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%
116.603983133982903979333975743978463979910.08
216.664012164011664011910.01
单位质量响应值RSD%判断
23975.3624081.090.32数据可信
供试品溶液-1批-shui(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1190896-19089647.62043.267.4347.6243.267.43
2161550-16155040.30040.30
3173616-17361643.31043.31
4178288-17828844.47544.48
5180358-18035844.99244.99
6155792-15579238.86438.86
10min1258726-25872664.54159.744.9164.6259.814.91
2236814-23681459.07559.14
3240915-24091560.09860.17
4235598-23559858.77258.85
5242212-24221260.42260.50
6222535-22253555.51355.58
15min1278617-27861769.50365.683.8269.6965.853.82
2264505-26450565.98366.15
3266572-26657266.49866.67
4257251-25725164.17364.35
5264336-26433665.94166.12
6248466-24846661.98262.14
20min1291680-29168072.76269.093.5073.0669.373.51
2278436-27843669.45869.73
3280444-28044469.95970.24
4271617-27161767.75768.04
5277208-27720869.15269.44
6262460-26246065.47365.73
30min1306602-30660276.48473.113.0976.9173.503.10
2295348-29534873.67774.07
3296636-29663673.99874.40
4286754-28675471.53371.92
5292972-29297273.08473.49
6280077-28007769.86770.24
45min1322475-32247580.44477.841.9981.0078.362.00
2313346-31334678.16778.68
3314239-31423978.38978.91
4305106-30510676.11176.62
5310032-31003277.34077.86
6307091-30709176.60677.09
60min1333613-33361383.22280.722.2783.9181.362.28
2326816-32681681.52782.17
3327295-32729581.64682.30
4317784-31778479.27479.91
5322832-32283280.53381.18
6313100-31310078.10578.72
极限1341243-34124385.12682.911.8585.9583.691.86
2335313-33531383.64684.43
3334565-33456583.46084.25
4328606-32860681.97382.74
5330902-33090282.54683.33
6323488-32348880.69781.44
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%
116.603997583991493995663992063992533993860.07
216.664031514031604031560.01
单位质量响应值RSD%判断
24059.4024199.040.41数据可信
供试品溶液-1批-shui(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1339810-33981084.41484.091.9784.4184.091.97
2329257-32925781.79281.79
3338945-33894584.19984.20
4332963-33296382.71382.71
5342177-34217785.00285.00
6347997-34799786.44886.45
10min1381865-38186594.86194.161.3795.0094.311.36
2371719-37171992.34092.48
3382566-38256695.03595.18
4373164-37316492.69992.84
5382564-38256495.03495.18
6382488-38248895.01695.16
15min1389062-38906296.64995.291.3696.9595.581.37
2377152-37715293.69093.98
3383601-38360195.29295.59
4377352-37735293.74094.03
5387326-38732696.21796.52
6387021-38702196.14296.44
20min1391025-39102597.13695.851.2497.6096.311.24
2379937-37993794.38294.83
3386076-38607695.90796.36
4380121-38012194.42894.88
5389286-38928696.70497.16
6388665-38866596.55097.01
30min1394328-39432897.95796.501.1898.5897.121.18
2383225-38322595.19995.80
3387963-38796396.37696.99
4383197-38319795.19295.80
5391847-39184797.34197.96
6390203-39020396.93297.56
45min1398903-39890399.09397.411.1499.8898.181.14
2387503-38750396.26197.02
3392630-39263097.53598.31
4386868-38686896.10496.87
5393467-39346797.74398.53
6393282-39328297.69798.48
60min1400920-40092099.59497.961.05100.5498.901.05
2390407-39040796.98397.91
3393837-39383797.83598.78
4389582-38958296.77897.70
5395223-39522398.17999.13
6396027-39602798.37999.33
极限1401491-40149199.73698.091.07100.8599.201.07
2391366-39136697.22198.31
3395086-39508698.14599.25
4389457-38945796.74797.83
5395562-39556298.26399.37
6396339-39633998.45699.57
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%
