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%
116.871053091054171053641049871056691053490.24
216.891049521056821053170.50
单位质量响应值RSD%判断
6244.756235.460.11数据可信
供试品溶液-2024120821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%
2min189325-8932585.37383.193.1385.3783.203.12
285894-8589482.09382.09
390117-9011786.13086.13
487029-8702983.17883.18
582485-8248578.83578.84
687428-8742883.56083.56
5min1103960-10396099.36099.570.9699.3699.580.96
2104031-10403199.42899.43
3102461-10246197.92797.93
4104485-10448599.86299.86
5105431-105431100.766100.77
6104739-104739100.105100.10
10min1104448-10444899.826100.561.1899.83100.561.18
2104666-104666100.035100.03
3105857-105857101.173101.17
4103516-10351698.93698.94
5106978-106978102.245102.24
6105799-105799101.118101.12
15min1104866-104866100.226100.200.38100.23100.200.38
2104659-104659100.028100.03
3104273-10427399.65999.66
4105042-105042100.394100.39
5105461-105461100.795100.79
6104737-104737100.103100.10
30min1103809-10380999.216100.080.7699.22100.080.76
2104560-10456099.93499.93
3104344-10434499.72799.73
4105264-105264100.606100.61
5105991-105991101.301101.30
6104286-10428699.67299.67
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%
116.871056741047621057511057401051681054190.42
216.891056521050311053420.42
单位质量响应值RSD%判断
6248.906236.940.14数据可信
供试品溶液-2024120821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%
2min189608-8960885.60582.456.5385.6082.456.53
290652-9065286.60286.60
377416-7741673.95773.96
490414-9041486.37586.37
581072-8107277.45077.45
688681-8868184.71984.72
5min1102095-10209597.53498.841.4997.5398.841.49
2102631-10263198.04698.05
3102867-10286798.27198.27
4105484-105484100.771100.77
5105368-105368100.660100.66
6102360-10236097.78797.79
10min1103191-10319198.58199.521.0098.5899.521.00
2104598-10459899.92599.92
3103109-10310998.50298.50
4105558-105558100.842100.84
5105033-105033100.340100.34
6103536-10353698.91098.91
15min1103503-10350398.87999.280.7598.8899.280.75
2103612-10361298.98398.98
3103480-10348098.85798.86
4104456-10445699.78999.79
5105250-105250100.548100.55
6103234-10323498.62298.62
30min1103186-10318698.57699.351.2298.5899.351.21
2103451-10345198.82998.83
3103082-10308298.47798.48
4104443-10444399.77799.78
5106367-106367101.615101.61
6103434-10343498.81398.81
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%
116.871047841049131047691047731047321047940.07
216.891048421048241048330.02
单位质量响应值RSD%判断
6211.866206.810.06数据可信
供试品溶液-2024120921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%
2min189488-8948885.95288.912.4985.9588.912.49
293143-9314389.46389.46
390369-9036986.79986.80
493615-9361589.91689.92
592972-9297289.29989.30
695803-9580392.01892.02
5min1105102-105102100.949100.770.63100.95100.770.63
2105043-105043100.893100.89
3104085-10408599.97399.97
4104747-104747100.608100.61
5104512-104512100.383100.38
6106021-106021101.832101.83
10min1105635-105635101.461101.250.34101.46101.250.33
2105300-105300101.140101.14
3105532-105532101.362101.36
4105311-105311101.150101.15
5105856-105856101.674101.67
6104842-104842100.700100.70
15min1105894-105894101.710101.350.51101.71101.350.51
2106064-106064101.873101.87
3105062-105062100.911100.91
4105032-105032100.882100.88
5105029-105029100.879100.88
6106062-106062101.871101.87
30min1104867-104867100.724101.500.63100.72101.500.63
2106389-106389102.186102.19
3105752-105752101.574101.57
4105361-105361101.198101.20
5105190-105190101.034101.03
6106509-106509102.301102.30
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%
