利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123197803199933206773196643199323200090.13
210.123196323196113196220.01
单位质量响应值RSD%判断
31621.4431583.200.09数据可信
加速6月-供试品溶液-2023072811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%
5min1117697-11769733.38531.717.0233.3831.707.01
2111300-11130031.57031.57
3115378-11537832.72732.73
4117759-11775933.40233.40
5111681-11168131.67831.68
696843-9684327.47027.47
10min1156829-15682944.48544.131.4044.5644.201.39
2152163-15216343.16143.23
3156538-15653844.40244.47
4157855-15785544.77644.85
5153742-15374243.60943.68
6156399-15639944.36344.42
15min1177796-17779650.43250.190.7750.6050.350.78
2175670-17567049.82949.99
3177055-17705550.22250.39
4179047-17904750.78750.96
5176539-17653950.07550.24
6175470-17547049.77249.93
20min1191696-19169654.37553.980.5354.6654.260.53
2189249-18924953.68153.96
3189569-18956953.77154.05
4191296-19129654.26154.55
5189691-18969153.80654.08
6190249-19024953.96454.23
30min1206062-20606258.45058.320.5758.8658.720.58
2205997-20599758.43158.83
3204935-20493558.13058.53
4207366-20736658.81959.23
5205250-20525058.21958.62
6203961-20396157.85458.24
45min1216677-21667761.46061.590.3162.0062.120.31
2218197-21819761.89262.42
3217184-21718461.60462.14
4217069-21706961.57262.11
5217382-21738261.66062.19
6216216-21621661.33061.85
60min1225251-22525163.89263.800.6864.5664.470.68
2226163-22616364.15164.81
3223132-22313263.29163.96
4226407-22640764.22064.90
5225737-22573764.03064.69
6222930-22293063.23463.89
极限1231639-23163965.70465.680.4966.5266.480.49
2233205-23320566.14966.95
3230227-23022765.30466.11
4232456-23245665.93666.75
5230799-23079965.46666.27
6230901-23090165.49566.29
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123231643234513228193223543219713227520.19
210.123213563215013214280.04
单位质量响应值RSD%判断
31892.4931761.660.30数据可信
长期6月-供试品溶液-2023072811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%
5min1111436-11143631.38630.643.7131.3930.643.71
2110632-11063231.15931.16
3113278-11327831.90531.90
4103442-10344229.13429.13
5109786-10978630.92130.92
6104202-10420229.34829.35
10min1153760-15376043.30642.621.8743.3842.691.88
2153335-15333543.18743.26
3154138-15413843.41343.48
4147440-14744041.52641.59
5150568-15056842.40742.48
6148787-14878741.90641.97
15min1174154-17415449.05048.571.2849.2248.731.29
2173828-17382848.95849.12
3174229-17422949.07149.24
4169099-16909947.62647.78
5173078-17307848.74748.91
6170296-17029647.96448.12
20min1187929-18792952.93052.471.2853.2052.741.28
2188134-18813452.98853.26
3188575-18857553.11253.39
4183249-18324951.61251.87
5186311-18631152.47452.75
6183546-18354651.69551.96
30min1204703-20470357.65457.390.8358.0557.780.84
2205694-20569457.93358.33
3203503-20350357.31657.71
4201312-20131256.69957.08
5205045-20504557.75158.14
6202387-20238757.00257.38
45min1217826-21782661.35061.390.7461.8761.910.74
2219338-21933861.77662.30
3219292-21929261.76362.29
4215490-21549060.69261.20
5219197-21919761.73662.25
6216749-21674961.04761.55
60min1225051-22505163.38563.430.4564.0464.080.45
2226499-22649963.79364.45
3225821-22582163.60264.26
4223999-22399963.08963.73
5225772-22577263.58864.24
6224145-22414563.13063.77
极限1233893-23389365.87665.910.3966.6766.700.40
2234828-23482866.13966.94
3234877-23487766.15366.95
4232417-23241765.46066.24
5234265-23426565.98066.78
6233878-23387865.87166.65
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123227603228483227753228463227953228050.02
