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500
标示量(mg)25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%
113.091635116328162941638616337163390.21
213.011643516447164410.06
单位质量响应值RSD%判断
1248.201263.720.88数据可信
供试品溶液-2024121521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%
2min115056-1505685.79689.263.0885.8089.263.08
216297-1629792.86892.87
315120-1512086.16186.16
415779-1577989.91689.92
515879-1587990.48690.49
615850-1585090.32190.32
5min117332-1733298.766100.902.7098.77100.902.70
218192-18192103.667103.67
317001-1700196.88096.88
418214-18214103.792103.79
517752-17752101.159101.16
617748-17748101.137101.14
10min116881-1688196.196100.533.2896.20100.533.28
218251-18251104.003104.00
317049-1704997.15397.15
418233-18233103.900103.90
517662-17662100.646100.65
617773-17773101.279101.28
15min116864-1686496.099100.413.1296.10100.413.12
218288-18288104.214104.21
317118-1711897.54797.55
418083-18083103.046103.05
517610-17610100.350100.35
617763-17763101.222101.22
30min116880-1688096.190100.353.2996.19100.353.29
218163-18163103.501103.50
316982-1698296.77296.77
418252-18252104.009104.01
517605-17605100.322100.32
617779-17779101.313101.31
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500
标示量(mg)25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%
113.091654216557164291655216404164970.45
213.011641616530164730.49
单位质量响应值RSD%判断
1260.281266.180.34数据可信
供试品溶液-2024121521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%
2min115937-1593790.29193.043.4290.2993.043.42
216233-1623391.96891.97
316701-1670194.62094.62
415802-1580289.52789.53
517333-1733398.20098.20
616526-1652693.62893.63
5min117856-17856101.164101.251.02101.16101.251.02
217837-17837101.056101.06
317850-17850101.130101.13
417657-17657100.036100.04
518210-18210103.169103.17
617819-17819100.954100.95
10min117870-17870101.243101.390.67101.24101.390.67
217920-17920101.526101.53
317949-17949101.690101.69
417726-17726100.427100.43
518080-18080102.433102.43
617835-17835101.045101.04
15min117865-17865101.214101.371.03101.21101.371.03
217882-17882101.311101.31
317835-17835101.045101.04
417599-1759999.70799.71
518085-18085102.461102.46
618092-18092102.501102.50
30min117854-17854101.152101.461.14101.15101.461.14
217924-17924101.549101.55
317869-17869101.237101.24
417594-1759499.67999.68
518223-18223103.243103.24
617982-17982101.877101.88
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500
标示量(mg)25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%
113.091655816430164091647616422164590.37
213.011645216522164870.31
单位质量响应值RSD%判断
1257.371267.260.56数据可信
供试品溶液-2024121621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%
2min115424-1542487.44989.721.8887.4589.721.88
215523-1552388.01088.01
316168-1616891.66791.67
416047-1604790.98190.98
515824-1582489.71789.72
615964-1596490.51190.51
5min118345-18345104.010102.611.52104.01102.611.52
217971-17971101.890101.89
318460-18460104.662104.66
417946-17946101.748101.75
517719-17719100.461100.46
618146-18146102.882102.88
10min118011-18011102.117102.091.11102.12102.091.11
217921-17921101.606101.61
318290-18290103.698103.70
417972-17972101.895101.90
517702-17702100.365100.36
618139-18139102.842102.84
15min118038-18038102.270102.161.18102.27102.161.18
217923-17923101.618101.62
318317-18317103.851103.85
417992-17992102.009102.01
517691-17691100.302100.30
618156-18156102.939102.94
30min118157-18157102.944102.800.91102.94102.800.91
218055-18055102.366102.37
318363-18363104.112104.11
418026-18026102.202102.20
517918-17918101.589101.59
618266-18266103.562103.56
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500
标示量(mg)25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%
113.091642416425165171646216507164670.27
213.011652416435164800.39
单位质量响应值RSD%判断
1257.981266.720.49数据可信
供试品溶液-2024121621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%
2min116189-1618991.78395.052.5791.7895.052.58
216929-1692995.97995.98
316281-1628192.30592.30
416868-1686895.63395.63
517091-1709196.89796.90
617231-1723197.69197.69
5min117845-17845101.172101.631.18101.17101.631.18
217852-17852101.212101.21
317738-17738100.565100.57
417790-17790100.860100.86
518021-18021102.170102.17
618309-18309103.803103.80
10min118026-18026102.198102.781.61102.20102.781.60
218206-18206103.219103.22
317971-17971101.886101.89
417694-17694100.316100.32
518443-18443104.562104.56
618432-18432104.500104.50
15min117860-17860101.257101.941.50101.26101.941.50
217808-17808100.962100.96
317726-17726100.497100.50
417853-17853101.217101.22
518242-18242103.423103.42
618390-18390104.262104.26
30min117991-17991102.000101.921.47102.00101.921.47
217832-17832101.098101.10
317750-17750100.633100.63
417707-17707100.390100.39
518260-18260103.525103.52
618324-18324103.888103.89
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500
标示量(mg)25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%
113.091654116476165971652116571165410.29
213.011644816473164600.11
单位质量响应值RSD%判断
1263.641265.180.09数据可信
供试品溶液-2024121721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%
2min116177-1617791.56590.932.4491.5790.932.44
215313-1531386.67586.67
316174-1617491.54891.55
416467-1646793.20693.21
516078-1607891.00591.00
616179-1617991.57691.58
5min118035-18035102.082103.361.15102.08103.361.15
218144-18144102.699102.70
318364-18364103.944103.94
418584-18584105.189105.19
518087-18087102.376102.38
618347-18347103.848103.85
10min118233-18233103.202103.400.74103.20103.400.74
218310-18310103.638103.64
318345-18345103.836103.84
418439-18439104.368104.37
518043-18043102.127102.13
618235-18235103.214103.21
15min118110-18110102.506103.290.82102.51103.290.82
218175-18175102.874102.87
318401-18401104.153104.15
418390-18390104.091104.09
518069-18069102.274102.27
618347-18347103.848103.85
30min118194-18194102.982103.370.77102.98103.380.77
218245-18245103.270103.27
318292-18292103.536103.54
418498-18498104.702104.70
518074-18074102.302102.30
618278-18278103.457103.46
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500
标示量(mg)25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%
113.091643216442164601644816458164480.08
213.011655516364164600.83
单位质量响应值RSD%判断
1256.531265.180.49数据可信
供试品溶液-2024121721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%
2min115230-1523086.44987.713.0986.4587.713.09
215137-1513785.92185.92
315279-1527986.72786.73
415500-1550087.98187.98
516390-1639093.03393.03
615174-1517486.13186.13
5min117132-1713297.245100.641.9797.24100.641.97
218162-18162103.091103.09
317609-1760999.95299.95
417944-17944101.854101.85
517748-17748100.741100.74
617786-17786100.957100.96
10min117674-17674100.321101.571.04100.32101.571.04
218140-18140102.966102.97
317681-17681100.361100.36
417930-17930101.774101.77
518017-18017102.268102.27
617921-17921101.723101.72
15min117774-17774100.889101.820.83100.89101.820.83
218134-18134102.932102.93
317777-17777100.906100.91
417978-17978102.047102.05
518060-18060102.512102.51
617901-17901101.610101.61
30min117744-17744100.719101.701.18100.72101.701.18
218234-18234103.500103.50
317627-17627100.055100.05
417980-17980102.058102.06
517947-17947101.871101.87
617964-17964101.967101.97
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