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Analytical Development

Analytical Development (ARD) is to support Chemical Process Development and Formulation Development during the pharmaceutical development. ARD offers GMP compliant Analytical 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.

Sundia 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
• Assay/potency
• Impurity/degradation
• Residual solvent
• Moisture
• Content uniformity
• Dissolution
• 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)

ARD Instrumentation
HPLC, LC-MS, LC-MSMS,UPLC-MS,GC, GC-MS, NMR (300, 400 MHz), Prep-LC, dissolution bath, UV,SFC Prep-LC 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

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