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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.793994964015984004104014514006494007210.22
216.804091974094634093300.05
单位质量响应值RSD%判断
23866.6524364.881.47数据可信
供试品溶液-2025050421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%
5min138966-389669.6869.762.329.699.762.32
237699-376999.3719.37
339825-398259.9009.90
440363-4036310.03310.03
539552-395529.8329.83
639220-392209.7499.75
10min175024-7502418.64918.902.4918.6718.912.48
273531-7353118.27818.29
375877-7587718.86118.88
479201-7920119.68819.70
576660-7666019.05619.07
675808-7580818.84418.86
15min1103650-10365025.76526.071.2925.8126.111.30
2103794-10379425.80125.85
3104502-10450225.97726.02
4107316-10731626.67626.73
5104515-10451525.98026.03
6105368-10536826.19226.24
20min1127871-12787131.78631.760.9931.8831.851.00
2127368-12736831.66131.75
3128407-12840731.91932.01
4129868-12986832.28232.38
5126717-12671731.49931.59
6126388-12638831.41731.51
30min1163595-16359540.66640.580.6240.8140.720.62
2162042-16204240.28040.42
3163893-16389340.74040.88
4164445-16444540.87741.03
5163516-16351640.64640.79
6162008-16200840.27240.42
45min1201988-20198850.21050.230.8950.4250.440.89
2204065-20406550.72650.93
3201779-20177950.15850.37
4204268-20426850.77650.99
5200104-20010449.74149.95
6200244-20024449.77649.99
60min1229942-22994257.15856.680.5757.4556.980.56
2226544-22654456.31456.61
3228572-22857256.81857.11
4228804-22880456.87657.18
5227057-22705756.44156.74
6227287-22728756.49856.79
90min1265531-26553166.00565.590.5566.3965.980.55
2264214-26421465.67866.07
3264102-26410265.65066.04
4264464-26446465.74066.14
5261216-26121664.93265.32
6263556-26355665.51465.90
120min1290736-29073672.27071.111.1072.7771.611.10
2284961-28496170.83571.33
3284510-28451070.72371.22
4288672-28867271.75772.26
5285499-28549970.96971.47
6281975-28197570.09370.59
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1318114-31811479.07679.020.5979.7079.640.59
2316714-31671478.72879.34
3321482-32148279.91380.53
4317416-31741678.90379.53
5316325-31632578.63179.25
6317307-31730778.87579.49
240min1334546-33454683.16182.891.3283.9183.641.31
2335713-33571383.45184.20
3336234-33623483.58084.33
4334114-33411483.05383.81
5324603-32460380.68981.44
6335465-33546583.38984.13
极限1341327-34132784.84684.170.5385.7485.060.53
2337692-33769283.94384.83
3338414-33841484.12285.01
4339420-33942084.37285.27
5338848-33884884.23085.11
6335941-33594183.50784.39
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.794079594087774088824081324093814086260.15
216.804129604137074133340.13
单位质量响应值RSD%判断
24337.4624603.210.77数据可信
供试品溶液-2025050621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%
5min141256-4125610.1069.683.8810.119.683.89
239981-399819.7949.79
340600-406009.9459.95
437873-378739.2779.28
537408-374089.1639.16
639874-398749.7679.77
10min175993-7599318.61517.863.4818.6317.873.47
274022-7402218.13218.15
374874-7487418.34118.36
469701-6970117.07417.09
570272-7027217.21417.23
672514-7251417.76317.78
15min1103753-10375325.41524.771.9625.4624.821.95
2102200-10220025.03525.08
3102487-10248725.10525.15
498521-9852124.13324.18
599851-9985124.45924.50
6100023-10002324.50124.55
20min1127533-12753331.24030.421.8231.3330.501.83
2125605-12560530.76830.86
3124638-12463830.53130.62
4121162-12116229.67929.76
5122688-12268830.05330.14
6123423-12342330.23330.32
30min1159828-15982839.15138.881.1239.2939.021.12
2159215-15921539.00139.14
3161274-16127439.50539.65
4156245-15624538.27338.41
5157744-15774438.64038.78
6157969-15796938.69638.83
45min1200987-20098749.23348.041.6949.4448.241.69
2198238-19823848.56048.76
3196194-19619448.05948.26
4193876-19387647.49147.69
5195880-19588047.98248.18
6191475-19147546.90347.10
