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%
117.141052151053491053281052751053691053070.06
217.191046721047961047340.09
单位质量响应值RSD%判断
6143.936092.730.60数据可信
供试品溶液-4批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
2min183685-8368581.57682.552.5281.5882.552.52
287996-8799685.77885.78
386685-8668584.50084.50
483333-8333381.23281.23
583708-8370881.59881.60
682720-8272080.63580.63
5min1100362-10036297.83297.930.8197.8397.930.81
2101080-10108098.53298.53
3100542-10054298.00898.01
4101555-10155598.99599.00
599943-9994397.42497.42
699279-9927996.77696.78
10min1102447-10244799.86599.620.7899.8699.620.78
2102634-102634100.047100.05
3102218-10221899.64199.64
4103263-103263100.660100.66
5101615-10161599.05499.05
6101017-10101798.47198.47
15min1103093-103093100.494100.290.75100.49100.290.75
2103396-103396100.790100.79
3102580-10258099.99499.99
4104031-104031101.409101.41
5102077-10207799.50499.50
6102111-10211199.53799.54
30min1103425-103425100.818100.470.84100.82100.470.84
2103617-103617101.005101.01
3102488-10248899.90599.90
4104327-104327101.697101.70
5102454-10245499.87199.87
6102081-10208199.50899.51
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%
117.141051031051231051151052041050841051260.05
217.191049331048171048750.08
单位质量响应值RSD%判断
6133.376100.930.38数据可信
供试品溶液-4批-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%
2min189800-8980087.55286.143.8887.5586.143.88
286124-8612483.96883.97
392925-9292590.59990.60
484737-8473782.61682.62
585303-8530383.16883.17
691218-9121888.93588.93
5min1101342-10134298.80599.780.7598.8199.780.75
2101443-10144398.90498.90
3103181-103181100.598100.60
4102631-102631100.062100.06
5102691-102691100.121100.12
6102785-102785100.212100.21
10min1101183-10118398.650100.000.8398.65100.000.82
2101908-10190899.35799.36
3103350-103350100.763100.76
4103139-103139100.557100.56
5102972-102972100.395100.39
6102857-102857100.283100.28
15min1101243-10124398.70999.970.8098.7199.980.80
2101827-10182799.27899.28
3103303-103303100.717100.72
4103023-103023100.444100.44
5102974-102974100.397100.40
6102870-102870100.295100.30
30min1101315-10131598.77999.960.7698.7899.960.76
2101841-10184199.29299.29
3103327-103327100.741100.74
4102899-102899100.323100.32
5102978-102978100.401100.40
6102798-102798100.225100.23
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%
117.141050371051341050301050781050871050730.05
217.191052571051331051950.09
单位质量响应值RSD%判断
6130.286119.550.13数据可信
供试品溶液-4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%
2min185154-8515482.91783.813.3982.9283.813.39
288390-8839086.06886.07
387227-8722784.93584.94
485279-8527983.03983.04
581151-8115179.01979.02
689227-8922786.88386.88
5min1101322-10132298.66099.250.9898.6699.250.98
2102674-10267499.97799.98
3101938-10193899.26099.26
4102501-10250199.80899.81
5100241-10024197.60897.61
6102864-102864100.162100.16
10min1100992-10099298.33999.591.1798.3499.581.17
2103212-103212100.501100.50
3102506-10250699.81399.81
4103103-103103100.394100.39
5100579-10057997.93797.94
6103245-103245100.533100.53
15min1101031-10103198.37799.551.0698.3899.551.06
2102841-102841100.139100.14
3102509-10250999.81699.82
4103180-103180100.469100.47
5100724-10072498.07898.08
6103126-103126100.417100.42
30min1101020-10102098.36699.521.1298.3799.521.12
2103111-103111100.402100.40
3102545-10254599.85199.85
4103017-103017100.311100.31
5100524-10052497.88397.88
6102997-102997100.291100.29
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%
117.141054131051681050041052071050941051770.15
217.191050811051141050980.03
单位质量响应值RSD%判断
6136.356113.900.26数据可信
供试品溶液-4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%
2min184930-8493082.69682.274.2182.7082.274.21
285599-8559983.34883.35
385188-8518882.94782.95
489184-8918486.83886.84
583789-8378981.58581.59
678267-7826776.20876.21
5min1101284-10128498.62098.461.6298.6298.461.61
2102885-102885100.179100.18
3101058-10105898.40098.40
4102681-10268199.98099.98
5100317-10031797.67897.68
698467-9846795.87795.88
10min1101503-10150398.83399.091.6098.8399.091.60
2103847-103847101.116101.12
3101861-10186199.18299.18
4103133-103133100.420100.42
5101039-10103998.38198.38
699244-9924496.63496.63
15min1101732-10173299.05699.241.6599.0699.241.65
2104108-104108101.370101.37
3101813-10181399.13599.14
4103303-103303100.586100.59
5101284-10128498.62098.62
699289-9928996.67796.68
30min1101923-10192399.24299.461.6399.2499.461.63
2104471-104471101.723101.72
3102020-10202099.33799.34
4103227-103227100.512100.51
5101717-10171799.04299.04
699503-9950396.88696.89
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