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101242-201201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(%)100.0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%
116.514007984011414011044010434009964010160.04
216.494016444019034017740.05
单位质量响应值RSD%判断
24289.2824364.710.22数据可信
供试品溶液-1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%
5min131330-313307.7278.8810.027.738.8810.01
232896-328968.1138.11
334474-344748.5038.50
438241-382419.4329.43
540149-401499.9029.90
639008-390089.6219.62
10min189276-8927622.01922.804.6022.0322.824.60
288614-8861421.85621.87
389507-8950722.07622.09
493809-9380923.13723.15
599732-9973224.59824.61
693826-9382623.14123.16
15min1130048-13004832.07532.843.4332.1232.893.44
2128090-12809031.59231.64
3131688-13168832.48032.53
4134251-13425133.11233.17
5141208-14120834.82834.89
6133505-13350532.92832.98
20min1159582-15958239.35940.141.9939.4640.251.99
2160949-16094939.69639.80
3161088-16108839.73139.84
4163205-16320540.25340.36
5168730-16873041.61641.73
6162904-16290440.17940.29
30min1199466-19946649.19649.721.2849.3649.891.29
2199749-19974949.26649.43
3200796-20079649.52449.70
4200858-20085849.54049.72
5206426-20642650.91351.10
6202227-20222749.87750.05
45min1233961-23396157.70458.561.2557.9558.821.26
2236220-23622058.26158.51
3236292-23629258.27958.53
4237113-23711358.48258.74
5242697-24269759.85960.13
6238301-23830158.77559.03
60min1259292-25929263.95264.520.9664.3064.880.97
2260589-26058964.27264.62
3260937-26093764.35864.71
4260119-26011964.15664.51
5266201-26620165.65666.03
6262507-26250764.74565.10
90min1290461-29046171.63972.531.0172.0973.001.02
2293420-29342072.36972.82
3293704-29370472.43972.90
4292072-29207272.03772.50
5298822-29882273.70274.18
6296028-29602873.01273.48
120min1310084-31008476.47977.280.8977.0577.870.90
2313708-31370877.37377.95
3312545-31254577.08677.67
4311106-31110676.73177.31
5317848-31784878.39479.00
6314788-31478877.63978.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1334613-33461382.52982.930.4783.2383.640.48
2335586-33558682.76983.47
3335728-33572882.80483.51
4335195-33519582.67383.38
5337787-33778783.31284.04
6338568-33856883.50484.22
240min1344529-34452984.97585.900.8785.8186.760.88
2347750-34775085.76986.61
3347646-34764685.74386.59
4347709-34770985.75986.61
5353770-35377087.25488.13
6348360-34836085.92086.78
极限1347159-34715985.62386.500.8486.6087.490.84
2351388-35138886.66687.65
3350144-35014486.36087.35
4349356-34935686.16587.16
5355976-35597687.79888.81
6350272-35027286.39187.39
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101242-201201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(%)100.0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%
116.514026044030114029324030334027144028590.05
216.494066504067754067120.03
单位质量响应值RSD%判断
24400.9124664.160.76数据可信
供试品溶液-1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%
5min145165-4516511.04613.249.7711.0513.249.76
255925-5592513.67813.68
352689-5268912.88712.89
455826-5582613.65413.65
561274-6127414.98614.99
653874-5387413.17713.18
10min1106394-10639426.02227.764.1526.0427.784.16
2110627-11062727.05727.08
3112867-11286727.60527.63
4114659-11465928.04328.07
5119881-11988129.32129.35
6116565-11656528.50928.53
15min1147586-14758636.09737.382.3136.1637.442.32
2152129-15212937.20837.28
3151429-15142937.03737.10
4152622-15262237.32837.40
5158030-15803038.65138.72
6155113-15511337.93838.01
20min1175180-17518042.84644.211.6942.9744.341.69
2181449-18144944.37944.51
3180360-18036044.11244.24
4181026-18102644.27544.41
5184218-18421845.05645.19
6182375-18237544.60544.74
30min1213522-21352252.22353.301.1652.4253.501.16
2220916-22091654.03254.24
3217378-21737853.16653.37
4217593-21759353.21953.42
5219418-21941853.66553.88
6218605-21860553.46653.67
45min1249723-24972361.07761.650.7261.3661.950.72
