| S.NO. | TESTS | SPECIFICATIONS | |||
| 1. | Description | White colored, rounded shaped, uncoated tablets having mid break line on one side and other side plain. | |||
| 2. | Average weight | 190.2 mg ±3% | |||
| 3. | Uniformity of weight | Within ± 7.5% of the Average weight. | |||
| 4. | Identification | 1.) Alprazolam: In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
2.) Propranolol Hcl: When examined in the range 230 nm to 360 nm, the final solution obtained in the Assay shows absorption maxima at about 290 nm, 306 nm and 319 nm. |
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| 5. | Hardness | NLT 2.5 kg/cm² | |||
| 6. | Disintegration Time | NMT 15 minutes | |||
| 7. | Dimension of Tablet | 1)Diameter: 8.19 mm ± 0.2 mm
2)Thickness: 3.15 mm ± 0.2 mm |
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| 8. | Friability | NMT 1.0% | |||
| 9. | Leak Test | Should be Pass | |||
| 10. | Uniformity of content (Alprazolam) | 85% to 115% | |||
| 11. | Assay: | ||||
| Each uncoated tablet contains: | Limit | ||||
| Claim | In mg | In % | |||
| Alprazolam I.P | 0.25mg | 0.225mg to 0.275mg | 90% to 110% | ||
| Propranolol HCL I.P | 20mg | 18.0mg to 22.0mg | 90% to 110% | ||
| 12. | Microbial Limit Test | ||||
| a)Total Bacterial count | NMT 100 cfu/gm | ||||
| b)Total Fungal Count | NMT 10cfu/gm | ||||
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c)Specific pathogens
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E. Coli | Should be absent | |||
| Salmonella | Should be absent | ||||
| S. aureus | Should be absent | ||||
| P. aeruginosa | Should be absent | ||||
| Pack size: | 10 x10 Blister | ||||
| Shelf life | 24 months | ||||
| Storage: Store protected from light and moisture. | |||||
