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%
116.794107814133734135234108404138734124780.38
216.804174354139104156720.60
单位质量响应值RSD%判断
24566.8924742.380.51数据可信
供试品溶液-y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%
5min144276-4427610.76410.034.5210.7610.034.51
241259-4125910.03110.03
342583-4258310.35310.35
440265-402659.7899.79
539859-398599.6919.69
639373-393739.5729.57
10min178380-7838019.05618.093.3319.0718.113.32
273179-7317917.79117.81
376642-7664218.63318.65
473007-7300717.75017.77
572642-7264217.66117.68
672586-7258617.64717.66
15min1107077-10707726.03325.063.5526.0825.113.54
299699-9969924.23924.29
3108230-10823026.31326.36
4101638-10163824.71024.76
5101838-10183824.75924.80
6100036-10003624.32124.37
20min1127983-12798331.11530.923.1531.2131.013.15
2121932-12193229.64429.73
3133903-13390332.55532.65
4128082-12808231.14031.23
5126045-12604530.64430.73
6125043-12504330.40130.49
30min1158541-15854138.54538.322.3938.6938.462.39
2152238-15223837.01237.15
3163824-16382439.82939.98
4157939-15793938.39838.54
5156390-15639038.02238.16
6156744-15674438.10838.24
45min1197949-19794948.12647.481.6848.3347.681.68
2189846-18984646.15646.35
3198173-19817348.18048.39
4193255-19325546.98447.19
5197309-19730947.97048.17
6195281-19528147.47747.68
60min1225790-22579054.89454.352.2455.1854.632.24
2216606-21660652.66252.94
3231484-23148456.27956.57
4220584-22058453.62953.91
5223543-22354354.34854.63
6223237-22323754.27454.55
90min1260112-26011263.23962.711.7263.6263.091.73
2252231-25223161.32361.69
3264724-26472464.36064.75
4255033-25503362.00462.37
5256015-25601562.24362.61
6259611-25961163.11763.49
120min1283825-28382569.00468.592.2769.4969.072.27
2272618-27261866.27966.74
3290553-29055370.64071.13
4276815-27681567.30067.77
5284278-28427869.11469.59
6284706-28470669.21869.69
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1308956-30895675.11474.262.2675.7274.852.26
2297126-29712672.23872.81
3311161-31116175.65076.26
4296265-29626572.02872.61
5307893-30789374.85575.45
6311202-31120275.66076.25
240min1324900-32490078.99078.991.7079.7279.701.70
2315688-31568876.75177.45
3330754-33075480.41381.15
4325446-32544679.12379.83
5330020-33002080.23580.95
6322494-32249478.40579.12
极限1326697-32669779.42780.101.2280.2980.941.22
2325642-32564279.17179.99
3336737-33673781.86882.74
4327580-32758079.64280.48
5330542-33054280.36281.21
6329470-32947080.10180.95
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%
116.794161754148854167324181484152244162330.32
216.804181644158174169900.40
单位质量响应值RSD%判断
24790.5324820.830.09数据可信
供试品溶液-y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%
5min140190-401909.71112.1220.569.7112.1220.57
239992-399929.6649.66
342608-4260810.29610.30
456174-5617413.57413.57
561012-6101214.74314.74
661023-6102314.74514.75
10min170430-7043017.01922.1422.5817.0322.1622.58
271355-7135517.24217.26
377008-7700818.60818.63
4107369-10736925.94425.97
5111269-11126926.88726.91
6112418-11241827.16427.19
15min198035-9803523.68929.9620.4023.7330.0220.42
298532-9853223.80923.85
3106831-10683125.81425.86
4143853-14385334.76034.83
5147316-14731635.59735.67
6149352-14935236.08936.16
20min1120695-12069529.16536.0918.3729.2536.1918.37
2121901-12190129.45629.54
3131212-13121231.70631.80
4170540-17054041.20941.33
5174430-17443042.14942.28
6177254-17725442.83142.96
30min1147947-14794735.75043.6117.2935.8843.7817.30
2151373-15137336.57836.71
3157425-15742538.04038.18
4205219-20521949.58949.78
5207375-20737550.11050.31
6213528-21352851.59751.80
45min1185333-18533344.78453.3315.5744.9853.5715.59
2188595-18859545.57245.77
3194802-19480247.07247.28
4248698-24869860.09560.37
5249136-24913660.20160.48
6257551-25755162.23462.52
60min1214036-21403651.71960.2613.7851.9960.5913.81
2216621-21662152.34452.61
3224166-22416654.16754.45
4279079-27907967.43667.81
5276665-27666566.85367.24
6285657-28565769.02669.42
90min1248270-24827059.99268.2512.3660.3468.6812.40
2251395-25139560.74761.10
3252643-25264361.04861.42
4310476-31047675.02375.51
5311910-31191075.36975.86
6320105-32010577.35077.86
120min1274322-27432266.28774.9111.0866.7475.4511.12
2277473-27747367.04867.51
3284652-28465268.78369.26
4341301-34130182.47183.08
5339639-33963982.07082.69
6342635-34263582.79483.43
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
180min1301609-30160972.88081.219.7773.4481.879.81
2307315-30731574.25974.83
3309935-30993574.89275.48
4364077-36407787.97588.73
5363498-36349887.83588.59
6369939-36993989.39190.16
240min1319273-31927377.14984.539.3677.8385.349.41
2317163-31716376.63977.33
3323811-32381178.24578.96
4379675-37967591.74492.64
5376297-37629790.92891.83
6382806-38280692.50193.42
极限1321759-32175977.74985.098.5378.5686.038.58
2323506-32350678.17178.99
3329777-32977779.68780.53
4381953-38195392.29493.34
5373490-37349090.24991.30
6382409-38240992.40593.48
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