Solvent | Minimum- maximum level measured during 0–36 months | ||||||
pH | Clarity | Colour | Weight loss | Transparency | Reducing substances | Absorbance (Au) | |
Phosphate buffer pH 2.0 | 2.2–2.3 | Clear | <BY7 | 0%–0.1% | Cloudiness perceptible | <0.01–0.03 | |
Phosphate buffer pH 5.8 | 5.4–5.9 | Clear | <BY7 | 0%–0.1% | Cloudiness perceptible | <0.01–0.03 | |
Phosphate buffer pH 8.0 | 7.8–7.9 | Clear | <BY7 | 0%–0.4% | Cloudiness perceptible | <0.01–0.02 | |
Phosphate buffer pH 11.4 | 11.4–11.6 | Clear | <BY7 | 0%–0.1% | Cloudiness perceptible | <0.01–0.06 | |
NaCl 0.9% | 4.7–8.9 | Clear | <BY7 | 0%–0.1% | Cloudiness perceptible | 0.2–1.3 mL | <0.01–0.02 |
IPA 5% | NA | Clear | <BY7 | 0%–0.1% | Cloudiness perceptible | 0.01–0.03 |