116.871046001048041047951047661048181047570.09
216.891058071058981058520.07
单位质量响应值RSD%判断
6209.666267.140.66数据可信
供试品溶液-2024120921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%
2min192482-9248288.41688.782.4688.4288.782.46
290429-9042986.45386.45
395491-9549191.29391.29
492296-9229688.23888.24
595738-9573891.52991.53
690760-9076086.77086.77
5min1104466-10446699.873100.640.9999.87100.640.99
2104650-104650100.049100.05
3104209-10420999.62799.63
4106237-106237101.566101.57
5106793-106793102.098102.10
6105277-105277100.648100.65
10min1104916-104916100.303100.790.73100.30100.790.73
2105291-105291100.662100.66
3105109-105109100.488100.49
4106668-106668101.978101.98
5105992-105992101.332101.33
6104599-104599100.000100.00
15min1105701-105701101.054101.030.51101.05101.030.51
2105612-105612100.969100.97
3105798-105798101.147101.15
4106590-106590101.904101.90
5105410-105410100.776100.78
6104959-104959100.344100.34
30min1104292-10429299.707100.900.6499.71100.900.64
2106108-106108101.443101.44
3105260-105260100.632100.63
4105785-105785101.134101.13
5105846-105846101.192101.19
6105923-105923101.266101.27
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%
116.871047001048511049021050471050991049200.16
216.891047701047531047620.02
单位质量响应值RSD%判断
6219.326202.610.20数据可信
供试品溶液-22024121021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%
2min189907-8990786.33289.332.7786.3389.332.77
294178-9417890.43390.43
395542-9554291.74391.74
494400-9440090.64790.65
589619-8961986.05686.06
694537-9453790.77890.78
5min1105002-105002100.827100.381.19100.83100.381.19
2103940-10394099.80799.81
3102307-10230798.23998.24
4105269-105269101.083101.08
5105715-105715101.512101.51
6104963-104963100.790100.79
10min1106610-106610102.371100.811.23102.37100.801.23
2105024-105024100.848100.85
3102684-10268498.60198.60
4104870-104870100.700100.70
5105571-105571101.373101.37
6105124-105124100.944100.94
15min1105172-105172100.990100.291.04100.99100.291.04
2103940-10394099.80799.81
3102493-10249398.41898.42
4104642-104642100.481100.48
5105363-105363101.174101.17
6105043-105043100.866100.87
30min1105408-105408101.217100.290.88101.22100.290.88
2103748-10374899.62399.62
3103292-10329299.18599.19
4104986-104986100.812100.81
5105354-105354101.165101.17
6103878-10387899.74899.75
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%
116.871048061049611050101050821050751049870.11
216.891056681048901052790.53
单位质量响应值RSD%判断
6223.306233.210.12数据可信
供试品溶液-22024121021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%
2min190018-9001886.19988.252.7186.2088.252.71
290130-9013086.30686.31
394758-9475890.73890.74
493720-9372089.74489.74
594725-9472590.70690.71
689609-8960985.80785.81
5min1105007-105007100.552100.071.58100.55100.071.58
2104884-104884100.434100.43
3103355-10335598.97098.97
4106916-106916102.380102.38
5102069-10206997.73897.74
6104776-104776100.331100.33
10min1106741-106741102.212100.961.51102.21100.961.51
2105666-105666101.183101.18
3103572-10357299.17899.18
4107217-107217102.668102.67
5103447-10344799.05899.06
6105956-105956101.461101.46
15min1105659-105659101.176100.301.48101.18100.301.48
2104834-104834100.386100.39
3103443-10344399.05499.05
4106500-106500101.981101.98
5102404-10240498.05998.06
6105624-105624101.143101.14
30min1106662-106662102.137100.791.74102.14100.781.74
2105540-105540101.062101.06
3102836-10283698.47398.47
4107127-107127102.582102.58
5103144-10314498.76898.77
6106195-106195101.689101.69
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