116.604013934002784008104011874013554010050.12
216.664023614031084027340.14
单位质量响应值RSD%判断
24156.9324173.710.05数据可信
供试品溶液-1批-shui(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1386223-38622395.79996.831.4295.8096.841.42
2387358-38735896.08196.08
3399238-39923899.02899.03
4395381-39538198.07198.07
5387448-38744896.10396.10
6386734-38673495.92695.93
10min1399667-39966799.134100.201.4099.29100.361.40
2400155-40015599.25599.42
3412651-412651102.355102.52
4409552-409552101.586101.75
5401389-40138999.56199.72
6400367-40036799.30899.47
15min1399215-39921599.022100.061.3599.35100.391.35
2399044-39904498.97999.31
3411962-411962102.184102.52
4408389-408389101.297101.63
5401311-40131199.54299.87
6400388-40038899.31399.64
20min1398706-39870698.896100.031.3599.39100.521.35
2399634-39963499.12699.62
3412275-412275102.261102.77
4407647-407647101.113101.61
5400808-40080899.41799.91
6400589-40058999.36399.85
30min1397763-39776398.66299.831.3299.32100.491.32
2398980-39898098.96499.62
3410518-410518101.825102.50
4407748-407748101.138101.81
5400393-40039399.31499.97
6399419-39941999.07299.73
45min1397267-39726798.53999.661.3499.36100.491.34
2398587-39858798.86699.69
3409558-409558101.587102.43
4407707-407707101.128101.97
5398670-39867098.88799.71
6398911-39891198.94699.77
60min1397207-39720798.52499.561.3099.51100.551.30
2397106-39710698.49999.48
3409658-409658101.612102.63
4405929-405929100.687101.69
5399948-39994899.204100.19
6398448-39844898.83299.82
极限1395501-39550198.10199.191.3399.25100.341.33
2396437-39643798.33399.48
3408237-408237101.260102.44
4404802-404802100.408101.58
5397191-39719198.52099.67
6397102-39710298.49899.65
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%
116.604034764036764039324035414030614035370.08
216.664051344057024054180.10
单位质量响应值RSD%判断
24309.4624334.810.08数据可信
供试品溶液-2批-shui(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345181-34518185.06784.690.4685.0784.690.46
2344146-34414684.81284.81
3344975-34497585.01685.02
4342634-34263484.43984.44
5343950-34395084.76484.76
6341021-34102184.04284.04
10min1402292-40229299.14299.681.1599.2899.821.15
2407794-407794100.498100.64
3403309-40330999.39299.53
4406924-406924100.283100.42
5409589-409589100.940101.08
6396870-39687097.80697.95
15min1407097-407097100.326100.491.15100.63100.801.15
2410775-410775101.232101.54
3406020-406020100.060100.37
4410240-410240101.100101.41
5412789-412789101.729102.04
6399690-39969098.50098.80
20min1406009-406009100.058100.491.30100.53100.961.30
2412068-412068101.551102.03
3405291-40529199.881100.35
4410774-410774101.232101.71
5413229-413229101.837102.32
6399210-39921098.38298.85
30min1405532-40553299.940100.251.30100.58100.891.30
2411079-411079101.307101.95
3405036-40503699.818100.46
4409488-409488100.915101.56
5411900-411900101.510102.16
6397705-39770598.01198.64
45min1405109-40510999.836100.191.03100.64101.001.03
2410185-410185101.087101.90
3403729-40372999.496100.30
4408778-408778100.740101.55
5411139-411139101.322102.14
6400354-40035498.66499.46
60min1404038-40403899.57299.871.40100.55100.851.39
2410301-410301101.115102.10
3402448-40244899.180100.15
4406577-406577100.198101.18
5411865-411865101.501102.49
6396367-39636797.68298.64
极限1403378-40337899.40999.731.29100.55100.881.29
2409047-409047100.806101.96
3402685-40268599.239100.38
4407038-407038100.311101.46
5410081-410081101.061102.22
6395963-39596397.58298.70
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