The production and assessment of a plastic rod for the Chinese Reference Preparation for Opacity.
A reference preparation for opacity consisting of a plastic rod was introduced by Perkins et al. in 1973. It was adopted as the International Reference Preparation for Opacity in 1975. This plastic rod opacity reference preparation has been used to standardize the Chinese National Bacterial Opacity Standard. The material was prepared from plastic sheet by a water-bath method and by a dry-heat method; the sheet was then machined into the plastic rods. We have studied the technical processes and set up methods for the examination of the sheets and rods. The water-bath method was found to be better than the dry-heat method in our tests. Collaborative assays in research institutes of biological products have shown that the plastic rod can replace the glass-powder suspension. The duration of validity of the plastic rod opacity reference preparation and that of the glass-powder suspension used for the Chinese National Bacterial Opacity Standard were studied and found to be similar. For this reason the plastic rod opacity reference preparation has not been widely used in China.
Yi
X B
XB
National Institute for the Control of Pharmaceutical and Biological Products, Temple of Heaven, Beijing, China.
Xu
H L
HL
Qin
J C
JC
Qiao
L Y
LY
D015169:Colony Count, Microbial; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000032:analysis*; D004586:Electrophoresis; D005898:Glass; D006801:Humans; D008970:Molecular Weight; D010969:Plastics; D011137:Polystyrenes / Q000032:analysis; D012015:Reference Standards; D013056:Spectrophotometry, Ultraviolet; D013997:Time Factors
D004365:Drugs, Chinese Herbal; D010969:Plastics; D011137:Polystyrenes