Pencillin G Benzathine

Benzathine Benzylpenicillinbuffered, sterile mixture

Molecular formula:
2(C16H18N2O4S).C16H20N2.4H2O
Molecular weight:
981.2
CAS registry no.:
41372-02-5
 Benzathine

Application

This mixture contains Penicillin G Benzathine (pulverized, 1.0 % lecithin, 0.2 % Tween) and approx. 9.2 % of sodium citrate buffer. The mixture can be filled into vials without adding any excipients. A homogeneous suspension for injection is prepared by adding water for injection and shaking briefly.

Antibiotic category

Depot penicillin for long-acting blood levels

Packaging

Storage

Store below 25°C,
Protect from light and moisture

Shelf life

48 months

Specification

Appearancewhite to whitish, crystalline powder
Injection testcorresponding (needle diameter: not more than 400 µm)
Water content
(Karl Fischer)		5.0 - 7.5 %
pH-value6.0 - 7.5
Sterility
(USP/Ph.Eur.)		sterile
Bacterial endotoxins
(LAL-test/USP)		not more than 0.010 EU/100 IU
Assay/ContentPenicillin G Benzathine (HPLC):
1010 - 1115 IU/mg

Pharmacopoeial quality

The active substance corresponds to USP, BP, Ph.Eur.