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 15.069662179673819647419667889674709665190.12
2 15.119658719649979654340.07
单位质量响应值RSD%判断
64177.8963893.710.32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%
5min1193547-19354718.06218.073.0618.0618.073.05
2188024-18802417.54717.55
3196902-19690218.37618.38
4197474-19747418.42918.43
5200398-20039818.70218.70
6185144-18514417.27817.28
10min1261095-26109524.36624.251.6424.4024.281.64
2258346-25834624.11024.14
3261328-26132824.38824.42
4261300-26130024.38524.42
5264902-26490224.72224.75
6252321-25232123.54723.58
15min1289260-28926026.99526.771.4827.0726.841.48
2285139-28513926.61026.68
3290250-29025027.08727.16
4287471-28747126.82826.90
5289804-28980427.04527.12
6279120-27912026.04826.12
20min1305182-30518228.48127.971.2928.6028.091.30
2298700-29870027.87627.99
3299003-29900327.90428.02
4300420-30042028.03628.15
5301694-30169428.15528.27
6293481-29348127.38927.50
30min1312539-31253929.16729.020.8029.3329.180.80
2311213-31121329.04329.20
3309792-30979228.91129.07
4312060-31206029.12229.29
5313398-31339829.24729.41
6306553-30655328.60928.77
45min1321643-32164330.01729.850.8530.2330.060.85
2319478-31947829.81530.02
3318194-31819429.69529.91
4322580-32258030.10430.32
5321599-32159930.01330.23
6315359-31535929.43029.64
60min1322946-32294630.13830.130.6830.4030.390.68
2322684-32268430.11430.37
3321741-32174130.02630.29
4325100-32510030.33930.60
5325095-32509530.33930.60
6319373-31937329.80530.06
极限1324572-32457230.29030.440.7330.6030.760.74
2326149-32614930.43730.75
3328315-32831530.63930.95
4328733-32873330.67830.99
5327169-32716930.53230.85
6322472-32247230.09430.40
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 15.069665019681639685879678599658849673990.12
2 15.119652809655379654080.02
单位质量响应值RSD%判断
64236.3263891.990.39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%
5min1208977-20897719.49419.301.8419.4919.301.83
2206579-20657919.27019.27
3211949-21194919.77119.77
4206197-20619719.23519.23
5200440-20044018.69718.70
6207037-20703719.31319.31
10min1263928-26392824.62024.550.9824.6524.580.98
2264964-26496424.71624.75
3266471-26647124.85724.89
4261647-26164724.40724.44
5259200-25920024.17924.21
6263089-26308924.54224.57
15min1287102-28710226.78126.620.8526.8626.690.85
2287787-28778726.84526.92
3287251-28725126.79526.87
4283657-28365726.46026.53
5281778-28177826.28526.36
6284609-28460926.54926.62
20min1297107-29710727.71527.650.6427.8327.770.64
2298926-29892627.88428.00
3297889-29788927.78827.91
4294539-29453927.47527.59
5294223-29422327.44627.56
6295934-29593427.60527.72
30min1310126-31012628.92928.710.7829.0928.880.78
2310154-31015428.93229.10
3309432-30943228.86429.03
4305374-30537428.48628.65
5305049-30504928.45628.62
6306553-30655328.59628.76
45min1316724-31672429.54529.440.4629.7629.660.47
2316747-31674729.54729.76
3317357-31735729.60429.82
4314534-31453429.34029.55
5314072-31407229.29729.51
6314432-31443229.33129.54
60min1320691-32069129.91529.770.7730.1830.040.76
2322041-32204130.04130.30
3321266-32126629.96830.23
4316249-31624929.50029.76
5317329-31732929.60129.86
6317492-31749229.61629.88
极限1325196-32519630.33529.831.2430.6530.141.23
2322157-32215730.05230.36
3320060-32006029.85630.17
4318034-31803429.66729.98
5319586-31958629.81230.12
6313421-31342129.23729.55
