富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.942522842550822521392527102536562531740.49
214.982523612510282516940.38
单位质量响应值RSD%判断
16946.0516802.000.61数据可信
中间条件24月-供试品溶液-2023031011批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1213512-21351285.05387.277.4585.0587.287.45
2234070-23407093.24293.24
3241342-24134296.13996.14
4195744-19574477.97577.98
5214488-21448885.44285.44
6215382-21538285.79885.80
10min1240509-24050995.80797.053.2895.9597.193.29
2252244-252244100.482100.64
3253732-253732101.075101.23
4232649-23264992.67692.81
5240471-24047195.79295.93
6242141-24214196.45796.60
15min1244352-24435297.33899.041.6497.6499.351.65
2254638-254638101.436101.76
3251404-251404100.147100.48
4245130-24513097.64897.93
5246214-24621498.08098.38
6250075-25007599.61899.92
20min1246239-24623998.09099.411.0398.5599.881.04
2252948-252948100.762101.25
3251714-251714100.271100.77
4248062-24806298.81699.26
5247923-24792398.76199.23
6250467-25046799.774100.24
30min1246041-24604198.01199.781.7598.64100.411.75
2256467-256467102.164102.82
3253269-253269100.890101.55
4253004-253004100.785101.40
5246070-24607098.02298.65
6247975-24797598.78199.42
45min1245756-24575697.89799.231.5598.69100.041.55
2253912-253912101.146101.98
3250950-25095099.966100.80
4252188-252188100.460101.24
5244107-24410797.24198.03
6247747-24774798.69199.49
60min1244624-24462497.44699.641.5998.40100.621.58
2255018-255018101.587102.59
3251864-251864100.331101.33
4253444-253444100.960101.91
5247512-24751298.59799.55
6248375-24837598.94199.91
极限1244276-24427697.30898.911.3998.42100.041.39
2251814-251814100.311101.48
3250054-25005499.610100.77
4251257-251257100.089101.20
5243983-24398397.19198.31
6248379-24837998.942100.07
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.942513642518182529872511602512172517090.31
214.982530622530372530500.01
单位质量响应值RSD%判断
16847.9916892.520.19数据可信
中间条件24月-供试品溶液-2023031111批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1173366-17336669.07572.8214.0569.0772.8214.05
2221889-22188988.40888.41
3143877-14387757.32657.33
4178239-17823971.01771.02
5184518-18451873.51873.52
6194656-19465677.55877.56
10min1212746-21274684.76590.827.3284.8890.947.33
2246685-24668598.28898.44
3203962-20396281.26581.36
4228067-22806790.87090.99
5241720-24172096.31096.43
6234427-23442793.40493.53
15min1229910-22991091.60495.073.9191.8695.343.93
2247284-24728498.52698.84
3224312-22431289.37489.60
4241550-24155096.24296.51
5246109-24610998.05898.34
6242469-24246996.60896.89
20min1236001-23600194.03196.792.4794.4497.222.49
2245968-24596898.00298.48
3234683-23468393.50693.89
4247863-24786398.75799.19
5247965-24796598.79899.24
6245043-24504397.63498.08
30min1241755-24175596.32498.721.4796.8999.321.46
2246311-24631198.13998.78
3252147-252147100.464101.00
4250688-25068899.883100.48
5248101-24810198.85299.46
6247682-24768298.68599.29
45min1242843-24284396.75798.721.7897.4899.481.75
2245101-24510197.65798.46
3255359-255359101.744102.45
4249811-24981199.533100.29
5247583-24758398.64699.42
6245955-24595597.99798.77
60min1240597-24059795.86298.061.6996.7598.981.66
2242405-24240596.58297.55
3251417-251417100.173101.05
4249790-24979099.525100.45
5245978-24597898.00698.95
6246532-24653298.22799.16
极限1241350-24135096.16298.491.7797.2199.581.74
2245316-24531697.74298.87
3254167-254167101.269102.31
4249711-24971199.493100.59
5246864-24686498.35999.46
6245768-24576897.92299.02
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.942531862532912534232533162530022532440.07
214.982505942523122514530.49
