Nitrogen analysis of pharmaceutical excipients


Courtesy of Courtesy of BÜCHI Labortechnik AG

Customer: Butterworth Laboratories, United Kingdom

Wilh nearly 40 years' experience, Butterworth Laboratories remains an independent UK con¬tract analytical service providing Method Development, Method Validation, Stability Testing and OC Testing to the pharmaceutical, medical device and chemical industries. They work in part¬nership with clients who not only recognize expertise in analytical chemistry and standards ot service but also value integrity and impartiality.

Application: Nitrogen analysis of pharmaceutical excipients

Butterworth Laboratories monitors the nitrogen content of pharmaceutical excipients such as povidone and crospovidone according to the Kjeldahl method; European Pharmacopoeia 2.5.9 and determination of nitrogen by sulphuric acid digestion and nitrogen determinations to United States Pharmacopoeia <461>. The Nitrogen value relates to the assay and purity of product. Butterworth Laboratories also use the BUCHI instrumentation to look at proteins such as N-Z amine and Bacto yeast extracts.

Equipment: Distillation Unit K-355 and SpeedDigester K-436

Up to 12 prepared samples are placed into the BUCHI K-436, a sealed system with mini¬mal sample loss. Once digested the ammonia is distilled and captured in boric acid using a BUCHI K-355 Kjeldahl unit followed by titration methods that are then used to provide a nitro¬gen value in %. Butterworth Laboratories previously used a classical glassware method for this application.

Benefit/Conclusion: Unprecedented speed and reliability

The BUCHI K-355 distillation unit in combination with the K-436 SpeedDigester provides an integrated solution that meets Butterworth's customer's requirements. Time is saved as a trans¬fer step of sample to distillation vessel is omitted and chemical handling is safer compared with classical glassware methods. The K-355 in conjunction with the K-436 delivers an efficient process workflow with a series of 6 samples now completed in 45 minutes rather than the 2-3 hours previously.

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