利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
110.163250733247933246203250143249463248890.06
210.183269783270783270280.03
单位质量响应值RSD%判断
31977.2632124.560.33数据可信
供试品溶液-JPS7149批-pH1.2
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min133122-331229.2649.284.569.269.284.57
234379-343799.6159.62
331184-311848.7228.72
433159-331599.2749.27
535325-353259.8809.88
631996-319968.9498.95
10min173490-7349020.55419.765.4120.5719.785.40
270885-7088519.82519.84
367908-6790818.99319.01
472989-7298920.41420.43
574270-7427020.77220.79
664438-6443818.02218.04
15min193892-9389226.26025.135.0026.3125.185.01
289800-8980025.11525.16
386587-8658724.21724.26
491913-9191325.70625.76
594168-9416826.33726.39
682729-8272923.13823.18
20min1108701-10870130.40229.284.5630.5029.374.57
2104755-10475529.29829.39
3101069-10106928.26728.35
4107304-10730430.01130.10
5109234-10923430.55130.65
697130-9713027.16527.25
30min1132112-13211236.94935.514.3837.0935.654.37
2127020-12702035.52535.66
3123110-12311034.43234.57
4129289-12928936.16036.30
5132280-13228036.99637.14
6118077-11807733.02433.15
45min1157132-15713243.94742.513.8344.1542.713.83
2152164-15216442.55742.76
3147909-14790941.36741.56
4154053-15405343.08643.29
5157967-15796744.18044.39
6142717-14271739.91540.10
60min1176432-17643249.34547.833.4149.6248.103.41
2171208-17120847.88448.15
3166998-16699846.70646.97
4172771-17277148.32148.60
5176880-17688049.47049.75
6161732-16173245.23345.48
极限1215427-21542760.25158.922.5760.6159.272.58
2209688-20968858.64659.00
3207267-20726757.96958.31
4212594-21259459.45959.81
5216726-21672660.61460.98
6202296-20229656.57856.90
利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
110.163243633244843245703247593245883245530.05
210.183291533287853289690.08
单位质量响应值RSD%判断
31944.1932315.230.82数据可信
供试品溶液-JPS7149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%
5min1122938-12293834.30035.863.0134.3035.853.01
2132417-13241736.94536.94
3128329-12832935.80435.80
4126354-12635435.25335.25
5133299-13329937.19137.19
6127744-12774435.64135.64
10min1170171-17017147.47848.461.5347.5448.521.53
2174735-17473548.75248.81
3176714-17671449.30449.36
4171982-17198247.98448.04
5176339-17633949.19949.26
6172098-17209848.01648.08
15min1193515-19351553.99154.741.4554.1354.881.45
2195344-19534454.50254.64
3200388-20038855.90956.05
4195012-19501254.40954.55
5199076-19907655.54355.69
6193934-19393454.10854.25
20min1208627-20862758.20858.891.2258.4359.121.22
2209470-20947058.44358.68
3215545-21554560.13860.37
4210912-21091258.84559.07
5212422-21242259.26659.50
6209451-20945158.43858.67
30min1226912-22691263.30963.851.1863.6364.181.18
2226150-22615063.09763.43
3233364-23336465.10965.44
4228929-22892963.87264.20
5230409-23040964.28564.62
6227282-22728263.41263.74
45min1243593-24359367.96368.251.2068.3968.691.19
2240858-24085867.20067.64
3249279-24927969.55069.99
4245750-24575068.56569.00
5245523-24552368.50268.94
6242783-24278367.73768.17
60min1253381-25338170.69470.911.2171.2471.461.21
2249856-24985669.71170.26
3258973-25897372.25472.81
4254956-25495671.13471.68
5255326-25532671.23771.79
6252538-25253870.45971.00
极限1261687-26168773.01273.041.2673.6773.711.26
2256812-25681271.65172.32
3266794-26679474.43675.12
4263369-26336973.48174.15
5261614-26161472.99173.67
6260391-26039172.65073.31
利伐沙班片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
110.163244853262043258143263693263473258440.25
210.183277613281493279550.09
单位质量响应值RSD%判断
32071.2632215.620.32数据可信
供试品溶液-JPS7149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%
5min162322-6232217.38016.902.3917.3816.902.38
260122-6012216.76716.77
362035-6203517.30017.30
459116-5911616.48616.49
561090-6109017.03717.04
658939-5893916.43716.44
10min191844-9184425.61324.293.9225.6424.323.91
288755-8875524.75224.78
387404-8740424.37524.40
482400-8240022.97923.01
588160-8816024.58624.61
684026-8402623.43323.46
15min1110620-11062030.84929.313.4830.9229.383.48
2107599-10759930.00730.08
3105122-10512229.31629.39
4100699-10069928.08328.15
5104795-10479529.22529.29
6101860-10186028.40628.47
20min1125410-12541034.97433.213.4835.1033.333.48
2121836-12183633.97734.10
3118648-11864833.08833.21
4113446-11344631.63731.75
5118397-11839733.01833.14
6116689-11668932.54232.66
30min1146959-14695940.98338.823.6441.1638.993.63
2142435-14243539.72239.90
3138815-13881538.71238.89
4132430-13243036.93237.10
5138582-13858238.64738.82
6135906-13590637.90138.07
45min1169153-16915347.17344.863.4747.4245.103.46
2164922-16492245.99346.23
3160561-16056144.77745.01
4153439-15343942.79143.02
5159860-15986044.58144.82
6157187-15718743.83644.07
60min1185664-18566451.77749.453.1252.1149.763.13
2181136-18113650.51550.83
3177281-17728149.43949.75
4169714-16971447.32947.63
5175752-17575249.01349.32
6174419-17441948.64148.95
极限1219881-21988161.32059.112.6961.7359.502.69
2216148-21614860.27960.68
3212240-21224059.18959.58
4203447-20344756.73757.11
5210761-21076158.77659.17
6209226-20922658.34858.73
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