佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.05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%
19.822046220491205612061620643205550.38
29.792059620474205350.43
单位质量响应值RSD%判断
2093.182097.550.15数据可信
供试品溶液-2025041221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%
5min11560-156013.36617.4713.9213.3717.4713.92
22128-212818.23318.23
31851-185115.86015.86
42195-219518.80718.81
52155-215518.46418.46
62342-234220.06620.07
10min15742-574249.19853.0310.0649.2253.0610.06
25964-596451.10051.13
35827-582749.92649.95
46835-683558.56358.59
55655-565548.45248.48
67112-711260.93660.97
15min19001-900177.12178.593.3177.2378.713.31
28866-886675.96576.08
39354-935480.14680.26
49494-949481.34581.47
58845-884575.78575.90
69476-947681.19181.33
20min111264-1126496.51194.693.7496.7494.943.72
210466-1046689.67389.92
311605-1160599.43299.68
411212-1121296.06596.33
511071-1107194.85795.09
610691-1069191.60191.87
30min113970-13970119.696113.703.86120.09114.113.85
213452-13452115.258115.65
313583-13583116.380116.79
413143-13143112.610113.03
512506-12506107.152107.55
612969-12969111.119111.54
45min116839-16839144.278135.053.72144.87135.653.70
215417-15417132.094132.68
315988-15988136.986137.59
415441-15441132.300132.91
515246-15246130.629131.20
615644-15644134.039134.65
60min117594-17594150.747147.232.53151.58148.052.52
216968-16968145.383146.19
317849-17849152.932153.76
416744-16744143.464144.30
516945-16945145.186145.98
617001-17001145.666146.50
90min116699-16699143.078152.516.33144.16153.586.28
217909-17909153.446154.49
319690-19690168.705169.79
417434-17434149.376150.45
518329-18329157.044158.08
616738-16738143.412144.49
极限120220-20220173.246165.133.48174.57166.453.46
218935-18935162.236163.54
320024-20024171.567172.93
418684-18684160.086161.41
518776-18776160.874162.17
618996-18996162.759164.07
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.05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%
19.822055720548205052049820645205510.29
29.792033120375203530.16
单位质量响应值RSD%判断
2092.772078.960.47数据可信
供试品溶液-2025041321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%
5min13173-317327.31122.0420.5527.3122.0420.55
22752-275223.68723.69
32761-276123.76423.76
41836-183615.80315.80
52851-285124.53924.54
61992-199217.14517.15
10min17335-733563.13458.9011.0863.1858.9411.09
27333-733363.11663.16
37359-735963.34063.38
45503-550347.36547.39
57163-716361.65361.69
66367-636754.80254.83
15min110227-1022788.02681.877.0188.1882.007.02
29657-965783.11983.26
310049-1004986.49486.64
48340-834071.78471.89
59423-942381.10581.25
69372-937280.66680.79
20min111978-11978103.09798.033.22103.3998.303.22
210990-1099094.59394.88
311059-1105995.18795.48
411334-1133497.55497.78
511619-11619100.007100.29
611357-1135797.75298.01
30min114125-14125121.576118.841.69122.05119.281.70
213586-13586116.937117.38
313901-13901119.648120.10
413529-13529116.446116.83
513728-13728118.159118.60
613975-13975120.285120.70
45min117143-17143147.553138.954.34148.22139.584.32
215094-15094129.917130.55
315769-15769135.727136.37
416591-16591142.802143.38
516092-16092138.507139.15
616174-16174139.212139.83
60min118063-18063155.471143.598.48156.39144.468.43
217202-17202148.061148.91
314297-14297123.057123.93
415700-15700135.133135.95
517229-17229148.293149.17
617607-17607151.547152.40
90min120013-20013172.255162.214.78173.43163.314.75
217405-17405149.808150.91
318826-18826162.039163.12
419333-19333166.403167.45
518328-18328157.752158.87
619168-19168164.982166.08
极限119599-19599168.692165.852.16170.16167.222.15
219193-19193165.198166.55
319784-19784170.284171.63
418913-18913162.788164.11
518693-18693160.894162.28
619430-19430167.237168.61
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.05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%
