Analytical Testing Labs

• Primary Methods Performed
• Analytical Services
• Instrumentation
• Samples Analyzed
• Method Validation Program

Primary Methods Performed
A wide range of methods are used to test both raw materials and finished products in accordance with compendial procedures including but not limited to:
USP/NF, BP, EP, JP, FCC, ACS, AOAC and In-house and client supplied methods


Analytical Services
We train our analysts in numerous routine and specialized techniques and provide support for NDA, ANDA, and IND submissions

• HPLC and GC Analyses
• Dissolution Studies
• Spectroscopy
• Physical and Wet Chemical Analysis
• Organic Volatile Impurities (OVI)
• Solvent Analyses
• Stability Storage and Testing
• Method Development and Validation
• Process and Cleaning Validations
• Thermal Analysis
• Total Organic Carbon (TOC)
• Container/Packaging Testing
• Antibiotic Assays

Instrumentation

• HPLC
  UV/Visible, diode-array, fluorometric, conductivity and refractive index detection
  -
• GC
  Flame ionization, and thermal conductivity detection. Capillary and headspace techniques.
  -
• Dissolution
  USP Methods I and II with automated sampling and quantitation.
  -
• Spectroscopy
  Atomic Absorption, UV/Visible, Infrared (FTIR and ATR), and fluorometric

back to top^

Samples Analysed
We analyze many types of samples including but not limited to:

• Finished products
  Including tablets, capsules, liquids, parenterals, and semi-solids
  -
• Raw Materials
  Including actives, fillers, binders, lubricants, colors, and other excipients
  -
• Container/Packaging
  Components including plastics, glass, foils, bottles, strip pack cards
  -
• In-process products
  Including bulk mixtures of solids or liquids prior to filling into capsules, bottles, vials, or syringes or before compressing into tablets

back to top^

Method Validation Program

Discussion

Celsis Laboratory Group will follow any client supplied validation format or make modifications to our standard defined protocol per client directives.

If a client does not wish to proceed with the full validation studies, or does not have access to the required validation materials, Celsis Laboratory Group will perform a spike validation study on a per product basis. For spike validation studies, a product is considered to be unique in terms of differing manufacturer or manufacturing site, formulation changes, or variance in the strength or combination of active ingredient(s).

The defined validation formats are applied according to the following:

• In-House Methodologies: All in-house testing procedures are subjected to either the ingredient method evaluation and the spike addition validation, or full product validation.
  
• USP Procedures Applied on NON-USP Products: These USP procedures are subjected to either the spike addition validation or full product validation.
  
• Compendial Procedures or Journal Procedures other than the USP or AOAC are subjected to either the spike addition validation or full product validation.

The following testing procedures are not subjected to validation studies unless specifically requested and initiated by a client.

• USP methods as directly applied to USP Products.
  
• AOAC procedures as specifically applied.
  
• Testing procedures supplied by a client for a defined product.
  
• Assay procedures for foods, feeds, and environmental concerns (pesticides, herbicides, etc.).

back to top^