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%
116.521088111087931088581088321088461088280.03
216.521085341085601085470.02
单位质量响应值RSD%判断
6587.656570.640.19数据可信
中间条件18月-供试品溶液-2022101211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%
2min196065-9606587.08385.101.4087.0885.101.40
294878-9487886.00786.01
393502-9350284.76084.76
492840-9284084.16084.16
592941-9294184.25184.25
693045-9304584.34584.35
5min1107122-10712297.10697.590.6097.1197.590.60
2108342-10834298.21298.21
3106775-10677596.79296.79
4107979-10797997.88397.88
5107432-10743297.38797.39
6108279-10827998.15598.16
10min1107345-10734597.30897.890.5097.3197.890.50
2108395-10839598.26098.26
3107313-10731397.27997.28
4108197-10819798.08198.08
5108119-10811998.01098.01
6108552-10855298.40398.40
15min1107390-10739097.34998.040.6097.3598.040.60
2108516-10851698.37098.37
3107489-10748997.43997.44
4108272-10827298.14998.15
5108130-10813098.02098.02
6109106-10910698.90598.90
30min1107741-10774197.66798.200.6397.6798.200.63
2108859-10885998.68198.68
3107379-10737997.33997.34
4108395-10839598.26098.26
5108384-10838498.25098.25
6109191-10919198.98298.98
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%
116.521085661086061086321084981085851085770.05
216.521082041080461081250.11
单位质量响应值RSD%判断
6572.466545.100.30数据可信
长期18月-供试品溶液-2022101211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%
2min195817-9581787.12887.073.9387.1387.063.93
2101416-10141692.22092.22
397646-9764688.79188.79
494939-9493986.33086.33
594689-9468986.10386.10
689984-8998481.82481.82
5min1105793-10579396.20097.851.3496.2097.851.34
2109290-10929099.38099.38
3109263-10926399.35599.36
4106429-10642996.77896.78
5107572-10757297.81797.82
6107296-10729697.56697.57
10min1106635-10663596.96598.261.2096.9798.261.20
2109493-10949399.56499.56
3109734-10973499.78399.78
4106906-10690697.21297.21
5107689-10768997.92497.92
6107919-10791998.13398.13
15min1106140-10614096.51597.451.4696.5297.451.46
2108229-10822998.41598.41
3109859-10985999.89799.90
4106002-10600296.39096.39
5106737-10673797.05897.06
6106046-10604696.43096.43
30min1106708-10670897.03298.081.2097.0398.081.20
2108869-10886998.99799.00
3109926-10992699.95899.96
4106690-10669097.01597.02
5107700-10770097.93497.93
6107299-10729997.56997.57
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%
116.521086551086021086501086671086071086360.03
216.521085531085161085340.03
单位质量响应值RSD%判断
6576.036569.850.07数据可信
中间条件18月-供试品溶液-2022101411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%
2min196065-9606587.16588.992.9887.1788.992.98
297144-9714488.14488.14
394340-9434085.60085.60
4102491-10249192.99693.00
5100128-10012890.85290.85
698291-9829189.18589.18
5min1108835-10883598.75298.880.6298.7598.880.62
2109437-10943799.29899.30
3109763-10976399.59499.59
4109424-10942499.28799.29
5108248-10824898.22098.22
6108167-10816798.14698.15
10min1109547-10954799.39899.310.6599.4099.310.65
2109546-10954699.39799.40
3109982-10998299.79399.79
4110367-110367100.142100.14
5108733-10873398.66098.66
6108546-10854698.49098.49
15min1110124-11012499.92299.750.6999.9299.750.69
2110078-11007899.88099.88
3110188-11018899.98099.98
4110967-110967100.687100.69
5109468-10946899.32699.33
6108752-10875298.67798.68
30min1110075-11007599.87799.770.6799.8899.770.68
2109925-10992599.74199.74
3110163-11016399.95799.96
4111165-111165100.866100.87
5109383-10938399.24999.25
6109028-10902898.92798.93
