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%
110.154218641969421284205642077420830.20
210.194201542070420420.10
单位质量响应值RSD%判断
4146.114125.810.35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%
60min19398-939820.39720.2412.2920.4020.2412.29
27626-762616.55116.55
310268-1026822.28622.29
410323-1032322.40522.40
510106-1010621.93421.93
68240-824017.88417.88
120min118926-1892641.07738.909.1341.3039.129.14
215422-1542233.47233.66
318840-1884040.89041.14
419078-1907841.40741.66
519005-1900541.24841.49
616261-1626135.29335.49
240min134833-3483375.60170.658.7976.2871.318.79
227111-2711158.84259.40
334668-3466875.24375.95
433195-3319572.04672.76
533505-3350572.71973.42
632011-3201169.47670.07
360min143945-4394595.37892.297.1696.9093.737.18
237253-3725380.85482.06
345872-4587299.560101.10
443817-4381795.10096.61
543390-4339094.17395.68
640850-4085088.66190.02
480min147508-47508103.111100.057.00105.69102.527.02
240651-4065188.22990.34
349116-49116106.601109.25
448832-48832105.985108.55
546324-46324100.541103.10
644168-4416895.86298.21
720min147836-47836103.823102.656.63107.55106.236.66
242902-4290293.11496.20
350919-50919110.514114.34
450156-50156108.858112.60
547520-47520103.137106.81
644439-4443996.45099.86
960min147722-47722103.575101.526.51108.46106.246.56
241605-4160590.29994.42
349935-49935108.379113.44
448908-48908106.150111.10
547587-47587103.282108.10
644895-4489597.440101.92
1200min147639-47639103.395101.658.24109.43107.508.17
240877-4087788.71993.85
350852-50852110.369116.63
450712-50712110.065116.20
546752-46752101.470107.44
644186-4418695.901101.47
1440min146221-46221100.318101.087.48107.50108.067.45
241850-4185090.83196.94
350960-50960110.603118.09
449931-49931108.370115.73
546664-46664101.279108.37
643800-4380095.063101.70
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147466-47466103.020100.727.14111.32108.827.15
241486-4148690.04197.16
349507-49507107.450116.17
449408-49408107.235115.79
547327-47327102.718110.94
643249-4324993.867101.56
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%
110.154184641959419774194041826419100.17
210.194233542330423320.01
单位质量响应值RSD%判断
4129.064154.270.44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%
60min110361-1036122.45722.984.5522.4622.984.55
210875-1087523.57123.57
310808-1080823.42523.43
410425-1042522.59522.60
511262-1126224.40924.41
69882-988221.41821.42
120min119989-1998943.32442.554.0443.5742.804.04
219989-1998943.32443.59
320404-2040444.22444.48
419473-1947342.20642.46
519790-1979042.89343.16
618135-1813539.30639.54
240min134177-3417774.07675.334.4874.8176.064.46
233682-3368273.00373.75
336706-3670679.55780.31
435544-3554477.03877.76
535879-3587977.76478.51
632543-3254370.53471.21
360min142571-4257192.26993.784.9793.8295.344.94
241719-4171990.42291.98
344674-4467496.82798.46
445237-4523798.04799.62
545312-4531298.21099.82
640083-4008386.87688.33
480min146079-4607999.872101.384.09102.45103.984.08
245168-4516897.898100.46
347906-47906103.832106.54
449554-49554107.404110.07
547531-47531103.019105.72
644397-4439796.22698.65
720min147735-47735103.461103.054.14107.15106.784.11
245599-4559998.832102.48
347850-47850103.710107.58
450792-50792110.087113.95
547920-47920103.862107.71
645373-4537398.342101.83
960min147687-47687103.357103.694.03108.20108.573.98
244832-4483297.169101.91
348525-48525105.173110.19
450686-50686109.857114.94
548292-48292104.668109.67
647033-47033101.940106.53
1200min146944-46944101.747102.814.04107.73108.844.01
245263-4526398.103103.93
347726-47726103.442109.63
450596-50596109.662115.96
548263-48263104.606110.77
645820-4582099.311105.03
1440min146786-46786101.404101.764.28108.52108.934.24
245204-4520497.976104.89
347558-47558103.078110.41
449675-49675107.666115.19
548265-48265104.610111.94
644211-4421195.823102.64
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146656-46656101.123100.694.21109.37108.994.16
244790-4479097.078105.08
346231-46231100.201108.68
449652-49652107.616116.33
547259-47259102.430110.92
644151-4415195.693103.58
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%
110.154203841950420434200641963420000.11
210.194177041736417530.06
单位质量响应值RSD%判断
4137.934097.450.70数据可信
供试品溶液批-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%
60min114635-1463531.90547.5239.0631.9147.5239.06
215545-1554533.88933.89
312129-1212926.44226.44
428930-2893063.06963.07
530213-3021365.86665.87
629338-2933863.95963.96
120min124768-2476853.99672.2028.4654.3572.7228.54
227407-2740759.74960.13
321847-2184747.62847.92
441317-4131790.07490.77
541030-4103089.44890.18
642334-4233492.29193.00
240min139334-3933485.75190.576.7286.7091.907.04
242237-4223792.07993.12
336981-3698180.62181.44
443352-4335294.51096.21
543303-4330394.40396.13
644058-4405896.04997.79
360min145211-4521198.56395.783.71100.4798.123.37
246664-46664101.730103.79
343098-4309893.95695.68
442826-4282693.36396.12
542669-4266993.02195.80
643138-4313894.04396.85
480min146344-46344101.03395.795.18104.0499.194.66
246422-46422101.203104.40
344574-4457497.17499.94
441941-4194191.43495.22
540883-4088389.12792.94
643474-4347494.77698.62
720min145307-4530798.77295.394.98102.9099.864.50
247031-47031102.530106.85
344043-4404396.01699.86
441900-4190091.34596.15
541189-4118989.79594.59
643077-4307793.91198.81
960min145069-4506998.25394.214.34103.4899.743.82
245113-4511398.349103.81
344208-4420896.376101.29
441137-4113789.68195.50
540976-4097689.33095.13
642783-4278393.27099.21
1200min143586-4358695.02092.425.12101.3398.994.55
245337-4533798.837105.39
343775-4377595.432101.41
440039-4003987.28794.10
540098-4009887.41694.20
641534-4153490.54797.53
1440min141228-4122889.88091.264.3997.2598.863.93
244644-4464497.327104.98
343308-4330894.414101.45
439584-3958486.29694.08
540684-4068488.69496.45
641732-4173290.97898.97
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143008-4300893.76091.884.45102.13100.503.97
245027-4502798.162106.89
342874-4287493.468101.56
440385-4038588.04296.79
540019-4001987.24495.99
641573-4157390.63299.63
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