盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.021899721899881900381899181898421899520.04
211.011899071899031899050.01
单位质量响应值RSD%判断
17237.0217248.410.05数据可信
供试品溶液-2025011721批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1159896-15989683.24283.390.5583.2483.390.55
2159738-15973883.16083.16
3161219-16121983.93183.93
4161336-16133683.99283.99
5159298-15929882.93182.93
6159646-15964683.11283.11
10min1158035-15803582.27381.540.6782.4181.680.67
2157760-15776082.13082.27
3155415-15541580.90981.05
4155852-15585281.13781.28
5156374-15637481.40981.55
6156360-15636081.40181.54
15min1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
20min1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
30min1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
45min1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
60min1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
极限1-0.0000.00-0.280.282.00
2-0.0000.28
3-0.0000.27
4-0.0000.28
5-0.0000.27
6-0.0000.27
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.021894331894271897731895891893891895220.09
211.011897731896021896880.07
单位质量响应值RSD%判断
17198.0017228.700.13数据可信
供试品溶液-2025011721批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1177645-17764592.64091.840.9292.6491.840.92
2177542-17754292.58792.59
3175928-17592891.74591.74
4177186-17718692.40192.40
5173977-17397790.72790.73
6174407-17440790.95290.95
10min1116958-11695860.99360.651.7961.1560.801.78
2114097-11409759.50159.65
3116454-11645460.73060.88
4115635-11563560.30360.46
5114744-11474459.83859.99
6119948-11994862.55262.70
15min1143864-14386475.02474.841.3775.2875.091.37
2140733-14073373.39173.64
3144283-14428375.24275.50
4143407-14340774.78575.04
5142241-14224174.17774.43
6146536-14653676.41776.67
20min1156803-15680381.77182.051.2182.1582.431.21
2154067-15406780.34580.72
3159020-15902082.92783.31
4157979-15797982.38582.76
5156907-15690781.82682.20
6159222-15922283.03383.42
30min1166958-16695887.06786.670.8087.5887.190.80
2163682-16368285.35985.87
3167181-16718187.18387.70
4166824-16682486.99787.51
5165806-16580686.46686.98
6166768-16676886.96887.49
45min1176805-17680592.20292.120.6992.8692.780.69
2174449-17444990.97491.63
3177919-17791992.78393.45
4177364-17736492.49493.16
5176237-17623791.90692.56
6177119-17711992.36693.03
60min1183586-18358695.73896.000.6796.5596.810.67
2182480-18248095.16295.97
3185605-18560596.79197.61
4185497-18549796.73597.55
5183737-18373795.81796.63
6183615-18361595.75496.57
极限1187137-18713797.59097.740.7498.5798.710.73
2185740-18574096.86297.82
3188925-18892598.52399.50
4189133-18913398.63199.61
5187293-18729397.67298.64
6186297-18629797.15298.13
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.021892001895651894141891811892821893280.09
211.011913511910251911880.13
单位质量响应值RSD%判断
17180.4017364.940.76数据可信
供试品溶液批-pH4.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min159075-5907530.70229.147.5230.7029.147.53
262199-6219932.32632.33
355536-5553628.86328.86
452852-5285227.46827.47
550451-5045126.22026.22
656249-5624929.23329.23
10min174887-7488738.92046.7017.2938.9746.7517.27
279637-7963741.38841.44
373372-7337238.13238.18
4105773-10577354.97255.02
599538-9953851.73151.78
6105956-10595655.06755.12
15min188083-8808345.77855.1719.2745.8955.2919.24
289715-8971546.62646.75
384877-8487744.11244.22
4126004-12600465.48665.62
5122902-12290263.87464.00
6125301-12530165.12165.26
20min196726-9672650.27059.0717.0150.4659.2917.00
298128-9812850.99951.20
393407-9340748.54548.73
4132846-13284669.04269.29
5130239-13023967.68767.92
6130607-13060767.87868.13
30min1108310-10831056.29064.2113.5556.5764.5313.55
2110121-11012157.23157.52
3106519-10651955.35955.63
4139601-13960172.55372.91
5137922-13792271.68072.03
6138823-13882372.14872.51
45min1117312-11731260.96968.1010.9061.3468.5310.92
2119962-11996262.34662.73
3116899-11689960.75461.11
4144901-14490175.30775.79
5142719-14271974.17374.64
6144447-14444775.07175.55
60min1125380-12538065.16270.618.6765.6371.158.71
2125833-12583365.39765.88
3124228-12422864.56365.02
4147420-14742076.61677.22
5145646-14564675.69476.29
6146708-14670876.24676.85
极限1129035-12903567.06172.307.3767.6472.967.42
2131544-13154468.36568.96
3128913-12891366.99867.57
4148738-14873877.30178.04
5147199-14719976.50177.22
6149314-14931477.60178.34
盐酸鲁拉西酮口崩片项目信息
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N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.021921521920891921331922771919631921230.06
211.011926111924101925100.08
单位质量响应值RSD%判断
17434.0317485.010.21数据可信
供试品溶液批-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13881-38811.9952.0411.052.002.0411.10
23676-36761.8901.89
33363-33631.7291.73
44490-44902.3082.31
54445-44452.2852.29
63933-39332.0222.02
10min18239-82394.2365.4526.544.245.4526.56
27909-79094.0664.07
37953-79534.0894.09
413347-133476.8626.87
513230-132306.8026.81
612887-128876.6266.63
15min19580-95804.9256.3427.504.946.3527.47
29300-93004.7814.79
38882-88824.5674.58
414912-149127.6677.68
516014-160148.2338.25
615254-152547.8437.86
20min19834-98345.0566.5724.895.076.5924.91
210023-100235.1535.17
39964-99645.1235.14
414540-145407.4767.50
516652-166528.5618.59
615654-156548.0488.08
30min19714-97144.9946.2621.315.026.3021.36
210185-101855.2375.26
39759-97595.0175.04
413426-134266.9036.94
515395-153957.9157.96
614603-146037.5087.55
45min19387-93874.8265.7118.814.865.7618.87
29231-92314.7464.78
39267-92674.7654.80
411870-118706.1036.15
513888-138887.1407.20
613020-130206.6946.75
60min18342-83424.2895.2218.994.335.2819.05
28587-85874.4154.46
38572-85724.4074.45
410815-108155.5605.62
512814-128146.5886.66
611847-118476.0916.16
极限18056-80564.1425.0018.924.195.0618.99
28167-81674.1994.25
38097-80974.1634.21
410545-105455.4225.49
512133-121336.2386.32
611329-113295.8255.90
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