阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514610046133461174608946114461110.04
211.414641646380463980.06
单位质量响应值RSD%判断
4006.174066.431.06数据可信
供试品溶液-24022501批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min140502-4050281.09982.703.5681.1082.703.56
238829-3882977.74977.75
342424-4242484.94884.95
442731-4273185.56385.56
542151-4215184.40184.40
641172-4117282.44182.44
10min147110-4711094.33195.321.3794.7895.781.37
247192-4719294.49594.93
347425-4742594.96295.43
448045-4804596.20396.68
548724-4872497.56398.03
647140-4714094.39194.85
15min147906-4790695.92596.730.9196.9097.720.90
248135-4813596.38397.34
348407-4840796.92897.93
448023-4802396.15997.17
548248-4824896.61097.62
649129-4912998.37499.36
20min149770-4977099.65796.193.72101.1697.723.66
246851-4685193.81295.30
348327-4832796.76898.31
445050-4505090.20691.75
548829-4882997.77399.32
649411-4941198.938100.47
30min152216-52216104.55599.383.59106.62101.443.52
250241-50241100.600102.61
349537-4953799.191101.27
446702-4670293.51495.56
549817-4981799.751101.84
649268-4926898.652100.73
45min152960-52960106.04599.584.44108.69102.204.35
247955-4795596.02398.60
349790-4979099.697102.32
446691-4669193.49296.06
550115-50115100.348102.99
650889-50889101.898104.52
60min151775-51775103.672100.013.41106.90103.183.36
248998-4899898.111101.22
350651-50651101.421104.60
447016-4701694.14397.23
550944-50944102.008105.21
650302-50302100.723103.92
极限153733-53733107.593101.284.46111.40105.004.36
250329-50329100.777104.43
351391-51391102.903106.65
446752-4675293.61497.22
550762-50762101.644105.41
650512-50512101.143104.90
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.604046894048534048244044134047434047040.05
211.624068884065094066980.07
单位质量响应值RSD%判断
34888.2834999.830.23数据可信
供试品溶液-24022501批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1172236-17223644.22736.5015.8444.2336.5015.84
2126471-12647132.47632.48
3167512-16751243.01443.01
4139104-13910435.71935.72
5118511-11851130.43230.43
6129030-12903033.13333.13
10min1324054-32405483.21176.7611.0083.4676.9711.00
2319737-31973782.10382.28
3324898-32489883.42883.67
4257834-25783466.20766.41
5256144-25614465.77365.94
6311023-31102379.86580.05
15min1346344-34634488.93589.757.2189.6490.387.19
2340558-34055887.44988.09
3360415-36041592.54893.25
4355724-35572491.34491.91
5308891-30889179.31879.85
6385176-38517698.90699.53
20min1349417-34941789.72493.167.4690.9394.297.30
2328857-32885784.44585.57
3348659-34865989.53090.75
4394277-394277101.243102.32
5396346-396346101.775102.75
6359168-35916892.22893.41
30min1368439-36843994.60996.607.7896.3198.257.62
2345486-34548688.71590.31
3354911-35491191.13592.85
4411434-411434105.649107.29
5413805-413805106.258107.80
6363178-36317893.25894.95
45min1382191-38219198.14097.688.35100.3799.868.19
2332808-33280885.45987.54
3360332-36033292.52794.75
4410279-410279105.352107.58
5418668-418668107.507109.64
6378095-37809597.08899.30
60min1393774-393774101.11499.497.63103.89102.227.48
2344480-34448088.45691.02
3371454-37145495.38398.12
4416198-416198106.872109.68
5422903-422903108.594111.32
6375864-37586496.51599.26
极限1391543-391543100.541103.504.26103.87106.784.19
2394310-394310101.252104.30
3392355-392355100.750104.01
4423757-423757108.813112.22
5426472-426472109.511112.84
6389926-389926100.126103.41
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514655846534465104643746440464960.12
211.414690346926469140.04
单位质量响应值RSD%判断
4039.624111.661.25数据可信
供试品溶液-24022502批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min139127-3912777.59283.955.6277.5983.945.62
243743-4374386.74686.75
340105-4010579.53179.53
445606-4560690.44090.44
542717-4271784.71184.71
642687-4268784.65184.65
10min146432-4643292.07892.954.6592.5193.424.64
248799-4879996.77297.25
345923-4592391.06991.51
449863-4986398.88299.38
546483-4648392.17992.65
643739-4373986.73887.21
15min146571-4657192.35495.013.8993.3096.003.89
248695-4869596.56697.59
345304-4530489.84190.79
450694-50694100.530101.58
547698-4769894.58995.57
648511-4851196.20197.15
20min148199-4819995.58296.072.6397.0497.582.64
249349-4934997.86399.42
347050-4705093.30494.75
450444-50444100.034101.64
547332-4733293.86395.37
648293-4829395.76997.26
30min148258-4825895.69997.003.9197.6999.053.89
250581-50581100.306102.41
348504-4850496.18798.15
451771-51771102.666104.83
547788-4778894.76796.80
646590-4659092.39194.41
