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Analytical Services
Methods Development Services
To develop and optimize methods, scientists at our cGMP compliant analytical facilities are equipped with an array of tools and techniques, including HPLC, LC-MS/MS, TLC, GC and GC/MS.
Syngene develops analytical methods for the following applications:
- Potency
- Impurities
- Residual solvents
- Physical and chemical tests
- Cleaning assessment
- Chiral purity
- Others as requested
Validation Services
After a successful method development, Syngene has the capabilities to validate analytical method as per ICH guidelines. Our analysts frame their methods validation activities using a practical approach coupled with outstanding quality and sound scientific expertise.
Analytical Method Validation is categorized as below:
Chromatographic Method Validation
HPLC
- Assay of actives
- Related compounds or impurities
- Cleaning validation
- Preservatives or Major excipients
GC
- Residual solvents by headspace GC
Non-chromatographic Method Validation
- Titrimetric assay methods
- TLC related substance methods
- UV assay methods
Typical characteristics include:
- Specificity
- Forced degradation or Stress study
- Oxidative
- Base
- Acid
- Photolytic
- Thermal
- Limit of detection
- Limit of quantitation
- Range (Accuracy, Linearity and Precision)
- Ruggedness or Intermediate precision
- Robustness
- Solution stability (Standard and Sample)
- Response factor determination
Steps in Analytical Method Validation (For external methods):
- Method Assessment/Evaluation for external methods
- Method optimization or modification (if required)
- Method development undertaken if existing methods are not specific
- Pre-validation assessment prior to approval of validation protocol
- Validations undertaken after protocol approval
- Protocol has sign off from both Syngene and clients QA.
- Post experimental validation report is written at Syngene
Report is reviewed and approved by QA (Syngene and Client’s)
Stability Studies
Syngene offers stability studies as an integral component of its analytical services.
Stability Testing
- APIs
- R&D preliminary stability (protocol development, testing and evaluations)
- QC release/stability
Stability Storage
- Walk-in/Reach-in units
- ICH conditions
- Continuous monitoring
- Continuous alarming
- Generator back-up
- IQPQ with mapping
Stability Reporting
- 4-week reporting windows
- Data trending
- Comprehensive reports
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