Penicillin G Benzathine
Benzathine Benzylpenicillin1.0 % lec., 0.2 % Tween, pulverized, sterile
|
 |
Application
Mainly used for the manufacture of powders for injection (vials); the product can be filled into vials using any customary filling machine. A homogeneous suspension is prepared by adding water for injection and shaking briefly. For better 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 |
|---|---|
| Particle size | x(50,3): 14 - 24 µm 80 %: 4 - 50 µm exceeding 70 µm: informative exceeding 125 µm: informative |
| Injection test | corresponding (needle diameter: not more than 300 µm) |
| 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 |
|
1) Based on the anhydrous and non-coated substance
Pharmacopoeial quality
The active substance corresponds to USP, BP, Ph.Eur.
