托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.641944401942951941611945721943781943690.08
216.861957551957971957760.02
单位质量响应值RSD%判断
11680.8311611.860.42数据可信
供试品溶液-2025050921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%
5min114090-140907.2597.396.067.267.396.08
215567-155678.0208.02
313629-136297.0217.02
413552-135526.9826.98
515307-153077.8867.89
613954-139547.1897.19
10min135588-3558818.33418.164.9718.3518.174.97
237745-3774519.44619.46
335119-3511918.09318.10
432623-3262316.80716.82
536221-3622118.66118.67
634192-3419217.61517.63
15min154163-5416327.90427.413.5127.9527.463.52
256293-5629329.00129.05
352293-5229326.94126.98
451424-5142426.49326.53
553547-5354727.58727.63
651526-5152626.54626.59
20min167567-6756734.81034.992.5034.9035.082.51
270871-7087136.51236.61
367652-6765234.85334.94
466959-6695934.49634.58
568529-6852935.30535.40
665870-6587033.93534.02
30min188160-8816045.41945.951.7645.5746.101.76
291597-9159747.19047.34
389036-8903645.87046.02
487071-8707144.85845.00
589126-8912645.91746.07
690148-9014846.44346.59
45min1108895-10889556.10156.731.1856.3256.951.18
2112366-11236657.89058.12
3110301-11030156.82657.05
4110287-11028756.81857.03
5110046-11004656.69456.92
6108807-10880756.05656.28
60min1125785-12578564.80365.192.3565.1265.512.35
2128346-12834666.12266.45
3126206-12620665.02065.34
4123603-12360363.67963.99
5131455-13145567.72468.04
6123815-12381563.78864.10
90min1145252-14525274.83274.471.2175.2674.891.21
2146860-14686075.66076.10
3144749-14474974.57375.00
4144692-14469274.54474.96
5144143-14414374.26174.69
6141543-14154372.92173.34
120min1157202-15720280.98980.640.5881.5481.200.59
2157869-15786981.33281.90
3156234-15623480.49081.04
4156703-15670380.73181.27
5155551-15555180.13880.69
6155643-15564380.18580.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1171893-17189388.55788.290.8589.2488.980.85
2173421-17342189.34490.05
3170877-17087788.03488.72
4172397-17239788.81789.49
5170151-17015187.66088.35
6169546-16954687.34888.02
240min1178614-17861492.02092.180.6492.8593.010.64
2180917-18091793.20694.06
3178748-17874892.08992.92
4179407-17940792.42893.25
5178013-17801391.71092.55
6177793-17779391.59792.42
极限1180877-18087793.18693.330.7394.1794.320.73
2182739-18273994.14595.15
3182663-18266394.10695.09
4180539-18053993.01193.99
5179337-17933792.39293.38
6180824-18082493.15894.13
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.641959691957301958681958801957401958370.06
216.861944991944111944550.04
单位质量响应值RSD%判断
11769.0511533.511.43数据可信
供试品溶液-2025051021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%
5min114243-142437.3357.604.897.347.614.88
214216-142167.3217.32
314555-145557.4967.50
415060-150607.7567.76
514423-144237.4287.43
616098-160988.2918.29
10min134834-3483417.94018.172.5317.9518.182.53
234269-3426917.64917.66
334661-3466117.85117.86
435609-3560918.33918.35
535554-3555418.31118.32
636752-3675218.92818.94
15min151499-5149926.52326.772.7626.5726.822.76
250376-5037625.94525.99
351163-5116326.35026.39
451737-5173726.64526.69
552609-5260927.09527.14
654495-5449528.06628.11
20min165124-6512433.54033.802.5633.6333.882.56
263951-6395132.93633.02
364948-6494833.44933.54
464899-6489933.42433.51
566036-6603634.01034.10
668770-6877035.41835.51
30min185430-8543043.99844.613.3444.1444.753.33
283795-8379543.15643.30
391771-9177147.26447.41
485136-8513643.84743.99
585459-8545944.01344.16
688089-8808945.36745.52
45min1105601-10560154.38654.621.6954.6054.841.69
2104017-10401753.57153.78
3104928-10492854.04054.26
4106739-10673954.97255.19
5105907-10590754.54454.76
6109188-10918856.23456.46
60min1120744-12074462.18562.401.4962.4962.701.50
