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200
标示量(mg)75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%
116.525181851726515545105051216514730.65
216.515167251858517650.26
单位质量响应值RSD%判断
3115.803135.370.45数据可信
供试品溶液-2024121221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%
2min149485-4948594.42491.862.1594.4291.862.15
247372-4737290.39290.39
349314-4931494.09894.10
447353-4735390.35690.36
547162-4716289.99289.99
648163-4816391.90291.90
5min154073-54073103.179103.640.79103.18103.640.79
254548-54548104.085104.09
354846-54846104.654104.65
454364-54364103.734103.73
553613-53613102.301102.30
654429-54429103.858103.86
10min153792-53792102.643103.590.89102.64103.590.89
254449-54449103.896103.90
354748-54748104.467104.47
454764-54764104.497104.50
553632-53632102.337102.34
654331-54331103.671103.67
15min153344-53344101.788103.480.85101.79103.480.85
254570-54570104.127104.13
354452-54452103.902103.90
454534-54534104.059104.06
554335-54335103.679103.68
654135-54135103.297103.30
30min153687-53687102.442103.830.68102.44103.830.68
254576-54576104.139104.14
354606-54606104.196104.20
454467-54467103.931103.93
554451-54451103.900103.90
654696-54696104.368104.37
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200
标示量(mg)75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%
116.525153151508514115202351834516610.50
216.515175151761517560.02
单位质量响应值RSD%判断
3127.183134.830.18数据可信
供试品溶液-2024121221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%
2min148238-4823891.88593.641.6691.8893.641.66
248200-4820091.81291.81
349597-4959794.47494.47
449473-4947394.23794.24
549192-4919293.70293.70
650269-5026995.75495.75
5min153119-53119101.182100.021.67101.18100.021.67
250995-5099597.13697.14
352290-5229099.60399.60
452614-52614100.220100.22
552480-5248099.96599.97
653567-53567102.036102.04
10min153462-53462101.836100.241.52101.84100.241.52
251442-5144297.98897.99
352800-52800100.575100.57
452197-5219799.42699.43
552344-5234499.70699.71
653503-53503101.914101.91
15min153126-53126101.19699.971.85101.2099.971.84
250796-5079696.75796.76
352424-5242499.85899.86
452437-5243799.88399.88
552442-5244299.89399.89
653666-53666102.224102.22
30min153525-53525101.956100.261.31101.96100.261.31
251562-5156298.21798.22
352479-5247999.96399.96
452619-52619100.230100.23
552405-5240599.82299.82
653203-53203101.342101.34
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200
标示量(mg)75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%
116.525154451845515555157451924516880.36
216.515143451544514890.16
单位质量响应值RSD%判断
3128.813118.660.23数据可信
供试品溶液-2024121321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%
2min145640-4564087.13992.424.4087.1492.424.40
245687-4568787.22887.23
349513-4951394.53394.53
449777-4977795.03795.04
550006-5000695.47495.47
649810-4981095.10095.10
5min152193-5219399.650100.801.7599.65100.801.75
252895-52895100.990100.99
351696-5169698.70198.70
454340-54340103.749103.75
553191-53191101.555101.56
652442-52442100.125100.13
10min152284-5228499.824100.771.5399.82100.771.53
252859-52859100.921100.92
351688-5168898.68698.69
453994-53994103.088103.09
553304-53304101.771101.77
652539-52539100.311100.31
15min151918-5191899.125101.001.7799.12101.001.77
252959-52959101.112101.11
351694-5169498.69798.70
454033-54033103.163103.16
553673-53673102.476102.48
653131-53131101.441101.44
30min152834-52834100.874101.501.10100.87101.501.10
253170-53170101.515101.52
352392-52392100.030100.03
454025-54025103.148103.15
553607-53607102.350102.35
652949-52949101.093101.09
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200
标示量(mg)75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%
116.525228951784520515223052038520780.38
216.515166451538516010.18
单位质量响应值RSD%判断
3152.423125.440.61数据可信
供试品溶液-2024121321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%
2min150534-5053496.01791.553.1996.0291.563.19
245998-4599887.39887.40
347765-4776590.75690.76
447678-4767890.59090.59
547959-4795991.12491.12
649177-4917793.43993.44
5min152579-5257999.90299.791.3099.9099.801.30
253379-53379101.423101.42
352076-5207698.94798.95
451813-5181398.44798.45
551992-5199298.78798.79
653291-53291101.255101.26
10min152609-5260999.959100.590.9599.96100.590.95
253833-53833102.285102.29
352778-52778100.281100.28
452409-5240999.57999.58
552903-52903100.518100.52
653117-53117100.925100.92
15min151964-5196498.73499.391.4998.7399.391.49
253617-53617101.875101.87
351854-5185498.52598.52
451832-5183298.48398.48
551689-5168998.21198.21
652903-52903100.518100.52
30min152527-5252799.80499.601.6399.8099.601.63
253297-53297101.267101.27
351917-5191798.64598.64
450969-5096996.84396.84
552833-52833100.385100.39
652977-52977100.659100.66
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200
标示量(mg)75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%
116.525145751276513435127851347513400.15
216.515153451595515640.09
单位质量响应值RSD%判断
3107.753123.200.36数据可信
供试品溶液-2024121421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%
2min144319-4431984.84190.614.6584.8490.614.65
244785-4478585.73385.73
348593-4859393.02393.02
448045-4804591.97491.97
548925-4892593.65893.66
649331-4933194.43694.44
5min151756-5175699.078100.291.2899.08100.291.28
252236-5223699.997100.00
352944-52944101.352101.35
452887-52887101.243101.24
553034-53034101.524101.52
651481-5148198.55298.55
10min151938-5193899.426100.441.1599.43100.441.15
252376-52376100.265100.26
352941-52941101.346101.35
452910-52910101.287101.29
553043-53043101.542101.54
651585-5158598.75198.75
15min152192-5219299.913100.771.1399.91100.771.13
252163-5216399.85799.86
352955-52955101.373101.37
453266-53266101.969101.97
553288-53288102.011102.01
651988-5198899.52299.52
30min152091-5209199.719100.591.0699.72100.591.06
252022-5202299.58799.59
352848-52848101.168101.17
453246-53246101.930101.93
553018-53018101.494101.49
652046-5204699.63399.63
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200
标示量(mg)75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%
116.525188952124518785191452092519790.23
216.515154251383514620.22
单位质量响应值RSD%判断
3146.433117.020.67数据可信
供试品溶液-2024121421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%
2min147405-4740590.27987.8411.0490.2887.8411.04
235838-3583868.25168.25
349088-4908893.48493.48
447608-4760890.66690.67
548996-4899693.30993.31
647818-4781891.06691.07
5min151054-5105497.22898.742.3297.2398.742.32
252879-52879100.704100.70
351864-5186498.77198.77
450472-5047296.12096.12
553633-53633102.140102.14
651192-5119297.49197.49
10min152050-5205099.12599.111.8199.1399.111.81
252558-52558100.093100.09
352086-5208699.19499.19
450554-5055496.27696.28
553373-53373101.645101.64
651642-5164298.34898.35
15min152306-5230699.61399.561.3199.6199.561.31
252378-5237899.75099.75
352427-5242799.84399.84
451259-5125997.61997.62
553352-53352101.605101.60
651946-5194698.92798.93
30min152451-5245199.88999.292.5799.8999.292.57
252850-52850100.649100.65
351499-5149998.07698.08
450088-5008895.38995.39
554051-54051102.936102.94
651881-5188198.80398.80
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