45min148820-4882096.81498.412.9499.33101.002.95
251325-51325101.781104.44
348120-4812095.42697.93
451571-51571102.269105.01
549213-4921397.593100.15
648714-4871496.60399.14
60min150545-50545100.23497.873.25103.29101.003.22
250987-50987101.111104.33
347729-4772994.65097.68
450865-50865100.869104.17
547745-4774594.68297.78
648260-4826095.70398.77
极限149888-4988898.93297.862.97102.54101.532.96
250590-50590100.324104.11
348138-4813895.46199.02
451296-51296101.724105.59
547647-4764794.48898.11
648515-4851596.20999.81
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.604092744089604085234079844077964085070.16
211.624113784114264114020.01
单位质量响应值RSD%判断
35216.1235404.650.38数据可信
供试品溶液-24022502批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min177195-7719519.61734.1325.9019.6234.1325.90
2127223-12722332.33032.33
3178264-17826445.30045.30
4133685-13368533.97233.97
5161864-16186441.13341.13
6127597-12759732.42532.42
10min1268714-26871468.28674.319.9568.3974.509.98
2297916-29791675.70675.89
3338106-33810685.91986.17
4297097-29709775.49875.69
5298767-29876775.92376.15
6253828-25382864.50364.68
15min1327330-32733083.18184.722.7383.6785.322.79
2339046-33904686.15886.76
3348213-34821388.48889.22
4334248-33424884.93985.55
5327414-32741483.20283.85
6323979-32397982.32982.87
20min1360573-36057391.62987.975.1392.5889.045.09
2356415-35641590.57291.65
3368689-36868993.69194.91
4333252-33325284.68685.77
5328561-32856183.49484.61
6329518-32951883.73784.73
30min1381733-38173397.00690.178.1098.4791.738.01
2372708-37270894.71296.29
3384309-38430997.66099.40
4343039-34303987.17388.72
5331060-33106084.12985.71
6316035-31603580.31181.77
45min1389683-38968399.02692.037.46101.0294.097.38
2381719-38171997.00299.11
3387896-38789698.572100.86
4342637-34263787.07189.11
5339303-33930386.22488.27
6331597-33159784.26586.17
60min1401726-401726102.08691.908.88104.6494.488.75
2379171-37917196.35599.00
3389662-38966299.021101.85
4335732-33573285.31687.83
5332309-33230984.44686.97
6331316-33131684.19486.57
极限1398061-398061101.15597.192.71104.27100.282.75
2377250-37725095.86799.05
3392791-39279199.816103.20
4374025-37402595.04798.04
5378558-37855896.19999.19
6374067-37406795.05897.90
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514679946750467964673846626467420.16
211.414725447298472760.07
单位质量响应值RSD%判断
4060.994143.381.43数据可信
供试品溶液-24022801批-左氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137733-3773374.34582.506.7474.3482.506.74
242205-4220583.15683.16
346046-4604690.72490.72
439977-3997778.76678.77
542201-4220183.14883.15
643076-4307684.87284.87
10min142477-4247783.69293.096.1584.1093.546.14
246653-4665391.92092.38
349005-4900596.55497.06
447249-4724993.09493.53
551219-51219100.916101.38
646868-4686892.34392.81
15min146026-4602690.68494.804.4791.5695.774.47
248265-4826595.09696.07
350615-5061599.726100.77
446876-4687692.35993.31
550754-50754100.000101.02
646140-4614090.90991.89
20min145567-4556789.78096.794.2191.1698.294.21
249154-4915496.84798.35
349672-4967297.86899.46
450821-50821100.132101.60
551300-51300101.076102.65
648237-4823795.04196.53
30min146526-4652691.66997.203.2893.5599.243.31
249450-4945097.43199.47
350452-5045299.405101.54
448836-4883696.22198.24
551241-51241100.959103.10
649481-4948197.49299.51
45min143828-4382886.35495.435.8588.7498.015.81
247919-4791994.41496.99
350204-5020498.916101.61
447634-4763493.85396.41
552278-52278103.003105.70
648755-4875596.06198.62
60min145980-4598090.59496.494.0293.4699.604.03
249262-4926297.060100.16
351815-51815102.090105.33
448504-4850495.56798.65
550127-5012798.764102.04
648137-4813794.84497.94
极限146171-4617190.97095.083.1094.3498.733.15
248543-4854395.64499.29
349807-4980798.134101.94
447597-4759793.78097.39
550037-5003798.587102.41
647393-4739393.37897.00
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.604107714109094109334105814094424105270.16
211.624152324153754153040.03
单位质量响应值RSD%判断
35390.2635740.450.70数据可信
供试品溶液-24022801批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1165485-16548541.75247.0915.7441.7547.0915.75
2218697-21869755.17855.18
3229651-22965157.94157.94
4168149-16814942.42442.42
5165520-16552041.76141.76
6172421-17242143.50243.50
10min1360146-36014690.86682.647.0191.1082.907.01
2343576-34357686.68586.99
3334568-33456884.41284.73
4318109-31810980.26080.50
5311921-31192178.69878.93
6297029-29702974.94175.18
