| Paclitaxel-Sino-Strong Pharmace
paclitaxel,natural paclitaxel,Taxol
Appearance Visual observation White to off-white powder
Identification Infrared Absorption USP <197K> In accordance with the reference
Standard spectrum of Paclitaxel USP<621>
The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the assay.
Assay(Potency) USP<621> 97.0%-102.0%
Water Method Ic USP<921> NMT 4.0%
Specific Rotation USP<781S> -49.0 - -55.0 (20 c)
Residue on Ignition USP<281> NMT 0.2%
Heavy Metals USP<231> NMT 0.002%(20ppm)
Microbial limits USP<61> Total aerobic microbial:
NMT 100cfu/g.
Absence of Staphaureusn aureus,
Pseudomonas aeruginosa,
Salmonella species,
and Escherichia coli.
Related
Substances Total
HPLC
USP<621>
NMT 2.0%
Cephalomannine NMT 0.5%
10-Deacetyl-7-epi
paclitaxel NMT 0.5%
7-Epipaclitaxel NMT 0.5%
Others NMT 0.1% each
Residue
Solvents Total
Method IV USP<467>
NMT 0.5%
Dichloromethane NMT 100ppm
Chloroform NMT 50ppm
Acetonitrile NMT 410 ppm
Ethyl acetate NMT 5000ppm
Methanol NMT 3000ppm
n-Hexane NMT 290ppm
Acetone NMT 5000ppm
Petroleum ether NMT 2000ppm
Mian products:(S)-1-phenyl-1,2,3,4-tetrahydroisoquinoline 118864-75-8 Solifenacin Intermediate Rocuronium Bromide 119302-91-9 Muscular relaxant Palonosetron Hydrochloride 135729-62-3 Antihypertension Oxaliplatin 61825-94-3
Zofenopril 81938-43-4 Antihypertension Adiphenine Hydrochloride50-42-0 Antispasmodic Dolasetron Mesylate 115956-13-3 Antihypertension Pregabalin 148553-50-8 Antiepileptic Gransetron Hydrochloride Pancuronium Bromide Vecuronium Bromide
Meptazinol Hydrochloride 59263-76-2 paclitaxel Docetaxel Darifenacin hydrobromide 133099-07-7Solifenacin Succinate Developing
(S)-1,2,3,4-tetrahedro-naphthoic acid 85977-52-2 5,6,7,8-tetrahydro-1-Naphthalenecarboxylicacid 4242-18-6 (R)-1,2,3,4-tetrahedro-naphthoic acid 23357-47-3 (S)-(-)-3-Aminoquinuclidine Dihydrochloride 119904-90-4
N-(1-azabicyalo[2,2,2]oct-3S-yl)-1,2,3,4-tetrahydronaphthalen-1S-ylcarboxamine 17-Oxo-5a-androst-2-ene 963-75-7 17-Acetoxy-5a-and rosta-2,16-diene 50588-42-6 2a,3a:16a,17a-Diepoxy-17b -acetoxy-5a androstane 50588-22-2
2,3-epoxy-1H-cyclopenta[a]phenanthrene,androstan-17-ol deriv 119302-19-1 (2b,3a,5a,16b,17b)-2-(4-morpholinyl)-16-(1-pyrrolidinyl)androstane-3,17-diol 119302-20-4 (2B,3a,5a,16b,17b)-17-acetoxy-3-hydroxy-2-(4-morpholinyl)-16-(1-pyrrolidinyl)androstane 119302-24-8 3-(Benzoylthio)-a-methylpropionic acid 74431-50-8 Dolasetron 115956-12-2 Endo-hexahydro-8-hydroxy-2.6-methano-2H-quinolizin-3(4H)-one 115956-07-5 Dolasetron intermediate |
