1 | Description | Clear, colorless, oily liquid having a slight aromatic odor. | Clear, colorless, oily liquid having a slight aromatic odor. (USP) |
2 | Solubility | Passes | Practically insoluble in water and in glycerin. Miscible with alcohol,with ether, and with chloroform. (USP) |
3 | Identification A (By IR) | Complies | IR Spectra of the sample should be concomitant with IR spectra of the corresponding standard (USP) |
4 | Assay | 99.85% | 99.0%-100.5% (USP) |
5 | Limit of Aldehydes (As benzaldehyde) | Less than 0.05% | NMT 0.05% (USP) |
6 | Specific gravity, 25°C | 1.116 | 1.116-1.120 (USP) |
7 | Congealing temperature | 18.2°C | Not less than 18.0°C (USP) |
8 | Refractive index,20° C | 1.568 | 1.568-1.570 (USP) |
9 | Acidity | Complies | NMT 1.5 mL of 0.02N sodium hydroxide should require to restore the pink color (USP) |
10 | Total aerobic microbial count | Absent | 100CFU/mL max (In-house) |
11 | Total combined yeast and molds count | Absent | 10CFU/mL max (In-house) |
12 | Bacterial endotoxins | Complies | NMT 0.25 EU/mL (In-house) |
13 | E.coli | Absent | It should be Absent/mL (In-house) |
14 | Salmonella | Absent | It should be Absent/10mL (In-house) |
15 | Staphylococcus aureus | Absent | It should be Absent/mL (In-house) |
16 | Pseud. aeruginosa | Absent | It should be Absent/mL (In-house) |
17 | Purity (By GC) | 100.0% | NLT 99.8% (In-house) |
18 | Any individual impurity (By GC) | Not detected | NMT 0.10% (In-house) |