多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316574066355661866608865760660260.41
210.256536465816655900.49
单位质量响应值RSD%判断
6404.076399.020.06数据可信
加速6月-供试品溶液-2025072121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%
5min14881-48816.8418.2235.356.848.2235.34
27387-738710.35310.35
37025-70259.8469.85
48545-854511.97611.98
53722-37225.2175.22
63615-36155.0675.07
10min111148-1114815.62418.0713.4115.6418.0913.41
214259-1425919.98520.00
313573-1357319.02319.04
414829-1482920.78420.80
510488-1048814.69914.71
613071-1307118.32018.33
15min116361-1636122.93124.628.1222.9724.668.14
218620-1862026.09726.15
317880-1788025.06025.11
419232-1923226.95527.01
515415-1541521.60521.64
617880-1788025.06025.10
20min120441-2044128.64929.736.4128.7229.816.42
222311-2231131.27031.36
321566-2156630.22630.32
422281-2228131.22831.33
518815-1881526.37026.44
621843-2184330.61430.69
30min125944-2594436.36237.153.9236.4937.283.92
226882-2688237.67737.82
326304-2630436.86637.01
427043-2704337.90238.05
524917-2491734.92235.04
627943-2794339.16439.30
45min130813-3081343.18643.412.4043.3743.602.42
231825-3182544.60444.81
330652-3065242.96043.16
431627-3162744.32744.54
529776-2977641.73341.90
631146-3114643.65343.85
60min133770-3377047.33048.082.0047.5948.352.03
234338-3433848.12648.41
334749-3474948.70348.98
435133-3513349.24149.53
533258-3325846.61346.85
634581-3458148.46748.74
90min138345-3834553.74254.051.3954.0854.401.40
239392-3939255.21055.57
338291-3829153.66754.02
438499-3849953.95854.33
537892-3789253.10853.43
638960-3896054.60454.96
120min140005-4000556.06957.651.6356.4958.091.64
241038-4103857.51757.97
341231-4123157.78758.23
441726-4172658.48158.94
540929-4092957.36457.77
641876-4187658.69159.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限142063-4206358.95359.760.8559.4760.300.88
243003-4300360.27160.82
342623-4262359.73860.28
442903-4290360.13160.69
542379-4237959.39659.90
642871-4287160.08660.63
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316541265524654596576565323654970.26
210.256573965724657320.02
单位质量响应值RSD%判断
6352.766412.880.67数据可信
加速6月-供试品溶液-2025072221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%
5min17057-70579.9209.606.799.929.606.79
27346-734610.32610.33
37024-70249.8749.87
47028-70289.8799.88
56328-63288.8958.90
66176-61768.6828.68
10min117178-1717824.14719.2313.1324.1619.2413.12
213595-1359519.11019.13
312417-1241717.45517.47
413658-1365819.19919.22
512661-1266117.79817.81
612570-1257017.67017.68
15min117943-1794325.22224.604.6225.2824.644.62
218043-1804325.36325.41
315954-1595422.42622.47
418100-1810025.44325.49
517391-1739124.44624.49
617551-1755124.67124.72
20min121505-2150530.22929.502.2030.3329.592.21
221169-2116929.75729.85
320194-2019428.38728.47
421273-2127329.90329.99
520764-2076429.18829.27
621011-2101129.53529.62
30min126470-2647037.20936.462.0537.3636.592.07
226436-2643637.16137.30
325050-2505035.21335.34
425958-2595836.48936.63
525652-2565236.05936.19
626042-2604236.60736.74
45min131254-3125443.93442.771.7044.1442.961.70
230764-3076443.24543.45
330058-3005842.25242.44
430302-3030242.59542.80
529817-2981741.91442.11
630347-3034742.65942.85
60min134749-3474948.84647.532.0949.1347.802.10
234432-3443248.40148.68
333464-3346447.04047.30
434065-3406547.88548.16
533137-3313746.58146.84
633047-3304746.45446.72
90min139200-3920055.10353.721.6355.4754.071.63
238421-3842154.00854.36
337823-3782353.16853.51
438011-3801153.43253.78
537403-3740352.57752.92
638445-3844554.04254.39
120min142570-4257059.84058.341.7860.3058.781.78
241522-4152258.36758.81
341293-4129358.04558.47
441091-4109157.76158.20
540482-4048256.90557.33
642060-4206059.12459.56
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限143314-4331460.88659.751.2561.4460.281.26
243040-4304060.50161.04
342102-4210259.18359.71
442219-4221959.34759.88
542135-4213559.22959.75
642223-4222359.35359.89
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316560665472659056543865370655580.33
