富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078561485597856018557385611855990.02
210.088546985419854440.05
单位质量响应值RSD%判断
8500.408476.590.20数据可信
长期3月-供试品溶液-2023101321批-富马酸比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190386-9038695.64196.431.4395.6496.421.43
292201-9220197.56297.56
393127-9312798.54198.54
491144-9114496.44396.44
589910-8991095.13795.14
689995-8999595.22795.23
10min191147-9114796.44697.171.4396.6197.341.43
292794-9279498.18998.35
393880-9388099.33899.50
491980-9198097.32897.49
590626-9062695.89596.05
690585-9058595.85296.01
15min191032-9103296.32596.941.4596.6497.261.45
292426-9242697.80098.13
393722-9372299.17199.50
491832-9183297.17197.49
590295-9029595.54595.86
690369-9036995.62395.94
20min190552-9055295.81796.631.4696.3097.121.46
292139-9213997.49697.99
393458-9345898.89299.39
491596-9159696.92197.41
590099-9009995.33795.82
690105-9010595.34495.82
30min190601-9060195.86996.441.4096.5197.091.40
291911-9191197.25597.91
393195-9319598.61399.27
491329-9132996.63997.29
589897-8989795.12495.76
689937-8993795.16695.80
45min190038-9003895.27395.901.4496.0796.701.44
291496-9149696.81697.63
392672-9267298.06098.88
490824-9082496.10596.91
589412-8941294.61095.41
689344-8934494.53995.33
极限189474-8947494.67695.401.4795.6496.361.47
291067-9106796.36297.34
392237-9223797.60098.59
490322-9032295.57396.54
588948-8894894.11995.07
688880-8888094.04895.00
富马酸比索洛尔左氨氯地平片项目信息
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705374453660538205381853825537730.14
214.695342953611535200.25
单位质量响应值RSD%判断
3658.033643.290.29数据可信
长期3月-供试品溶液-2023101321批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152514-5251490.82390.291.8690.8290.291.86
252518-5251890.83090.83
351810-5181089.60589.61
453376-5337692.31492.31
552524-5252490.84090.84
650507-5050787.35287.35
10min153868-5386893.16592.591.5293.3292.741.52
253341-5334192.25392.40
353325-5332592.22692.37
454584-5458494.40394.56
553907-5390793.23293.38
652176-5217690.23890.38
15min154060-5406093.49792.431.2493.8092.731.24
253024-5302491.70592.01
353228-5322892.05892.36
454238-5423893.80594.12
553610-5361092.71993.03
652485-5248590.77391.07
20min153726-5372692.91992.071.2693.3892.531.26
252807-5280791.33091.79
352695-5269591.13691.59
454216-5421693.76794.23
553452-5345292.44592.91
652529-5252990.84991.30
30min153116-5311691.86490.741.5792.4891.351.57
252038-5203890.00090.61
351960-5196089.86590.47
453543-5354392.60393.23
552785-5278591.29291.91
651345-5134588.80189.40
45min152728-5272891.19390.361.3591.9691.121.35
251503-5150389.07589.83
351491-5149189.05489.81
453228-5322892.05892.84
552542-5254290.87191.64
651978-5197889.89690.64
极限152458-5245890.72690.151.1791.6591.061.17
251767-5176789.53190.44
351513-5151389.09290.00
453070-5307091.78592.72
552331-5233190.50791.43
651597-5159789.23790.13
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078610686156861198612586109861230.03
210.088594285956859490.02
单位质量响应值RSD%判断
8552.438526.690.22数据可信
长期3月-供试品溶液-2023101322批-富马酸比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194324-9432499.21198.322.1299.2198.322.12
291601-9160196.34796.35
392178-9217896.95496.95
494773-9477399.68399.68
591600-9160096.34696.35
696390-96390101.384101.38
10min195188-95188100.12099.192.14100.2999.362.14
292313-9231397.09697.26
393219-9321998.04998.21
495374-95374100.316100.48
592372-9237297.15897.32
697372-97372102.417102.59
15min194706-9470699.61398.862.1199.9599.192.12
292060-9206096.83097.15
392951-9295197.76798.09
495145-95145100.075100.41
592056-9205696.82697.15
697030-97030102.057102.40
20min194529-9452999.42798.872.1199.9399.362.11
292143-9214396.91797.40
392968-9296897.78598.27
495234-95234100.168100.67
592055-9205596.82597.31
697071-97071102.101102.61
30min194439-9443999.33298.512.08100.0099.182.08
291792-9179296.54897.19
392488-9248897.28097.93
494752-9475299.661100.33
591853-9185396.61297.26
696648-96648101.656102.34
45min194265-9426599.14998.362.0399.9899.182.03
291641-9164196.38997.20
392512-9251297.30598.12
494563-9456399.463100.30
591671-9167196.42197.23
696415-96415101.411102.26
极限194419-9441999.31197.912.23100.3198.902.23
291177-9117795.90196.87
391864-9186496.62497.60
494291-9429199.177100.18
590859-9085995.56796.53
695925-95925100.895101.91
富马酸比索洛尔左氨氯地平片项目信息
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705389353837539945394553976539290.12
214.695369453658536760.05
