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%
112.284906848886489804895649002489780.14
212.294912049279492000.23
单位质量响应值RSD%判断
3988.444003.250.27数据可信
供试品溶液-24050701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%
5min114124-1412428.56651.1251.3128.5751.1251.31
235148-3514871.08871.09
341146-4114683.21983.22
414819-1481929.97229.97
534378-3437869.53069.53
612051-1205124.37324.37
10min141470-4147083.87488.917.2384.0389.207.36
245429-4542991.88192.28
347521-4752196.11296.57
443060-4306087.09087.26
546835-4683594.72595.11
639455-3945579.79979.93
15min144927-4492790.86694.122.0591.4994.902.14
246584-4658494.21795.12
347602-4760296.27697.27
447328-4732895.72296.37
546629-4662994.30895.22
646151-4615193.34193.92
20min145497-4549792.01994.702.5293.1596.012.51
245135-4513591.28792.72
347482-4748296.03397.56
447560-4756096.19197.37
547767-4776796.61098.05
647509-4750996.08897.19
30min142543-4254386.04493.844.4587.6895.664.42
245801-4580192.63494.57
346574-4657494.19796.26
447787-4778796.65098.37
547783-4778396.64298.62
647886-4788696.85198.48
45min145306-4530691.63294.452.1793.7596.802.15
246900-4690094.85697.31
346900-4690094.85697.44
448302-4830297.69299.95
545994-4599493.02495.53
646792-4679294.63896.81
60min144706-4470690.41994.582.5093.0597.452.51
246643-4664394.33797.31
346776-4677694.60697.72
448241-4824197.569100.36
547376-4737695.81998.85
646838-4683894.73197.43
极限144394-4439489.78894.613.0592.9298.013.03
245718-4571892.46695.97
347625-4762596.32399.96
447900-4790096.879100.22
547167-4716795.39698.96
647874-4787496.826100.05
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%
110.843786483781483782233789153781313784130.10
210.963813223803433808320.19
单位质量响应值RSD%判断
34908.9534747.450.33数据可信
供试品溶液-24050701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%
5min160285-6028515.53213.7615.6815.5313.7615.69
251524-5152413.27513.27
361480-6148015.84015.84
453359-5335913.74713.75
538245-382459.8539.85
655565-5556514.31614.32
10min1226832-22683258.44054.7311.7658.5354.8011.77
2210924-21092454.34254.42
3255042-25504265.70865.80
4199373-19937351.36651.44
5188048-18804848.44848.50
6194309-19430950.06150.14
15min1357410-35741092.08283.059.2292.4983.439.23
2310142-31014279.90480.28
3362875-36287593.49093.94
4307290-30729079.16979.53
5297538-29753876.65776.98
6298905-29890577.00977.37
20min1378894-37889497.61792.404.4498.5493.244.48
2343444-34344488.48489.30
3374320-37432096.43997.41
4363682-36368293.69894.50
5342448-34244888.22788.98
6349092-34909289.93990.72
30min1370687-37068795.50394.081.8696.9795.441.90
2353250-35325091.01092.32
3371471-37147195.70597.21
4367451-36745194.66995.99
5366428-36642894.40695.65
6361802-36180293.21494.50
45min1377422-37742297.23894.622.5399.2396.502.56
2354810-35481091.41293.23
3371265-37126595.65297.69
4376374-37637496.96898.82
5364439-36443993.89395.66
6359194-35919492.54294.34
60min1373543-37354396.23994.512.3198.7796.922.32
2353931-35393191.18693.51
3371449-37144995.69998.27
4372909-37290996.07598.46
5370821-37082195.53797.82
6358443-35844392.34894.67
极限1391869-391869100.96099.811.42104.03102.741.50
2383063-38306398.691101.52
3395677-395677101.941105.04
4388179-388179100.009102.93
5382896-38289698.648101.47
6382736-38273698.607101.44
