pengujian mutu tablet

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PENGUJIAN MUTU TABLET 1. Keseragaman Bobot Bobot tablet yang didinginkan : 500 mg Rentang bobot : ± 5 % ( 475 mg- 525 mg) Persyaratan : Tabel Keseragaman Bobot No Bobot tablet (gram) No Bobot tablet (gram) 1 0,461 g 1 0,471 g 2 0,466 g 2 0,464 g 3 0,464 g 3 0,468 g 4 0,463 g 4 0,460 g 5 0,469 g 5 0,468 g 6 0,460 g 6 0,465 g 7 0,464 g 7 0,470 g 8 0,465 g 8 0,464 g 9 0,464 g 9 0,465 g 10 0,463 g 10 0,466 g Bobot rata-rata : 0,465 g ( 0,422 g-0,489 g ) Kesimpulan : memenuhi keseragaman bobot 10% 5% Lebih dari 300 mg 15% 7,50% 151 mg-300 mg 20% 10% 26 mg-150 mg 30% 15% 25 mg atau kurang B A Penyimpangan terhadap bobot rata- rata Bobot rata-rata

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Pengujian mutu tablet:

PENGUJIAN MUTU TABLET1. Keseragaman Bobot Bobot tablet yang didinginkan : 500 mg

Rentang bobot : 5 % ( 475 mg- 525 mg)

Persyaratan :

Tabel Keseragaman Bobot

NoBobot tablet (gram)NoBobot tablet (gram)

10,461 g10,471 g

20,466 g20,464 g

30,464 g30,468 g

40,463 g40,460 g

50,469 g50,468 g

60,460 g60,465 g

70,464 g70,470 g

80,465 g80,464 g

90,464 g90,465 g

100,463 g100,466 g

Bobot rata-rata: 0,465 g ( 0,422 g-0,489 g )

Kesimpulan

: memenuhi keseragaman bobot

2. Keseragaman Ukuran

NoDiameter (mm)Tebal (mm)D/T

111,30 mm3,5 mm3,23

2

3

Rata-rata :

Persyaratan : Diameter tablet tidak lebih dari 3 kali dan tidak

kurang dari 1 1/3 tebal tablet.

Kesimpulan : D/T memenuhi syarat.

3. Waktu Hancur Tablet : 2,25 menit

- Persyaratan : < 15 menit

- Kesimpulan : tablet hancur terlalu cepat.

4. Kekerasan Tablet

NoKekerasan Tablet

11,1 kg

21,0 kg

31,0 kg

- Rata rata : 1,03 kg

- Persyaratan : tablet oral yang ideal adalah 4-8 kg

- Kesimpulan : tidak memenuhi syarat5. Kerapuhan Tablet :

NoBobot awal ( g )Bobot akhir ( g )Kerapuhan ( % )

14,645 g3,728 g19,74 %

24,612 g3,774 g18,17 %

34,654 g3,712 g20,24 %

- Rata rata : 19,56 %

- Persyaratan : < 1 %

- Kesimpulan : Tidak memenuhi syarat (Tablet terlalu rapuh/friabilitas

jelek).

6. Keseragaman kandungan : ( tidak dilakukan )

7. Uji Disolusi : ( tidak dilakukan )

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Bobot rata-rata

Penyimpangan terhadap bobot rata-rata

A

B

25 mg atau kurang

15%

30%

26 mg-150 mg

10%

20%

151 mg-300 mg

7,50%

15%

Lebih dari 300 mg

5%

10%

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