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%
110.313188332448323543223832068321980.71
210.253264832682326650.08
单位质量响应值RSD%判断
3122.993186.831.44数据可信
中间条件6月-供试品溶液-2025072421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%
5min15116-511614.55111.3218.6814.5511.3218.67
23040-30408.6468.65
33291-32919.3609.36
44271-427112.14712.15
54023-402311.44211.44
64145-414511.78911.79
10min19311-931126.48225.084.3526.5125.104.36
28407-840723.91123.93
39042-904225.71725.73
48964-896425.49525.52
58319-831923.66023.68
68859-885925.19625.22
15min112207-1220734.71832.974.0134.7933.034.01
211069-1106931.48231.54
311581-1158132.93833.00
411428-1142832.50332.57
511188-1118831.82031.88
612078-1207834.35234.41
20min114200-1420040.38738.612.7040.5138.722.70
213150-1315037.40137.51
313650-1365038.82338.94
413534-1353438.49338.61
513281-1328137.77337.88
613626-1362638.75438.87
30min116666-1666647.40146.232.4347.5946.412.43
216553-1655347.07947.25
316291-1629146.33446.51
415664-1566444.55144.73
515897-1589745.21345.39
616462-1646246.82047.00
45min119445-1944555.30452.803.0955.5853.063.09
218680-1868053.12953.38
318319-1831952.10252.36
418280-1828051.99152.25
517782-1778250.57550.82
618882-1888253.70353.96
60min121182-2118260.24558.542.4460.6158.892.43
220848-2084859.29559.63
320210-2021057.48057.82
419949-1994956.73857.08
521028-2102859.80760.14
620286-2028657.69658.05
90min123591-2359167.09664.652.0167.5665.092.01
222747-2274764.69665.13
322739-2273964.67365.11
422304-2230463.43663.87
522597-2259764.26964.70
622412-2241263.74364.19
120min124432-2443269.48868.371.4170.0768.921.42
224333-2433369.20769.75
324246-2424668.95969.50
423834-2383467.78768.33
523646-2364667.25367.79
623733-2373367.50068.05
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124115-2411568.58768.992.5869.2869.652.55
224237-2423768.93469.59
324671-2467170.16870.83
424368-2436869.30669.96
524985-2498571.06171.71
623156-2315665.85966.52
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%
110.313208731665321563171532019319280.71
210.253252632291324080.52
单位质量响应值RSD%判断
3096.803161.761.47数据可信
中间条件6月-供试品溶液-2025072521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%
5min15451-545115.63110.9826.6215.6310.9826.62
24739-473913.58913.59
33319-33199.5179.52
43440-34409.8649.86
53004-30048.6148.61
63027-30278.6808.68
10min19007-900725.82722.1211.7825.8522.1411.78
28598-859824.65424.68
37267-726720.83820.85
47691-769122.05422.07
56944-694419.91219.93
66777-677719.43319.45
15min112072-1207234.61631.266.9534.6931.326.97
211572-1157233.18233.25
310576-1057630.32630.38
410669-1066930.59330.65
510444-1044429.94830.00
610079-1007928.90128.95
20min113925-1392539.92937.414.1040.0637.514.13
213461-1346138.59938.72
312556-1255636.00436.10
412895-1289536.97637.08
512699-1269936.41436.51
612733-1273336.51136.61
30min116544-1654447.43945.772.8547.6345.942.87
216533-1653347.40847.59
315519-1551944.50044.66
415762-1576245.19745.36
515721-1572145.07945.24
615700-1570045.01945.17
45min118708-1870853.64453.440.8353.9253.690.83
218438-1843852.87053.13
318714-1871453.66253.90
418571-1857153.25253.49
518529-1852953.13153.36
618865-1886554.09554.33
60min120586-2058659.02958.550.8959.3958.890.90
220560-2056058.95559.31
320190-2019057.89458.22
420211-2021157.95458.28
520558-2055858.94959.27
620418-2041858.54858.87
90min122500-2250064.51865.571.3864.9866.001.34
222686-2268665.05165.50
322618-2261864.85665.28
422964-2296465.84866.27
523279-2327966.75267.17
623155-2315566.39666.81
120min124032-2403268.91169.771.1369.4870.321.10
224254-2425469.54770.10
324388-2438869.93270.46
424049-2404968.95969.50
524695-2469570.81271.34
624579-2457970.47971.01
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125129-2512972.05671.810.7372.7472.470.74
225203-2520372.26872.94
324716-2471670.87271.52
425181-2518172.20572.86
525064-2506471.87072.52
624969-2496971.59872.24
