Place of Origin: China | Type: Auxiliaries and Other Medicinal Chemicals |
1. PVP K30, PVP K90, PVP K17: tech grade/cosmetic grade/USP26 2. Povidone iodines: USP26 3. Polyvinylpyrrolidone vinyl acetates (PVP VA) Packing: 25kg/drum
Tests | Standard USP32 | Examinations | |
Appearance | White or off-white powder | White powder | |
Identification | A. An orange-yellow precipitate is formed. | Conform | |
B. A pale blue precipitate is formed | Conform | ||
C. A deep red color is produced. | Conform | ||
5% in water) | 3.0-7.0 | 3.80 | |
Water | ≤5.0% | 3.50 | |
Residue on ignition | ≤0.1% | 0.029 | |
Lead | ≤10ppm | <1 | |
Limit of Aldehydes | ≤0.05% | <0.05 | |
Limti of Hydrazine | ≤1ppm | <1 | |
Vinylpyrrolidone (HPLC) | ≤0.001% | 0.0008 | |
K-Value (1% aqueous solution) | 27-32.4 | 30.10 | |
Nitrogen content(on anhydrous basis) | 11.5%-12.8% | 12.10 | |
Total Aerobic plate count CFU/g | ≤100 | <10 | |
Mold/Yeast ,CFU/g | ≤100 | <10 | |
Stalococcus Aureus, CFU/g | Negative | Negative | |
Salmonella, CFU/g | Negative | Negative | |
Pseudomonas aeruginosa, CFU/g | Negative | Negative | |
E.coli CFU/g | Negative | Negative | |
Conclusion | This batch meets the requirement of USP32/NF27 |
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