BRIEFING

 Distilled Lime Oil. Because there is no existing NF monograph for this excipient and to align with the Lime Oil, Distilled monograph in the Food Chemicals Codex, a new monograph based on validated methods of analysis is proposed.

1. A gas chromatographic method with flame-ionization detection (GC-FID) was based on analyses developed for the determination of Citral Content (sum of neral and geranial) and validated using the Agilent DB-1 brand of column (0.25-mm × 30-m) with a 0.25-µm layer of G2 stationary phase. The relative retention times for neral and geranial are 0.95 and 1.0, respectively.

2. The Assay is based on the determination of d-limonene content with a validated GC-FID method using the Agilent DB-1 brand of column (0.25-mm × 30-m) with a 0.25-µm layer of G2 stationary phase. The typical retention time for d-limonene is about 10.74 min.

 (CE: R. Challa)

 Case ID—SUB-561