磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.713959603956833955983955813953103956260.06
212.643948793939693944240.17
单位质量响应值RSD%判断
31127.1431204.430.18数据可信
中间条件24月-供试品溶液-2022030701批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327570-32757073.58474.586.5773.5874.586.57
2297356-29735666.79766.80
3351578-35157878.97778.98
4317894-31789471.41171.41
5350135-35013578.65378.65
6347590-34759078.08278.08
10min1388108-38810887.18386.012.8387.3186.142.84
2363519-36351981.66081.77
3395048-39504888.74288.87
4378766-37876685.08585.20
5386100-38610086.73286.86
6385882-38588286.68386.81
15min1400880-40088090.05289.901.0790.3290.161.07
2391769-39176988.00688.25
3403519-40351990.64590.92
4402439-40243990.40390.66
5401550-40155090.20390.48
6401007-40100790.08190.36
20min1406066-40606691.21791.500.4691.6491.920.46
2405276-40527691.04091.43
3406046-40604691.21391.64
4409727-40972792.04092.45
5407610-40761091.56491.99
6409201-40920191.92292.35
30min1414186-41418693.04293.390.5193.6193.960.51
2414265-41426593.05993.61
3415263-41526393.28393.87
4419440-41944094.22294.79
5414279-41427993.06293.64
6417048-41704893.68494.26
45min1419929-41992994.33295.010.4595.0695.740.45
2422228-42222894.84895.55
3422569-42256994.92595.66
4425477-42547795.57896.30
5423434-42343495.11995.85
6424058-42405895.25995.99
极限1428304-42830496.21396.470.5897.1097.350.57
2431145-43114596.85197.71
3426708-42670895.85496.75
4432928-43292897.25298.13
5427014-42701495.92396.82
6430481-43048196.70297.59
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.713945093943593942683941823938903942420.06
212.643934143932863933500.03
单位质量响应值RSD%判断
31018.2531119.460.24数据可信
中间条件24月-供试品溶液-2022030801批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1322514-32251472.67571.075.4072.6771.075.40
2309435-30943569.72769.73
3311541-31154170.20270.20
4293238-29323866.07866.08
5311259-31125970.13970.14
6344383-34438377.60377.60
10min1375485-37548584.61183.402.7884.7383.512.78
2366631-36663182.61682.73
3367113-36711382.72582.84
4356382-35638280.30680.42
5367942-36794282.91183.03
6386978-38697887.20187.33
15min1394449-39444988.88487.881.3489.1588.141.35
2388199-38819987.47687.73
3390294-39029487.94888.20
4382516-38251686.19586.44
5387368-38736887.28987.54
6397094-39709489.48089.76
20min1405001-40500191.26290.161.0291.6790.561.02
2400378-40037890.22090.62
3400408-40040890.22790.63
4393012-39301288.56188.95
5399125-39912589.93890.34
6402636-40263690.72991.15
30min1416708-41670893.90092.350.9994.4692.911.00
2408843-40884392.12892.68
3410371-41037192.47293.02
4404429-40442991.13391.67
5407983-40798391.93492.48
6410740-41074092.55593.13
45min1424001-42400195.54494.080.9496.2694.790.95
2416400-41640093.83194.53
3418293-41829394.25794.96
4412029-41202992.84693.53
5416169-41616993.77994.48
6418216-41821694.24094.97
极限1430470-43047097.00195.690.8697.8896.560.86
2425660-42566095.91796.78
3426062-42606296.00896.87
4419886-41988694.61695.46
5422637-42263795.23696.10
6423191-42319195.36196.25
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.713930543934463933253933243932443932790.04
212.643923833922793923310.02
单位质量响应值RSD%判断
30942.4931038.840.22数据可信
中间条件24月-供试品溶液-2022030901批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1309563-30956369.93273.056.9469.9373.046.94
2364408-36440882.32282.32
3326877-32687773.84473.84
4315699-31569971.31871.32
5299493-29949367.65767.66
6324040-32404073.20373.20
10min1367131-36713182.93784.702.7783.0584.822.78
2393052-39305288.79388.93
3380717-38071786.00686.13
4373853-37385384.45684.57
5367014-36701482.91183.02
6367848-36784883.09983.22
15min1391197-39119788.37489.011.3088.6389.281.31
2400998-40099890.58890.87
3398748-39874890.08090.35
4394089-39408989.02789.29
5392051-39205188.56788.82
6387090-38709087.44687.71
20min1401361-40136190.67090.920.8491.0791.330.85
2406590-40659091.85192.29
3405033-40503391.50091.92
4404217-40421791.31591.72
5399580-39958090.26890.67
6397914-39791489.89190.30
30min1411926-41192693.05792.950.7593.6193.510.76
2414030-41403093.53294.12
3413311-41331193.37093.94
4414108-41410893.55094.11
5407841-40784192.13492.68
6407387-40738792.03192.59
45min1418884-41888494.62994.610.5995.3495.320.60
2421146-42114695.14095.88
3420065-42006594.89595.62
4421016-42101695.11095.83
5415564-41556493.87994.58
6416025-41602593.98394.69
极限1426717-42671796.39896.310.6097.2697.190.60
2426949-42694996.45197.35
3426829-42682996.42397.31
4430334-43033497.21598.09
5423627-42362795.70096.56
6423559-42355995.68596.55
磷酸西格列汀片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101546-202101对照品来源中检院对照品使用方法直接使用
对照品含量(%)96.5对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数0.8061
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.713922213921133923253921423922433922090.03
212.643923233921923922580.03
单位质量响应值RSD%判断
30858.3031033.070.40数据可信
中间条件24月-供试品溶液-U011530批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1280016-28001663.35061.1111.3463.3561.1211.34
2270242-27024261.13961.14
3257831-25783158.33158.33
4324874-32487473.49873.50
5249873-24987356.53056.53
6237966-23796653.83753.84
10min1335422-33542275.88575.997.9075.9976.107.91
2331995-33199575.10975.21
3330121-33012174.68574.78
4387132-38713287.58387.71
5314102-31410271.06171.16
6316613-31661371.62971.72
15min1362264-36226481.95782.944.7582.1983.174.76
2365445-36544582.67782.90
3363680-36368082.27882.50
4400514-40051490.61190.88
5351423-35142379.50579.72
6356429-35642980.63780.85
20min1377489-37748985.40287.103.0985.7787.463.10
2387324-38732487.62787.99
3382059-38205986.43686.79
4407736-40773692.24592.66
5375670-37567084.99085.34
6379598-37959885.87986.22
30min1398327-39832790.11691.791.7090.6392.301.72
2409352-40935292.61093.12
3402761-40276191.11991.62
4417762-41776294.51395.09
5402103-40210390.97091.46
6404000-40400091.39991.89
45min1410653-41065392.90594.501.2593.5795.161.27
2421653-42165395.39396.06
3415023-41502393.89394.55
4425389-42538996.23896.97
5417639-41763994.48595.12
6415743-41574394.05694.70
极限1423177-42317795.73897.250.9696.5598.070.95
2435255-43525598.47099.29
3427458-42745896.70697.52
4430759-43075997.45398.34
5431010-43101097.51098.31
6431404-43140497.59998.39
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