比索洛尔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2000
标示量(mg)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%
110.298615086145860298596586036860650.10
210.298605585970860120.07
单位质量响应值RSD%判断
8363.958358.790.05数据可信
供试品溶液-2024021821批-5mg/5mg规格-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%
5min181255-8125587.28689.361.8587.2989.361.85
284814-8481491.10991.11
381925-8192588.00688.01
482728-8272888.86988.87
583305-8330589.48889.49
685082-8508291.39791.40
10min189396-8939696.03297.631.6996.1897.781.69
293313-93313100.239100.39
389890-8989096.56296.71
490905-9090597.65397.80
589755-8975596.41796.57
692070-9207098.90499.06
15min191327-9132798.10699.141.2998.4199.451.30
294354-94354101.358101.68
391671-9167198.47598.78
492021-9202198.85199.16
591353-9135398.13498.44
693028-9302899.933100.25
20min191275-9127598.05099.401.3198.5299.871.31
294629-94629101.653102.14
392301-9230199.15299.62
492321-9232199.17499.65
591559-9155998.35598.83
693080-9308099.989100.47
30min191546-9154698.34199.521.3398.97100.171.34
294821-94821101.859102.52
392481-9248199.34599.98
492261-9226199.10999.75
591575-9157598.37299.01
693205-93205100.123100.77
45min191057-9105797.81699.001.4098.6199.811.40
294532-94532101.549102.38
392221-9222199.06699.87
491715-9171598.52399.33
591074-9107497.83498.64
692371-9237199.227100.04
极限190649-9064997.37898.581.3398.3499.561.33
293965-93965100.940101.94
391817-9181798.63299.60
491262-9126298.03699.01
590810-9081097.55098.51
692130-9213098.96899.95
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
113.631034691033751033471033481032451033570.08
213.711034481032891033680.11
单位质量响应值RSD%判断
7583.057539.610.41数据可信
供试品溶液-2024021821批-5mg/5mg规格-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%
5min183557-8355771.63671.572.2371.6471.572.23
281132-8113269.55769.56
383410-8341071.51071.51
482697-8269770.89970.90
583295-8329571.41171.41
686806-8680674.42274.42
10min1101580-10158087.08887.031.4987.2187.151.49
2100048-10004885.77485.89
3100908-10090886.51286.63
4101666-10166687.16187.28
5100555-10055586.20986.33
6104331-10433189.44689.57
15min1106271-10627191.10990.891.7091.3791.151.70
2103517-10351788.74889.01
3105421-10542190.38190.64
4106516-10651691.32091.58
5105382-10538290.34790.61
6108987-10898793.43893.71
20min1108664-10866493.16192.631.9693.5893.051.96
2104800-10480089.84890.26
3107561-10756192.21592.63
4109429-10942993.81794.23
5106954-10695491.69592.11
6110876-11087695.05795.49
30min1109449-10944993.83493.022.0994.4193.592.09
2105440-10544090.39790.95
3106165-10616591.01991.59
4110231-11023194.50495.08
5108589-10858993.09793.66
6111127-11112795.27395.86
45min1109751-10975194.09393.281.8194.8294.011.81
2105157-10515790.15490.86
3108963-10896393.41794.14
4109562-10956293.93194.66
5108482-10848293.00593.73
6110920-11092095.09595.84
极限1109319-10931993.72392.762.0494.6193.642.04
2104294-10429489.41590.27
3108439-10843992.96893.84
4108869-10886993.33794.22
5107457-10745792.12693.00
6110807-11080794.99895.90
比索洛尔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2000
标示量(mg)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%
110.2985950859068588685906859120.04
210.298595585821858880.12
单位质量响应值RSD%判断
8349.088346.740.02数据可信
供试品溶液-2024021821批-5mg/5mg规格-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%
5min182642-8264288.91989.032.1388.9289.032.13
282642-8264288.91988.92
382708-8270888.99088.99
479651-7965185.70185.70
584776-8477691.21591.22
684064-8406490.44990.45
10min178895-7889584.88896.586.1085.0496.736.09
291641-9164198.60298.75
393532-93532100.636100.78
489865-8986596.69196.83
591791-9179198.76398.92
692856-9285699.909100.06
15min187796-8779694.46599.322.5994.7599.632.60
292993-92993100.057100.37
393856-93856100.985101.30
491650-9165098.61298.92
593281-93281100.366100.68
694279-94279101.440101.76
20min189215-8921595.99299.882.1296.44100.352.12
293071-93071100.140100.62
394304-94304101.467101.95
492110-9211099.10699.57
593911-93911101.044101.53
694336-94336101.502101.99
30min189693-8969396.50699.971.9397.11100.611.93
293154-93154100.230100.88
