沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11096669109936210981031098484109955110984340.11
228.21128084111870111233920.60
单位质量响应值RSD%判断
39090.1839836.601.34数据可信
影响因素30天-包装高温-供试品溶液-2024022221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%
5min117236-172364.3685.5055.144.375.5055.11
213363-133633.3863.39
332292-322928.1848.18
420606-206065.2225.22
539278-392789.9549.95
67425-74251.8821.88
10min1194677-19467749.33545.2437.1049.3445.2637.10
2184389-18438946.72846.74
3226860-22686057.49157.51
4167451-16745142.43642.45
5242256-24225661.39361.41
655587-5558714.08714.09
15min1397094-397094100.63294.1820.62100.7494.2820.64
2378187-37818795.84195.94
3433197-433197109.782109.91
4363729-36372992.17792.27
5431531-431531109.359109.50
6225943-22594357.25957.29
20min1559659-559659141.830138.5417.60142.14138.8317.62
2533882-533882135.297135.59
3683255-683255173.152173.50
4523022-523022132.545132.83
5591004-591004149.773150.13
6389313-38931398.66198.81
30min1768517-768517194.759203.5111.43195.35204.0811.45
2766844-766844194.335194.90
3961259-961259243.604244.30
4773939-773939196.133196.68
5851384-851384215.760216.42
6696426-696426176.490176.83
45min1877502-877502222.378240.286.73223.36241.266.76
2941741-941741238.658239.61
31047557-1047557265.474266.66
4944675-944675239.402240.34
5989979-989979250.883251.98
6887490-887490224.910225.61
60min1930896-930896235.910256.116.23237.34257.576.26
21012892-1012892256.689258.12
31100777-1100777278.961280.68
41023003-1023003259.252260.67
51047315-1047315265.413267.01
6948834-948834240.456241.60
极限11180904-1180904299.267297.100.97301.17299.070.98
21182419-1182419299.651301.59
31181616-1181616299.448301.72
41171665-1171665296.926298.86
51157228-1157228293.267295.39
61160330-1160330294.053295.68
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11142688114394311440581144227114343811436710.06
228.21134752113429811345250.03
单位质量响应值RSD%判断
40700.0440231.380.82数据可信
影响因素30天-包装高温-供试品溶液-2024022221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%
5min129839-298397.3749.2228.077.379.2228.07
225516-255166.3066.31
352761-5276113.03913.04
432928-329288.1388.14
546960-4696011.60511.61
635854-358548.8618.86
10min1212380-21238052.48666.3339.9652.5066.3539.95
2353693-35369387.40987.42
3213916-21391652.86552.89
4173882-17388242.97242.99
5446629-446629110.376110.40
6209975-20997551.89151.91
15min1483844-483844119.573128.1821.57119.69128.3321.59
2554781-554781137.104137.29
3517883-517883127.985128.12
4425150-425150105.068105.17
5718473-718473177.557177.80
6411940-411940101.803101.92
20min1689949-689949170.508175.0514.66170.87175.4614.68
2661625-661625163.508163.97
3733294-733294181.220181.61
4685837-685837169.492169.80
5895014-895014221.186221.78
6584308-584308144.401144.73
30min1938305-938305231.884225.9810.11232.58226.7310.10
2784606-784606193.901194.69
3994894-994894245.869246.62
4947065-947065234.049234.70
51004776-1004776248.311249.35
6816758-816758201.846202.46
45min11065999-1065999263.442252.488.76264.61253.698.74
2858174-858174212.081213.26
31088482-1088482268.998270.24
41074796-1074796265.616266.73
51066020-1066020263.447264.98
6976337-976337241.283242.30
60min11113715-1113715275.234265.457.70276.92267.177.68
2918259-918259226.930228.53
31134930-1134930280.477282.26
41122122-1122122277.311278.96
51111434-1111434274.670276.73
61044401-1044401258.104259.60
极限11204924-1204924297.774294.991.37300.02297.241.39
21169629-1169629289.052291.11
31215197-1215197300.313302.65
41200206-1200206296.608298.81
51187553-1187553293.481296.10
61184417-1184417292.706294.72
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11141301114067011405851141273114134311410340.04
