| Product Name | Semaglutide | Sample Source | Workshop 106 |
| Batch Number | LX106S2305107 | Packing Size | 131.03g/bag, 401.6g/bag, 477.57g/bag |
| Quantity | 1010.2g | Manufacturing Date | Apr-10-2023 |
| Number of Packages | 3 | Retest Date | Apr-09-2025 |
| Sample Date | Apr-28-2023 | Report Date | May-08-2023 |
| Testing Reference | QC-03-1003-02, QC-02-1595-03 |
| TEST ITEM | SPECIFICATION | TEST RESULT |
| Appearance | White or almost white loose powder | white loose powder |
| Solubility | Freely soluble in water, soluble in DMF at 1 mg/mL, 30 mg/mL in DMSO, 0.2 mg/ml in a 1:4 solution of DMSO:PBS | conforms |
| Identification (MS) | 4111.12±0.5Da | 4111.15 |
| Identification (HPLC) | Examine the chromatograms obtained in the assay. The principal peak in the chromatogram obtained with the test solution is similar in retention time and size to the principal peak in the chromatogram obtained with reference solution. | conforms |
| Specific Optical Rotation [α]20D (anhydrous substance) | -6.0° to -16.0° | -10.3° |
| Purity (HPLC) | NLT 98.0% | 99.47% |
| Water Content | NMT 8.0% | 3.9% |
| pH | 7.0 to 9.0 | 7.9 |
| Solution Clarity and Color | Clear and colorless | conforms |
| Acid Group Ions | Trifluoroacetate ion NMT 0.1% | N.D. |
| Phosphate ion NMT 0.1% | N.D. |
| Chloride ion NMT 0.1% | 0.003% |
| Acetate ion NMT 0.1% | N.D. |
| Sodium Ion | NMT 4.0% | 2.1% |
| Related Substances I | SPEC054-Z18 NMT 0.50% | N.D. |
| SPEC054-Z20 NMT 0.30% | 0.03% |
| SPEC054-Z21 NMT 0.50% | N.D. |
| SPEC054-Z57 NMT 0.20% | N.D. |
| Any other impurities NMT 0.10% | 0.02% |
| Total impurities NMT 1.0% | 0.08% |
| Related Substances II | SPEC054-Z19 NMT 0.30% | 0.02% |
| SPEC054-Z23 NMT 0.20% | 0.03% |
| SPEC054-Z69 NMT 0.20% | N.D. |
| Total related substances I and II NMT 1.50% | 0.12% |
| Amino Acid Analysis | Asp:0.8-1.2 | 1.1 |
| His:0.8-1.2 | 1.0 |
| Tyr: 0.8-1.2 | 1.2 |
| Lys: 0.8-1.2 | 1.0 |
| Ile: 0.8-1.2 | 1.0 |
| Aib: 0.8-1.2 | 0.8 |
| Leu: 1.6-2.4 | 2.2 |
| Val: 1.6-2.4 | 2.1 |
| Arg: 1.6-2.4 | 2.0 |
| Thr: 1.6-2.4 | 1.9 |
| Phe: 1.6-2.4 | 1.9 |
| AEEA: 1.6-2.4 | 1.7 |
| Ser: 2.4-3.6 | 2.8 |
| Ala: 2.4-3.6 | 3.0 |
| Gly: 3.2-4.8 | 4.0 |
| Glu: 4.0-6.0 | 5.2 |
| Trp (Partially destroyed during acid hydrolysis) | detected |
| Bacterial Endotoxins | 2 EU/mg | < 2 EU/mg |
| Microbial Limits | Total aerobic microbial count NMT 100 cfu/g | < 10 cfu/g |
| Total yeasts and molds count NMT 50 cfu/g | < 10 cfu/g |
| Escherichia coli count | Absent in 1g |
| Conclusion: This batch of product COMPLIES with the prescribed standards. |
| Storage condition: -20°C ± 5°C, well-closed containers, protected from light. |
Complaint
