Analytical Chemistry

Analytical chemistry is critical to the entire API manufacturing process as it is the suitability and sensitivity of the analytical methods that underpins the API manufacturing process and ultimately, the quality of the API.

RML Pharma Consulting will provide all of the following services as part of an outsourcing campaign at contract or we can provide a more tailored approach depending on your requirements.

  • Testing schedule for starting materials, isolated intermediates and API

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      • API buying specification

          • Analytical method development and validation

              • Development of stability indicating methods

                  • Development of in-process monitoring (IPM) to support manufacture

                      • Analysis of API against agreed target specification

                          • Drug substance release including appropriate documentation (Certificate of Analysis, Certificate of GMP Conformance, TSE/BSE statements)

                              • Genotoxic Risk Assessment of manufacturing process - for clinical supplies only and may involve the development of specific limit tests to detect potential genotoxic impurities in API to acceptable levels.