60min1227115-22711555.63354.661.3955.9254.941.39
2224449-22444954.98055.27
3224719-22471955.04655.33
4222023-22202354.38654.66
5222560-22256054.51854.80
6218036-21803653.40953.69
90min1261735-26173564.11463.450.7764.5063.830.78
2259433-25943363.55063.93
3259515-25951563.57063.95
4255578-25557862.60662.97
5258695-25869563.36963.74
6259271-25927163.51063.88
120min1287284-28728470.37269.440.7970.8669.920.80
2281320-28132068.91169.39
3283985-28398569.56470.05
4283250-28325069.38469.86
5283765-28376569.51069.99
6281146-28114668.86969.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1317444-31744477.76075.653.2778.3776.243.24
2289644-28964470.95071.55
3315974-31597477.40078.00
4307557-30755775.33875.93
5312229-31222976.48377.07
6310026-31002675.94376.53
240min1335105-33510582.08681.210.7082.8281.940.70
2330856-33085681.04581.76
3333591-33359181.71582.44
4330478-33047880.95381.67
5330073-33007380.85481.57
6329174-32917480.63381.35
极限1337681-33768182.71782.050.5383.5982.910.53
2333434-33343481.67782.53
3334152-33415281.85382.72
4332996-33299681.57082.42
5335599-33559982.20783.06
6335908-33590882.28383.13
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101242-202302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(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)15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%
116.794106764094554093544098004096614097890.13
216.804098144067654082900.53
单位质量响应值RSD%判断
24406.7324302.980.31数据可信
供试品溶液-2025050821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%
5min135931-359318.8439.157.458.849.157.44
240925-4092510.07210.07
336273-362738.9278.93
437819-378199.3089.31
539150-391509.6359.64
632977-329778.1168.12
10min170921-7092117.45517.703.6317.4717.713.64
274842-7484218.42018.44
368221-6822116.79016.80
471561-7156117.61217.63
574995-7499518.45718.47
670865-7086517.44117.45
15min199623-9962324.51824.672.6824.5624.712.69
2101054-10105424.87124.92
395766-9576623.56923.61
4100701-10070124.78424.83
5104066-10406625.61225.66
6100151-10015124.64824.69
20min1122928-12292830.25430.493.1230.3430.583.11
2127219-12721931.31031.40
3117449-11744928.90628.99
4124171-12417130.56030.65
5128409-12840931.60331.69
6123248-12324830.33330.42
30min1157781-15778138.83238.825.0438.9738.965.03
2161640-16164039.78239.92
3141953-14195334.93635.07
4160625-16062539.53239.67
5163496-16349640.23840.38
6160829-16082939.58239.72
45min1193086-19308647.52148.234.1047.7248.434.10
2199534-19953449.10849.32
3180932-18093244.53044.72
4199476-19947649.09349.30
5202907-20290749.93850.15
6199770-19977049.16649.37
60min1225839-22583955.58254.467.7155.8654.747.69
2227380-22738055.96156.25
3186687-18668745.94646.21
4226930-22693055.85056.14
5230287-23028756.67656.97
6230484-23048456.72557.01
90min1260081-26008164.00963.704.7764.3864.074.77
2264066-26406664.99065.37
3234216-23421657.64357.98
4261557-26155764.37264.75
5266705-26670565.63966.03
6266304-26630465.54165.92
120min1290330-29033071.45470.025.0571.9370.505.05
2288161-28816170.92071.41
3255386-25538662.85463.29
4288785-28878571.07471.56
5291569-29156971.75972.26
6292759-29275972.05272.54
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1317004-31700478.01977.195.5978.6277.785.58
2321203-32120379.05279.66
3278112-27811268.44768.99
4321906-32190679.22579.83
5322593-32259379.39480.01
6320925-32092578.98479.59
240min1333740-33374082.13781.165.4882.8681.885.48
2335706-33570682.62183.36
3293272-29327272.17872.83
4340055-34005583.69284.43
5340138-34013883.71284.46
6335746-33574682.63183.37
极限1338351-33835183.27282.026.0884.1482.886.06
2341932-34193284.15485.03
3292162-29216271.90572.68
4344707-34470784.83785.71
5340670-34067083.84384.73
6341690-34169084.09484.97
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