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%
112.284889648666490444898249000489180.31
212.294898348921489520.09
单位质量响应值RSD%判断
3983.553983.080.01数据可信
供试品溶液-24050701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%
5min142693-4269386.61983.0110.2286.6283.0110.23
243824-4382488.91488.91
341463-4146384.12384.12
432547-3254766.03466.03
543008-4300887.25887.26
641956-4195685.12485.12
10min146712-4671294.77395.351.7995.2595.811.81
247221-4722195.80696.30
348383-4838398.16398.63
446076-4607693.48393.85
546264-4626493.86494.35
647314-4731495.99496.47
15min146763-4676394.87695.681.4795.8896.671.47
247636-4763696.64897.67
348134-4813497.65898.67
446982-4698295.32196.21
546153-4615393.63994.65
647286-4728695.93896.94
20min147437-4743796.24497.131.1797.7898.651.15
247700-4770096.77898.34
348657-4865798.719100.27
447987-4798797.36098.78
547150-4715095.66297.19
648301-4830197.99799.54
30min147208-4720895.77996.041.0597.8598.111.05
247652-4765296.68098.78
348193-4819397.77899.88
447077-4707795.51497.47
546946-4694695.24897.31
646953-4695395.26297.35
45min146928-4692895.21195.681.1297.8198.271.10
247941-4794197.26699.90
347470-4747096.31198.96
447353-4735396.07498.56
546737-4673794.82497.41
646524-4652494.39297.00
60min147022-4702295.40295.831.2698.5398.961.26
247125-4712595.61198.79
348069-4806997.526100.71
446575-4657594.49597.52
546780-4678094.91198.02
647833-4783397.047100.18
极限147167-4716795.69696.460.9399.36100.120.87
247492-4749296.356100.06
347834-4783497.049100.77
448266-4826697.926101.47
547116-4711695.59399.23
647377-4737796.12299.80
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%
110.843762993776033782003780743774483775250.20
210.963777223770843774030.12
单位质量响应值RSD%判断
34827.0334434.580.81数据可信
供试品溶液-24050701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%
5min143622-4362211.30314.1725.8811.3014.1725.89
249696-4969612.87712.88
349268-4926812.76612.77
472080-7208018.67718.68
572781-7278118.85818.86
640714-4071410.55010.55
10min1178785-17878546.32554.5219.2546.3954.6019.26
2170748-17074844.24344.31
3226118-22611858.59058.66
4257204-25720466.64566.75
5254476-25447665.93866.04
6175071-17507145.36345.42
15min1308471-30847179.92981.3214.9380.2581.7114.94
2243596-24359663.11963.44
3351275-35127591.02091.42
4351555-35155591.09291.57
5354006-35400691.72892.20
6274195-27419571.04771.36
20min1381661-38166198.89391.688.8299.6692.518.84
2296499-29649976.82777.49
3369339-36933995.70096.60
4367152-36715295.13496.11
5367951-36795195.34196.32
6340313-34031388.17988.88
30min1398154-398154103.16797.273.47104.4898.613.34
2383267-38326799.309100.40
3370679-37067996.04897.48
4363235-36323594.11995.63
5367669-36766995.26896.78
6369344-36934495.70296.90
45min1400831-400831103.86099.384.58105.75101.264.36
2407832-407832105.675107.32
3371669-37166996.30498.27
4367060-36706095.11097.14
5368211-36821195.40897.45
6385576-38557699.908101.63
60min1398950-398950103.373100.015.83105.84102.455.56
2417755-417755108.246110.48
3369129-36912995.64698.15
4364139-36413994.35396.91
5366137-36613794.87197.44
6399783-399783103.589105.87
极限1412638-412638106.920103.025.64109.96106.015.38
2422981-422981109.600112.43
3380562-38056298.609101.64
4374382-37438297.007100.09
5377399-37739997.789100.89
6417545-417545108.191111.05
