| Meets U.S.P. Requirements |
| Assay (C6H14N4O2 HCl) (dried basis) | 98.5 - 101.5 % |
| Identification | Passes Test |
| Specific Rotation [a]20D | + 21.4 - 23.6 |
| Loss on Drying at 105°C | max. 0.2 % |
| Residue after Ignition | max. 0.1 % |
| Sulfate (SO4) | max. 0.03 % |
| Heavy Metals (as Pb) | max. 0.002 % |
| Chromatographic Purity: |
| Individual Impurities | max. 0.5 % |
| Total Impurities | max. 2.0 % |
| Organic Volatile Impurities | Conforms to USP/NF |
| Chloride (Cl) | 16.5 - 17.1 % |
| Assay (C6H14N4O2 HCl) (dried basis) | 98.5 - 101.5 % |
| Identification | Passes Test |
| Heavy Metals (as Pb) | max. 0.002 % |
| Loss on Drying | max. 0.3 % |
| Residue after Ignition | max. 0.1 % |
| Specific Rotation [a]20D | + 21.3 - 23.5 |
| Lead (Pb) | 5 mg/kg max |
| Meets BP/Ph.Eur. Chemical Specifications |
| Assay (C6H14N4O2 HCl) (dried basis) | 98.5 - 101.0 % |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Identification E | Passes Test |
| Appearance of Solution | Passes Test |
| Specific Rotation [a]20D | + 21.0 - 23.5 |
| Ninhydrin-Positive Substances | Passes Test |
| Sulfate (SO4) | max. 300 ppm |
| Ammonium (NH4) | max. 200 ppm |
| Iron (Fe) | max. 10 ppm |
| Heavy Metals (as Pb) | max. 10 ppm |
| Loss on Drying | max. 0.5 % |
| Ash (sulfated) | max. 0.1 % |
| Meets JP Chemical Specifications |
| Assay (C6H14N4O2 HCl) (dried basis) | 98.5 - 101.0 % |
| Identification | Passes Test |
| Optical Rotation | + 21.5 - 23.5 |
| pH (1 in 10) | 4.7 - 6.2 |
| Clarity and Color of Solution | Passes Test |
| Sulfate (SO4) | max. 0.028 % |
| Ammonium (NH4) | max. 0.02 % |
| Heavy Metals (as Pb) | max. 20 ppm |
| Arsenic (As) | max. 2 ppm |
| Other Amino Acids | Passes Test |
| Loss on Drying at 105°C | max. 0.20 % |
| Residue after Ignition | max. 0.10 % |
| Preserve in well-closed containers |
| Store protected from light |