普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871036211039851037721037441038421037930.13
216.891049171047701048440.10
单位质量响应值RSD%判断
6152.526207.460.63数据可信
供试品溶液-HM1191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%
2min152655-5265550.81650.012.4550.8250.012.45
252062-5206250.24350.24
353312-5331251.45051.45
450118-5011848.36748.37
552336-5233650.50850.51
650455-5045548.69348.69
5min197643-9764394.23291.582.5194.2391.582.51
293179-9317989.92489.92
397932-9793294.51194.51
493065-9306589.81489.81
594931-9493191.61591.61
692641-9264189.40589.40
10min1104570-104570100.91799.591.29100.9299.601.29
2102459-10245998.88098.88
3105200-105200101.525101.53
4102231-10223198.66098.66
5102274-10227498.70198.70
6102463-10246398.88498.88
15min1105137-105137101.46499.991.26101.4699.991.25
2103061-10306199.46199.46
3105391-105391101.710101.71
4102529-10252998.94898.95
5102745-10274599.15699.16
6102787-10278799.19799.20
30min1105279-105279101.602100.121.15101.60100.121.15
2102944-10294499.34899.35
3105202-105202101.527101.53
4102709-10270999.12199.12
5103500-10350099.88599.88
6102860-10286099.26799.27
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871040771041591040431041771042271041370.08
216.891040931042441041680.11
单位质量响应值RSD%判断
6172.916167.440.07数据可信
供试品溶液-HM1191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%
2min152548-5254850.79250.083.0350.7950.083.03
252992-5299251.22151.22
349373-4937347.72347.72
451599-5159949.87549.87
553618-5361851.82651.83
650768-5076849.07249.07
5min195183-9518392.00391.233.0092.0091.233.00
299270-9927095.95395.95
393720-9372090.58890.59
491596-9159688.53588.54
594811-9481191.64391.64
691720-9172088.65588.66
10min1103567-103567100.10699.701.79100.1199.701.79
2105870-105870102.332102.33
3103270-10327099.81999.82
4101492-10149298.10198.10
5103977-103977100.503100.50
6100712-10071297.34797.35
15min1104020-104020100.544100.291.84100.54100.291.84
2106783-106783103.215103.21
3103818-103818100.349100.35
4101713-10171398.31498.31
5104487-104487100.996101.00
6101706-10170698.30898.31
30min1104051-104051100.574100.131.77100.57100.121.77
2106454-106454102.897102.90
3103867-103867100.396100.40
4101576-10157698.18298.18
5103989-103989100.514100.51
6101586-10158698.19298.19
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871041651041871044671041641043711042710.14
216.891045401046851046120.10
单位质量响应值RSD%判断
6180.856193.720.15数据可信
供试品溶液-HM1191批-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%
2min150912-5091249.07549.5711.3949.0749.5711.39
243782-4378242.20242.20
347197-4719745.49445.49
451708-5170849.84249.84
560740-6074058.54858.55
654232-5423252.27552.27
5min195764-9576492.30892.391.8292.3192.391.82
296612-9661293.12693.13
395087-9508791.65691.66
494610-9461091.19691.20
598922-9892295.35295.35
694106-9410690.71090.71
10min1102546-10254698.84599.161.5698.8599.161.56
2103876-103876100.127100.13
3103094-10309499.37499.37
4101936-10193698.25798.26
5105225-105225101.428101.43
6100579-10057996.94996.95
15min1103464-10346499.73099.841.4899.7399.841.48
2104476-104476100.706100.71
3104095-104095100.338100.34
4102695-10269598.98998.99
5105565-105565101.755101.76
6101147-10114797.49797.50
30min1103842-103842100.09599.881.45100.0999.881.46
2104512-104512100.740100.74
3104099-104099100.342100.34
4102508-10250898.80998.81
5105483-105483101.676101.68
6101278-10127897.62397.62
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150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%
116.871043571045471045341043741044521044530.09
216.891042281044351043320.15
单位质量响应值RSD%判断
6191.646177.150.17数据可信
供试品溶液-HM1191批-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%
2min146278-4627844.62948.959.1144.6348.969.11
249728-4972847.95647.96
356223-5622354.21954.22
450066-5006648.28248.28
545894-4589444.25944.26
656391-5639154.38154.38
5min196027-9602792.60592.590.6592.6092.580.65
295087-9508791.69891.70
396686-9668693.24193.24
495493-9549392.09092.09
596193-9619392.76592.77
696553-9655393.11293.11
10min1103405-10340599.72099.190.4199.7299.190.42
2102754-10275499.09299.09
3102495-10249598.84398.84
4102404-10240498.75598.75
5103334-10333499.65299.65
6102750-10275099.08899.09
15min1104359-104359100.640100.070.47100.64100.070.47
2103612-10361299.92099.92
3103361-10336199.67899.68
4103662-10366299.96899.97
5104349-104349100.630100.63
6103264-10326499.58499.58
30min1104521-104521100.796100.200.50100.80100.200.50
2103668-10366899.97499.97
3103583-10358399.89299.89
4103525-10352599.83699.84
5104593-104593100.866100.87
6103509-10350999.82099.82
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