Item | Specification | Result | Test Method |
Active Ingredient | |||
Assay(%,on dry basis) | 99.00% ~ 102.00% | 99.62% | HPLC |
Purity | NLT 99.00% | 99.91% | HPLC |
Excipient impurities | PVP Free | Negative | GC |
Physical Control | |||
Identification | 1H NMR spectra correspond to reference standard | Conforms | 1H NMR |
13C NMR spectra correspond to reference standard | Conforms | 13C NMR | |
LC-MS retention time and m/z correspond to reference standard | Conforms | LC-MS | |
Appearance | White to off-white crystalline powder | Conforms | Visual |
Odor & taste | Characteristic | Conforms | Organoleptic |
Appearance of solution | 5%w/v in water: Colorless to pale yellow and clear | Conforms | Organoleptic |
Sodium Content | NMT 1.0% | Conforms | GB5009.268-2016 |
Water Content | NMT 1.0% | 0.09% | Karl Fischer |
PH(1.0g/100mL(25℃) | 3.0-4.5 | 3.68 | ChP2020 |
Bulk Density | 0.60-0.80g/ml | 0.73g/ml | USP-NF 2024 |
Residue Solvents | Ethanol: NMT 500ppm | 20ppm | USP-NF 2024 |
Chemical Control | |||
Arsenic (As) | NMT 0.5ppm | Conforms | ICP-MS |
Cadmium (Cd) | NMT 0.5ppm | Conforms | ICP-MS |
Lead (Pb) | NMT 0.5ppm | Conforms | ICP-MS |
Mercury (Hg) | NMT 0.1ppm | Conforms | ICP-MS |
Microbiological Control | |||
Total Plate Count | NMT 1000cfu/g | Conforms | USP-NF 2024 |
Yeast & Mold | NMT 100cfu/g | Conforms | USP-NF 2024 |
Salmonella | Negative | Negative | USP-NF 2024 |
E.Coli | Negative | Negative | USP-NF 2024 |
Staphylococcus Aureus | Negative | Negative | USP-NF 2024 |
Pseudomonas aeruginosa | Negative | Negative | USP-NF 2024 |
Bile-tolerant Gram- Negative Bacteria |
Negative | Negative | USP-NF 2024 |
Candida albicans | Negative | Negative | USP-NF 2024 |
Clostridia | Negative | Negative | USP-NF 2024 |
Coliforms | NMT 0.92MPN/g | Conforms | GB4789.3 |
NMN–Beta-Nicotinamide Mononucleotide, Сырье для производства товаров для здоровья
NMN–Beta-Nicotinamide Mononucleotide
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