ALPRAZOLAM(0.25 MG) AND PROPRANOLOL HYDROCHLORIDE(20 MG) TABLETS

ALPRAZOLAM(0.25 MG) AND PROPRANOLOL HYDROCHLORIDE(20 MG) TABLETS

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.

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

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
 

c)Specific pathogens

 

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.

 

Specification