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%
112.284888048887490134897048898489300.13
212.294908149104490920.04
单位质量响应值RSD%判断
3984.533994.470.18数据可信
供试品溶液-24050702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%
5min139689-3968980.39962.3742.8680.4062.3742.86
214048-1404828.45828.46
339636-3963680.29280.29
413531-1353127.41027.41
540145-4014581.32381.32
637677-3767776.32476.32
10min146163-4616393.51493.313.2893.9693.653.42
244489-4448990.12390.28
347103-4710395.41895.86
444031-4403189.19589.35
547880-4788096.99297.44
646698-4669894.59895.02
15min147964-4796497.16295.781.4798.1396.651.49
247063-4706395.33796.00
346577-4657794.35395.33
447402-4740296.02496.67
548178-4817897.59698.59
646520-4652094.23795.19
20min146796-4679694.79697.101.4396.3098.501.36
248529-4852998.30799.50
347911-4791197.05598.56
448040-4804097.31698.50
548693-4869398.639100.17
647628-4762896.48297.95
30min147582-4758296.38997.271.0098.4299.210.94
248380-4838098.00599.74
347702-4770296.63298.67
448236-4823697.71399.44
548674-4867498.601100.68
647530-4753096.28398.29
45min146996-4699695.20295.921.1597.7798.401.09
247455-4745596.13198.41
347265-4726595.74698.32
447834-4783496.89999.16
548012-4801297.26099.89
646538-4653894.27496.82
60min146414-4641494.02395.671.4497.1298.681.33
248140-4814097.519100.33
347190-4719095.59598.70
447405-4740596.03098.83
547728-4772896.68499.85
646496-4649694.18997.26
极限146737-4673794.67795.311.4198.3098.851.31
247417-4741796.05499.41
347296-4729695.80999.45
447681-4768196.58999.93
547312-4731295.84299.55
645850-4585092.88096.47
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%
110.843772243768193779313775803774553774020.11
210.963776313788133782220.23
单位质量响应值RSD%判断
34815.6834509.310.63数据可信
供试品溶液-24050702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%
5min137389-373899.67912.4429.589.6812.4429.57
260083-6008315.55415.55
364616-6461616.72716.73
457031-5703114.76414.76
530441-304417.8807.88
638771-3877110.03710.04
10min1132238-13223834.23345.5723.3834.2945.6423.39
2197938-19793851.24151.33
3242064-24206462.66462.76
4187493-18749348.53748.62
5144757-14475737.47437.52
6151590-15159039.24339.30
15min1212270-21227054.95166.8216.4455.1967.1416.46
2275317-27531771.27271.64
3309928-30992880.23280.67
4273646-27364670.83971.19
5200515-20051551.90852.16
6277038-27703871.71871.99
20min1273096-27309670.69779.6812.5171.2580.3812.55
2343546-34354688.93589.70
3341057-34105788.29089.18
4318308-31830882.40183.15
5248659-24865964.37164.91
6322226-32222683.41684.09
30min1323985-32398583.87189.344.6384.8190.484.65
2364365-36436594.32495.59
3355019-35501991.90593.28
4333435-33343586.31787.52
5357299-35729992.49593.39
6336615-33661587.14088.28
45min1347113-34711389.85892.446.6691.2794.086.50
2368864-36886495.48997.27
3358645-35864592.84394.73
4338848-33884887.71989.40
5397273-397273102.843104.25
6331877-33187785.91487.53
60min1358766-35876692.87594.097.6294.7896.247.45
2379566-37956698.259100.57
3367064-36706495.02397.43
4336538-33653887.12189.29
5406469-406469105.224107.21
6332401-33240186.05088.15
极限1399369-399369103.386101.953.56105.81104.623.37
2391216-391216101.275104.14
3377690-37769097.774100.71
4396831-396831102.729105.38
5416536-416536107.830110.40
6381349-38134998.721101.30
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%
