Item | Specification |
Appearance | Clear, colourless, volatile liquid |
Identification | IR spectrum of sample is consistent with that of reference standard. |
Acidity or alkalinity | Colour reaction: ≤0.10mL of 0.01M sodium hydroxide or ≤0.60mL of 0.01M hydrochloric acid. |
Refractive index | 1.2745 - 1.2760 |
Related substances | Impurity A: ≤25ppm |
Impurity B: ≤100ppm | |
Impurity C: ≤100ppm | |
Sevochlorance: ≤60ppm | |
Any unspecified impurity: ≤100ppm | |
Total impurities: ≤300ppm (Disregard any impurity less than 5ppm) | |
Fluorides | ≤2μg/mL |
Non-volatile residue | ≤1.0mg per 10.0mL |
Water | ≤0.050% |
Microbial limit | Total aerobic microbial limit: Not exceed 100CFU/mL |
Total yeast and molds count: Not exceed 10CFU/mL | |
Bile-tolerant gram-negative bacteria: It is absent per mL | |
Staphylococcus aureus: It is absent per mL | |
Pseudomonas aeruginosa: It is absent per mL | |
Assay | Contains 99.97% - 100.00% of C4H3F7O |