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STABILITY STUDY
Alpha-Lipoic Acid Injection
40 mg/mL, 15mL Single Dose Vial
Summary of Long-Term Storage Data (25°C ± 2°C / 60%RH ± 5%RH)
| Test | Method | Months | |||
|---|---|---|---|---|---|
| 0 | 3 | 6 | 9 | ||
| Product Appearance (Description) | Visual | PASS | PASS | PASS | PASS |
| Package Appearance (Seal) | PASS | PASS | PASS | PASS | |
| Package Appearance (Vial) | PASS | PASS | PASS | PASS | |
| Container Closure Integrity | Bonfiglioli Leak Tester | PASS | PASS | PASS | PASS |
| Foreign Matter (Visible) | USP <1> and USP <790>, supplement with USP <1790> | PASS | PASS | PASS | PASS |
| pH | USP <791> | 7.3 | 7.1 | 7.0 | 6.8 |
| Assay | HPLC / UPLC | 39 mg/mL | 39 mg/mL | 39 mg/mL | 39 mg/mL |
| Identification | PASS | PASS | PASS | PASS | |
| Impurities | Conforms to Specification | ||||
| Particulate Matter (Sub-Visible) | USP <788> Method I | PASS | PASS | PASS | PASS |
| Bacterial Endotoxin | USP <85> | PASS | PASS | PASS | PASS |
| Sterility | USP <71> | PASS | PASS | PASS | PASS |
Reduced L-Glutathione Injection
200 mg/mL, 30 mL Multi-Dose Vial
SUMMARY OF LONG-TERM STORAGE DATA (REAL-TIME AT 5°C ± 3°C)
| Test | Method | Months | |||||
|---|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 5 | 6 | ||
| Product Appearance (Description) | Visual | PASS | PASS | PASS | PASS | PASS | PASS |
| Package Appearance (Seal) | PASS | PASS | PASS | PASS | PASS | PASS | |
| Package Appearance (Vial) | PASS | PASS | PASS | PASS | PASS | PASS | |
| Container Closure Integrity | Bonfiglioli Leak Tester | PASS | PASS | PASS | PASS | PASS | PASS |
| Foreign Matter (Visible) | USP <1> and USP <790> | PASS | PASS | PASS | PASS | PASS | PASS |
| pH | USP <791> | 5.9 | 5.8 | 5.7 | 5.8 | 5.8 | 5.8 |
| Assay | HPLC / UPLC | 207 mg/mL | 208 mg/mL | 200 mg/mL | 199 mg/mL | 197 mg/mL | 195 mg/mL |
| Identification | PASS | PASS | PASS | PASS | PASS | PASS | |
| Benzyl Alcohol | 0.9% | 0.9% | 0.9% | 0.9% | 0.9% | 0.9% | |
| Impurities | Conforms to Specification | ||||||
| Particulate Matter | USP <788> Method I | PASS | PASS | PASS | PASS | PASS | PASS |
| Bacterial Endotoxin | USP <85> | PASS | PASS | PASS | PASS | PASS | PASS |
| Sterility | USP <71> | PASS | PASS | PASS | PASS | PASS | PASS |
| Antimicrobial Effectiveness | USP <51> | PASS | PASS | PASS | PASS | N/A | PASS |
Methylcobalamin Injection
5000 mcg/mL, 30 mL Multi-Dose Vial
SUMMARY OF LONG-TERM STORAGE DATA (25°C ± 2°C / 60%RH ± 5%RH)
| Test | Method | Months | |||
|---|---|---|---|---|---|
| 0 Months | 3 Months | 6 Months | 9 Months | ||
| Product Appearance (Description) | Visual | PASS | PASS | PASS | PASS |
| Package Appearance (Seal) | PASS | PASS | PASS | PASS | |
| Package Appearance (Vial) | PASS | PASS | PASS | PASS | |
| Container Closure Integrity | Bentiglioli Leak Tester | PASS | PASS | PASS | PASS |
| Foreign Matter (Visible) | USP <1> and USP <790>, supplement with USP <1790> | PASS | PASS | PASS | PASS |
| pH | USP <791> | 7.8 | 7.5 | 7.3 | 7.5 |
| Assay | HPLC / UPLC | 5.1 mg/mL | 5.4 mg/mL | 5.3 mg/mL | 5.0 mg/mL |
| Identification | PASS | PASS | PASS | PASS | |
| Benzyl Alcohol | 0.9% | 0.9% | 0.9% | 1.0% | |
| Impurities | Conforms to Specification | ||||
| Particulate Matter (Sub-Visible) | USP <788> Method I | PASS | PASS | PASS | PASS |
| Bacterial Endotoxin | USP <85> | PASS | PASS | PASS | PASS |
| Sterility | USP <71> | PASS | PASS | PASS | PASS |
| Antimicrobial Effectiveness Test | USP <51> | PASS | N/A | PASS | N/A |
Procaine HCl Injection
20 mg/mL, 30 mL Multi-Dose Vial
SUMMARY OF LONG-TERM STORAGE DATA (25°C ± 2°C / 60%RH ± 5%RH)
| Test | Method | Months | ||||
|---|---|---|---|---|---|---|
| 0 | 3 | 6 | 9 | 12 | ||
| Product Appearance (Description) | Visual | PASS | PASS | PASS | PASS | PASS |
| Package Appearance (Seal) | PASS | PASS | PASS | PASS | PASS | |
| Package Appearance (Vial) | PASS | PASS | PASS | PASS | PASS | |
| Container Closure Integrity | Bonfiglioli Leak Tester | PASS | PASS | PASS | PASS | PASS |
| Foreign Matter (Visible) | USP <1> and USP <790> | PASS | PASS | PASS | PASS | PASS |
| pH | USP <791> | 4.2 | 3.7 | 4.1 | 3.6 | 3.7 |
| Assay | HPLC / UPLC | 19.8 mg/mL | 19.9 mg/mL | 20.3 mg/mL | 20.0 mg/mL | 20.1 mg/mL |
| Identification | PASS | PASS | PASS | PASS | PASS | |
| Impurities | Conforms to Specification | |||||
| Particulate Matter (Sub-Visible) | USP <788> Method I | PASS | PASS | PASS | PASS | PASS |
| Bacterial Endotoxin | USP <85> | PASS | PASS | PASS | PASS | PASS |
| Sterility | USP <71> | PASS | PASS | PASS | PASS | PASS |
| Antimicrobial Effectiveness Test | USP <51> | PASS | PASS | PASS | N/A | PASS |
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