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| Item | Specification | Result | Test Method |
| Appearance | White or off-white crystalline powder | Complies | Visual |
| Identification (FTIR/HPLC) | Conforms to reference standard | Conforms | USP <197> / USP <621> |
| Assay (on dried basis) | 99.0% - 101.0% | 99.70% | HPLC (USP <621>) |
| Melting Range | 234C - 238C | 236.5C | USP <741> |
| Loss on Drying | 0.5% | 0.12% | USP <731>(105C, 2 hrs) |
| Residue on Ignition (Sulfated Ash) | 0.1% | 0.04% | USP <281> |
| Heavy Metals (as Pb) | 10 ppm | < 5 ppm | (USP <232>) |
| Lead (Pb) | 3 ppm | < 1 ppm | ICP-MS |
| Arsenic (As) | 2 ppm | < 0.5 ppm | ICP-MS |
| Related Substances (HPLC) | Total impurities 0.5% | 0.18% | USP <621> |
| Individual unspecified impurity | 0.1% | 0.05% | IN-HOUSE |
| pH (Saturated aqueous solution) | 3.0 - 4.0 | 3.5 | USP <791> |
| Specific Rotation (if applicable) | -0.10 to +0.10 | +0.03 | USP <781> |
| Total Aerobic Microbial Count | 1000 CFU/g | 80 CFU/g | USP <61> |
| Total Yeast & Mold Count | 100 CFU/g | < 10 CFU/g | USP <61> |
| Escherichia coli | Absent in 10 g | Absent | USP <62> |
| Salmonella spp. | Absent in 25 g | Absent | USP <62> |
Packaging: 25 kg per fiber drum with double polyethylene liner."
Storage Conditions: Preserve in well-closed, light-resistant containers, in a cool, dry place."
Shelf Life/Expiry Date: Validity period under recommended storage
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