112.284901148989490314899949044490150.05
212.294891948902489100.03
单位质量响应值RSD%判断
3991.453979.660.21数据可信
供试品溶液-24050702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%
5min137719-3771976.48456.0454.7376.4856.0454.73
214454-1445429.30929.31
343132-4313287.46187.46
413637-1363727.65227.65
513759-1375927.90027.90
643119-4311987.43487.43
10min145669-4566992.60590.145.9793.0390.456.13
243088-4308887.37187.53
347057-4705795.41995.91
442821-4282186.83086.98
540720-4072082.57082.72
647355-4735596.02496.51
15min146964-4696495.23194.302.9596.1795.113.08
245711-4571192.69093.34
347113-4711395.53396.55
447197-4719795.70396.34
544122-4412289.46890.08
647924-4792497.17898.20
20min146855-4685595.01094.421.5896.4895.761.63
245837-4583792.94694.11
346236-4623693.75595.30
447616-4761696.55397.72
545785-4578592.84093.95
647057-4705795.41996.98
30min147082-4708295.47095.542.8197.4797.402.86
245699-4569992.66694.35
347936-4793697.20299.27
448871-4887199.098100.80
545477-4547792.21693.84
647624-4762496.56998.66
45min146457-4645794.20395.451.7996.7397.841.77
246998-4699895.30097.49
346972-4697295.24797.85
448482-4848298.309100.56
546073-4607393.42495.56
647460-4746096.23798.86
60min146838-4683894.97594.941.8598.0397.861.87
246314-4631493.91396.64
347060-4706095.42698.56
448295-4829597.930100.73
545703-4570392.67495.33
646705-4670594.70697.87
极限145605-4560592.47594.301.5796.0597.741.59
246464-4646494.21797.46
346868-4686895.03698.70
447400-4740096.11599.46
545693-4569392.65495.83
646988-4698895.28098.97
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%
110.843806273804893805053803203808313805540.05
210.963771113769733770420.03
单位质量响应值RSD%判断
35106.4634401.641.44数据可信
供试品溶液-24050702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%
5min135554-355549.18013.8228.579.1813.8228.56
265205-6520516.83716.84
347507-4750712.26712.27
477900-7790020.11520.11
546060-4606011.89311.89
648812-4881212.60412.60
10min1162770-16277042.02945.0719.5542.0845.1519.55
2190513-19051349.19349.29
3126955-12695532.78132.85
4228876-22887659.09959.21
5177766-17776645.90145.97
6160463-16046341.43441.50
15min1242422-24242262.59667.4620.8362.8867.7920.82
2307326-30732679.35579.72
3194247-19424750.15750.41
4344215-34421588.88189.32
5236995-23699561.19561.52
6242381-24238162.58662.89
20min1302792-30279278.18581.7813.1378.8282.4813.18
2359381-35938192.79793.60
3276254-27625471.33271.86
4372224-37222496.11397.05
5316590-31659081.74782.41
6273033-27303370.50071.15
30min1347938-34793889.84292.827.7790.9193.977.80
2375630-37563096.99298.32
3366121-36612194.53795.46
4388961-388961100.435101.90
5368600-36860095.17796.29
6309464-30946479.90780.95
45min1373728-37372896.50197.116.4498.0798.796.44
2389041-389041100.455102.32
3389276-389276100.516101.97
4385882-38588299.639101.67
5390346-390346100.792102.44
6328281-32828184.76686.25
60min1383803-38380399.10397.885.11101.20100.095.10
2383842-38384299.113101.53
3394529-394529101.872103.88
4386181-38618199.717102.30
5385600-38560099.567101.77
6340432-34043287.90489.86
极限1382999-38299998.89599.131.37101.55101.881.30
2385313-38531399.493102.46
3392631-392631101.382103.96
4378415-37841597.711100.84
5385268-38526899.481102.24
6378733-37873397.794100.24
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%