394210-94210101.366102.02
492100-9210099.09699.73
593994-93994101.134101.79
694331-94331101.496102.15
45min189694-8969496.50799.581.7697.27100.391.77
292967-92967100.029100.84
393841-93841100.969101.79
491590-9159098.54799.35
593537-93537100.642101.46
693667-93667100.782101.61
极限189102-8910295.87099.101.7996.80100.081.80
292073-9207399.067100.05
393132-93132100.206101.20
491597-9159798.55599.52
593285-93285100.371101.36
693444-93444100.542101.53
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
113.631034461032021032621033801033220.11
213.711031711030261030980.10
单位质量响应值RSD%判断
7580.487519.910.57数据可信
供试品溶液-2024021821批-5mg/5mg规格-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%
5min158039-5803949.83254.8851.2449.8354.8851.24
2-0.0000.00
379290-7929068.07968.08
480135-8013568.80468.80
585629-8562973.52173.52
680448-8044869.07369.07
10min183877-8387772.01782.136.4472.1082.226.45
294621-9462181.24281.24
396358-9635882.73382.85
499266-9926685.23085.34
5100054-10005485.90786.03
699763-9976385.65785.77
15min1104290-10429089.54488.741.4089.7588.971.43
2101240-10124086.92587.06
3103666-10366689.00889.26
4101942-10194287.52887.78
5104089-10408989.37189.64
6104893-10489390.06190.32
20min1106487-10648791.43089.922.2991.7890.302.31
2101866-10186687.46287.74
3102638-10263888.12588.52
4103786-10378689.11189.51
5108099-10809992.81493.23
6105526-10552690.60591.01
30min1110337-11033794.73688.856.8895.2489.386.86
297599-9759983.79984.22
392348-9234879.29079.84
4105379-10537990.47991.03
5109795-10979594.27094.84
6105460-10546090.54891.11
45min1112187-11218796.32492.013.1296.9992.683.11
2104396-10439689.63590.20
3105639-10563990.70291.38
4105720-10572090.77191.47
5110517-11051794.89095.62
6104514-10451489.73690.45
极限1110538-11053894.90891.512.5995.7392.332.61
2103108-10310888.52989.24
3105347-10534790.45191.28
4105039-10503990.18791.04
5109093-10909393.66794.55
6106338-10633891.30292.16
比索洛尔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2000
标示量(mg)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%
110.298596285977860178598285956859790.03
210.298601786010860140.01
单位质量响应值RSD%判断
8355.598358.990.03数据可信
供试品溶液-2024021821批-5mg/5mg规格-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min178371-7837184.22989.363.2884.2389.363.28
286367-8636792.82392.82
384482-8448290.79790.80
484023-8402390.30490.30
582073-8207388.20888.21
683566-8356689.81389.81
10min188959-8895995.60998.661.9795.7598.801.97
293779-93779100.789100.94
391376-9137698.20698.36
491222-9122298.04198.19
591691-9169198.54598.69
693734-93734100.741100.89
15min191332-9133298.159100.901.7998.46101.211.79
295325-95325102.451102.77
393254-93254100.225100.54
492855-9285599.796100.11
594944-94944102.041102.35
695589-95589102.734103.05
20min191982-9198298.858101.331.7799.32101.811.77
295339-95339102.466102.96
393396-93396100.377100.86
493294-93294100.268100.75
595223-95223102.341102.82
696464-96464103.675104.16
30min191779-9177998.640101.522.0899.27102.182.08
295679-95679102.831103.50
393510-93510100.500101.15
493099-93099100.058100.71
595804-95804102.965103.62
696900-96900104.143104.80
45min191809-9180998.672101.372.0899.46102.192.08
295418-95418102.551103.39
393343-93343100.320101.14
492797-9279799.734100.55
595676-95676102.828103.65
696881-96881104.123104.96
极限191724-9172498.580101.271.9799.54102.261.97
295113-95113102.223103.23
393308-93308100.283101.27
492979-9297999.929100.91
595648-95648102.798103.79
696609-96609103.831104.84
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
113.631031021033141033441031311033511032480.12
213.711031351029901030620.10
单位质量响应值RSD%判断
7575.067517.290.55数据可信
供试品溶液-2024021821批-5mg/5mg规格-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176589-7658965.79471.905.0965.7971.905.10
286514-8651474.32174.32
385590-8559073.52773.53
488657-8865776.16276.16
583016-8301671.31671.32
681800-8180070.27170.27
10min189205-8920576.63283.324.8576.7483.444.85
2101435-10143587.13987.26
3100057-10005785.95586.08
4100296-10029686.16086.29
597035-9703583.35983.48
693883-9388380.65180.77
15min194424-9442481.11688.074.8381.3588.334.83