228.21139974114144811407110.10
单位质量响应值RSD%判断
40606.1940450.740.28数据可信
影响因素30天-包装高湿-供试品溶液-2024022221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%
5min1152392-15239237.60120.7453.6637.6020.7453.65
277998-7799819.24519.25
3116369-11636928.71328.71
450592-5059212.48312.48
580174-8017419.78219.78
626773-267736.6066.61
10min1492839-492839121.60488.8022.52121.6888.8422.53
2349227-34922786.16986.21
3401614-40161499.09599.15
4268762-26876266.31566.34
5289303-28930371.38371.42
6357581-35758188.23088.24
15min1760461-760461187.637144.6415.60187.96144.8615.61
2538404-538404132.846133.06
3580509-580509143.235143.49
4555834-555834137.147137.30
5495717-495717122.314122.50
6586268-586268144.656144.85
20min1940998-940998232.183191.6311.48232.88192.1411.49
2780768-780768192.648193.12
3719473-719473177.524178.07
4760178-760178187.567188.00
5681046-681046168.042168.47
6777387-777387191.813192.29
30min11025374-1025374253.002236.615.07254.16237.505.09
2962885-962885237.583238.45
3906480-906480223.666224.56
4976322-976322240.899241.71
5898394-898394221.671222.43
6984126-984126242.824243.69
45min11074292-1074292265.072256.213.77266.74257.583.79
21072551-1072551264.642265.98
3984595-984595242.940244.28
41047713-1047713258.514259.80
5994894-994894245.481246.69
61056310-1056310260.635261.98
60min11112781-1112781274.569268.312.94276.76270.182.96
21123759-1123759277.277279.14
31049324-1049324258.911260.74
41089636-1089636268.858270.66
51048695-1048695258.756260.45
61100274-1100274271.483273.35
极限11182948-1182948291.882292.391.22294.63294.811.22
21208178-1208178298.107300.53
31188148-1188148293.165295.51
41163050-1163050286.972289.32
51183456-1183456292.007294.22
61184308-1184308292.217294.63
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11133365113320511322671132982113239211328420.05
228.21160443115973811600900.05
单位质量响应值RSD%判断
40314.6641137.941.43数据可信
影响因素30天-包装高湿-供试品溶液-2024022221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%
5min131099-310997.63711.5342.547.6411.5342.54
253310-5331013.09113.09
372065-7206517.69717.70
422614-226145.5535.55
566113-6611316.23516.24
636427-364278.9458.95
10min1334019-33401982.02477.4624.1882.0477.4824.18
2259658-25965863.76363.79
3398126-39812697.76697.80
4217429-21742953.39353.40
5404133-40413399.24299.27
6279317-27931768.59168.61
15min1549370-549370134.907129.1815.25135.09129.3615.26
2450321-450321110.584110.74
3650495-650495159.740159.97
4436081-436081107.087107.20
5567658-567658139.398139.63
6502312-502312123.351123.51
20min1683203-683203167.772166.5310.34168.22166.9610.35
2605381-605381148.661149.04
3802456-802456197.056197.61
4617771-617771151.704152.04
5672419-672419165.124165.63
6687603-687603168.852169.25
30min1890831-890831218.758208.996.84219.54209.766.84
2792877-792877194.704195.38
3932066-932066228.884229.83
4842121-842121206.797207.43
5780209-780209191.593192.43
6868116-868116213.180213.92
45min11065530-1065530261.659235.127.80262.88236.307.78
2904541-904541222.125223.19
3996470-996470244.700246.10
4951655-951655233.695234.74
5850292-850292208.803210.03
6976180-976180239.717240.88
60min11084255-1084255266.257247.376.27268.00249.036.26
2961236-961236236.048237.55
31050482-1050482257.963259.86
41012512-1012512248.639250.16
5909216-909216223.273224.91
61026383-1026383252.045253.69
极限11194355-1194355293.294291.011.09295.57293.171.12
21183876-1183876290.720292.70
31200458-1200458294.792297.20
41177171-1177171289.074291.09
51189961-1189961292.215294.30
61164608-1164608285.989288.14
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11121044112051811200011120639112013211204670.04
228.21111445111078911111170.05
单位质量响应值RSD%判断