112.284892248955491374892249074490020.20
212.294890348933489180.05
单位质量响应值RSD%判断
3990.393980.310.18数据可信
供试品溶液-24050703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%
5min113947-1394728.28271.0930.8028.2871.0930.80
238889-3888978.86178.86
342992-4299287.18187.18
433807-3380768.55568.56
539403-3940379.90379.90
641305-4130583.76083.76
10min142234-4223485.64495.335.6785.8095.725.75
246273-4627393.83494.27
348261-4826197.86698.35
448045-4804597.42897.81
550081-50081101.557102.00
647155-4715595.62396.09
15min145810-4581092.89696.222.2793.5397.142.37
246465-4646594.22495.18
348260-4826097.86498.89
448260-4826097.86498.79
548343-4834398.03299.04
647559-4755996.44297.44
20min146945-4694595.19796.401.6396.3597.861.69
246398-4639894.08895.57
348116-4811697.57299.14
447860-4786097.05398.52
548471-4847198.29299.84
647443-4744396.20797.74
30min147974-4797497.28497.550.8198.9699.540.85
247648-4764896.62398.63
347901-4790197.13699.25
448269-4826997.88299.89
548774-4877498.906101.00
648055-4805597.44899.51
45min147060-4706095.43096.361.3597.6598.901.40
246568-4656894.43396.98
347619-4761996.56499.22
447671-4767196.66999.22
548424-4842498.196100.84
647778-4777896.88699.49
60min144999-4499991.25195.683.0494.0098.753.09
245924-4592493.12796.19
347345-4734596.00899.20
447878-4787897.089100.18
548632-4863298.618101.81
648324-4832497.994101.14
极限146255-4625593.79896.282.0697.0599.882.12
246673-4667394.64698.23
347879-4787997.091100.81
448623-4862398.600102.23
548442-4844298.233101.97
646998-4699895.30599.00
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%
110.843773643768553768523769693769893770060.06
210.963768873771623770240.06
单位质量响应值RSD%判断
34779.1534400.000.78数据可信
供试品溶液-24050703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%
5min137823-378239.81213.0529.589.8113.0529.56
266505-6650517.25317.25
330793-307937.9887.99
450999-5099913.23013.23
567708-6770817.56517.56
648109-4810912.48012.48
10min1158965-15896541.23953.8019.3541.2953.8719.36
2210733-21073354.66954.76
3172220-17222044.67844.72
4232437-23243760.29960.37
5268945-26894569.77069.87
6201070-20107052.16252.23
15min1256956-25695666.66082.3712.8866.9482.7412.90
2347912-34791290.25690.66
3273627-27362770.98571.28
4341084-34108488.48488.89
5344877-34487789.46889.95
6340543-34054388.34488.70
20min1360057-36005793.40694.791.8094.0695.621.78
2369588-36958895.87996.78
3366446-36644695.06495.75
4362192-36219293.96094.86
5358290-35829092.94893.93
6375694-37569497.46398.31
30min1392321-392321101.77699.543.75102.95100.903.60
2386740-386740100.329101.76
3403980-403980104.801106.02
4372201-37220196.55797.98
5363509-36350994.30295.80
6383467-38346799.479100.87
45min1389841-389841101.13399.644.47102.87101.554.30
2384824-38482499.832101.82
3409300-409300106.181107.98
4364695-36469594.61096.57
5364786-36478694.63396.66
6391128-391128101.467103.41
60min1388781-388781100.85899.825.38103.16102.285.21
2395717-395717102.657105.20
3418916-418916108.676111.06
4372223-37222396.56399.05
5363449-36344994.28696.83
6369695-36969595.90798.41
极限1413567-413567107.288103.014.36110.15106.034.18
2389822-389822101.128104.24
3420581-420581109.108112.10
4391003-391003101.434104.46
5373112-37311296.79399.87
6394341-394341102.300105.34
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%