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%
116.521080841084341084151083221083671083240.14
216.521082881081871082380.07
单位质量响应值RSD%判断
6557.146551.940.06数据可信
长期18月-供试品溶液-2022101411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%
2min193821-9382185.36885.417.6385.3785.427.63
294467-9446785.95685.96
3100406-10040691.36091.36
4100180-10018091.15491.15
593655-9365585.21785.22
680699-8069973.42873.43
5min1108449-10844998.67898.910.5598.6898.920.55
2108982-10898299.16399.16
3108290-10829098.53398.53
4107876-10787698.15798.16
5109294-10929499.44799.45
6109363-10936399.51099.51
10min1109920-109920100.01799.450.74100.0299.450.74
2109134-10913499.30199.30
3108575-10857598.79398.79
4108165-10816598.42098.42
5109827-10982799.93299.93
6110163-110163100.238100.24
15min1109996-109996100.08699.400.77100.0999.400.77
2109099-10909999.27099.27
3108393-10839398.62798.63
4108141-10814198.39898.40
5109862-10986299.96499.96
6109995-109995100.085100.08
30min1110094-110094100.17599.410.84100.1799.400.84
2109232-10923299.39199.39
3108154-10815498.41098.41
4108137-10813798.39498.39
5109743-10974399.85699.86
6110135-110135100.212100.21
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%
116.521020141020731021901021221020691020940.07
216.521012071018251015160.44
单位质量响应值RSD%判断
6180.026145.040.41数据可信
中间条件18月-供试品溶液-2022101511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%
2min185260-8526082.51482.361.4282.5182.361.42
285017-8501782.27982.28
384585-8458581.86181.86
483406-8340680.72080.72
585198-8519882.45482.45
687119-8711984.31384.31
5min198651-9865195.47494.631.2795.4794.631.27
298394-9839495.22595.22
396017-9601792.92492.92
497082-9708293.95593.96
597155-9715594.02694.03
699387-9938796.18696.19
10min199425-9942596.22394.991.5596.2294.991.55
298527-9852795.35495.35
395731-9573192.64892.65
497211-9721194.08094.08
598119-9811994.95994.96
699902-9990296.68496.68
15min199501-9950196.29695.080.8796.3095.080.87
298149-9814994.98894.99
397035-9703593.91093.91
498214-9821495.05195.05
597775-9777594.62694.63
698813-9881395.63095.63
30min199558-9955896.35195.121.4396.3595.121.43
298531-9853195.35895.36
395876-9587692.78892.79
498318-9831895.15195.15
597696-9769694.54994.55
699709-9970996.49896.50
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%
116.521017121015711017071018381018381017330.11
216.521008241012051010140.27
单位质量响应值RSD%判断
6158.176114.650.51数据可信
长期18月-供试品溶液-2022101511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%
2min185529-8552983.12786.914.4683.1386.914.46
291235-9123588.67388.67
391310-9131088.74688.75
488318-8831885.83885.84
595342-9534292.66492.66
684817-8481782.43582.43
5min198945-9894596.16696.851.0796.1796.851.07
2101073-10107398.23498.23
399260-9926096.47296.47
499992-9999297.18497.18
5100453-10045397.63297.63
698152-9815295.39595.40
10min198629-9862995.85997.081.6995.8697.081.69
2102010-10201099.14599.15
399640-9964096.84296.84
4100215-10021597.40197.40
5101334-10133498.48898.49
697476-9747694.73894.74
15min199303-9930396.51497.321.4596.5197.321.46
2102333-10233399.45999.46
399940-9994097.13397.13
499930-9993097.12497.12
5101150-10115098.30998.31
698159-9815995.40295.40
30min198297-9829795.53696.461.6895.5496.461.68
2101809-10180998.95098.95
398696-9869695.92495.92
4100087-10008797.27697.28
599621-9962196.82396.82
696980-9698094.25694.26
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