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%
1 10.193335433198333283310633504332980.46
2 10.203318033162331710.04
单位质量响应值RSD%判断
3267.713252.060.34数据可信
供试品溶液-25041502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%
5min14771-477113.13113.737.9813.1313.727.96
25414-541414.90114.90
34861-486113.37913.38
45488-548815.10515.10
54940-494013.59613.60
64447-444712.23912.24
10min18909-890924.52024.572.6324.5424.592.64
29115-911525.08725.11
39100-910025.04625.07
49061-906124.93824.96
58882-888224.44624.47
68492-849223.37223.39
15min111774-1177432.40532.031.7932.4732.101.80
211580-1158031.87231.94
311851-1185132.61732.68
411718-1171832.25132.32
511652-1165232.07032.13
611260-1126030.99131.05
20min113653-1365337.57737.141.0537.6937.261.04
213559-1355937.31837.44
313603-1360337.43937.56
413264-1326436.50636.63
513463-1346337.05437.17
613432-1343236.96937.08
30min116282-1628244.81344.151.3344.9944.331.33
215911-1591143.79243.97
316290-1629044.83545.02
415935-1593543.85844.04
515762-1576243.38243.56
616067-1606744.22144.39
45min118912-1891252.05151.211.4152.3151.461.40
218296-1829650.35650.61
318831-1883151.82852.08
418502-1850250.92351.18
518340-1834050.47750.73
618749-1874951.60351.85
60min120845-2084557.37156.271.2757.7156.611.27
220274-2027455.80056.14
320520-2052056.47756.82
420159-2015955.48355.82
520265-2026555.77556.11
620612-2061256.73057.06
90min123244-2324463.97462.571.4764.4163.001.46
222400-2240061.65162.08
322974-2297463.23163.67
422591-2259162.17762.61
522416-2241661.69562.12
622773-2277362.67863.10
120min124721-2472168.03966.751.4968.5867.291.48
224132-2413266.41866.95
324490-2449067.40467.94
424026-2402666.12766.66
523725-2372565.29865.83
624427-2442767.23067.76
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125125-2512569.15168.771.2869.8169.421.27
224573-2457367.63268.28
325130-2513069.16569.82
424845-2484568.38169.03
524777-2477768.19368.83
625468-2546870.09570.74
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%
1 10.193332533362332543346233375333560.23
2 10.203316133125331430.08
单位质量响应值RSD%判断
3273.413249.310.53数据可信
供试品溶液-25041901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%
5min14973-497313.68114.324.1213.6814.324.13
24901-490113.48313.48
35357-535714.73714.74
45397-539714.84814.85
55348-534814.71314.71
65252-525214.44914.45
10min18910-891024.51225.772.9124.5325.802.92
29336-933625.68425.71
39269-926925.50025.52
49664-966426.58626.61
59614-961426.44926.47
69418-941825.91025.93
15min111850-1185032.60033.051.6132.6633.121.62
211736-1173632.28732.35
312111-1211133.31833.39
412224-1222433.62933.70
512180-1218033.50833.58
611980-1198032.95833.03
20min113980-1398038.46038.181.3438.5838.301.33
213690-1369037.66237.78
314137-1413738.89239.01
413928-1392838.31738.44
513643-1364337.53337.66
613893-1389338.22138.34
30min116483-1648345.34644.641.9245.5344.831.91
216227-1622744.64244.82
316417-1641745.16445.35
416402-1640245.12345.31
515635-1563543.01343.20
616200-1620044.56744.75
45min118200-1820050.06951.212.3850.3351.472.38
218042-1804249.63549.89
318902-1890252.00152.26
419052-1905252.41352.68
518450-1845050.75751.02
619039-1903952.37852.64
60min120985-2098557.73156.631.4158.0756.981.40
220305-2030555.86056.20
320646-2064656.79957.15
420805-2080557.23657.59
520233-2023355.66256.01
620535-2053556.49356.84
90min123064-2306463.45162.641.2663.8963.081.25
222481-2248161.84762.28
322641-2264162.28762.73
423069-2306963.46463.91
522444-2244461.74562.18
622925-2292563.06863.51
120min124744-2474468.07267.381.4668.6267.921.46
224053-2405366.17166.71
324597-2459767.66868.22
424912-2491268.53569.09
524064-2406466.20266.74
624582-2458267.62768.17
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125256-2525669.48168.751.5470.1469.401.53
224822-2482268.28768.93
325206-2520669.34370.00
425323-2532369.66570.33
524302-2430266.85667.51
625030-2503068.85969.52
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%
1 10.193319333372331563327833123332240.31
2 10.203336733024331960.74
单位质量响应值RSD%判断
3260.453254.510.13数据可信
供试品溶液-25041902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%
5min14617-461712.71712.968.6912.7212.968.68
24818-481813.27013.27
34858-485813.38013.38
45028-502813.84913.85
53924-392410.80810.81
64983-498313.72513.72
10min18691-869123.93824.255.8723.9624.285.86
29085-908525.02325.05
38944-894424.63524.66
49209-920925.36425.39
57816-781621.52821.55
69088-908825.03125.05
15min111348-1134831.25631.743.9631.3231.803.97
211488-1148831.64131.71
311603-1160331.95832.02
412208-1220833.62533.69
510812-1081229.78029.83
611686-1168632.18732.25
20min113232-1323236.44537.292.3136.5637.402.31
213629-1362937.53837.66
313670-1367037.65137.77
413971-1397138.48038.60
513119-1311936.13436.24
613605-1360537.47237.59
30min116057-1605744.22644.391.1944.4044.571.20
216443-1644345.28945.47
316011-1601144.09944.28
416222-1622244.68044.87
515897-1589743.78543.95
616074-1607444.27344.45
45min118601-1860151.23351.711.2051.4851.961.20
218848-1884851.91352.17
318564-1856451.13151.38
419174-1917452.81153.07
518671-1867151.42651.66
618779-1877951.72351.98
60min120453-2045356.33456.750.8956.6757.080.89
220795-2079557.27657.62
320413-2041356.22456.56
420786-2078657.25157.60
520451-2045156.32856.65
620716-2071657.05857.40
90min122624-2262462.31362.900.8462.7463.330.82
222834-2283462.89263.33
322763-2276362.69663.13
422668-2266862.43562.88
523094-2309463.60864.02
623029-2302963.42963.86
120min124229-2422966.73467.370.6767.2667.910.68
224512-2451267.51468.06
324374-2437467.13467.67
424724-2472468.09868.65
524448-2444867.33767.86
624478-2447867.42067.96
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124567-2456767.66568.360.8568.3169.000.85
224861-2486168.47569.13
324619-2461967.80868.46
425118-2511869.18369.84
524764-2476468.20868.84
624976-2497668.79269.45
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