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)10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 9.232995223005743003362997372983262996990.30
2 9.282983972992262988120.20
单位质量响应值RSD%判断
32470.1032199.570.60数据可信
供试品溶液-2批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255785-25578570.91163.548.9270.9163.548.92
2200283-20028355.52455.52
3209870-20987058.18258.18
4233260-23326064.66664.67
5237846-23784665.93865.94
6238038-23803865.99165.99
10min1323572-32357289.70486.053.1789.8286.163.18
2296598-29659882.22682.32
3302106-30210683.75383.85
4313475-31347586.90487.01
5309791-30979185.88385.99
6316822-31682287.83287.94
15min1342475-34247594.94492.551.5895.2192.801.59
2327791-32779190.87391.10
3332554-33255492.19492.43
4336414-33641493.26493.52
5329566-32956691.36591.62
6334283-33428392.67392.93
20min1351100-35110097.33594.931.4397.7695.341.43
2339634-33963494.15694.54
3340370-34037094.36094.75
4344773-34477395.58195.99
5337447-33744793.55093.96
6341233-34123394.60095.01
30min1356416-35641698.80996.981.2099.4097.551.20
2347307-34730796.28496.82
3349931-34993197.01197.56
4351664-35166497.49198.06
5344026-34402695.37495.94
6349647-34964796.93297.50
45min1361320-361320100.16898.311.16100.9299.041.17
2350278-35027897.10797.81
3355685-35568598.60699.32
4356407-35640798.80699.54
5350877-35087797.27397.99
6353173-35317397.91098.64
60min1363203-363203100.69098.761.18101.6199.641.18
2351832-35183297.53898.40
3357240-35724099.03799.91
4357513-35751399.113100.01
5352270-35227097.65998.54
6355297-35529798.49999.39
极限1363219-363219100.69598.921.19101.7899.971.20
2351365-35136597.40998.43
3359336-35933699.618100.66
4357888-35788899.217100.28
5354075-35407598.16099.20
6354920-35492098.39499.45
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)10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 9.232988042989192996472995962988162991560.15
2 9.283005332999703002520.14
单位质量响应值RSD%判断
32411.2732354.740.13数据可信
供试品溶液-2批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1192187-19218753.20053.962.4153.2053.962.41
2197763-19776354.74354.74
3197639-19763954.70954.71
4198412-19841254.92354.92
5197007-19700754.53454.53
6186506-18650651.62751.63
10min1270953-27095375.00373.641.0675.0973.731.06
2263226-26322672.86472.96
3265593-26559373.51973.61
4267437-26743774.03074.12
5265069-26506973.37473.47
6263944-26394473.06373.15
15min1299197-29919782.82180.711.5183.0480.921.51
2287359-28735979.54479.76
3287873-28787379.68779.90
4292447-29244780.95381.17
5289519-28951980.14280.36
6292963-29296381.09681.30
20min1311898-31189886.33784.411.4786.6984.761.46
2299779-29977982.98283.33
3302075-30207583.61883.96
4305402-30540284.53984.89
5302448-30244883.72184.07
6308050-30805085.27285.61
30min1324713-32471389.88488.041.3990.3888.531.39
2313158-31315886.68687.17
3314407-31440787.03287.52
4319495-31949588.44088.93
5315650-31565087.37687.86
6320902-32090288.83089.31
45min1330394-33039491.45790.001.0492.1090.641.04
2321909-32190989.10889.74
3321681-32168189.04589.68
4326435-32643590.36191.00
5323644-32364489.58990.22
6326748-32674890.44891.08
60min1331165-33116591.67090.430.9692.4791.220.96
2322302-32230289.21789.99
3324662-32466289.87090.65
4328486-32848690.92991.72
5325746-32574690.17090.95
6327800-32780090.73991.52
极限1334367-33436792.55790.581.3293.5191.511.31
2322698-32269889.32790.25
3323528-32352889.55690.49
4328274-32827490.87091.81
5325485-32548590.09891.03
6328945-32894591.05691.99
