USD $140.00-190.00 / Kilogram
USD $140.00-190.00 / Kilogram
USD $10.00-40.00 / Kilogram
USD $40.00-65.00 / Kilogram
USD $135.00-200.00 / Kilogram
含量(按干燥品计) (hplc) assay (calculated on the anhydrous, solvent-free basis) |
97.0%~102.0% |
99.92% |
|
鉴别identification |
红外光谱定性:样品的红外光吸收图谱应与对照品的图谱一致 infrared absorption:in accordance with the reference standard spectrum of paclitaxel |
符合规定conforms |
|
高效液相色谱定性:紫杉醇出峰保留时间与标准品对照保留时间应一致 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. |
符合规定conforms |
||
比旋度[α]d20specific rotation |
-49.0°~-55.0° |
-53.5° |
|
有关物质(hplc) related compounds
|
巴卡亭ⅲ baccatin iii |
nmt 0.2% |
0.0359 |
10-去乙酰基紫杉醇10-deacetylpaclitaxel |
nmt 0.5% |
未检出undetected |
|
photodegradant 光学降解物 |
nmt 0.2% |
未检出undetected |
|
10-debenzoylbaccatin iii 10-去乙酰基巴卡亭ⅲ |
nmt 0.1% |
未检出undetected |
|
2-debenzoylpaclitaxel-2-pentenoate 2-去苯酰基紫杉醇-2-戊烯酸酯 |
nmt 0.7% |
0.0545% |
|
10,13-bissidechainpaclitaxel 10,13-二支链紫杉醇 |
nmt 0.5% |
未检出undetected |
|
7-acetylpaclitaxel 7-乙酰紫杉醇 |
nmt 0.6% |
未检出undetected |
|
7-tes-paclitaxel 7-三甲基紫杉醇 |
nmt 0.3% |
未检出undetected |
|
13-tes-baccatin iii 13-甲基巴卡亭iii |
nmt 0.1% |
未检出undetected |
|
7-表-紫杉醇 7-epipaclitaxel |
nmt 0.5% |
0.0826% |
|
其它单个杂质 others |
nmt 0.1% (each) |
0.0221% |
|
杂质总和 total |
nmt 2.0% |
0.36% |
|
残留溶剂organic volatile impurities |
二氯甲烷 dichloromethane |
nmt 600ppm |
51ppm |
丙酮 acetone |
nmt 5000ppm |
37ppm |
|
正庚烷 n-heptane |
nmt 5000ppm |
438ppm |
|
乙醚 ether |
nmt 5000ppm |
undetected |
|
水分 water
|
nmt 4,0% |
2.2% |
|
炽灼残渣 residue on ignition |
nmt 0.2% |
0.063% |
|
重金属 heavy metals |
nmt 0.002% |
符合规定conforms |
|
细菌内毒素bacterial endotoxins |
nmt 0.4 eu/mg |
符合规定conforms |
|
微生物限度microbial limits |
总的需氧微生物菌落数不得超过100 cfu/g total aerobic microbial count nmt100 cfu/g |
<20 cfu/g |
|
不得检出金黄色葡萄球菌,铜绿假单胞杆菌,沙门氏菌和大肠杆菌 it meets the requirements of the tests for the absence of staphylococcus aureus, pseudomonas aeruginosa, salmonella species, and escherichia coli |
未检出undetected |
含量(按干燥品计) (hplc) assay (calculated on the anhydrous, solvent-free basis) |
97.0%~102.0% |
99.92% |
|
鉴别identification |
红外光谱定性:样品的红外光吸收图谱应与对照品的图谱一致 infrared absorption:in accordance with the reference standard spectrum of paclitaxel |
符合规定conforms |
|
高效液相色谱定性:紫杉醇出峰保留时间与标准品对照保留时间应一致 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. |
符合规定conforms |
||
比旋度[α]d20specific rotation |
-49.0°~-55.0° |
-53.5° |
|
有关物质(hplc) related compounds
|
巴卡亭ⅲ baccatin iii |
nmt 0.2% |
0.0359 |
10-去乙酰基紫杉醇10-deacetylpaclitaxel |
nmt 0.5% |
未检出undetected |
|
photodegradant 光学降解物 |
nmt 0.2% |
未检出undetected |
|
10-debenzoylbaccatin iii 10-去乙酰基巴卡亭ⅲ |
nmt 0.1% |
未检出undetected |
|
2-debenzoylpaclitaxel-2-pentenoate 2-去苯酰基紫杉醇-2-戊烯酸酯 |
nmt 0.7% |
0.0545% |
|
10,13-bissidechainpaclitaxel 10,13-二支链紫杉醇 |
nmt 0.5% |
未检出undetected |
|
7-acetylpaclitaxel 7-乙酰紫杉醇 |
nmt 0.6% |
未检出undetected |
|
7-tes-paclitaxel 7-三甲基紫杉醇 |
nmt 0.3% |
未检出undetected |
|
13-tes-baccatin iii 13-甲基巴卡亭iii |
nmt 0.1% |
未检出undetected |
|
7-表-紫杉醇 7-epipaclitaxel |
nmt 0.5% |
0.0826% |
|
其它单个杂质 others |
nmt 0.1% (each) |
0.0221% |
|
杂质总和 total |
nmt 2.0% |
0.36% |
|
残留溶剂organic volatile impurities |
二氯甲烷 dichloromethane |
nmt 600ppm |
51ppm |
丙酮 acetone |
nmt 5000ppm |
37ppm |
|
正庚烷 n-heptane |
nmt 5000ppm |
438ppm |
|
乙醚 ether |
nmt 5000ppm |
undetected |
|
水分 water
|
nmt 4,0% |
2.2% |
|
炽灼残渣 residue on ignition |
nmt 0.2% |
0.063% |
|
重金属 heavy metals |
nmt 0.002% |
符合规定conforms |
|
细菌内毒素bacterial endotoxins |
nmt 0.4 eu/mg |
符合规定conforms |
|
微生物限度microbial limits |
总的需氧微生物菌落数不得超过100 cfu/g total aerobic microbial count nmt100 cfu/g |
<20 cfu/g |
|
不得检出金黄色葡萄球菌,铜绿假单胞杆菌,沙门氏菌和大肠杆菌 it meets the requirements of the tests for the absence of staphylococcus aureus, pseudomonas aeruginosa, salmonella species, and escherichia coli |
未检出undetected |