詳細說明名稱: 微晶纖維素 PH301
CAS NO.: 9004-34-6
主要用途:
微晶纖維素PH 301 廣泛應用于藥物制劑,主要在口服片劑和膠囊中用作稀釋劑和粘合劑,不僅可用于濕法制粒也可用于干法直接壓片。還有一定的潤滑和崩解作用,在片劑制備中非常有用。
微晶纖維素301密度高,流動性更好,以便于壓制小劑量片劑。
藥品生產許可證編號:浙20120013,藥品注冊批準文號:浙藥準字F20140001
TEST ITEMS SPECIFICATION
Appearance White or almost white,fine or granular powder.
Identification A Conform
Identification B The degree of Polymerization≤350
Granulometry Remains 60mesh≤1%
Remains 200mesh≤30%
Conductivity ≤75us/cm
PH value 5.0-7.5
Loss on drying ≤7.0%
Residue on ignition ≤0.10%
Water Soluble Substances ≤0.25%
Ether-Soluble Substances ≤0.05%
Heavy metal ≤0.001%
Microbial limits
TAMC ≤1000cfu/g
TYMC ≤100cfu/g
Escherichia coli Absent
Salmonella species Absent
Staphylococcus aureus Absent
Pseudomonas aeruginosa Absent