Method Development

CAL offers Method Development services for the following applications

  • Potency
  • Related Impurities/ Compounds
  • Cleaning Assessment
  • Drug Master File (DMF) Updates

Method Development can be conducted with the expertise of our highly qualified professionals through:

  • HPLC
  • GC, GC MSMS
  • AA, ICP
  • Titration – wet chemistry
  • UV-VIS spectroscopy
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CAL’s R&D Team can provide rapid method development services for different analytes.

Providing customized Method Development services is just one of the many ways in which CAL strives to meet customer needs.

CAL offers extensive expertise in the area of natural product analysis as many of the scientists employed at CAL have traditional training in pharmacognosy and natural product chemistry.

Our analytical professionals are skilled at recognizing and understanding specific requirements and solving unique problems. Many of our customers find these services useful as their products undergo the transition from R&D to production.

Sometimes official methods do not work for all types of formulations. This is especially true with complex formulations, such as Natural Health Products where multi-ingredient products are compounded into very complex matrices of botanicals. Our services provide solutions to complex natural health product analyses.

Method Development: Chromatography

CAL

Chromatographic method development begins with fundamental separation science concepts. Once the marker molecules are characterized and suitable chemical parameters (structure, solubility, chromophore etc.) have been established, experiments begin with the selected technology (HPLC, GC, etc.). Validation studies then confirm the system and method parameters.

CAL has expert knowledge of Chromatographic Methods complemented by extensive laboratory experience of more than 25 years.

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Method Development: Spectroscopy

CAL

Spectroscopic methods are developed or employed to characterize many classes of materials. Assay methods can be developed for molecules depending on absorption characteristics. This has led to the elucidation of many quantitative methods for botanical and enzymes.

CAL has expert knowledge of Spectroscopic Methods complemented by extensive laboratory experience of more than 25 years.