FabriChem Specifications
| ITEMS | SPECIFICATIONS |
|---|---|
| Appearance | Yellow crystalline powder |
| Identification A. HPLC B. Infrared Absorption | Positive Positive |
| Melting Point | 60 – 62°C |
| Solubility (1N NaOH) | Clear & Pale Yellow |
| Residue on Ignition | 0.10% Max. |
| Heavy Metals | 10 ppm Max. |
| Chloride | 0.07% Max. |
| Loss on Drying (Vacuum 40°C 3hr) | 0.20% Max. |
| Assay (by HPLC, USP Method) | 99.0% - 101.0% |
| Specific Optical Rotation | 1° to +1° |
| Chromatographic Purity (Test 1) A. Individual Impurity B. Total Impurities | A. 0.1% Max. B. 2.0% Max. |
| Chromatographic Purity (Test 2) | 2.0% Max. |
| Residual Solvents (by GC): | |
| Toluene | 30 ppm Max. |
| Ethyl Acetate | 0.20% Max. |
| Cyclohexane | 0.20% Max. |
| Microbiology: | |
| Total Aerobic Count | 1,000 CFU/g Max. |
| Yeast & Mold | 100 CFU/g Max. |
| E. Coli | Not Detectable |
| Salmonella | Not Detectable |