1 | Description | Clear, colorless, oily liquid having a slight aromatic odor. | Clear, colorless, oily liquid having a slight aromatic odor. |
2 | Solubility | Complies | Practically insoluble in water and in glycerin. Miscible with alcohol,with ether, and with chloroform. |
3 | Identification A (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the corresponding standard |
4 | Assay | 99.6% | 99.0%-100.5% |
5 | Limit of Aldehydes (As benzaldehyde) | Less than 0.05% | NMT 0.05% |
6 | Specific gravity, 25°C | 1.117 | 1.116-1.120 |
7 | Congealing temperature | 19.2°C | Not less than 18.0°C |
8 | Refractive index,20° C | 1.569 | 1.568-1.570 |
9 | Acidity | Complies | NMT 1.5 mL of 0.02N sodium hydroxide should require to restore the pink color |
10 | Residue on ignition | 0.06% | NMT 0.1% |
11 | Total aerobic microbial count | Less than 100 CFU/ml | NMT 100 CFU/ml |
12 | Total combined yeast and molds count | Less than 10 CFU/ml | NMT 10 CFU/ml |
13 | Bacterial endotoxins | Less than 0.25 EU/ml | NMT 0.25 EU/ml |
14 | E.coli | Absent/ml | should be Absent/ml |
15 | Salmonella | Absent/10ml | should be Absent/10ml |
16 | Staphylococcus aureus | Absent/ml | should be Absent/ml |
17 | Pseud. aeruginosa | Absent/ml | should be Absent/ml |
18 | Purity (By GC) | 99.98% | NLT 99.8% |
19 | Any individual impurity (By GC) | 0.003% | NMT 0.10% |