Formula: HOCH2(CHOH)4CH2OH
Formula Weight: 182.17
CAS Number: 69-65-8
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
| Assay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis) | 96.0 - 101.5 % |
| Acidity | Passes Test |
| Arsenic (As) | max. 1 ppm |
| Chloride (Cl) | max. 0.007 % |
| Identification | Passes Test |
| Loss on Drying at 105°C | max. 0.3 % |
| Melting Range | 164 - 169°C |
| Reducing Sugars | Passes Test |
| Specific Rotation [a]25D | + 137 - 145 |
| Sulfate (SO4) | max. 0.01 % |
| Meets BP/Ph.Eur. Chemical Specifications |
| Assay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis) | 98.0 - 102.0 % |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Identification C | Passes Test |
| Identification D | Passes Test |
| Appearance of Solution | Passes Test |
| Conductivity, µS cm-1 | max. 20 |
| Reducing Sugars | max. 0.2 % |
| Related Substances | Passes Test |
| Lead (Pb) | max. 0.5 ppm |
| Nickel (Ni) | max. 1 ppm |
| Water (H2O) | max. 0.5 % |
| Endotoxin Concentration, <2.5 IU/g | Passes Test |
| Total Viable Aerobic Count (cfu): |
| Bacterial Count (per g) | max. 100 |
| Fungi Count (per g) | max. 100 |
| Eschericha coli and Salmonella | Passes Test |
| Meets JP Chemical Specifications |
| Assay (as HOCH2(CHOH)4CH2OH) (calculated on anhydrous basis) | 98.0 - 101.0 % |
| Identification A | Passes Test |
| Identification B | Passes Test |
| Specific Rotation [a]25D | + 137 - 145 |
| Melting Point | 166 - 169°C |
| Clarity and Color | Passes Test |
| Acidity | Passes Test |
| Chloride (Cl) | max. 0.007 % |
| Sulfate (SO4) | max. 0.010 % |
| Heavy Metals (as Pb) | max. 5 ppm |
| Nickel (Ni) | Passes Test |
| Arsenic (As) | max. 1.3 ppm |
| Sugars | Passes Test |
| Loss on Drying at 105°C | max. 0.30 % |
| Residue on Ignition | max. 0.10 % |