Quality parameters
• Appearance: White solid
• Identification:
– HPLC: Retention time of main peak corresponds to that of L-HCT HCl reference standard
– Mass spectrometry: m/z = 135.2 ± 4
• Residual heavy metals (ICP-OES): ≤ 100 ppm
• Purity (HPLC): ≥ 98.0%
• Bacterial endotoxins (gel-clot method): ≤ 10.0 EU/vial
• Bioburden (microbial enumeration tests):
– TAMC ≤ 10² CFU/vial
– TYMC ≤ 10¹ CFU/vial
Bioburden tests are performed for non-sterile products.