Many Japanese pharmaceutical companies are now intensively investigating methods for inspection of starting materials. One of the reasons is the PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) accession of Japan in the near future. Since samples taken from all containers must be tested, speed of identification is strongly required.
Another requirement is the protection of the materials. There are contamination risks for opening the packages, and direct material identification through a glass bottle or a transparent bag is often required.
Handheld Raman spectrometers are recently recognized as an effective tool for starting material inspection. In the past, near infrared absorption spectroscopy was often used in this field. However, Raman spectroscopy, which supplies us much more information for samples, has a higher capability of material identification. The direct material identification through a glass bottle or a transparent bag is possible by Raman spectroscopy only.
Raman spectrometers used for pharmaceutical inspections must have performance characteristics described in USP <1120>. The portable Raman spectrometer reported here meets the requirements of USP <1120>.