39874.2739401.310.85数据可信
影响因素30天-包装光照-供试品溶液-2024022221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%
5min1126993-12699332.04017.5156.9932.0417.5156.98
274354-7435418.75918.76
327948-279487.0517.05
445579-4557911.49911.50
5103809-10380926.19026.19
637682-376829.5079.51
10min1342702-34270286.46180.1219.9786.5380.1619.98
2326888-32688882.47282.51
3246244-24624462.12662.14
4271031-27103168.37968.40
5425010-425010107.227107.28
6293579-29357974.06874.09
15min1531121-531121133.998141.2214.96134.24141.4114.96
2534859-534859134.941135.14
3480065-480065121.117121.26
4494828-494828124.842125.00
5700089-700089176.628176.89
6617425-617425155.772155.94
20min1707203-707203178.423190.7412.49178.93191.2212.49
2717047-717047180.906181.38
3654970-654970165.245165.63
4715534-715534180.525180.93
5905802-905802228.528229.15
6835640-835640210.827211.31
30min1916619-916619231.257239.498.32232.12240.358.34
2938662-938662236.818237.65
3868508-868508219.119219.83
4887466-887466223.902224.67
51076652-1076652271.632272.71
61007686-1007686254.233255.13
45min11048727-1048727264.587263.756.75265.91265.096.78
21057017-1057017266.678267.99
3967322-967322244.049245.20
4967235-967235244.027245.25
51151695-1151695290.565292.19
61080513-1080513272.606274.02
60min11098943-1098943277.256276.766.33279.11278.636.36
21117954-1117954282.052283.89
31016728-1016728256.514258.15
41019344-1019344257.174258.88
51196539-1196539301.879304.08
61132420-1132420285.702287.66
极限11201040-1201040303.015305.041.83305.42307.461.87
21198681-1198681302.419304.82
31182203-1182203298.262300.41
41227814-1227814309.769311.99
51242875-1242875313.569316.37
61201894-1201894303.230305.76
沙库巴曲缬沙坦钠片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号DSMF-4022-230920对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数1000
标示量(mg)10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%
128.11125589112484511250381124284112461711248750.05
228.21121862112118211215220.05
单位质量响应值RSD%判断
40031.1439770.280.47数据可信
影响因素30天-包装光照-供试品溶液-2024022221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%
5min175650-7565018.96013.4542.2618.9613.4542.26
240400-4040010.12510.13
339375-393759.8689.87
487501-8750121.93021.93
530459-304597.6347.63
648644-4864412.19112.19
10min1288490-28849072.30367.8019.9372.3467.8319.94
2199248-19924849.93649.96
3252077-25207763.17763.20
4358600-35860089.87489.92
5241158-24115860.44060.46
6283517-28351771.05671.08
15min1482478-482478120.921131.3416.30121.10131.5016.29
2432184-432184108.316108.44
3471383-471383118.140118.29
4669170-669170167.711167.93
5572819-572819143.563143.70
6516305-516305129.399129.57
20min1659284-659284165.233178.9712.40165.66179.4012.41
2599810-599810150.327150.66
3696800-696800174.635175.02
4857985-857985215.032215.59
5760111-760111190.503190.93
6710658-710658178.109178.53
30min1853639-853639213.943232.359.56214.70233.149.57
2789505-789505197.870198.51
3982800-982800246.314247.05
41017541-1017541255.021256.01
5987174-987174247.410248.21
6931849-931849233.544234.33
45min1954019-954019239.101256.048.14240.28257.298.15
2889884-889884223.027224.06
31093839-1093839274.143275.37
41086629-1086629272.336273.84
51077893-1077893270.147271.45
61027473-1027473257.510258.76
60min1999879-999879250.594269.117.77252.26270.877.77
2944977-944977236.835238.31
31145279-1145279287.035288.81
41135925-1135925284.691286.73
51133941-1133941284.194286.03
61082637-1082637271.336273.10
极限11171054-1171054293.495298.291.20295.66300.581.25
21176973-1176973294.979296.93
31206864-1206864302.470304.82
41203867-1203867301.719304.33
51190283-1190283298.314300.72
61191993-1191993298.743301.05
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