单位质量响应值RSD%判断
3668.643653.910.29数据可信
长期3月-供试品溶液-2023101322批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152310-5231090.20890.051.5490.2190.051.54
253487-5348792.23892.24
350989-5098987.93087.93
452343-5234390.26590.26
552238-5223890.08490.08
651959-5195989.60389.60
10min153115-5311591.59691.990.8491.7592.140.83
253821-5382192.81492.97
352699-5269990.87991.03
453214-5321491.76791.92
553356-5335692.01292.16
653862-5386292.88493.03
15min153056-5305691.49491.431.1591.8091.731.15
253811-5381192.79693.10
352093-5209389.83490.13
453056-5305691.49491.80
552618-5261890.73991.04
653464-5346492.19892.50
20min152876-5287691.18491.421.0091.6491.881.00
253841-5384192.84893.31
352215-5221590.04490.49
452887-5288791.20391.66
553103-5310391.57592.03
653151-5315191.65892.12
30min152452-5245290.45391.121.0791.0691.731.07
253661-5366192.53893.16
352048-5204889.75690.35
452754-5275490.97491.58
553167-5316791.68692.29
652964-5296491.33691.95
45min150972-5097287.90188.311.5988.6689.071.59
252340-5234090.26091.03
349856-4985685.97686.72
451162-5116288.22888.99
551509-5150988.82789.59
651418-5141888.67089.43
极限151782-5178289.29788.881.1590.2089.781.15
252362-5236290.29891.22
350762-5076287.53888.43
451206-5120688.30489.21
551169-5116988.24089.15
651943-5194389.57590.49
富马酸比索洛尔左氨氯地平片项目信息
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100711-202203对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2.5供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.078623986349863198627486286862930.05
210.088652786524865260.01
单位质量响应值RSD%判断
8569.318583.930.13数据可信
长期3月-供试品溶液-2024010421批-富马酸比索洛尔-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min190096-9009694.35594.920.4194.3594.920.41
290917-9091795.21495.21
390304-9030494.57294.57
490838-9083895.13295.13
590633-9063394.91794.92
691008-9100895.31095.31
10min190724-9072495.01295.470.4795.1795.630.47
291744-9174496.08096.24
390608-9060894.89195.05
491321-9132195.63795.80
591266-9126695.58095.74
691295-9129595.61095.77
15min190320-9032094.58995.160.4894.9095.480.48
291515-9151595.84196.16
390439-9043994.71495.03
490977-9097795.27795.60
590974-9097495.27495.59
690984-9098495.28495.60
20min190034-9003494.29095.020.5994.7695.500.59
291443-9144395.76596.24
390227-9022794.49294.97
490859-9085995.15495.63
590713-9071395.00195.48
691102-9110295.40895.89
30min189696-8969693.93694.620.6494.5795.250.63
291238-9123895.55096.19
389776-8977694.01994.65
490556-9055694.83695.47
590525-9052594.80495.44
690295-9029594.56395.20
45min190005-9000594.25994.310.6495.0595.100.63
290832-9083295.12595.92
389194-8919493.41094.20
490049-9004994.30595.10
589772-8977294.01594.81
690483-9048394.76095.55
极限188824-8882493.02293.640.7793.9794.590.77
290389-9038994.66195.62
388611-8861192.79993.74
489329-8932993.55194.50
589287-8928793.50794.46
690019-9001994.27495.23
富马酸比索洛尔左氨氯地平片项目信息
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4000
标示量(mg)2.5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.705382353804539185369953685537860.18
214.695410453972540380.18
单位质量响应值RSD%判断
3658.913678.560.38数据可信
长期3月-供试品溶液-2024010421批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151158-5115888.04287.421.5188.0487.421.51
249905-4990585.88685.89
351785-5178589.12189.12
450460-5046086.84186.84
551400-5140088.45988.46
650057-5005786.14786.15
10min152240-5224089.90489.790.9290.0589.930.92
251970-5197089.44089.58
353057-5305791.31091.46
452005-5200589.50089.64
551650-5165088.88989.04
652111-5211189.68289.83
15min151788-5178889.12688.732.4489.4289.022.44
249223-4922384.71285.00
352856-5285690.96491.27
451297-5129788.28188.58
551905-5190589.32889.62
652265-5226589.94790.24
20min151480-5148088.59689.381.5289.0489.821.51
251775-5177589.10489.54
353209-5320991.57292.02
452153-5215389.75590.20
550866-5086687.54087.98
652136-5213689.72590.17
30min151695-5169588.96688.541.4489.5689.131.44
251522-5152288.66989.25
352209-5220989.85190.46
450023-5002386.08986.68
551560-5156088.73489.32
651674-5167488.93089.52
45min151754-5175489.06888.861.7189.8189.601.71
250074-5007486.17786.91
352628-5262890.57291.33
451663-5166388.91189.65
551412-5141288.47989.22
652265-5226589.94790.69
极限151519-5151988.66487.971.0389.5588.861.01
251396-5139688.45289.33
350225-5022586.43787.34
450859-5085987.52888.41
551063-5106387.87988.76
651633-5163388.86089.75
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