TEST

SPECIFICATION

1) Description

A brown coloured, round shaped, plain on both sides, film-coated tablet.

2) Identification

· Test A - IR

Infrared spectrum of sample should comply with that of standard sample.

· Test B - HPLC

The principal peak in the chromatogram obtained with the test solution should correspond to the peak in the chromatogram obtained with the reference solution.

3) Thickness

3.7 mm ± 0.2 mm

4) Diameter

8.1mm ± 0.1 mm

5) Average Weight

195.00 mg ± 7.5%

6) Uniformity of weight

within ±7.5.0% of average weight

7) Disintegration Time

NMT 30 min in water medium at 37???

8) Dissolution

NLT 70.0%

9) Assay - Valsartan USP

80 mg/Tab

90.0% to 110.0% of Label claim

(72.0 mg to 88.0 mg)

NAME OF PRODUCT : Atenolol Tablets

TEST

SPECIFICATION AS PER BP

Description

A white circular, flat uncoated tablet having breakline on each side of tablet.

Identification by IR

Should comply as per BP

Uniformity of weight

within ± 5% of average weight

Average Weight

0.2006 gm

Hardness

NLT 4.0 kg/cm2

Thickness

3.00 mm ± 0.2 mm

Diameter

8.00 mm ± 0.2 mm

Friability

NMT 1.0 %

Disintegration Time

NMT 15 min

Assay of Isosorbide Dinitrate

90.0% to 110.0% of Label claim

TEST

SPECIFICATION

Description

A blue coloured, oval shaped biconvex uncoated tablet, plain on both sides.

Identification:

Should comply as per IH

Uniformity of weight

± 5% of average weight

Average Weight

302.00 mg ± 3%

Thickness

4.40 mm (± 0.2 mm)

Height

12.50 mm (± 0.2 mm)

Friability

NMT 1.0 %

Hardness

NLT 4 kg/cm²

Assay by HPLC

Each uncoated chewable tablet contains:

Tadalafil……20 mg

(90 % to 110 %)

TEST

SPECIFICATION

Description

A yellow coloured, round shaped biconvex, film coated tablet plain on both sides.

Identification:

A. IR

B. TLC

C. Colour Development

The IR spectrum of the test residue should be concordant with the reference spectrum of Methyldopa

The principal spot in the chromatogram obtained with test solution should correspond with the reference solution

Green colour should be produced when reacted with Ferric Chloride & HCl. On further reacted with ammonia purple colour should be produced & red colour should be produced when reacted with NaOH

Uniformity of weight

± 5%  of average weight

Average Weight

530.40 mg ± 5%

Weight of 20 Tablets

10.608 g ± 3%

Thickness

4.40 mm (± 0.2 mm)

Diameter

12.80 mm (± 0.2 mm)

Optical Rotation

-0.98° to -1.09°

Disintegration time

NMT 30 minutes in water medium at 37???

Dissolution

NLT 80% (Q) of LA

Assay of Methyldopa

95.0% to 105.0% of LA

(237.5 mg to 262.5 mg)

TEST

SPECIFICATION

Description

A blue coloured, oval shaped biconvex uncoated tablet, plain on both sides.

Identification:

Should comply as per IH

Uniformity of weight

± 5% of average weight

Average Weight

302.00 mg ± 3%

Thickness

4.40 mm (± 0.2 mm)

Height

12.50 mm (± 0.2 mm)

Friability

NMT 1.0 %

Hardness

NLT 4 kg/cm²

Assay by HPLC

Each uncoated chewable tablet contains:

Tadalafil……20 mg

(90 % to 110 %)