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%
1 15.069555069561649559389537059556719553970.11
2 15.119600819634659617730.25
单位质量响应值RSD%判断
63439.3863651.420.24数据可信
供试品溶液-2024122521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%
5min1204403-20440319.22318.533.6219.2218.533.62
2204882-20488219.26819.27
3191529-19152918.01218.01
4198692-19869218.68618.69
5186930-18693017.58017.58
6195654-19565418.40018.40
10min1262330-26233024.67024.471.2824.7024.501.28
2264253-26425324.85124.88
3258663-25866324.32624.36
4261611-26161124.60324.63
5254740-25474023.95723.99
6259602-25960224.41424.44
15min1285943-28594326.89126.750.8226.9626.820.82
2287280-28728027.01727.09
3284348-28434826.74126.81
4285626-28562626.86126.93
5281067-28106726.43226.50
6282522-28252226.56926.64
20min1299107-29910728.12927.970.6428.2528.080.64
2299979-29997928.21128.33
3297358-29735827.96528.08
4296927-29692727.92428.04
5295247-29524727.76627.88
6295630-29563027.80227.92
30min1308509-30850929.01329.010.5429.1829.180.54
2311274-31127429.27329.44
3308026-30802628.96829.13
4308529-30852929.01529.18
5308559-30855929.01829.18
6306096-30609628.78628.95
45min1317200-31720029.83129.810.3730.0430.020.38
2318800-31880029.98130.20
3317577-31757729.86630.08
4316805-31680529.79330.01
5316049-31604929.72229.93
6315523-31552329.67329.88
60min1322467-32246730.32630.180.5430.5930.440.55
2322756-32275630.35330.62
3318992-31899229.99930.26
4321590-32159030.24330.50
5320803-32080330.16930.43
6318734-31873429.97530.23
极限1320386-32038630.13030.310.4230.4430.620.42
2323977-32397730.46830.78
3323648-32364830.43730.75
4321439-32143930.22930.54
5322418-32241830.32130.63
6322095-32209530.29130.60
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%
1 15.069524659515899535059521719533359526130.09
2 15.119525839529799527810.03
单位质量响应值RSD%判断
63254.5263056.320.23数据可信
供试品溶液-t3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%
5min1210539-21053919.92219.401.6919.9219.401.69
2201906-20190619.10519.11
3203120-20312019.22019.22
4205305-20530519.42719.43
5201755-20175519.09119.09
6207334-20733419.61919.62
10min1263860-26386024.96724.750.5325.0024.790.54
2261279-26127924.72324.76
3260208-26020824.62224.65
4262676-26267624.85524.89
5260612-26061224.66024.69
6261044-26104424.70124.73
15min1284206-28420626.89326.860.4226.9726.940.41
2282746-28274626.75526.83
3282983-28298326.77726.85
4285397-28539727.00527.08
5282831-28283126.76326.84
6285007-28500726.96827.04
20min1295278-29527827.94027.900.4528.0628.020.44
2294572-29457227.87427.99
3293839-29383927.80427.92
4296698-29669828.07528.19
5295581-29558127.96928.09
6293021-29302127.72727.85
30min1305815-30581528.93728.980.5329.1029.150.52
2306295-30629528.98329.15
3305534-30553428.91129.07
4308775-30877529.21829.38
5307265-30726529.07529.24
6304089-30408928.77428.94
45min1313977-31397729.71029.760.5129.9229.970.51
2315697-31569729.87230.08
3313157-31315729.63229.84
4316165-31616529.91730.13
5315691-31569129.87230.08
6312262-31226229.54729.76
60min1316925-31692529.98930.070.4730.2530.340.48
2319198-31919830.20430.47
3317064-31706430.00230.26
4319072-31907230.19230.46
5319065-31906530.19130.45
6315645-31564529.86830.13
极限1317829-31782930.07430.240.6630.3930.550.65
2322242-32224230.49230.80
3317479-31747930.04130.35
4321055-32105530.37930.69
5321158-32115830.38930.70
6317868-31786830.07830.39
