利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.024815164820844823034803664809124814360.17
215.044849594846304847940.05
单位质量响应值RSD%判断
32053.0032233.640.40数据可信
供试品溶液-2024122821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%
5min1114401-11440121.26920.595.8521.2720.595.85
2112851-11285120.98120.98
3119089-11908922.14122.14
4111644-11164420.75720.76
5101215-10121518.81818.82
6105226-10522619.56319.56
10min1171107-17110731.81231.962.0731.8532.002.07
2171082-17108231.80731.84
3178077-17807733.10833.14
4173764-17376432.30632.34
5168306-16830631.29131.32
6169191-16919131.45631.49
15min1200796-20079637.33237.921.5737.4238.001.57
2202502-20250237.64937.74
3208917-20891738.84238.93
4206612-20661238.41338.50
5201269-20126937.42037.50
6203589-20358937.85137.94
20min1222655-22265541.39642.151.6541.5542.301.65
2224641-22464141.76541.92
3229710-22971042.70742.86
4232647-23264743.25343.41
5224721-22472141.78041.93
6225928-22592842.00442.15
30min1249695-24969546.42347.130.9846.6447.350.99
2252698-25269846.98147.20
3256929-25692947.76848.00
4254425-25442547.30247.53
5252388-25238846.92447.14
6254838-25483847.37947.60
45min1274570-27457051.04851.640.6451.3451.940.65
2277899-27789951.66751.97
3279596-27959651.98252.29
4278850-27885051.84352.15
5277170-27717051.53151.82
6278384-27838451.75752.05
60min1288446-28844653.62854.120.5654.0154.500.56
2291126-29112654.12654.51
3292785-29278554.43454.83
4291116-29111654.12454.51
5290333-29033353.97854.36
6292681-29268154.41554.80
极限1298659-29865955.52656.060.5956.0056.540.59
2302305-30230556.20456.68
3303381-30338156.40456.89
4302011-30201156.15056.63
5300192-30019255.81156.28
6302578-30257856.25556.73
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.024862524863594844834849104862004856410.19
215.044808424793504800960.22
单位质量响应值RSD%判断
32332.9631921.280.91数据可信
供试品溶液-2024122821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%
5min1177895-17789533.09231.466.6233.0931.466.63
2178723-17872333.24633.25
3171917-17191731.98031.98
4154468-15446828.73428.73
5155579-15557928.94128.94
6176278-17627832.79132.79
10min1237160-23716044.11643.023.6744.1743.073.68
2238160-23816044.30244.36
3234783-23478343.67443.73
4217914-21791440.53640.58
5223387-22338741.55441.60
6236212-23621243.94043.99
15min1262240-26224048.78248.412.1248.9148.532.13
2265633-26563349.41349.54
3265222-26522249.33649.46
4251199-25119946.72846.84
5256808-25680847.77147.89
6260250-26025048.41148.54
20min1275168-27516851.18651.341.0951.4051.551.09
2279207-27920751.93852.15
3279592-27959252.00952.22
4271980-27198050.59350.79
5276150-27615051.36951.57
6273869-27386950.94551.15
30min1290464-29046454.03254.220.8854.3354.510.88
2291993-29199354.31654.61
3294347-29434754.75455.05
4292037-29203754.32454.60
5293000-29300054.50354.79
6286934-28693453.37553.67
45min1301196-30119656.02856.391.0356.4156.771.02
2303972-30397256.54456.93
3305324-30532456.79657.18
4305153-30515356.76457.13
5305460-30546056.82157.19
6297725-29772555.38255.76
60min1306357-30635756.98857.420.9357.4757.900.92
2309673-30967357.60558.09
3310597-31059757.77758.26
4310405-31040557.74158.20
5311104-31110457.87158.34
6303998-30399856.54957.02
极限1311220-31122057.89358.190.8158.4758.760.80
2314009-31400958.41258.99
3313897-31389758.39158.97
4314336-31433658.47259.03
5314949-31494958.58659.15
6308375-30837557.36457.93
利伐沙班口崩片项目信息
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430060-202202对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.6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%
115.024805384797064784904790884787044793050.18
215.044791614808874800240.26
单位质量响应值RSD%判断
31911.1231916.490.02数据可信
供试品溶液-2024122821批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1121723-12172322.79323.212.0122.7923.212.01
2125817-12581723.56023.56
3122717-12271722.97922.98
4122607-12260722.95922.96
5128117-12811723.99023.99
6122636-12263622.96422.96
10min1180481-18048133.79633.921.4533.8333.951.45
2181897-18189734.06134.10
3179384-17938433.59033.63
4185656-18565634.76534.80
5181312-18131233.95133.99
6178028-17802833.33733.37
15min1209573-20957339.24339.130.5639.3439.220.56
2210255-21025539.37139.47
3208520-20852039.04639.14
4208897-20889739.11739.21
5209502-20950239.23039.33
6206913-20691338.74538.84
20min1229437-22943742.96342.660.7243.1242.820.72
2229592-22959242.99243.15
3227772-22777242.65142.81
4227850-22785042.66642.83
5226907-22690742.48942.65
6225217-22521742.17342.33
30min1251661-25166147.12546.860.7447.3647.100.74
2251803-25180347.15147.38
3250254-25025446.86147.09
4251845-25184547.15947.39
5248454-24845446.52446.76
6247611-24761146.36646.59
45min1269551-26955150.47550.190.8150.7850.500.81
2269508-26950850.46750.78
3268519-26851950.28150.59
4269873-26987350.53550.85
5266105-26610549.82950.14
6264630-26463049.55349.86
60min1278773-27877352.20151.810.7052.6052.200.70
2277688-27768851.99852.39
3276103-27610351.70252.09
4278246-27824652.10352.50
5273643-27364351.24151.63
6275593-27559351.60651.99
极限1285484-28548453.45853.080.6853.9453.560.68
2284230-28423053.22353.71
3282456-28245652.89153.37
4285596-28559653.47953.96
5281735-28173552.75653.23
6281213-28121352.65853.13
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