HV-24-0117 · Metformin HCl 500 mg tablets
- Product
- Metformin HCl 500 mg tablets
- Batch
- MF-2410-07
- Purpose
- Release
- Specification
- SPEC-MF500 v7
- Logged
- 2026-10-18 11:05 by A. Analyst
- Storage
- Room temperature, 15 to 25 °C
- Location
- Retain cabinet R2, shelf 3
- Status
- Awaiting review
| Test | Acceptance criteria | Result | Analyst | Instrument | Status |
|---|---|---|---|---|---|
| Identification (IR) | Conforms to reference spectrum | Conforms | A. Analyst | IR-01 | Approved |
| Assay (HPLC) | 95.0 to 105.0 % of label claim | 99.2 % | A. Analyst | HPLC-03 | Awaiting review |
| Water (KF) | NMT 0.5 % w/w | 0.41 % w/w | A. Analyst | KF-02 | Awaiting review |
| Dissolution, 30 min | Q NLT 80 % | 94 % (lowest unit 91 %) | B. Analyst | DISS-01 | Approved |
| Uniformity of dosage units | Acceptance value NMT 15.0 | Not started |
The sample is released for disposition once every test is approved.