单位质量响应值RSD%判断
16950.7416785.910.70数据可信
中间条件24月-供试品溶液-2023031011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%
5min1213120-21312084.92680.238.4084.9380.238.40
2187345-18734574.65574.65
3202957-20295780.87680.88
4176783-17678370.44670.45
5223195-22319588.94188.94
6204558-20455881.51481.51
10min1243337-24333796.96794.383.7097.1194.523.71
2231170-23117092.11992.24
3234957-23495793.62893.76
4223024-22302488.87388.99
5245603-24560397.87098.02
6243032-24303296.84696.98
15min1247337-24733798.56197.321.7098.8697.611.71
2243520-24352097.04097.32
3243621-24362197.08097.37
4236875-23687594.39294.66
5248740-24874099.12099.43
6245203-24520397.71198.01
20min1248076-24807698.85697.721.5999.3298.181.60
2245873-24587397.97898.42
3244667-24466797.49797.95
4238149-23814994.90095.32
5249298-24929899.34299.82
6245351-24535197.77098.23
30min1247884-24788498.77998.520.7999.4199.140.80
2248247-24824798.92499.53
3245132-24513297.68298.30
4245848-24584897.96898.55
5250310-25031099.746100.39
6245974-24597498.01898.64
45min1251387-251387100.17599.380.97100.97100.160.96
2248991-24899199.22099.99
3246380-24638098.18098.96
4252294-252294100.536101.28
5250417-25041799.788100.60
6246902-24690298.38899.17
60min1251786-251786100.33499.560.94101.30100.500.92
2251001-251001100.021100.95
3246566-24656698.25499.20
4251579-251579100.251101.16
5250892-25089299.978100.95
6247179-24717998.49899.45
极限1251312-251312100.14599.381.02101.28100.501.00
2250117-25011799.669100.77
3247361-24736198.57199.68
4252996-252996100.816101.90
5248267-24826798.932100.07
6246328-24632898.15999.27
富马酸伏诺拉生片项目信息
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17570对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.78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0.7485
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.942528762513222517492530352516722521310.31
214.982524252515382519820.25
单位质量响应值RSD%判断
16876.2416821.230.24数据可信
中间条件24月-供试品溶液-2023031111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%
5min1190541-19054176.01578.685.1876.0278.685.18
2211447-21144784.35584.36
3201152-20115280.24880.25
4192743-19274376.89476.89
5204045-20404581.40281.40
6183381-18338173.15973.16
10min1228983-22898391.35192.902.6891.4893.032.69
2239357-23935795.49095.63
3232961-23296192.93893.07
4231956-23195692.53792.67
5240149-24014995.80695.94
6223739-22373989.25989.38
15min1239892-23989295.70396.492.1695.9896.782.17
2245891-24589198.09798.40
3241548-24154896.36496.65
4240559-24055995.97096.25
5249227-24922799.42899.72
6234103-23410393.39493.66
20min1242458-24245896.72797.491.9697.1797.941.97
2250702-250702100.016100.48
3242907-24290796.90697.36
4240814-24081496.07196.51
5249967-24996799.723100.18
6239391-23939195.50495.93
30min1241231-24123196.23897.641.6796.8498.251.67
2251826-251826100.464101.09
3242670-24267096.81297.42
4242550-24255096.76497.37
5247463-24746398.72499.35
6242738-24273896.83997.42
45min1243926-24392697.31398.591.5098.0799.361.51
2253132-253132100.985101.78
3243705-24370597.22598.00
4245667-24566798.00798.77
5249965-24996599.722100.51
6246402-24640298.30199.05
60min1242842-24284296.88098.871.7297.8099.801.72
2253570-253570101.160102.13
3244603-24460397.58398.52
4245006-24500697.74498.67
5251049-251049100.154101.11
6249893-24989399.693100.60
极限1245307-24530797.86498.991.5498.95100.091.53
2254041-254041101.348102.48
3243231-24323197.03598.13
4247168-24716898.60699.70
5250042-25004299.753100.88
6248949-24894999.317100.39
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