112.284927749372493364947049381493670.15
212.294913449047490900.13
单位质量响应值RSD%判断
4020.113994.300.46数据可信
供试品溶液-24050703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%
5min112362-1236224.93269.1033.4124.9369.1033.41
242037-4203784.78084.78
331305-3130563.13663.14
441762-4176284.22684.23
540452-4045281.58481.58
637649-3764975.93175.93
10min143894-4389488.52593.543.1688.6693.933.26
246409-4640993.59894.07
347407-4740795.61095.96
447737-4773796.27696.74
547331-4733195.45795.91
645517-4551791.79992.22
15min147214-4721495.22195.312.4895.8596.222.46
246546-4654693.87494.87
348274-4827497.35998.24
447961-4796196.72897.73
548247-4824797.30598.29
645308-4530891.37792.31
20min147677-4767796.15596.611.4997.3198.041.48
246586-4658693.95595.47
348569-4856997.95499.38
448317-4831797.44698.99
548004-4800496.81598.34
648258-4825897.32798.77
30min148087-4808796.98296.402.4698.6898.372.41
246712-4671294.20996.24
349010-4901098.843100.81
448495-4849597.80599.89
548472-4847297.75899.82
646012-4601292.79794.78
45min147383-4738395.56296.182.5297.7998.682.50
246847-4684794.48197.04
349036-4903698.896101.41
448613-4861398.043100.67
548362-4836297.537100.14
645880-4588092.53195.03
60min147601-4760196.00295.312.4998.7698.342.43
245967-4596792.70695.79
348626-4862698.069101.13
447908-4790896.62199.79
547774-4777496.35199.50
645661-4566192.08995.10
极限147487-4748795.77295.902.8699.0799.472.81
247391-4739195.57899.18
349033-4903398.890102.50
448630-4863098.077101.78
547638-4763896.07699.76
645134-4513491.02694.55
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%
110.843798073794413796463795203796843796200.04
210.963778983778073778520.02
单位质量响应值RSD%判断
35020.3034475.551.11数据可信
供试品溶液-24050703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%
5min162836-6283616.22715.9518.8316.2315.9518.83
270765-7076518.27518.27
361065-6106515.77015.77
449500-4950012.78312.78
548451-4845112.51212.51
678072-7807220.16220.16
10min1204095-20409552.70758.6413.8952.8058.7313.89
2246891-24689163.75963.86
3212877-21287754.97555.06
4204141-20414152.71952.79
5211744-21174454.68254.75
6282625-28262572.98773.10
15min1347461-34746189.73188.213.8690.1188.633.90
2351929-35192990.88591.34
3332561-33256185.88386.28
4331618-33161885.63986.00
5326495-32649584.31684.69
6359444-35944492.82593.34
20min1372848-37284896.28794.222.0397.1795.122.05
2363815-36381593.95494.91
3352898-35289891.13592.01
4363528-36352893.88094.72
5363362-36336293.83794.68
6372617-37261796.22797.26
30min1379877-37987798.10295.701.6299.5297.131.60
2370366-37036695.64697.13
3361995-36199593.48494.86
4368413-36841395.14296.50
5373887-37388796.55597.92
6368946-36894695.27996.85
45min1372568-37256896.21595.541.6198.1897.501.59
2367836-36783694.99397.01
3359974-35997492.96294.86
4370490-37049095.67897.57
5377972-37797297.61099.51
6370990-37099095.80797.90
60min1374882-37488296.81295.121.9299.3197.611.88
2365002-36500294.26196.80
3356989-35698992.19194.60
4368424-36842495.14497.57
5376406-37640697.20699.65
6368318-36831895.11797.75
极限1392278-392278101.30599.792.22104.34102.812.14
2391474-391474101.097104.16
3374798-37479896.79199.71
4389050-389050100.471103.42
5394436-394436101.862104.84
6376468-37646897.222100.38
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