“nm he RT
SHENYANG ANTIBIOTIC MANUFACTURER
Hew
CERTIFICATE OF ANALYSIS
845) Nou: ZLIS64-02
aa 1a 175Kg
. Rifmpicin Quantity
EM
Batch No. =o Date of manufacture soe
1 E HEE
32, EK. P2021 peeled AuG2722021
23Kes) FEM
PRE, 23k dn neat ba Juans
aA aR
‘Test Item Specification Result
ae ARCRRLE ARCA M RR
Appearance Reddish brown or brownish ed erystalline powder Reddish brown crystalline powder
aoe BOF, AFENINE, GAP TREATZARE (9690). eae
Solabiliey Slightly soluble in water, soluble in methanol, slightly soluble in Casha
‘acetone and in ethanol (96%)
AUVs MFHRAPBIXE 237mm. 254nm. 334nms 475mm AA EAA
We, BL 334nm $5 475mm JERE AWC CLE 1.755 Role
A. By UV: The solution shows 4 absorption maxima, at 237am, ie
254nm, 334nm and 47Snm, The ratio ofthe absorbance at the re
xa ‘maximum of 334nm to that at 475nm is about 1.75
Wentitiation BIR: INO MRC por
B, By IR: The IR spectrum shall correspond with the Rifumpicin Coo
standard spectrum, complies
C RARK: MOGCRORARLE, FERRER. RoW
. By colour reaction: The colour changes from orange-yellow to cols
violet-red and no precipitate is formed,
WE Acidity pH 45-65 57.
FORA REAP z
Impurity A (Rifampicin Quinone) 15% 015%
Ld TEAR
Related Substances Any other impurity <10% 0.76%
TEEAREAT Gel AD. =
“ota impurities oer than A hiss 217%
eee z Wome
Heavy Metals <20ppm Qualified
FH
Loss on Drying <10% 0%
oy =
Sulpated Ash <0.10% 0.08%
FE OFFRRE
‘Assy (On dried basis) 97.0% 102.0% 99.3%
Ban ETA n-Butano!