Biological and chemical quality control of spermicidal raw material nonoxynol-9 and nonoxynol-9 containing vaginal contraceptive (ABF contraceptive film): determination of spermicidal activity and assay of nonoxynol-9.
The paper presents a routine biological and chemical quality control of nonoxynol-9 raw material and pharmaceutical formulation containing nonoxynol-9 (ABF contraceptive film). The biological control performed based on the determination and comparison of the spermicidal activities different dilutions of the standard raw materials solution and assay raw material or nonoxynol-9 pharmaceutical formulation solution on the human or breeding bull sperm using a modified Sander-Cramer method. The test preparations of the nonoxynol-9 raw materials or pharmaceutical formulation should show equal or higher spermicidal activity than the standard. The spermicidal activity should not be lower than dilution 1:90. The chemical control is performed based on the determination and comparison of nonoxynol-9 content in the standard raw material solution and assay raw material or nonoxynol-9 pharmaceutical formulation solution using UV-spectrophotometric method determining and comparing the absorbances at the maximum absorbance wavelength (275 nm). The content of nonoxynol-9 in the raw material assay solution or pharmaceutical formulation (ABF contraceptive film) should be within 90-110% of the declared value.
Arambasić
M B
MB
Pharmaceutical Factory GALENIKA a.d., Quality Control Sector, Department of Biological Control, Batajnicki put b.b., Beograd-Zemun, Yugoslavia.
Zlatković
V
V
Dimitrijević
R
R
Ilić
N
N
D000818:Animals; D001681:Biological Assay; D002417:Cattle; D006801:Humans; D066298:In Vitro Techniques; D008297:Male; D017137:Nonoxynol / Q000737:chemistry* / Q000494:pharmacology*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013081:Sperm Motility / Q000187:drug effects; D013089:Spermatocidal Agents / Q000737:chemistry* / Q000494:pharmacology*
D013089:Spermatocidal Agents; D017137:Nonoxynol