苯磺酸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%
113.881013471007211012391009951012241011050.25
213.961020331019881020100.04
单位质量响应值RSD%判断
7284.227307.310.23数据可信
供试品溶液-8178316批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182692-8269271.56270.096.6371.5670.096.63
284278-8427872.93572.93
384234-8423472.89772.90
471286-7128661.69161.69
578218-7821867.69067.69
685221-8522173.75173.75
10min1102707-10270788.88387.535.0989.0087.655.09
2103676-10367689.72289.84
3104929-10492990.80690.93
491814-9181479.45779.56
598633-9863385.35885.47
6105111-10511190.96491.09
15min1110434-11043495.57093.984.1295.8494.244.12
2111678-11167896.64796.92
3111825-11182596.77497.05
4100016-10001686.55586.79
5107665-10766593.17493.43
6109953-10995395.15495.43
20min1113289-11328998.04197.043.1698.4797.463.17
2114746-11474699.30299.73
3114615-11461599.18999.62
4105490-10549091.29291.67
5110911-11091195.98396.39
6113720-11372098.41498.85
30min1115929-115929100.32699.271.73100.9299.851.75
2116059-116059100.438101.04
3116583-116583100.892101.49
4111300-11130096.32096.85
5113595-11359598.30698.88
6114787-11478799.33899.93
45min1116072-116072100.450100.080.98101.21100.830.99
2116782-116782101.064101.83
3116681-116681100.977101.74
4115474-11547499.932100.62
5113776-11377698.46399.20
6115087-11508799.597100.36
极限1115562-115562100.00899.881.04100.93100.801.03
2115975-115975100.366101.30
3116543-116543100.857101.79
4116391-116391100.726101.58
5113462-11346298.19199.09
6114571-11457199.151100.08
苯磺酸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%
113.881016261013701011861016071010641013710.25
213.961015911009971012940.42
单位质量响应值RSD%判断
7303.397256.020.47数据可信
供试品溶液-8178316批-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min182307-8230771.38771.052.6471.3971.052.64
283585-8358572.49572.50
380379-8037969.71569.71
481716-8171670.87470.87
584747-8474773.50373.50
678771-7877168.32068.32
10min1103031-10303189.36189.512.9989.4889.632.99
2103563-10356389.82389.94
3101011-10101187.60987.73
4104056-10405690.25090.37
5108310-10831093.94094.06
699227-9922786.06286.18
15min1109529-10952994.99795.792.3395.2796.062.33
2110953-11095396.23296.50
3107913-10791393.59693.86
4112033-11203397.16997.44
5114438-11443899.25599.53
6107796-10779693.49493.75
20min1111808-11180896.97498.202.0697.4098.632.06
2112649-11264997.70398.13
3111482-11148296.69197.11
4115407-115407100.095100.53
5116799-116799101.303101.75
6111214-11121496.45996.87
30min1113112-11311298.105100.172.0498.69100.762.04
2114311-11431199.14599.74
3113142-11314298.13198.71
4117689-117689102.075102.67
5118634-118634102.894103.51
6116038-116038100.643101.22
45min1112821-11282197.852100.302.1698.60101.062.15
2115017-11501799.757100.52
3112705-11270597.75298.49
4117978-117978102.325103.09
5118052-118052102.389103.17
6117316-117316101.751102.49
极限1112827-11282797.858100.212.6898.77101.132.67
2115050-11505099.786100.71
3111128-11112896.38497.29
4117475-117475101.889102.83
5117645-117645102.036102.99
6119093-119093103.292104.20
苯磺酸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%
113.881017561006601014161014371005081011550.54
213.961012421010441011430.14
单位质量响应值RSD%判断
7287.827245.200.42数据可信
供试品溶液-8178316批-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%
5min176846-7684666.77169.782.6466.7769.782.64
282628-8262871.79571.80
380962-8096270.34870.35
478986-7898668.63168.63
581991-8199171.24271.24
680444-8044469.89869.90
10min192114-9211480.03884.133.6880.1584.253.68
2102465-10246589.03289.15
394724-9472482.30582.42
498206-9820685.33185.45
597949-9794985.10885.23
695508-9550882.98783.10
15min1100710-10071087.50792.293.5087.7592.553.50
2111187-11118796.61096.88
3104308-10430890.63390.89
4107055-10705593.02093.28
5109041-10904194.74595.01
6105019-10501991.25191.51
20min1105902-10590292.01896.293.2392.4196.703.23
2115422-115422100.290100.72
3108375-10837594.16794.57
4111091-11109196.52796.94
5114236-11423699.25999.68
6109893-10989395.48695.89
30min1110139-11013995.699100.703.4596.24101.273.45
2119644-119644103.958104.55
3113071-11307198.24798.81
4116779-116779101.469102.04
5120695-120695104.872105.46
6115051-11505199.967100.53
45min1112021-11202197.335101.522.8398.04102.262.83
2120912-120912105.060105.83
3115276-115276100.163100.89
4116834-116834101.517102.26
5120191-120191104.434105.19
6115796-115796100.615101.35
极限1112582-11258297.822102.032.8498.69102.942.84
2120974-120974105.114106.06
3116113-116113100.890101.78
4116981-116981101.644102.56
5121486-121486105.559106.49
6116419-116419101.156102.06
苯磺酸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%
113.881007311008971008581011191010511009310.16
213.961013811010171011990.26
单位质量响应值RSD%判断
7271.697249.210.22数据可信
供试品溶液-8178316批-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%
5min172124-7212462.72066.625.2862.7266.625.28
273941-7394164.30064.30
381272-8127270.67670.68
474539-7453964.82064.82
575912-7591266.01466.01
681888-8188871.21171.21
10min185729-8572974.55182.027.7674.6682.137.76
287637-8763776.21176.32
3100772-10077287.63387.75
493684-9368481.46981.58
593442-9344281.25981.37
6104630-10463090.98891.11
15min196343-9634383.78290.626.5184.0190.876.51
297459-9745984.75284.99
3110074-11007495.72295.99
4104604-10460490.96591.21
5103252-10325289.79090.04
6113538-11353898.73599.00
20min1101787-10178788.51694.886.0488.8895.286.04
2103138-10313889.69190.07
3114669-11466999.718100.14
4108912-10891294.71295.11
5107344-10734493.34893.74
6118778-118778103.291103.73
30min1110311-11031195.92899.204.0496.4499.764.05
2108971-10897194.76395.29
3117376-117376102.072102.66
4113990-11399099.12899.68
5112486-11248697.82098.37
6121314-121314105.497106.10
45min1114293-11429399.391100.842.97100.07101.562.99
2113513-11351398.71399.40
3117426-117426102.116102.88
4116091-116091100.955101.67
5112466-11246697.80298.52
6121967-121967106.065106.85
极限1117447-117447102.134101.562.77102.98102.452.78
2114796-11479699.829100.68
3116334-116334101.166102.10
4116674-116674101.462102.35
5112952-11295298.22599.10
6122528-122528106.552107.51
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