2118869-11886961.22061.52
3119662-11966261.62861.94
4121955-12195562.80963.12
5121760-12176062.70963.02
6123922-12392263.82264.14
90min1140109-14010972.15972.802.5072.5773.222.50
2137693-13769370.91471.32
3139801-13980172.00072.41
4148058-14805876.25276.67
5141063-14106372.65073.06
6141413-14141372.83073.26
120min1152112-15211278.34078.801.8978.8779.341.88
2150386-15038677.45177.97
3151488-15148878.01978.55
4154060-15406079.34479.88
5158349-15834981.55282.09
6151666-15166678.11178.66
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1166745-16674585.87786.221.0286.5486.891.02
2164933-16493384.94385.59
3167281-16728186.15386.82
4169171-16917187.12687.80
5169495-16949587.29387.96
6166888-16688885.95086.63
240min1175244-17524490.25490.972.1391.0691.782.12
2172820-17282089.00589.80
3175848-17584890.56591.37
4183707-18370794.61295.43
5177263-17726391.29492.11
6174923-17492390.08890.91
极限1178345-17834591.85191.791.2892.8192.751.27
2176783-17678391.04691.99
3177705-17770591.52192.48
4181579-18157993.51694.49
5179823-17982392.61293.58
6175101-17510190.18091.15
托伐普坦口崩片项目信息
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101242-201201对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)7.5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%
116.641946891949351946851946961948201947650.06
216.861957251956391956820.04
单位质量响应值RSD%判断
11704.6311606.290.60数据可信
供试品溶液-2025051121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%
5min112922-129226.6526.446.106.656.446.12
211718-117186.0326.03
311893-118936.1226.12
411990-119906.1726.17
512896-128966.6396.64
613652-136527.0287.03
10min133258-3325817.12117.541.8617.1317.551.85
233814-3381417.40717.42
333973-3397317.48917.50
433827-3382717.41417.42
535108-3510818.07318.08
634413-3441317.71517.73
15min151286-5128626.40126.831.7426.4426.861.75
250729-5072926.11526.15
352342-5234226.94526.98
453001-5300127.28427.32
552435-5243526.99327.03
652865-5286527.21427.26
20min165145-6514533.53634.102.1433.6234.182.13
264024-6402432.95933.04
366556-6655634.26234.35
467557-6755734.77834.86
566515-6651534.24134.33
667633-6763334.81734.90
30min186334-8633444.44444.911.7644.5845.051.75
284617-8461743.56043.70
387536-8753645.06345.20
488329-8832945.47145.61
587789-8778945.19345.34
688781-8878145.70445.85
45min1108896-10889656.05956.391.5556.2756.611.55
2106581-10658154.86755.08
3109723-10972356.48456.70
4111278-11127857.28557.50
5109821-10982156.53556.75
6110964-11096457.12357.34
60min1124841-12484164.26764.471.5864.5764.781.58
2121736-12173662.66862.97
3125912-12591264.81865.13
4127719-12771965.74866.06
5125400-12540064.55564.87
6125813-12581364.76765.08
90min1146808-14680875.57575.251.0475.9975.671.05
2143462-14346273.85374.26
3145918-14591875.11775.54
4147647-14764776.00776.43
5145845-14584575.07975.50
6147379-14737975.86976.29
120min1161155-16115582.96182.300.8183.5082.840.82
2157683-15768381.17481.70
3159649-15964982.18682.73
4161205-16120582.98783.54
5159636-15963682.17982.72
6159840-15984082.28482.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1177568-17756891.41089.881.0292.0990.561.01
2172235-17223588.66589.33
3173523-17352389.32890.01
4174746-17474689.95790.65
5174757-17475789.96390.65
6174784-17478489.97790.66
240min1187656-18765696.60394.271.4297.4395.101.41
2179936-17993692.62993.44
3182267-18226793.82994.66
4183794-18379494.61595.45
5181856-18185693.61894.45
6183259-18325994.34095.18
极限1189865-18986597.74195.511.9098.7396.501.89
2183533-18353394.48195.45
3181629-18162993.50194.49
4189903-18990397.76098.76
5183400-18340094.41295.40
6184895-18489595.18296.18
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