 % have a master's degree or higher. The team can provide quick solutions to various analytical problems. They can provide complete analytical services for various dosage forms such as orals and injectables. At present, the analytical team not only supports the project of formulation development and production, but also provides independent analysis services.


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Main analysis services

 Analysis Research & Development 

● Analytical method development, verification, validation and transfer
● Stability studies to support formulation development
● Screening of packaging materials, extractable/leacheable studies
● Establishment of specifications for raw materials, packaging materials and products
● Rapid resolution of various analytical problems encountered by customers
● Preparation of relevant CMC sections and assistance with IND / NDA / ANDA and other filing
● Laboratory area ~ 450 m2, capable of supporting GMP and non-GMP projects


 Key Analytical Equipment 

● HPLC
● HS-GC
● Dissolution Apparatus
● UV-Vis
● Osmometer
● Residual oxygen meter
● Clarity Tester
● Particulate Matter Instrument
● Turbidimeter
● Separate Microbiology Labs
● Large Instrument Lab with LC-MS(MS)/ICP-MS/ICP-OES


 QC 

● Release of raw materials, packaging materials and products
● Stability studies including those per ICH standard storage conditions
● Analytical method verification and transfer
● Establishment of specifications for raw materials, packaging materials and products
● Laboratory area ~ 200 m2, managed according to cGMP


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Postal Address
  • Asymchem Inc. 600 Airport Blvd PO Box 1310
  • Morrisville NC 27560 USA
Physical Address
  • Asymchem Inc.
  • 600 Airport Blvd., Suite 1000 Morrisville, NC 27560 USA
Contact Us
  • information@asymchem.com
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