坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.297626576170762187625876468762760.15
216.337615176148761500.01
单位质量响应值RSD%判断
4682.384663.200.30数据可信
长期6月-供试品溶液-2025022821批-含0.35%吐温20的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%
5min120578-2057824.72218.8925.5924.7218.8925.60
213297-1329715.97515.97
317394-1739420.89720.90
417551-1755121.08521.09
59034-903410.85310.85
616499-1649919.82119.82
10min144873-4487353.90946.5418.2953.9546.5718.30
235367-3536742.48942.52
344288-4428853.20753.24
441841-4184150.26750.30
526090-2609031.34431.36
639971-3997148.02048.05
15min158296-5829670.03567.2811.0770.1767.3911.09
254767-5476765.79665.89
361974-6197474.45474.58
457813-5781369.45569.57
544261-4426153.17453.24
658893-5889370.75370.87
20min167552-6755281.15580.926.3581.4081.146.37
268057-6805781.76281.97
370907-7090785.18685.43
468728-6872882.56882.80
558992-5899270.87271.03
669877-6987783.94984.18
30min174681-7468189.72091.211.5090.1091.571.52
276413-7641391.80192.14
376644-7664492.07892.47
476074-7607491.39391.77
574438-7443889.42889.71
677300-7730092.86693.24
45min177892-7789293.57894.240.7894.1194.750.80
278479-7847994.28394.78
378332-7833294.10694.65
478674-7867494.51795.04
577817-7781793.48793.91
679488-7948895.49596.02
60min177254-7725492.81194.471.0093.5095.131.01
278890-7889094.77695.43
378799-7879994.66795.37
479095-7909595.02395.70
578262-7826294.02294.60
679494-7949495.50296.19
极限177164-7716492.70394.871.2793.5595.691.25
278807-7880794.67795.49
378865-7886594.74695.60
479781-7978195.84796.69
579233-7923395.18995.93
679944-7994496.04396.89
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.297598976286763957612376298762180.22
216.337621176424763180.20
单位质量响应值RSD%判断
4678.824673.480.09数据可信
长期6月-供试品溶液-2025030121批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min18513-851310.22011.2412.2310.2211.2412.22
28171-81719.8099.81
39897-989711.88111.88
411062-1106213.28013.28
510043-1004312.05712.06
68487-848710.18910.19
10min132874-3287439.46535.099.3539.4835.119.34
227371-2737132.85932.88
327843-2784333.42633.45
432368-3236838.85838.88
528590-2859034.32234.34
626337-2633731.61831.63
15min156367-5636767.66958.4311.5267.7558.5111.51
246206-4620655.47155.54
345624-4562454.77254.85
455140-5514066.19666.28
545632-4563254.78254.86
643065-4306551.70051.77
20min170564-7056484.71375.789.1284.9175.959.12
261976-6197674.40374.57
360086-6008672.13472.30
469773-6977383.76383.96
559946-5994671.96672.13
656391-5639167.69867.85
30min177961-7796193.59389.803.8793.9390.103.88
275674-7567490.84791.13
372048-7204886.49486.78
477699-7769993.27893.61
574471-7447189.40389.69
670945-7094585.17085.44
45min179465-7946595.39893.682.3395.8994.132.35
279385-7938595.30295.74
375723-7572390.90691.34
479185-7918595.06295.55
578764-7876494.55794.99
675699-7569990.87791.29
60min179694-7969495.67394.162.2296.3294.772.24
279756-7975695.74896.35
376341-7634191.64892.23
479489-7948995.42796.08
579264-7926495.15795.75
676060-7606091.31191.87
极限179737-7973795.72594.631.7896.5495.401.80
279972-7997296.00796.76
377110-7711092.57193.31
479456-7945695.38796.20
579740-7974095.72896.48
676957-7695792.38793.10
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.297636276574768657658176684766130.24
216.337685376797768250.06
单位质量响应值RSD%判断
4703.074704.530.03数据可信
长期6月-供试品溶液-2025030221批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min118098-1809821.59919.9824.4921.6019.9824.50
215434-1543418.42018.42
319805-1980523.63623.64
416401-1640119.57419.57
59568-956811.41911.42
621164-2116425.25825.26
10min148702-4870258.12351.3019.6458.1651.3319.64
240690-4069048.56148.59
348552-4855257.94457.98
444955-4495553.65253.68
526937-2693732.14832.17
648077-4807757.37757.42
15min166357-6635779.19473.2114.2679.3373.3314.28
262473-6247374.55874.67
365059-6505977.64577.78
465772-6577278.49678.62
543697-4369752.15052.22
664711-6471177.22977.37
20min174323-7432388.70185.119.1488.9785.359.16
273012-7301287.13687.37
373626-7362687.86988.13
474823-7482389.29889.55
558082-5808269.31869.48
674029-7402988.35088.62
30min177897-7789792.96692.393.6093.3892.783.64
277951-7795193.03193.41
378329-7832993.48293.89
480298-8029895.83296.23
572059-7205985.99986.27
677970-7797093.05393.47
45min178616-7861693.82493.941.5094.3994.481.55
278709-7870993.93594.47
379181-7918194.49995.07
480152-8015295.65796.22
576582-7658291.39791.82
679033-7903394.32294.89
60min178439-7843993.61393.911.3494.3494.601.39
278606-7860693.81294.51
378880-7888094.13994.86
480344-8034495.88796.61
577047-7704791.95292.52
678818-7881894.06594.79
极限178921-7892194.18894.800.6795.0795.650.66
279232-7923294.55995.41
379261-7926194.59495.48
480433-8043395.99396.87
579557-7955794.94795.67
679190-7919094.50995.39
坎地沙坦酯片项目信息
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100685-201903对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8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%
116.297644276639765647620276308764310.24
216.337658976325764570.25
单位质量响应值RSD%判断
4691.904682.000.15数据可信
长期6月-供试品溶液-12412515批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min19786-978611.72110.9919.4211.7210.9919.40
27983-79839.5629.56
312117-1211714.51314.51
47762-77629.2979.30
57487-74878.9678.97
69935-993511.90011.90
10min128360-2836033.96833.0212.9233.9933.0412.92
225304-2530430.30830.32
333202-3320239.76739.79
424800-2480029.70429.72
523932-2393228.66428.68
629805-2980535.69935.72
15min147260-4726056.60555.259.9356.6855.339.94
242967-4296751.46351.53
352643-5264363.05363.14
443039-4303951.55051.61
540929-4092949.02249.09
649949-4994959.82659.91
20min162462-6246274.81374.298.7074.9874.468.71
258262-5826269.78369.94
369053-6905382.70882.90
460013-6001371.88072.03
555013-5501365.89166.04
667367-6736780.68880.87
30min181556-8155697.68395.254.6797.9895.544.69
278377-7837793.87594.14
383100-8310099.53299.87
479132-7913294.78095.05
572898-7289887.31387.57
682104-8210498.33998.65
45min184316-84316100.98999.371.90101.4599.821.92
282828-8282899.20799.63
383697-83697100.247100.75
482940-8294099.34199.77
579981-7998195.79796.20
684002-84002100.613101.09
60min183667-83667100.21299.141.44100.8499.761.46
283086-8308699.516100.11
383329-8332999.807100.47
482850-8285099.23399.83
580417-8041796.31996.88
683303-8330399.776100.42
极限184980-84980101.784100.391.29102.58101.171.29
285253-85253102.111102.87
383514-83514100.028100.86
483576-83576100.103100.86
582500-8250098.81499.53
683077-8307799.505100.32
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