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GEOAnalytical, Inc. offers a number of solutions to our pharmaceutical client base ranging from standard compendial methods to unique problem solving using multiple trace analytical techniques. We offer contract services, which include stability indicating method development and validation, finished product and raw materials testing, and stability storage and testing.

Method Development and Validation
GEOAnalytical can provide method validation and development based upon your specific project needs. We can design a protocol to satisfy your intended purpose or requirements, or implement protocols for validation supplied by your staff. We can refine or modify existing methods to better meet your analytical requirements and validate them if necessary to ensure compliance with your particular study objectives. These services can be utilized in support of:

• Product development
• Stability testing
• Residual solvents studies
• Process/cleaning validations
• Container studies

• Formulation development
• Release testing
• Raw materials testing
• Extractable/leachable studies
• Stability indicating/forced degradation studies


Method development and validation can be done using a variety of organic and inorganic techniques including HPLC, LC/MS, GC and GC/MS, ICP and ICP/MS, Flame Atomic Absorption and UV/VIS.

Study protocols are developed at GEOAnalytical, Inc. and are submitted for client approval prior to project initiation. A comprehensive report will be issued upon completion including all methods used, tabular and graphic test results, chromatograms, spectra and pertinent overlays. Modifications to our reporting format may be accommodated upon request.

Product and Material Testing
GEOAnalytical, Inc. provides a wide range of compendial and non-compendial testing on both drug product and drug substances. Based upon your required application, testing can be conducted on finished products or as part of a stability program including release as well as long term or accelerated studies. Additional testing can be done on API, raw materials and excipients for compliance requirements or for investigative purposes. GEOAnalytical specializes in trace analysis and can assist with the identification of unknown contaminants or interferences by utilizing various organic and inorganic mass spectrometry techniques. We have been involved with method development by GCMS for recent USP changes involving residual solvents compliance, and are currently involved with development of heavy metals analysis by ICP/MS for compliance for residual catalyst. Our analytical capabilities include:

• GCMS Testing, Purge and Trap/Headspace/Direct injection/SPME
• GC Testing FID/ECD, Purge and Trap/Headspace/Direct injection
• HPLC Testing, Diode Array/UV/Refractive Index
• LCMS Testing
• Metals Analysis, ICP-MS/ICP/Flame AA/Mercury Cold vapor
• Spectroscopic Testing, UV/VIS
• Physical and chemical testing

 

* * * Click HERE for a brochure about our General Capabilities* * *

 

* * * Click HERE for a brochure about our Heavy Metals Testing* * *

 

* * * Click HERE for a brochure about our Leachables/Extractables Testing* * *