19.822046620463204972054020494204920.16
29.792044820410204290.14
单位质量响应值RSD%判断
2086.762086.720.01数据可信
供试品溶液-2025041421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%
5min12755-275523.70320.5620.4323.7020.5620.43
22467-246721.22521.22
32136-213618.37718.38
41669-166914.35914.36
52249-224919.34919.35
63059-305926.31826.32
10min17224-722462.15159.797.3562.1959.827.36
27316-731662.94362.98
36981-698160.06160.09
46085-608552.35252.38
56641-664157.13657.17
67450-745064.09664.14
15min19399-939980.86481.843.9281.0181.983.93
29507-950781.79381.93
39630-963082.85182.98
49119-911978.45578.57
59246-924679.54879.68
610177-1017787.55787.71
20min111863-11863102.063100.301.94102.34100.571.94
211400-1140098.07998.36
311545-1154599.32799.60
411428-1142898.32098.56
511861-11861102.046102.31
611853-11853101.977102.27
30min114245-14245122.556121.320.94123.00121.760.93
214205-14205122.212122.65
313966-13966120.156120.59
414035-14035120.750121.16
514206-14206122.221122.65
613954-13954120.053120.52
45min116365-16365140.796137.123.67141.45137.763.67
216400-16400141.097141.74
316106-16106138.567139.20
414807-14807127.391128.00
515940-15940137.139137.77
616011-16011137.750138.42
60min116420-16420141.269150.233.99142.16151.103.96
217616-17616151.559152.44
317747-17747152.686153.55
418085-18085155.594156.41
516799-16799144.530145.39
618100-18100155.723156.62
90min119115-19115164.455161.123.54165.58162.243.50
219019-19019163.629164.76
318623-18623160.222161.34
418871-18871162.356163.43
519279-19279165.866166.97
617456-17456150.182151.34
极限119486-19486167.647168.062.61169.04169.452.58
219916-19916171.347172.75
318693-18693160.825162.21
419988-19988171.966173.32
519899-19899171.200172.58
619225-19225165.402166.81
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DHX240702对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数100000
标示量(mg)0.05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%
19.822053920569206062051620471205400.25
29.792045420276203650.62
单位质量响应值RSD%判断
2091.652080.180.39数据可信
供试品溶液-SI4S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%
5min12448-244821.07016.6525.5921.0716.6625.59
21662-166214.30514.30
31525-152513.12613.13
41839-183915.82815.83
51487-148712.79912.80
62649-264922.80022.80
10min16786-678658.40752.209.7558.4452.229.76
25733-573349.34449.37
35702-570249.07749.10
45779-577949.73949.77
55533-553347.62247.64
66853-685358.98359.02
15min110112-1011287.03381.504.4987.1781.624.50
29404-940480.94081.05
38896-889676.56776.67
49256-925679.66679.78
59362-936280.57880.68
69786-978684.22784.36
20min111313-1131397.37098.503.0797.6598.763.07
211184-1118496.26096.50
311811-11811101.656101.89
411787-11787101.450101.69
510948-1094894.22994.46
611626-11626100.064100.34
30min115101-15101129.973124.063.09130.41124.483.09
213982-13982120.342120.74
314538-14538125.128125.53
414534-14534125.093125.50
513868-13868119.361119.75
614464-14464124.491124.93
45min117297-17297148.874141.882.75149.53142.502.75
216362-16362140.827141.43
315919-15919137.014137.62
416463-16463141.696142.32
516535-16535142.316142.91
616328-16328140.534141.18
60min118461-18461158.892155.642.95159.80156.502.95
217251-17251148.478149.31
318568-18568159.813160.65
418451-18451158.806159.66
517624-17624151.688152.52
618144-18144156.164157.05
90min120175-20175173.645170.311.47174.81171.421.47
219642-19642169.057170.14
320019-20019172.302173.41
419877-19877171.080172.20
519626-19626168.920170.00
619385-19385166.845167.99
极限120275-20275174.505170.903.08175.96172.303.05
220060-20060172.655174.02
319928-19928171.519172.91
419968-19968171.863173.27
520260-20260174.376175.74
618644-18644160.468161.89
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