Penicillin G Benzathine
Benzathine Benzylpenicillin1.0 % lec., 0.2 % Tween, microfine, sterile
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Application
Mainly used in the manufacture of ready-for-use aqueous suspensions for injection. It must be suspended in water for injection using an agitator. The result is a homogeneous, agglomerate-free suspension, which shows an excellent physical stability due to the optimized particle size of the material. In order to improve the wettability and suspendibility the material is coated with 1.0 % of lecithin and 0.2 % of Tween.
Category
Depot penicillin for long-acting blood levels
Packaging
Storage
Store below 25°C,
Protect from light and moisture
Shelf life
60 months
Specification
| Appearance | white to whitish, crystalline powder |
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| Particle size | x(50,3): 4 - 10 µm 80 %: 2 - 20 µm exceeding 50 µm: informative exceeding 125 µm: informative |
| Acidity or alkalinity | corresponding to BP/Ph.Eur. |
| Water content (Karl Fischer) | 5.0 – 8.0 % |
| pH-value | 4.0 – 6.5 |
| Sterility (USP/Ph.Eur.) | sterile |
| Bacterial endotoxins (LAL-test/USP) | not more than 0.010 EU/100 IU |
| Largest impurity (Ph.Eur./HPLC) | not more than 1.0 % |
| Benzylpenicilloic acid benzathide (Ph.Eur./HPLC) | not more than 2.0 % |
| Assay/Content |
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1) Based on the anhydrous and non-coated substance
Pharmacopoeial quality
The active substance corresponds to USP, BP, Ph.Eur.