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%
1 15.069534459563099570469554979554169555430.15
2 15.119578159597359587750.15
单位质量响应值RSD%判断
63449.0763453.010.01数据可信
供试品溶液-2024122621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%
5min1206985-20698519.49419.903.0819.4919.903.08
2209521-20952119.73319.73
3206209-20620919.42119.42
4211486-21148619.91819.92
5223936-22393621.09121.09
6209535-20953519.73519.73
10min1263580-26358024.82524.870.7724.8624.900.78
2261087-26108724.59024.62
3263911-26391124.85624.89
4266000-26600025.05325.09
5266675-26667525.11625.15
6263174-26317424.78624.82
15min1287346-28734627.06327.060.4227.1427.140.43
2286460-28646026.98027.05
3285917-28591726.92827.00
4286991-28699127.03027.10
5289282-28928227.24527.32
6288001-28800127.12527.20
20min1302350-30235028.47628.180.7228.6028.300.73
2298633-29863328.12628.24
3297965-29796528.06328.18
4300961-30096128.34528.47
5299187-29918728.17828.30
6296391-29639127.91528.03
30min1308960-30896029.09929.160.3329.2729.320.33
2309545-30954529.15429.32
3308528-30852829.05829.22
4310699-31069929.26329.43
5310920-31092029.28329.45
6308871-30887129.09029.26
45min1318750-31875030.02129.940.4930.2430.150.49
2318050-31805029.95530.17
3317715-31771529.92330.14
4319218-31921830.06530.28
5318566-31856630.00330.22
6314880-31488029.65629.87
60min1322398-32239830.36430.220.4430.6330.490.43
2321261-32126130.25730.52
3321230-32123030.25430.52
4321680-32168030.29730.56
5320484-32048430.18430.45
6318334-31833429.98230.25
极限1323186-32318630.43930.320.6930.7530.640.69
2323166-32316630.43730.75
3322825-32282530.40530.72
4323275-32327530.44730.76
5321746-32174630.30330.62
6317584-31758429.91130.22
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%
1 15.069499889527369497069546279535959521300.24
2 15.119563309558909561100.04
单位质量响应值RSD%判断
63222.4463276.640.07数据可信
供试品溶液-t3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%
5min1214145-21414520.23320.541.6720.2320.541.68
2221049-22104920.88520.89
3217446-21744620.54520.54
4222432-22243221.01621.02
5213901-21390120.21020.21
6215369-21536920.34920.35
10min1267806-26780625.30325.180.6825.3425.210.68
2269149-26914925.43025.46
3266872-26687225.21525.25
4264677-26467725.00725.04
5264662-26466225.00625.04
6265734-26573425.10725.14
15min1290379-29037927.43627.180.8627.5127.250.85
2290810-29081027.47727.55
3287524-28752427.16627.24
4284992-28499226.92727.00
5285519-28551926.97727.05
6286622-28662227.08127.16
20min1299907-29990728.33628.120.8528.4628.240.85
2301285-30128528.46628.59
3297802-29780228.13728.26
4295653-29565327.93428.06
5295942-29594227.96128.08
6295096-29509627.88228.00
30min1310187-31018729.30729.280.7729.4829.450.77
2313892-31389229.65729.83
3309765-30976529.26829.44
4307779-30777929.08029.25
5307183-30718329.02429.19
6310414-31041429.32929.50
45min1318488-31848830.09229.970.8330.3130.190.83
2321642-32164230.39030.61
3317744-31774430.02130.24
4315653-31565329.82430.04
5315459-31545929.80530.02
6314499-31449929.71529.93
60min1321877-32187730.41230.270.7030.6830.540.71
2324155-32415530.62730.90
3320029-32002930.23730.50
4319031-31903130.14330.41
5318363-31836330.08030.34
6318829-31882930.12430.39
极限1321704-32170430.39630.430.8430.7130.750.84
2327028-32702830.89931.22
3322122-32212230.43530.75
4322141-32214130.43730.75
5320388-32038830.27130.59
6319110-31911030.15030.47
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