uji penetapan volume injeksi dalam wadah

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Penetapan Volume Injeksi dalam Wadah Sumber : FI IV & USP

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Page 1: Uji Penetapan Volume Injeksi Dalam Wadah

Penetapan Volume Injeksi dalam Wadah

Sumber : FI IV & USP

Page 2: Uji Penetapan Volume Injeksi Dalam Wadah

Bila volume:

• ≥10 ml 1 wadah atau lebih

• 3 ml<v<10 ml 3 wadah atau lebih

• ≤3 ml 5 wadah atau lebih

Jumlah Sampel

Page 3: Uji Penetapan Volume Injeksi Dalam Wadah

VOLUME INJEKSI

Ukuran Label Larutan Encer Larutan Kental

0.5 mL 0.1 mL 0.12 mL

1 mL 0.1 mL 0.15 mL

2 mL 0.15 mL 0.25 mL

5 mL 0.3 mL 0.5 mL

10 mL 0.5 mL 0.7 mL

20 mL 0.6 mL 0.9 mL

50 mL or more 2% 3%

Page 4: Uji Penetapan Volume Injeksi Dalam Wadah

PROCEDURES•Take up individually the content of each

container into a dry hypodermic syringe fitted with 21-guage needle, 2.5 cm length.

•Discharge the contents of the syringe into a dry cylinder or in dry tared beaker, weigh the solution.

•The content of two or three containers (each 1 or 2-mL) may be pooled for the measurement using separate dry syringe.

 

Page 5: Uji Penetapan Volume Injeksi Dalam Wadah

RESULT•The volume is not less than the labeled volume

in the case of containers examined individually,

•or in the case of pooled samples, is not less than the sum of the labeled volumes of the containers taken collectively.

•For injections containing oil, warm the containers and shake them thoroughly and remove the content. Cool to 25 C before measuring the volume

Page 6: Uji Penetapan Volume Injeksi Dalam Wadah

Volume InjeksiKelebihan Volume yang dianjurkan

Labeled size Mobile liquid Viscous liquid

0.5 mL 0.1 mL 0.12 mL

1 mL 0.1 mL 0.15 mL

2 mL 0.15 mL 0.25 mL

5 mL 0.3 mL 0.5 mL

10 mL 0.5 mL 0.7 mL

20 mL 0.6 mL 0.9 mL

50 mL or more 2% 3%