210.123227663233193230420.13
单位质量响应值RSD%判断
31897.7331921.150.06数据可信
中间条件6月-供试品溶液-2023072811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%
5min1117775-11777533.08535.466.4633.0935.466.46
2117000-11700032.86832.87
3134893-13489337.89437.89
4136082-13608238.22838.23
5127079-12707935.69935.70
6124586-12458634.99935.00
10min1155523-15552343.69045.453.7543.7645.533.75
2156445-15644543.94944.02
3164166-16416646.11846.20
4172236-17223648.38548.47
5161495-16149545.36745.45
6160969-16096945.21945.30
15min1178806-17880650.23051.362.3250.4051.542.33
2178635-17863550.18250.35
3188851-18885153.05253.24
4186984-18698452.52852.72
5181496-18149650.98651.17
6182232-18223251.19351.37
20min1196954-19695455.32855.572.1955.6155.862.19
2193164-19316454.26454.55
3203101-20310157.05557.36
4203220-20322057.08957.40
5195092-19509254.80555.10
6195269-19526954.85555.15
30min1210131-21013159.03059.651.5059.4460.061.51
2209497-20949758.85259.25
3216499-21649960.81961.25
4216238-21623860.74661.18
5210664-21066459.18059.59
6210927-21092759.25459.67
45min1222602-22260262.53363.100.9863.0763.661.00
2223381-22338162.75263.29
3226628-22662863.66464.23
4227846-22784664.00764.58
5224742-22474263.13563.68
6222602-22260262.53363.08
60min1236210-23621066.35665.490.8667.0366.180.85
2232019-23201965.17965.85
3233795-23379565.67866.39
4234320-23432065.82566.54
5231354-23135464.99265.68
6231119-23111964.92665.61
极限1237642-23764266.75866.900.5867.5867.740.60
2237856-23785666.81967.64
3239977-23997767.41468.27
4239693-23969367.33568.19
5236657-23665766.48267.31
6237079-23707966.60067.43
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123236323233683237003233803236393235440.05
210.123235803234643235220.03
单位质量响应值RSD%判断
31970.7531968.580.01数据可信
加速6月-供试品溶液-2023072911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%
5min1112901-11290131.65631.472.1731.6631.472.17
2109515-10951530.70730.71
3114974-11497432.23832.24
4109514-10951430.70730.71
5114799-11479932.18932.19
6111713-11171331.32331.32
10min1151180-15118042.38942.692.4242.4642.762.42
2153249-15324942.97043.04
3146362-14636241.03941.11
4151049-15104942.35342.42
5157191-15719144.07544.15
6154523-15452343.32743.40
15min1174257-17425748.86048.761.9849.0248.921.97
2176984-17698449.62549.79
3167420-16742046.94347.11
4174075-17407548.80948.97
5176630-17663049.52549.69
6173952-17395248.77548.94
20min1188120-18812052.74752.591.9053.0252.861.90
2191184-19118453.60653.88
3180686-18068650.66350.93
4188101-18810152.74253.01
5188902-18890252.96653.25
6188270-18827052.78953.06
30min1206403-20640357.87458.190.6858.2658.580.67
2208711-20871158.52158.91
3207926-20792658.30158.68
4207317-20731758.13058.52
5205569-20556957.64058.04
6209287-20928758.68259.07
45min1220869-22086961.93061.750.6162.4562.270.61
2222458-22245862.37562.90
3220555-22055561.84262.35
4219347-21934761.50362.02
5219234-21923461.47162.00
6218906-21890661.37961.90
60min1228184-22818463.98163.920.4464.6464.570.44
2229156-22915664.25364.92
3228507-22850764.07164.72
4228320-22832064.01964.67
5227106-22710663.67864.34
6226428-22642863.48864.15
极限1235425-23542566.01165.990.3666.8166.780.36
2236657-23665766.35667.16
3235763-23576366.10666.89
4235316-23531665.98066.78
5234560-23456065.76866.57
6234333-23433365.70566.50
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123234673231273231933230913231903232140.05
210.123213853213033213440.02
单位质量响应值RSD%判断
31938.1431753.360.42数据可信