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)10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 9.234826584824114844994822424816454826910.23
2 9.284828004828024828010.01
单位质量响应值RSD%判断
52295.8852025.970.37数据可信
供试品溶液-1批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338200-33820058.12158.493.1658.1258.493.16
2349476-34947660.05960.06
3345366-34536659.35359.35
4342772-34277258.90758.91
5319826-31982654.96354.96
6346338-34633859.52059.52
10min1442990-44299076.13077.131.3676.2377.221.36
2454481-45448178.10478.20
3447786-44778676.95477.05
4456606-45660678.47078.57
5441341-44134175.84675.94
6449514-44951477.25177.35
15min1476086-47608681.81782.531.3182.0482.751.31
2485976-48597683.51783.75
3480919-48091982.64882.87
4488873-48887384.01584.24
5472401-47240181.18481.40
6476996-47699681.97482.20
20min1488754-48875483.99484.821.1784.3585.181.18
2499238-49923885.79686.17
3493576-49357684.82385.19
4501431-50143186.17386.54
5486912-48691283.67884.03
6491335-49133584.43884.80
30min1501580-50158086.19887.181.2386.7087.681.23
2512176-51217688.01988.53
3508018-50801887.30587.81
4516519-51651988.76689.28
5500528-50052886.01886.51
6504752-50475286.74487.25
45min1510611-51061187.75188.991.2888.3989.641.29
2523510-52351089.96790.63
3518654-51865489.13389.78
4527054-52705490.57691.24
5511059-51105987.82788.46
6515911-51591188.66189.31
60min1513825-51382588.30389.561.2789.0990.361.27
2525467-52546790.30491.11
3523079-52307989.89390.69
4530679-53067991.19992.01
5514254-51425488.37789.16
6519454-51945489.27090.07
极限1516462-51646288.75689.931.3089.6990.881.30
2528641-52864190.84991.81
3524597-52459790.15491.10
4532933-53293391.58792.55
5515717-51571788.62889.56
6521476-52147689.61890.56
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)10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 9.234841564854534851644839224854654848320.16
2 9.284845114831484838300.20
单位质量响应值RSD%判断
52527.8452136.850.53数据可信
供试品溶液-1批-pH1.2(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1249788-24978842.78744.198.3042.7944.198.31
2265167-26516745.42145.42
3284164-28416448.67548.68
4222101-22210138.04438.04
5254879-25487943.65943.66
6271753-27175346.54946.55
10min1368980-36898063.20362.562.9563.2762.632.95
2366908-36690862.84862.92
3380321-38032165.14665.23
4347186-34718659.47059.53
5365390-36539062.58862.66
6362538-36253862.10062.18
15min1407840-40784069.86069.071.7070.0469.251.71
2401117-40111768.70868.89
3414692-41469271.03471.22
4395718-39571867.78367.95
5400120-40012068.53768.71
6399947-39994768.50868.69
20min1428400-42840073.38272.491.5173.6772.781.52
2422252-42225272.32872.62
3433285-43328574.21874.53
4417570-41757071.52671.80
5420174-42017471.97372.26
6417466-41746671.50971.80
30min1447758-44775876.69776.191.0277.1176.611.03
2442931-44293175.87176.29
3452124-45212477.44577.88
4439456-43945675.27575.67
5444643-44464376.16476.58
6441913-44191375.69676.11
45min1465886-46588679.80379.111.5080.3579.661.51
2458048-45804878.46079.00
3473617-47361781.12781.69
4458880-45888078.60379.12
5460639-46063978.90479.44
6454108-45410877.78578.33
60min1468666-46866680.27979.801.4980.9680.471.49
2460573-46057378.89379.57
3478514-47851481.96682.66
4461860-46186079.11379.76
5464715-46471579.60280.27
6460767-46076778.92679.60
极限1479420-47942082.12181.351.4182.9382.161.41
2470612-47061280.61281.42
3484954-48495483.06983.90
4469197-46919780.37081.15
5477249-47724981.74982.55
6468146-46814680.19080.99
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