2254077-25407762.14262.44
3252671-25267161.79862.09
4252017-25201761.63861.93
5253747-25374762.06162.36
6250234-25023461.20261.50
60min1272832-27283266.72967.170.6067.1167.560.61
2277056-27705667.76268.16
3275863-27586367.47167.86
4273297-27329766.84367.24
5275097-27509767.28367.69
6273674-27367466.93567.33
90min1303411-30341174.20874.480.3874.7074.980.38
2305837-30583774.80275.31
3305662-30566274.75975.27
4303151-30315174.14574.65
5304835-30483574.55775.07
6304156-30415674.39174.90
120min1321031-32103178.51878.690.5579.1379.320.54
2323443-32344379.10879.74
3324222-32422279.29879.93
4320224-32022478.32078.95
5321479-32147978.62779.27
6319946-31994678.25278.89
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1346567-34656784.76384.280.5185.5185.040.50
2345469-34546984.49585.26
3346234-34623484.68285.45
4342335-34233583.72884.49
5343666-34366684.05484.83
6343262-34326283.95584.72
240min1358007-35800787.56186.860.7788.4587.770.75
2357260-35726087.37988.29
3357550-35755087.45088.35
4352933-35293386.32087.22
5352258-35225886.15587.07
6352926-35292686.31987.22
极限1356539-35653987.20287.080.8788.2488.130.86
2360009-36000988.05189.10
3359283-35928387.87488.92
4352676-35267686.25887.30
5353993-35399386.58087.64
6353726-35372686.51487.56
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101242-201201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(%)100.0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%
116.512012882015702013212010532007222011910.16
216.492041502040832041160.03
单位质量响应值RSD%判断
12186.0112378.171.11数据可信
供试品溶液-2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%
5min110481-104815.1207.2214.765.127.2214.76
215216-152167.4347.43
314758-147587.2107.21
416105-161057.8687.87
516278-162787.9537.95
615828-158287.7337.73
10min146761-4676122.84521.483.7922.8521.493.77
242930-4293020.97320.99
344720-4472021.84821.86
443913-4391321.45421.47
541936-4193620.48820.50
643483-4348321.24321.26
15min167939-6793933.19132.282.1533.2432.332.14
266262-6626232.37232.42
365872-6587232.18232.23
467142-6714232.80232.85
563904-6390431.22031.27
665298-6529831.90131.95
20min184857-8485741.45740.512.0641.5640.622.06
282694-8269440.40040.50
382526-8252640.31840.42
484894-8489441.47541.58
580467-8046739.31239.41
682129-8212940.12440.23
30min1108015-10801552.77051.511.7452.9451.681.74
2105153-10515351.37251.54
3104355-10435550.98251.15
4107176-10717652.36052.53
5103100-10310050.36950.53
6104803-10480351.20151.37
45min1129786-12978663.40662.401.3563.6762.651.35
2127104-12710462.09662.35
3127666-12766662.37162.62
4129532-12953263.28263.54
5125224-12522461.17861.43
6127018-12701862.05462.31
60min1144912-14491270.79669.991.0271.1670.351.03
2142178-14217869.46169.82
3143458-14345870.08670.44
4145055-14505570.86671.23
5141582-14158269.16969.52
6142438-14243869.58869.94
90min1162692-16269279.48379.051.0179.9779.531.02
2160967-16096778.64079.11
3161985-16198579.13779.61
4164474-16447480.35380.84
5159848-15984878.09378.56
6160923-16092378.61879.09
120min1172614-17261484.33084.030.9284.9584.640.92
2171755-17175583.91084.51
3172072-17207284.06584.67
4174666-17466685.33285.95
5170247-17024783.17483.77
6170660-17066083.37583.98
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
180min1183417-18341789.60889.180.8790.3689.920.87
2182879-18287989.34590.09
3182723-18272389.26990.02
4184637-18463790.20490.96
5180119-18011987.99688.73
6181421-18142188.63389.38
240min1188246-18824691.96791.250.7592.8792.140.75
2187782-18778291.74092.63
3185212-18521290.48591.38
4188030-18803091.86192.77
5185968-18596890.85491.74
6185389-18538990.57191.46
极限1189694-18969492.67491.950.8693.7392.990.86
2188655-18865592.16793.21
3188850-18885092.26293.31
4189321-18932192.49293.56
5185370-18537090.56291.59
6187336-18733691.52292.56
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