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%
113.101679316825168451680416800168130.13
213.091690016727168140.73
单位质量响应值RSD%判断
1283.441284.490.06数据可信
供试品溶液-2024121521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%
2min115908-1590888.67189.813.8388.6789.813.83
215343-1534385.52285.52
316812-1681293.71093.71
416888-1688894.13494.13
516018-1601889.28489.28
615708-1570887.55687.56
5min119293-19293107.539102.552.77107.54102.562.77
218180-18180101.335101.34
317731-1773198.83298.83
418436-18436102.762102.76
518379-18379102.444102.44
618374-18374102.417102.42
10min118372-18372102.405101.271.39102.41101.271.38
217939-1793999.99299.99
317807-1780799.25699.26
418274-18274101.859101.86
518449-18449102.835102.83
618164-18164101.246101.25
15min118557-18557103.437102.762.80103.44102.762.81
218219-18219101.553101.55
317787-1778799.14599.14
418427-18427102.712102.71
518278-18278101.881101.88
619344-19344107.823107.82
30min118515-18515103.202101.601.33103.20101.591.33
218023-18023100.460100.46
317869-1786999.60299.60
418291-18291101.954101.95
518414-18414102.639102.64
618248-18248101.714101.71
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%
113.101662416515165941647016441165290.48
213.091664316587166150.24
单位质量响应值RSD%判断
1261.761269.290.43数据可信
供试品溶液-2024121521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%
2min116591-1659193.82687.929.4393.8387.929.43
212626-1262671.40371.40
315810-1581089.41089.41
416110-1611091.10691.11
515780-1578089.24089.24
616364-1636492.54392.54
5min118451-18451104.345101.222.22104.35101.222.22
217986-17986101.716101.72
318120-18120102.473102.47
417618-1761899.63499.63
517901-17901101.235101.23
617312-1731297.90497.90
10min118236-18236103.129101.171.80103.13101.171.80
218131-18131102.536102.54
317995-17995101.766101.77
417785-17785100.579100.58
517858-17858100.992100.99
617328-1732897.99497.99
15min118209-18209102.977101.451.72102.98101.451.72
218002-18002101.806101.81
318311-18311103.554103.55
417660-1766099.87299.87
517938-17938101.444101.44
617514-1751499.04699.05
30min118023-18023101.925100.491.42101.92100.491.42
217888-17888101.161101.16
317858-17858100.992100.99
417648-1764899.80499.80
517885-17885101.144101.14
617318-1731897.93897.94
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%
113.101681116729168171680416696167710.33
213.091686216815168380.20
单位质量响应值RSD%判断
1280.231286.330.34数据可信
供试品溶液-2024121621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%
2min115872-1587288.51889.529.6288.5289.529.61
213033-1303372.68572.69
317202-1720295.93695.94
416596-1659692.55692.56
516843-1684393.93393.93
616767-1676793.51093.51
5min118063-18063100.73799.931.61100.7499.931.62
217463-1746397.39197.39
317869-1786999.65599.66
418319-18319102.165102.17
517789-1778999.20999.21
618004-18004100.408100.41
10min117797-1779799.25499.461.0999.2599.461.09
217521-1752197.71597.71
317886-1788699.75099.75
418105-18105100.972100.97
517772-1777299.11499.11
617923-1792399.95799.96
15min117761-1776199.05399.531.4899.0599.531.48
217474-1747497.45397.45
317840-1784099.49499.49
418242-18242101.736101.74
517738-1773898.92598.92
618025-18025100.525100.53
30min117503-1750397.61498.881.4097.6198.881.40
217476-1747697.46497.46
317749-1774998.98698.99
418080-18080100.832100.83
517615-1761598.23998.24
617962-17962100.174100.17
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%
113.101654816546164841641116336164650.56
213.091675016603166760.63
单位质量响应值RSD%判断
1256.871273.950.96数据可信
供试品溶液-2024121621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%
2min116374-1637492.61191.264.2092.6191.264.20
216458-1645893.08693.09
315258-1525886.29986.30
416865-1686595.38895.39
515318-1531886.63886.64
616533-1653393.51093.51
5min117705-17705100.139100.781.02100.14100.781.02
218103-18103102.390102.39
317651-1765199.83499.83
417886-17886101.163101.16
517650-1765099.82899.83
617913-17913101.315101.32
10min117437-1743798.623100.871.6398.62100.871.63
218283-18283103.408103.41
317668-1766899.93099.93
417868-17868101.061101.06
517757-17757100.433100.43
617993-17993101.768101.77
15min117696-17696100.088100.741.20100.09100.741.21
218159-18159102.707102.71
317633-1763399.73299.73
417814-17814100.756100.76
517607-1760799.58599.58
617955-17955101.553101.55
30min117685-17685100.026100.991.24100.03100.991.24
218196-18196102.916102.92
317684-17684100.020100.02
417754-17754100.416100.42
517744-17744100.360100.36
618072-18072102.215102.21
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%
113.101666916671166731662916697166680.15
213.091654116617165790.33
单位质量响应值RSD%判断
1272.371266.540.33数据可信
供试品溶液-2024121721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%
2min115040-1504084.79286.522.4084.7986.512.41
215873-1587389.48889.49
314863-1486383.79483.79
415468-1546887.20487.20
515260-1526086.03286.03
615570-1557087.78087.78
5min118259-18259102.939101.421.92102.94101.421.92
217980-17980101.366101.37
317367-1736797.91197.91
417925-17925101.056101.06
518340-18340103.396103.40
618069-18069101.868101.87
10min118519-18519104.405102.181.80104.41102.181.80
218281-18281103.063103.06
317569-1756999.04999.05
418051-18051101.767101.77
518037-18037101.688101.69
618293-18293103.131103.13
15min118384-18384103.644102.691.60103.64102.691.60
218345-18345103.424103.42
317685-1768599.70399.70
418093-18093102.004102.00
518485-18485104.214104.21
618301-18301103.176103.18
30min118432-18432103.915102.121.55103.91102.121.55
218178-18178102.483102.48
317671-1767199.62499.62
417950-17950101.197101.20
518365-18365103.537103.54
618083-18083101.947101.95
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%
113.101664416776166901676416563166870.53
213.091678716615167010.73
单位质量响应值RSD%判断
1273.821275.860.12数据可信
供试品溶液-2024121721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%
2min116914-1691494.95389.093.9894.9589.093.97
216358-1635891.83291.83
315622-1562287.70087.70
415618-1561887.67887.68
515379-1537986.33686.34
615329-1532986.05586.06
5min118518-18518103.958102.421.48103.96102.421.48
217820-17820100.040100.04
318178-18178102.049102.05
418171-18171102.010102.01
518218-18218102.274102.27
618555-18555104.166104.17
10min118614-18614104.497102.611.22104.50102.611.22
217958-17958100.814100.81
318207-18207102.212102.21
418262-18262102.521102.52
518207-18207102.212102.21
618421-18421103.414103.41
15min118508-18508103.902102.141.24103.90102.141.24
217878-17878100.365100.37
318054-18054101.353101.35
418380-18380103.183103.18
518178-18178102.049102.05
618168-18168101.993101.99
30min118588-18588104.351101.721.71104.35101.721.71
217768-1776899.74899.75
318059-18059101.381101.38
418277-18277102.605102.61
518216-18216102.263102.26
617810-1781099.98399.98
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