2106989-10698991.91092.18
3106291-10629191.31091.58
4105236-10523690.40490.67
5103448-10344888.86889.13
698708-9870884.79685.05
20min1100860-10086086.64592.164.0887.0292.564.08
2108459-10845993.17393.59
3111668-11166895.92996.35
4111481-11148195.76996.19
5107897-10789792.69093.10
6103304-10330488.74489.14
30min1105185-10518590.36096.513.9290.8897.073.92
2113473-11347397.48098.06
3116496-116496100.077100.65
4115547-11554799.26299.84
5114486-11448698.35098.91
6108863-10886393.52094.06
45min1110737-11073795.13099.432.8095.80100.152.81
2116451-116451100.038100.78
3119729-119729102.854103.60
4118016-118016101.383102.13
5116092-11609299.730100.45
6113412-11341297.42898.12
极限1111205-11120595.53299.642.7196.36100.522.71
2115533-11553399.250100.16
3120658-120658103.652104.57
4117538-117538100.972101.89
5116283-11628399.894100.78
6114699-11469998.53399.39
比索洛尔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2000
标示量(mg)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%
110.298610286135860818612086150861180.04
210.298607186060860660.01
单位质量响应值RSD%判断
8369.108364.040.05数据可信
供试品溶液-2024021821批-5mg/5mg规格-比索洛尔-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min173435-7343578.83784.147.1878.8484.147.19
277205-7720582.88482.88
371270-7127076.51376.51
479504-7950485.35285.35
582452-8245288.51788.52
686387-8638792.74192.74
10min188073-8807394.55296.683.5494.6896.823.55
288947-8894795.49095.63
386547-8654792.91393.04
490576-9057697.23997.38
590389-9038997.03897.19
695787-95787102.833102.99
15min191073-9107397.77299.622.5298.0699.922.53
292017-9201798.78699.08
391597-9159798.33598.62
492999-9299999.840100.14
591698-9169898.44398.75
697377-97377104.540104.87
20min192209-9220998.99299.981.7699.44100.451.77
292322-9232299.11399.57
392615-9261599.42899.87
493665-93665100.555101.03
591781-9178198.53299.01
696204-96204103.281103.78
30min192620-9262099.433100.181.80100.05100.811.80
291937-9193798.70099.33
393256-93256100.116100.73
494405-94405101.349101.99
591606-9160698.34498.98
696065-96065103.131103.80
45min192429-9242999.22899.871.73100.01100.671.74
291087-9108797.78798.58
393416-93416100.288101.07
493943-93943100.853101.66
591754-9175498.50399.30
695516-95516102.542103.39
极限190847-9084797.53099.761.9498.48100.731.94
292749-9274999.571100.53
393584-93584100.468101.41
493393-93393100.263101.24
591198-9119897.90698.87
695793-95793102.839103.85
比索洛尔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100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)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%
113.631033831033451033831032971032861033390.05
213.711030101031951031020.13
单位质量响应值RSD%判断
7581.737520.200.58数据可信
供试品溶液-2024021821批-5mg/5mg规格-氨氯地平-0.005mhcl
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min165721-6572156.42266.1311.4156.4266.1311.41
274533-7453363.98863.99
370361-7036160.40660.41
478721-7872167.58367.58
590188-9018877.42877.43
682632-8263270.94170.94
10min187256-8725674.91179.507.6375.0079.617.64
289651-8965176.96777.07
384712-8471272.72772.83
492914-9291479.76879.88
5104006-10400689.29189.42
697049-9704983.31883.44
15min191243-9124378.33384.727.1378.5584.967.14
297214-9721483.46083.69
392294-9229479.23679.46
498015-9801584.14784.39
5109942-10994294.38794.66
6103358-10335888.73488.99
20min196870-9687083.16487.686.4783.5188.066.48
2100412-10041286.20586.58
394830-9483081.41381.77
4102564-10256488.05388.44
5113422-11342297.37497.81
6104661-10466189.85390.26
30min1103364-10336488.74092.385.1789.2392.915.18
2105125-10512590.25190.77
3101359-10135987.01887.51
4110853-11085395.16995.70
5116550-116550100.060100.66
6108372-10837293.03993.59
45min1105021-10502190.16295.264.3490.8095.954.34
2109139-10913993.69794.37
3110218-11021894.62495.26
4114737-11473798.50399.19
5118373-118373101.625102.39
6108293-10829392.97193.68
极限1107448-10744892.24697.434.0393.0398.274.02
2115501-11550199.15999.98
3115662-11566299.298100.09
4115839-11583999.450100.30
5118415-118415101.661102.59
6108073-10807392.78293.65
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