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%
110.313214432059317963196132133320190.46
210.253182332170319960.77
单位质量响应值RSD%判断
3105.633121.560.37数据可信
中间条件6月-供试品溶液-2025072522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%
5min15433-543315.65613.1121.1015.6613.1121.11
25263-526315.16615.17
34813-481313.86913.87
45111-511114.72814.73
53282-32829.4579.46
63398-33989.7929.79
10min19603-960327.67224.699.6427.7024.719.65
28684-868425.02425.05
39198-919826.50526.53
48682-868225.01825.04
57862-786222.65522.67
67379-737921.26321.28
15min112039-1203934.69233.065.9634.7633.125.97
211695-1169533.70033.77
312134-1213434.96535.03
411724-1172433.78433.85
510676-1067630.76430.82
610563-1056330.43830.49
20min114203-1420340.92738.855.3541.0638.975.36
213984-1398440.29640.42
314058-1405840.51040.64
413407-1340738.63438.76
512621-1262136.36936.47
612619-1261936.36336.47
30min117044-1704449.11446.973.7049.3147.153.71
216640-1664047.95048.14
316811-1681148.44348.64
415884-1588445.77145.96
515778-1577845.46645.63
615642-1564245.07445.24
45min119290-1929055.58654.702.7055.8754.962.72
219231-1923155.41655.69
319732-1973256.86057.13
418469-1846953.22053.48
518493-1849353.29053.53
618680-1868053.82854.07
60min121666-2166662.43360.322.2862.8160.672.30
221039-2103960.62660.99
321248-2124861.22861.60
420561-2056159.24959.60
520402-2040258.79159.12
620671-2067159.56659.89
90min123523-2352367.78466.492.3568.2666.942.36
223370-2337067.34367.81
323768-2376868.49068.96
422589-2258965.09365.54
522599-2259965.12165.55
622594-2259465.10765.53
120min125229-2522972.70070.942.2773.2971.502.29
224614-2461470.92871.50
325323-2532372.97173.56
424016-2401669.20569.76
524071-2407169.36369.90
624450-2445070.45570.99
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125754-2575474.21372.731.5874.9273.421.60
225244-2524472.74373.44
325586-2558673.72974.44
425275-2527572.83373.51
524740-2474071.29171.94
624845-2484571.59472.25
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%
110.313219832476320813239032046322380.59
210.253236931925321470.98
单位质量响应值RSD%判断
3126.873136.290.22数据可信
加速6月-供试品溶液-2025072522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%
5min13168-31689.07610.3023.209.0810.3023.19
22754-27547.8907.89
33185-31859.1259.13
43324-33249.5239.52
54089-408911.71511.72
65044-504414.45114.45
10min16699-669919.19322.4510.7219.2122.4610.71
28098-809823.20123.21
38054-805423.07523.09
48178-817823.43023.45
57001-700120.05820.08
68975-897525.71425.74
15min19798-979828.07230.505.3428.1230.565.35
210910-1091031.25831.31
310588-1058830.33530.39
411068-1106831.71031.77
510201-1020129.22629.28
611312-1131232.40932.48
20min111758-1175833.68735.853.6233.7835.963.63
212625-1262536.17136.28
312525-1252535.88535.99
412769-1276936.58436.69
512314-1231435.28035.38
613093-1309337.51237.63
30min114577-1457741.76443.032.0641.9143.202.07
215393-1539344.10244.27
315223-1522343.61543.78
415226-1522643.62343.79
514815-1481542.44642.61
614888-1488842.65542.84
45min116672-1667247.76650.033.1747.9950.273.17
217913-1791351.32251.56
317736-1773650.81451.05
417643-1764350.54850.79
516861-1686148.30848.54
617945-1794551.41351.67
60min119020-1902054.49355.641.2954.7955.961.31
219574-1957456.08056.40
319598-1959856.14956.47
419570-1957056.06956.39
519191-1919154.98355.29
619572-1957256.07556.41
90min121380-2138061.25561.720.5461.6462.130.55
221485-2148561.55661.97
321689-2168962.14062.55
421591-2159161.85962.28
521475-2147561.52761.93
621631-2163161.97462.41
120min122807-2280765.34365.291.1065.8465.811.10
223196-2319666.45866.98
322829-2282965.40665.92
422812-2281265.35765.88
522432-2243264.26964.77
622663-2266364.93165.47
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123503-2350367.33767.251.2367.9467.871.22
223783-2378368.13968.77
323191-2319166.44367.07
423847-2384768.32368.95
523289-2328966.72467.34
623217-2321766.51867.16
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