非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651822504182415218230001823640182118918228970.07
29.711825742182624418259930.02
单位质量响应值RSD%判断
188901.24188052.830.32数据可信
供试品溶液-2024112321批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1739980-73998070.67065.456.6370.6765.456.63
2738873-73887370.56470.56
3670585-67058564.04364.04
4679212-67921264.86764.87
5655390-65539062.59262.59
6627898-62789859.96659.97
10min1933053-93305389.10988.552.0889.2788.692.08
2953091-95309191.02391.18
3939767-93976789.75089.89
4916454-91645487.52487.67
5898173-89817385.77885.92
6922479-92247988.09988.23
15min11003631-100363195.85094.731.9296.2095.071.93
21012772-101277296.72397.08
31003573-100357395.84496.19
4975814-97581493.19393.53
5962938-96293891.96392.29
6992777-99277794.81395.14
20min11033558-103355898.70897.292.0099.2897.842.01
21037757-103775799.10999.68
31030890-103089098.45399.01
41007027-100702796.17496.72
5984044-98404493.97994.51
61019152-101915297.33297.87
30min11051358-1051358100.40898.882.14101.2099.642.15
21056927-1056927100.940101.73
31050340-1050340100.310101.08
41018786-101878697.29798.06
51000298-100029895.53196.27
61034202-103420298.76999.53
45min11053463-1053463100.60999.431.89101.62100.421.89
21064971-1064971101.708102.73
31046644-104664499.957100.95
41030054-103005498.37399.35
51008865-100886596.34997.30
61042923-104292399.602100.58
60min11068847-1068847102.07899.982.62103.31101.192.62
21084634-1084634103.586104.83
31052654-1052654100.531101.75
41025154-102515497.90599.10
51011228-101122896.57597.74
61038905-103890599.218100.42
极限11057272-1057272100.972100.062.37102.43101.502.36
21058232-1058232101.064102.54
31051703-1051703100.441101.88
41029053-102905398.27799.69
51009831-100983196.44297.83
61080519-1080519103.193104.61
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651873330187223818716341867281186501318698990.20
29.711892325189181418920700.02
单位质量响应值RSD%判断
193771.92194857.880.40数据可信
供试品溶液-b批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1785871-78587172.79866.228.2872.8066.228.28
2699442-69944264.79264.79
3730177-73017767.63967.64
4675913-67591362.61262.61
5769428-76942871.27571.28
6628419-62841958.21358.21
10min1962159-96215989.12988.342.9789.2988.492.97
2977293-97729390.53090.67
3976938-97693890.49890.65
4914313-91431384.69684.84
5969694-96969489.82789.98
6921749-92174985.38585.51
15min11012732-101273293.81395.404.2294.1795.744.21
21055053-105505397.73498.08
31093651-1093651101.309101.66
4976000-97600090.41190.74
51046833-104683396.97297.33
6994979-99497992.16992.49
20min11019010-101901094.39598.712.8494.9699.262.81
21080148-1080148100.058100.62
31058795-105879598.08098.66
41086798-1086798100.674101.20
51046584-104658496.94997.52
61102183-1102183102.099102.62
30min11047944-104794497.075101.383.5297.85102.153.48
21100123-1100123101.909102.69
31084442-1084442100.456101.25
41134394-1134394105.083105.84
51058247-105824798.03098.82
61141165-1141165105.711106.46
45min11054608-105460897.692101.563.0398.69102.563.00
21115928-1115928103.373104.38
31090117-1090117100.982102.00
41131222-1131222104.789105.77
51060576-106057698.24599.25
61125402-1125402104.250105.24
60min11055882-105588297.810101.492.5199.02102.722.49
21106701-1106701102.518103.76
31115188-1115188103.304104.55
41126911-1126911104.390105.61
51069506-106950699.072100.30
61099540-1099540101.855103.07
极限11060153-106015398.206101.262.3799.63102.712.34
21104065-1104065102.274103.74
31094762-1094762101.412102.88
41129857-1129857104.663106.11
51067022-106702298.842100.29
61103157-1103157102.190103.63
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)10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%
19.651828994182892918298201831360182647518291160.10
29.711858518185951918590180.04
单位质量响应值RSD%判断
189545.70191453.960.71数据可信
供试品溶液-2024112421批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1571745-57174554.02558.439.4354.0258.439.43
2691961-69196165.38465.38
3630002-63000259.52959.53
4552230-55223052.18152.18
5679544-67954464.21164.21
6584689-58468955.24855.25
10min1895451-89545184.61286.791.6984.7386.921.71
2930486-93048687.92288.07
3933702-93370288.22688.36
4906397-90639785.64685.76
5930247-93024787.90088.04
6914756-91475686.43686.56
15min1995159-99515994.03395.112.8994.3495.432.88
21000203-100020394.51094.85
3997167-99716794.22394.55
41064657-1064657100.600100.91
5998407-99840794.34094.68
6983755-98375592.95693.27
20min11025926-102592696.94096.360.7097.4696.890.70
21016319-101631996.03396.58
31025008-102500896.85497.39
41022542-102254296.62197.15
51021755-102175596.54697.09
61007001-100700195.15295.67
30min11042451-104245198.50297.980.3999.2398.730.38
21031710-103171097.48798.25
31039488-103948898.22298.97
41036835-103683597.97198.72
51037834-103783498.06698.83
61033318-103331897.63998.37
45min11058828-1058828100.04999.140.92101.00100.110.90
21038988-103898898.17599.16
31053008-105300899.499100.47
41060541-1060541100.211101.17
51038780-103878098.15599.14
61045045-104504598.74799.70
60min11063482-1063482100.48999.991.20101.66101.181.19
21042569-104256998.51399.71
31053789-105378999.573100.77
41061041-1061041100.258101.44
51078895-1078895101.945103.14
61049575-104957599.175100.34
极限11052508-105250899.45298.730.95100.85100.140.93
21039661-103966198.23899.66
31052174-105217499.421100.83
41055823-105582399.765101.17
51036304-103630497.92199.35
61032602-103260297.57198.96
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