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 15.069696369696449697989708019705829700920.06
2 15.119591299678679634980.65
单位质量响应值RSD%判断
64415.1463765.590.72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%
5min1215362-21536220.08220.022.3020.0820.022.29
2221725-22172520.67520.67
3214506-21450620.00220.00
4217814-21781420.31020.31
5210812-21081219.65719.66
6207847-20784719.38119.38
10min1269587-26958725.13825.160.5225.1725.200.52
2271879-27187925.35225.39
3271120-27112025.28125.31
4268126-26812625.00225.04
5269057-26905725.08825.12
6269349-26934925.11625.15
15min1293258-29325827.34527.270.7927.4227.340.79
2293905-29390527.40527.48
3295260-29526027.53227.61
4290269-29026927.06627.14
5289146-28914626.96227.04
6292612-29261227.28527.36
20min1303122-30312228.26528.230.4628.3928.350.47
2303895-30389528.33728.46
3302941-30294128.24828.37
4302508-30250828.20828.33
5300121-30012127.98528.10
6303715-30371528.32028.44
30min1315020-31502029.37429.290.4229.5429.460.41
2314205-31420529.29829.47
3315220-31522029.39329.56
4313884-31388429.26829.44
5311675-31167529.06229.23
6314718-31471829.34629.51
45min1322582-32258230.07930.040.4330.3030.250.43
2323516-32351630.16630.38
3323466-32346630.16230.38
4321461-32146129.97530.19
5321721-32172129.99930.21
6319950-31995029.83430.05
60min1327583-32758330.54630.390.4430.8130.660.44
2326221-32622130.41930.69
3324664-32466430.27430.54
4325697-32569730.37030.64
5323916-32391630.20430.47
6327224-32722430.51230.78
极限1325987-32598730.39730.470.2430.7130.790.25
2327253-32725330.51530.83
3328040-32804030.58830.91
4326069-32606930.40530.72
5326691-32669130.46330.78
6326665-32666530.46030.78
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 15.069677259689899638889700429680349677360.25
2 15.119668919610049639480.44
单位质量响应值RSD%判断
64258.7063795.370.52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%
5min1225128-22512821.01320.682.5821.0120.682.58
2226239-22623921.11621.12
3223542-22354220.86520.86
4223631-22363120.87320.87
5219832-21983220.51820.52
6210751-21075119.67119.67
10min1275442-27544225.70925.401.5325.7425.431.53
2276139-27613925.77425.81
3273185-27318525.49825.53
4272660-27266025.44925.48
5270488-27048825.24625.28
6264747-26474724.71124.74
15min1294982-29498227.53327.271.3227.6127.351.32
2296704-29670427.69327.77
3292425-29242527.29427.37
4293616-29361627.40527.48
5289018-28901826.97627.05
6286412-28641226.73326.81
20min1304744-30474428.44428.221.0528.5728.351.05
2305593-30559328.52328.65
3303325-30332528.31128.43
4302744-30274428.25728.38
5301184-30118428.11228.23
6296761-29676127.69927.82
30min1316670-31667029.55729.290.8629.7329.460.86
2316697-31669729.55929.73
3313104-31310429.22429.39
4314572-31457229.36129.53
5311590-31159029.08329.25
6310178-31017828.95129.12
45min1323079-32307930.15529.931.0530.3830.151.05
2323625-32362530.20630.43
3322097-32209730.06430.28
4321516-32151630.00930.23
5319338-31933829.80630.02
6314586-31458629.36229.58
60min1326936-32693630.51530.231.1230.7930.501.13
2326544-32654430.47930.75
3325451-32545130.37730.65
4324940-32494030.32930.60
5322004-32200430.05530.32
6317443-31744329.62929.89
极限1327501-32750130.56830.380.9030.8930.700.90
2328746-32874630.68431.01
3325665-32566530.39730.72
4326502-32650230.47530.79
5323687-32368730.21230.53
6320658-32065829.92930.24
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