佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.134260042624425924262742551425990.08
210.144258642725426560.24
单位质量响应值RSD%判断
4205.234206.710.03数据可信
供试品溶液-6042501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%
60min11285-12852.7432.818.572.742.818.47
21204-12042.5702.57
31249-12492.6662.67
41436-14363.0653.06
51245-12452.6572.66
61478-14783.1543.15
120min12431-24315.1886.248.815.226.278.78
23035-30356.4776.51
32875-28756.1366.17
43138-31386.6976.73
52983-29836.3666.40
63079-30796.5716.61
240min15233-523311.16912.717.0811.2612.817.07
26220-622013.27513.38
35656-565612.07112.17
46109-610913.03813.15
56269-626913.38013.48
66245-624513.32813.44
360min19039-903919.29219.544.2919.5019.784.26
29202-920219.63919.89
38792-879218.76419.00
49436-943620.13920.39
59751-975120.81121.06
68721-872118.61318.87
480min112174-1217425.98225.423.2826.4125.873.25
211786-1178625.15425.62
311486-1148624.51424.95
412252-1225226.14926.63
512311-1231126.27526.75
611442-1144224.42024.88
720min117631-1763137.62936.483.4438.3437.223.40
217235-1723536.78437.53
316239-1623934.65835.37
417647-1764737.66338.43
517292-1729236.90537.68
616514-1651435.24535.98
960min123052-2305249.19947.443.7550.3348.593.69
222999-2299949.08650.24
321652-2165246.21147.31
422696-2269648.43949.63
522012-2201246.97948.16
620963-2096344.74045.87
1200min127852-2785259.44357.872.4961.1259.542.45
227931-2793159.61261.31
326425-2642556.39858.01
427217-2721758.08859.81
526405-2640556.35558.06
626864-2686457.33558.96
1440min132371-3237169.08867.112.3171.4369.422.28
232138-3213868.59170.95
330810-3081065.75667.99
431596-3159667.43469.80
530557-3055765.21667.55
631186-3118666.55968.82
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132228-3222868.78367.172.7571.8970.232.72
232673-3267369.73272.86
330565-3056565.23368.20
431713-3171367.68470.80
530913-3091365.97669.03
630748-3074865.62468.62
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.134257242584424094243842531425070.19
210.144271742808427620.16
单位质量响应值RSD%判断
4196.154217.160.36数据可信
供试品溶液-1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%
60min18608-860818.36917.596.1818.3717.596.18
28225-822517.55117.55
38766-876618.70618.71
48598-859818.34718.35
57652-765216.32916.33
67602-760216.22216.22
120min115980-1598034.10034.443.5034.3034.643.51
216080-1608034.31334.51
316766-1676635.77735.99
416804-1680435.85836.06
515319-1531932.68932.87
615898-1589833.92534.11
240min128835-2883561.53259.912.0262.1160.492.02
227662-2766259.02859.60
328470-2847060.75361.36
428215-2821560.20860.81
527258-2725858.16658.71
628022-2802259.79760.35
360min136264-3626477.38475.233.2178.6576.473.20
234825-3482574.31475.55
335805-3580576.40577.69
436598-3659878.09779.37
534091-3409172.74773.94
633937-3393772.41973.64
480min140119-4011985.61182.833.5087.7484.913.48
238356-3835681.84983.91
339596-3959684.49586.62
439873-3987385.08687.22
536477-3647777.83979.84
638471-3847182.09484.12
720min142735-4273591.19390.391.7794.2793.391.81
242306-4230690.27893.24
342905-4290591.55694.62
443235-4323592.26095.34
541290-4129088.10990.97
641692-4169288.96791.91
960min144052-4405294.00392.433.2598.0996.433.23
243148-4314892.07496.04
344765-4476595.52599.61
444471-4447194.89799.01
541088-4108887.67891.52
642360-4236090.39394.32
1200min145590-4559097.28594.063.23102.4299.103.19
242807-4280791.34796.34
345878-4587897.900103.05
444295-4429594.52299.69
542508-4250890.70995.53
643398-4339892.60897.54
1440min143986-4398693.86392.493.75100.0898.573.67
242416-4241690.51296.52
345908-4590897.964104.20
443548-4354892.92899.14
541054-4105487.60693.43
643156-4315692.09198.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限144864-4486495.73693.023.05103.00100.123.03
242990-4299091.73798.75
345141-4514196.327103.65
443873-4387393.621100.87
541561-4156188.68895.49
643106-4310691.98598.97
佩玛贝特片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DHX240702对照品来源自制对照品使用方法自制
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数50000
标示量(mg)0.4供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.134266542527424704250842541425420.18
210.144267442581426280.16
单位质量响应值RSD%判断
4199.614203.940.08数据可信
供试品溶液-2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%
60min13448-34487.3667.086.547.377.086.52
23313-33137.0787.08
33592-35927.6747.67
43229-32296.8986.90
52952-29526.3076.31
63350-33507.1577.16
120min16404-640413.68114.119.6013.7614.199.58
26800-680014.52714.61
37679-767916.40516.49
46348-634813.56213.64
55763-576312.31212.38
66627-662714.15814.24
240min110875-1087523.23324.007.0923.4724.237.10
211704-1170425.00425.24
312475-1247526.65126.92
411010-1101023.52223.75
510128-1012821.63721.84
611206-1120623.94024.18
360min114655-1465531.30932.146.8231.8032.646.82
215026-1502632.10132.62
316769-1676935.82536.39
415051-1505132.15532.64
513593-1359329.04029.49
615176-1517632.42232.92
480min117005-1700536.32938.377.6737.1739.237.66
218285-1828539.06439.94
320305-2030543.37944.34
417976-1797638.40439.25
516239-1623934.69335.46
617958-1795838.36539.23
720min121939-2193946.87046.794.7848.1148.074.83
221525-2152545.98647.29
323788-2378850.82052.26
421729-2172946.42147.69
520589-2058943.98645.14
621834-2183446.64647.94
960min124572-2457252.49552.773.7054.2654.573.79
224309-2430951.93353.75
326221-2622156.01858.03
424471-2447152.27954.07
523498-2349850.20151.84
625130-2513053.68755.49
1200min127203-2720358.11657.663.4960.4660.053.57
227346-2734658.42260.82
328366-2836660.60163.23
426732-2673257.11059.48
525492-2549254.46156.66
626788-2678857.22959.63
1440min128900-2890061.74160.413.9964.7363.443.87
228314-2831460.49063.54
329300-2930062.59665.90
428894-2889461.72964.73
528093-2809360.01762.82
626159-2615955.88658.93
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限128662-2866261.23361.463.0364.9165.163.11
229039-2903962.03865.76
330091-3009164.28668.29
428836-2883661.60565.29
527388-2738858.51161.99
628593-2859361.08664.75
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