Assay (GC) | 98.0 - 100.5 % |
Özdeşlik (IR) | conforms |
Appearance of solution (nephelometric) | conforms |
Clarity of solution | conforms |
Renk of solution | conforms |
Asitlik | conforms |
Refractive index (n 20/D) | 1.538 - 1.541 |
Yoğunluk (d 20 °C/20 °C) | 1.043 - 1.049 |
Peroxide value | ≤ 5.0 |
Related substances (GC) (Benzaldehyde (Impurity A)) | ≤ 0.05 % |
Related substances (GC) (Cyclohexylmethanol (Impurity B)) | ≤ 0.10 % |
Related substances (GC) (Sum of peaks with a relative retention less than that of benzyl alcohol) | ≤ 0.02 % |
Related substances (GC) (Sum of peaks with a relative retention greater than that of benzyl alcohol) | ≤ 0.20 % |
Related substances (GC) (disregard limit) | ≤ 0.0001 % |
Benzene (GC) | ≤ 0.0002 % |
Chlorobenzene (GC) | ≤ 0.01 % |
Toluene (GC) | ≤ 0.01 % |
Other residual solvents (ICH Q3C) | excluded by manufacturing process |
Buharlaşma Kalıntısı | ≤ 0.050 % |
Su | ≤ 0.1 % |
Bacterial endotoxins | ≤ 2.5 I.U./ml |
Parameter with periodic testing ¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯ Total aerobic microbial count (TAMC) ≤ 10² CFU/ml Total combined yeasts/moulds count (TYMC) ≤ 10¹ CFU/ml
|
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). Conforms to Ph Eur, BP, JP, NF |