他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382547802546772550182544962543082546560.11
212.442533572540272536920.19
单位质量响应值RSD%判断
20569.9520393.250.62数据可信
供试品溶液-2025091622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%
5min134264-3426413.3749.5436.0413.379.5436.06
228427-2842711.09611.10
322562-225628.8078.81
411079-110794.3244.32
518350-183507.1637.16
631935-3193512.46512.47
10min152381-5238120.44617.4016.0720.4517.4016.07
248692-4869219.00619.01
344639-4463917.42417.42
431862-3186212.43712.44
542038-4203816.40916.41
647818-4781818.66518.66
15min160271-6027123.52521.2410.4023.5321.2410.41
257001-5700122.24922.25
354640-5464021.32821.33
443809-4380917.10017.10
553850-5385021.01921.02
656916-5691622.21622.22
20min166044-6604425.77923.797.7725.7823.797.78
262685-6268524.46824.47
361022-6102223.81923.82
452071-5207120.32520.32
560879-6087923.76323.76
662972-6297224.58024.58
30min172772-7277228.40526.875.2928.4026.875.28
269767-6976727.23227.23
369166-6916626.99727.00
461911-6191124.16624.17
569567-6956727.15427.15
669918-6991827.29127.29
45min178427-7842730.61229.453.3530.6129.453.36
276148-7614829.72329.72
376252-7625229.76329.76
470771-7077127.62427.62
575516-7551629.47629.48
675566-7556629.49629.50
极限182817-8281732.32631.721.6732.3331.721.67
281710-8171031.89431.89
382397-8239732.16232.16
479079-7907930.86730.87
580962-8096231.60231.60
680600-8060031.46031.46
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382546402544392545472544952548302545900.07
212.442548882551782550330.09
单位质量响应值RSD%判断
20564.6220501.050.22数据可信
供试品溶液-2025091721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%
5min119676-196767.6618.1041.287.668.1041.30
214026-140265.4615.46
316272-162726.3356.34
412315-123154.7954.79
533405-3340513.00613.01
629192-2919211.36611.37
10min139553-3955315.40016.3419.4515.4016.3419.44
238155-3815514.85614.86
337374-3737414.55114.55
432803-3280312.77212.77
553817-5381720.95420.95
650167-5016719.53219.53
15min150063-5006319.49220.2912.5419.4920.2912.54
249709-4970919.35419.35
348419-4841918.85218.85
444539-4453917.34117.34
562081-6208124.17124.17
657841-5784122.52022.52
20min156909-5690922.15722.819.5322.1622.819.53
256436-5643621.97321.97
355304-5530421.53321.53
452268-5226820.35020.35
567270-6727026.19126.19
663274-6327424.63624.64
30min166291-6629125.81026.046.6025.8126.046.60
265260-6526025.40925.41
364185-6418524.99024.99
461346-6134623.88523.88
573029-7302928.43428.43
671193-7119327.71927.72
45min172710-7271028.30928.723.9728.3128.723.97
272846-7284628.36228.36
372409-7240928.19228.19
470136-7013627.30727.31
578183-7818330.44030.44
676281-7628129.70029.70
极限180745-8074531.43831.251.5531.4431.251.55
279359-7935930.89830.90
379664-7966431.01731.02
478661-7866130.62730.63
582002-8200231.92731.93
681100-8110031.57631.58
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.382565032561012565152563772555112562010.17
212.442580022577382578700.08
单位质量响应值RSD%判断
20694.7520729.100.12数据可信
供试品溶液-2025091722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%
5min122349-223498.6266.7627.758.636.7627.76
217215-172156.6456.64
314259-142595.5045.50
410489-104894.0494.05
523399-233999.0329.03
617376-173766.7076.71
10min142810-4281016.52415.397.6416.5215.397.65
241660-4166016.08016.08
335168-3516813.57413.57
437911-3791114.63314.63
542694-4269416.47916.48
639064-3906415.07815.08
15min153463-5346320.63619.465.8420.6419.465.85
252477-5247720.25520.26
346103-4610317.79517.79
448445-4844518.69918.70
552804-5280420.38120.38
649165-4916518.97718.98
20min160057-6005723.18122.034.2023.1822.034.20
259125-5912522.82122.82
353901-5390120.80520.80
455093-5509321.26521.26
558040-5804022.40222.40
656302-5630221.73121.73
30min167639-6763926.10725.113.5826.1125.113.59
267514-6751426.05926.06
362451-6245124.10524.10
463495-6349524.50824.51
566175-6617525.54225.54
663083-6308324.34924.35
45min175005-7500528.95028.012.8828.9528.012.87
274936-7493628.92428.92
370795-7079527.32627.33
471403-7140327.56027.56
573043-7304328.19328.19
670226-7022627.10627.11
极限180831-8083131.19930.661.5831.2030.661.59
280909-8090931.22931.23
379151-7915130.55130.55
479001-7900130.49330.49
579114-7911430.53630.54
677601-7760129.95229.95
他达拉非片项目信息
介质体积(ml)1000取样体积(ml) 0补液体积(ml) 0
对照品批号D533-190826对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.93对照品水分(%)0对照品稀释倍数2500
标示量(mg)5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%
112.385108055106265101535094395103555102760.11
212.445108365105535106940.04
单位质量响应值RSD%判断
41217.7741052.570.29数据可信
供试品溶液-2025091821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%
5min135307-353076.8626.836.926.866.836.94
238482-384827.4797.48
336430-364307.0807.08
431099-310996.0446.04
534862-348626.7756.78
634658-346586.7366.74
10min156938-5693811.06611.093.8011.0711.093.80
260985-6098511.85211.85
356454-5645410.97210.97
454350-5435010.56310.56
557155-5715511.10811.11
656524-5652410.98510.99
15min167674-6767413.15213.132.8013.1513.132.79
270737-7073713.74713.75
367025-6702513.02613.03
465066-6506612.64512.65
568199-6819913.25413.25
666676-6667612.95812.96
20min173452-7345214.27514.352.6114.2814.362.58
277618-7761815.08515.08
373045-7304514.19614.20
472530-7253014.09614.10
573957-7395714.37314.37
672538-7253814.09714.10
30min179950-7995015.53815.511.1715.5415.511.17
281524-8152415.84415.84
379139-7913915.38015.38
479515-7951515.45315.45
579931-7993115.53415.53
678904-7890415.33515.33
45min183723-8372316.27116.230.9616.2716.230.98
284521-8452116.42616.43
383473-8347316.22316.22
483430-8343016.21416.21
583844-8384416.29516.29
682089-8208915.95415.95
极限187054-8705416.91916.850.5816.9216.850.58
287403-8740316.98616.99
386120-8612016.73716.74
486722-8672216.85416.85
586621-8662116.83416.83
686184-8618416.74916.75
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