uji penetapan volume injeksi dalam wadah
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Penetapan Volume Injeksi dalam Wadah
Sumber : FI IV & USP
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
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%
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.
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
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%