210.256558165857657190.30
单位质量响应值RSD%判断
6358.686411.610.59数据可信
加速6月-供试品溶液-2025072321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%
5min16389-63898.97810.4213.128.9810.4213.11
28119-811911.40911.41
37903-790311.10511.11
47673-767310.78210.78
58373-837311.76611.77
66018-60188.4568.46
10min112392-1239217.41318.557.5517.4318.577.57
214573-1457320.47820.50
314196-1419619.94819.97
412699-1269917.84417.86
513239-1323918.60318.62
612113-1211317.02117.03
15min116733-1673323.51325.546.7223.5625.586.72
219255-1925527.05727.11
319288-1928827.10327.15
418083-1808325.41025.46
519010-1901026.71226.76
616671-1667123.42623.47
20min120544-2054428.86830.384.8328.9530.474.83
222926-2292632.21532.31
322395-2239531.46931.57
421464-2146430.16130.25
522094-2209431.04631.14
620308-2030828.53628.62
30min125380-2538035.66337.383.3935.7937.523.40
227602-2760238.78638.94
327101-2710138.08238.23
426552-2655237.31037.45
527276-2727638.32838.47
625685-2568536.09236.22
45min131140-3114043.75743.671.7143.9543.871.72
231884-3188444.80345.02
331415-3141544.14444.36
430950-3095043.49043.69
530408-3040842.72942.94
630664-3066443.08843.28
60min134186-3418648.03748.381.7748.3048.651.79
235273-3527349.56549.86
334854-3485448.97649.26
434515-3451548.50048.77
534226-3422648.09448.38
633505-3350547.08047.34
90min138338-3833853.87254.411.5654.2254.761.57
239674-3967455.74956.12
339047-3904754.86855.24
438873-3887354.62354.98
538365-3836553.91054.27
638012-3801253.41453.75
120min141383-4138358.15058.411.5858.5858.861.59
242473-4247359.68260.15
341817-4181758.76059.22
441814-4181458.75659.20
541433-4143358.22158.67
640500-4050056.91057.34
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限142443-4244359.64059.832.9560.1760.382.94
243884-4388461.66562.23
343387-4338760.96661.52
443589-4358961.25061.80
540968-4096857.56758.12
641217-4121757.91758.44
多替诺雷片项目信息
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D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.316559465690657776598465631657350.24
210.256570465641656720.07
单位质量响应值RSD%判断
6375.856407.020.35数据可信
中间条件6月-供试品溶液-2025072321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%
5min18770-877012.31111.947.9812.3111.947.98
27563-756310.61710.62
38107-810711.38011.38
48833-883312.40012.40
58261-826111.59711.60
69515-951513.35713.36
10min116123-1612322.63321.925.3022.6521.945.29
214210-1421019.94819.97
315187-1518721.31921.34
416264-1626422.83122.85
515531-1553121.80221.82
616376-1637622.98823.01
15min121212-2121229.77728.732.8829.8428.792.89
219583-1958327.49027.54
320323-2032328.52928.58
420273-2027328.45928.52
520372-2037228.59828.65
621034-2103429.52729.59
20min125295-2529535.50933.913.5235.6234.023.52
222810-2281032.02032.12
324066-2406633.78333.89
423718-2371833.29533.40
524436-2443634.30334.41
624613-2461334.55134.66
30min129590-2959041.53840.722.2241.7040.882.22
227971-2797139.26539.42
328699-2869940.28740.45
428781-2878140.40240.56
529539-2953941.46641.63
629481-2948141.38541.55
45min134278-3427848.11946.672.7448.3546.902.72
232626-3262645.80046.02
333397-3339746.88247.11
432985-3298546.30446.53
534230-3423048.05148.28
631974-3197444.88445.12
60min137392-3739252.49051.292.1952.8151.602.20
235310-3531049.56749.86
336620-3662051.40651.71
436296-3629650.95151.26
537420-3742052.52952.84
636195-3619550.81051.12
90min141979-4197958.92957.452.2559.3357.842.24
240580-4058056.96557.34
340057-4005756.23156.62
439904-3990456.01656.41
542013-4201358.97759.37
641018-4101857.58057.98
120min144185-4418562.02660.751.4662.5361.241.46
242934-4293460.27060.74
342786-4278660.06260.55
442572-4257259.76260.25
543818-4381861.51162.01
643351-4335160.85561.35
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限145753-4575364.22762.831.4664.8363.421.46
244123-4412361.93962.51
344093-4409361.89762.48
445267-4526763.54564.13
544686-4468662.72963.33
644638-4463862.66263.26
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