15min1395034-39503499.66893.874.05100.4094.594.02
2375428-37542894.72195.51
3356954-35695490.06090.85
4380325-38032595.95796.64
5355063-35506389.58390.25
6369468-36946893.21893.88
20min1394980-39498099.65498.246.31100.9499.486.21
2386378-38637897.48498.80
3354082-35408289.33690.63
4425822-425822107.436108.65
5373561-37356194.25095.42
6401391-401391101.272102.45
30min1405246-405246102.244100.385.60104.09102.175.52
2396288-39628899.984101.84
3364453-36445391.95293.74
4419882-419882105.937107.75
5380531-38053196.00997.70
6420731-420731106.151107.89
45min1403217-403217101.733100.043.61104.14102.393.56
2390137-39013798.432100.84
3375281-37528194.68496.98
4409446-409446103.304105.70
5388596-38859698.044100.27
6412458-412458104.064106.39
60min1406560-406560102.576100.233.78105.55103.143.74
2392192-39219298.951101.91
3390718-39071898.579101.40
4415356-415356104.795107.77
5373329-37332994.19296.96
6405531-405531102.316105.22
极限1414768-414768104.64799.394.13108.19102.844.08
2384952-38495297.124100.63
3384069-38406996.901100.27
4406462-406462102.551106.11
5371731-37173193.78997.08
6401562-401562101.315104.79
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.514710447128471264710347129471180.03
211.414733547360473480.04
单位质量响应值RSD%判断
4093.664149.690.97数据可信
供试品溶液-24022801批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150739-5073999.49297.426.0299.4997.436.02
250788-5078899.58899.59
352659-52659103.257103.26
444521-4452187.30087.30
551552-51552101.086101.09
647849-4784993.82593.83
10min152148-52148102.255100.945.02102.81101.485.02
252782-52782103.498104.05
354769-54769107.394107.97
447250-4725092.65193.14
551941-51941101.849102.41
649980-4998098.00498.53
15min151697-51697101.37199.975.24102.49101.085.25
252317-52317102.586103.71
352827-52827103.586104.76
446390-4639090.96491.96
553415-53415104.739105.87
649260-4926096.59297.66
20min149959-4995997.96398.223.6299.6599.873.65
251591-51591101.163102.86
351501-51501100.986102.73
447100-4710092.35793.86
551451-51451100.888102.60
648927-4892795.93997.54
30min149060-4906096.20097.474.0498.4399.674.05
251295-51295100.582102.84
350897-5089799.802102.11
446617-4661791.40993.43
551879-51879101.728104.00
648498-4849895.09897.23
45min148909-4890995.90496.554.6798.6799.304.67
251248-51248100.490103.31
351425-51425100.837103.70
445491-4549189.20291.73
550481-5048198.986101.82
647875-4787593.87696.54
60min149082-4908296.24396.883.7599.54100.173.77
250438-5043898.902102.28
352012-52012101.988105.41
447077-4707792.31195.33
550200-5020098.435101.82
647648-4764893.43196.62
极限148436-4843694.97698.065.6698.81101.885.60
250428-5042898.882102.81
353987-53987105.861109.85
445904-4590490.01193.55
552029-52029102.022105.95
649255-4925596.582100.29
阿齐沙坦左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数1000
标示量(mg)20供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.604138164138134137444138704140044138490.03
211.624168434167794168110.02
单位质量响应值RSD%判断
35676.6435870.140.39数据可信
供试品溶液-24022801批-阿齐沙坦-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19750-97502.4461.9936.622.452.0036.70
24802-48021.2041.20
311229-112292.8172.82
44427-44271.1101.11
510285-102852.5802.58
67209-72091.8081.81
10min126451-264516.6355.8614.016.655.8714.00
220369-203695.1095.12
327983-279837.0197.03
421148-211485.3055.31
520435-204355.1265.14
623737-237375.9545.96
15min136903-369039.2568.486.079.318.526.14
231949-319498.0148.05
335723-357238.9609.02
432394-323948.1258.16
532338-323388.1118.15
633462-334628.3938.44
20min142263-4226310.60110.033.6710.7010.123.69
238522-385229.6639.74
340541-4054110.16910.27
440382-4038210.12910.21
538276-382769.6019.69
639947-3994710.02010.11
30min148078-4807812.05911.831.5812.2211.981.61
246121-4612111.56911.70
346620-4662011.69411.85
447778-4777811.98412.12
546930-4693011.77111.91
647523-4752311.92012.07
45min153443-5344313.40513.240.7613.6313.460.78
252682-5268213.21413.41
352574-5257413.18713.41
452962-5296213.28413.49
552267-5226713.11013.32
652883-5288313.26513.48
60min156728-5672814.22914.152.0614.5314.442.02
255509-5550913.92314.19
356511-5651114.17514.47
458513-5851314.67714.95
555360-5536013.88614.17
655916-5591614.02514.31
极限157683-5768314.46914.822.2514.8515.182.20
257324-5732414.37914.73
360584-6058415.19615.57
458996-5899614.79815.16
559744-5974414.98615.34
660092-6009215.07315.44
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