长期6月-供试品溶液-2023072911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%
5min1118181-11818133.26633.753.2633.2733.753.25
2116978-11697832.92732.93
3117809-11780933.16133.16
4118787-11878733.43733.44
5127589-12758935.91435.91
6120100-12010033.80633.81
10min1156507-15650744.05444.331.9944.1344.401.98
2155312-15531243.71843.79
3155005-15500543.63143.71
4157189-15718944.24644.32
5163541-16354146.03446.11
6157331-15733144.28644.36
15min1177209-17720949.88250.561.2550.0550.731.25
2179889-17988950.63650.81
3177111-17711149.85450.02
4180338-18033850.76250.93
5183103-18310351.54151.72
6180070-18007050.68750.86
20min1191301-19130153.84854.540.8554.1354.830.85
2194303-19430354.69354.98
3192578-19257854.20854.49
4193866-19386654.57054.86
5195927-19592755.15055.45
6194673-19467354.79755.08
30min1208466-20846658.68059.090.7659.0859.500.76
2210668-21066859.30059.70
3207647-20764758.44958.85
4210703-21070359.31059.72
5211896-21189659.64560.06
6210235-21023559.17859.59
45min1217261-21726161.15662.161.4161.6962.701.40
2222510-22251062.63363.17
3222286-22228662.57063.10
4223353-22335362.87063.41
5216487-21648760.93861.49
6223164-22316462.81763.36
60min1228686-22868664.37165.130.6265.0465.800.62
2232038-23203865.31565.99
3230957-23095765.01165.68
4232389-23238965.41466.09
5231893-23189365.27465.96
6232325-23232565.39666.07
极限1235240-23524066.21666.842.6267.0367.662.59
2230459-23045964.87165.69
3237313-23731366.80067.62
4249014-24901470.09470.92
5237524-23752466.85967.69
6235180-23518066.19967.02
利伐沙班颗粒项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430060-202202对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6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%
110.123257043257793257293257153258713257600.03
210.123243413246593245000.07
单位质量响应值RSD%判断
32189.7232065.220.28数据可信
中间条件6月-供试品溶液-2023072911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%
5min1121007-12100733.76331.6511.4533.7631.6511.46
2114547-11454731.96031.96
3135110-13511037.69837.70
4104968-10496829.28829.29
5101470-10147028.31228.31
6103440-10344028.86128.86
10min1154901-15490143.22042.203.6943.2942.273.70
2153053-15305342.70442.78
3159669-15966944.55044.63
4148064-14806441.31241.38
5145260-14526040.53040.59
6146585-14658540.89940.96
15min1175266-17526648.90248.431.7849.0748.601.80
2174304-17430448.63348.80
3178605-17860549.83350.02
4171528-17152847.85948.02
5171227-17122747.77547.93
6170589-17058947.59747.75
20min1188697-18869752.64952.500.7252.9352.770.74
2189384-18938452.84153.11
3189906-18990652.98753.28
4187263-18726352.24952.51
5187051-18705152.19052.45
6186682-18668252.08752.35
30min1205235-20523557.26457.460.5457.6657.850.51
2206294-20629457.55957.95
3204060-20406056.93657.35
4207043-20704357.76858.15
5206636-20663657.65458.03
6206365-20636557.57957.96
45min1218299-21829960.90961.461.5061.4361.981.46
2222085-22208561.96562.48
3214548-21454859.86260.40
4221977-22197761.93562.44
5223437-22343762.34262.85
6221284-22128461.74162.25
60min1225960-22596063.04663.601.2463.7164.251.21
2227931-22793163.59664.25
3223416-22341662.33663.01
4229372-22937263.99864.64
5230916-23091664.42965.07
6230053-23005364.18864.83
极限1233606-23360665.17965.561.4265.9866.351.39
2235362-23536265.66966.47
3228901-22890163.86764.68
4237145-23714566.16766.95
5237621-23762166.30067.08
6237167-23716766.17366.96
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢鑫慧 于 2024-02-23 14:50:46 完成)
生成报告数据部分(等待生成报告)
Current page cost:109 ms