| Description |
White to almost white powder |
| Odour |
Natural Sweet taste |
| Particle Size |
NMT 80% smaller than 0.7 mm (200mesh) |
| Solubility |
Freely Soluble in water, Insoluble in ethanol (95%) |
| Appearance solution |
Clear meet the reference solution BYS7 |
| Identification (B & C) |
(B&C)should comply with pharma (IP)
(IP) Should comply with pharma (IP) |
| Identification by IR |
Should comply with pharma (IP/BP/USP) |
| Identification by TLC |
Should comply with pharma (BP/USP) |
| Lactose Monohydrate(by Mass) |
Min. 98.0% |
| Water Content (w/w) |
4.5% to 5.5% |
| Light Absorption (400 nm) |
NMT 0.04% |
| Light Absorption (210-220 nm) |
NMT 0.25% |
| Light Absorption (270-300 nm) |
NMT 0.07% |
| Heavy Metals (as Pb) |
NLT 5 PPM |
| Arsenic (As) |
NLT 1 PPM |
| Ash (sulphated) w/w |
NMT 0.1% |
| Specific Rotation |
+54.40 to 55.900 |
| Acidity & Alkalinity |
NMT 0.4ml of 0.1M NaOH |
| Loss on drying (@800C) |
NMT 0.5% |
| Bulk Density (g/cc) |
NLT 0.70 |
