非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654230594423018842313274233850423681642325550.07
210.774143252414315641432040.01
单位质量响应值RSD%判断
397423.00384698.612.31数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-250601批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1782805-78280518.00221.6521.0318.0021.6521.02
2751863-75186317.29117.29
31028482-102848223.65223.65
4925676-92567621.28821.29
5869528-86952819.99720.00
61290310-129031029.67429.67
10min12169272-216927249.88850.7710.5149.9350.8210.52
21831375-183137542.11742.16
32335318-233531853.70653.76
42165597-216559749.80349.85
52208089-220808950.78050.82
62536228-253622858.32758.39
15min12824957-282495764.96764.804.5765.1264.964.59
22592463-259246359.62059.75
32863258-286325865.84766.02
42845896-284589665.44865.61
52792747-279274764.22664.38
62986289-298628968.67768.87
20min13095436-309543671.18771.362.3471.4871.672.36
22976038-297603868.44168.71
33138993-313899372.18972.51
43113532-311353271.60371.91
53098617-309861771.26071.56
63195658-319565873.49273.84
30min13373467-337346777.58178.141.0978.0378.601.12
23348416-334841677.00577.42
33412754-341275478.48478.96
43401425-340142578.22478.69
53394497-339449778.06578.52
63456874-345687479.49980.01
45min13608642-360864282.98983.640.6583.6284.280.67
23623839-362383983.33983.93
33648168-364816883.89884.55
43619233-361923383.23383.87
53653109-365310984.01284.64
63669473-366947384.38885.08
60min13751235-375123586.26986.860.4187.0887.680.42
23784772-378477287.04087.81
33781360-378136086.96187.80
43772317-377231786.75387.57
53775540-377554086.82887.65
63797279-379727987.32888.20
极限13845730-384573088.44289.170.5389.4490.180.55
23881486-388148689.26490.23
33886107-388610789.37090.40
43861694-386169488.80989.82
53885590-388559089.35890.37
63903750-390375089.77690.85
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654258731426410242610484261014425993742609660.05
210.774340654434024743404500.01
单位质量响应值RSD%判断
400090.70403013.000.52数据可信
供试品溶液-250601批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11092655-109265524.46620.4027.5424.4720.4027.55
2793526-79352617.76817.77
3974390-97439021.81721.82
4599968-59996813.43413.43
5729374-72937416.33116.33
61277521-127752128.60528.60
10min12299772-229977251.49447.907.9551.5547.947.96
22084038-208403846.66446.70
32223952-222395249.79649.84
42036166-203616645.59245.62
51879172-187917242.07642.11
62312606-231260651.78151.84
15min12854877-285487763.92362.075.1964.0962.225.20
22765217-276521761.91662.06
32845660-284566063.71763.88
42781627-278162762.28362.41
52495054-249505455.86756.00
62890377-289037764.71864.90
20min13133900-313390070.17169.012.6670.4869.302.68
23071868-307186868.78269.06
33116043-311604369.77170.07
43083881-308388169.05169.32
52928246-292824665.56665.82
63157867-315786770.70871.03
30min13446957-344695777.18176.561.1577.6577.001.16
23386373-338637375.82476.26
33411622-341162276.38976.85
43475681-347568177.82478.25
53369113-336911375.43875.84
63424865-342486576.68677.17
45min13702058-370205882.89381.820.8883.5382.440.90
23605396-360539680.72881.33
33656037-365603781.86282.49
43648683-364868381.69782.29
53643102-364310281.57282.14
63670757-367075782.19282.84
60min13828445-382844585.72284.950.6486.5485.750.65
23759835-375983584.18684.97
33787701-378770184.81085.62
43803260-380326085.15985.94
53778257-377825784.59985.35
63806522-380652285.23286.06
极限13943758-394375888.30487.330.7289.3288.310.75
23868976-386897686.63087.60
33893837-389383787.18788.18
43896403-389640387.24488.21
53876359-387635986.79587.73
63920929-392092987.79388.82
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654287630429051342796944276037426833342804410.21
210.774368293436617643672340.04
单位质量响应值RSD%判断
401919.34405499.910.63数据可信
供试品溶液-250602批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11307108-130710829.11122.9014.4129.1122.9014.41
2994322-99432222.14522.14
3993770-99377022.13322.13
4883121-88312119.66819.67
51052611-105261123.44323.44
6938731-93873120.90720.91
10min12596968-259696857.83851.078.6857.9051.128.69
22200547-220054749.00949.06
32213822-221382249.30549.35
42250726-225072650.12750.17
52454699-245469954.67054.72
62042402-204240245.48745.53
15min12957013-295701365.85762.963.7266.0563.123.73
22817222-281722262.74362.90
32769640-276964061.68461.84
42869169-286916963.90064.06
52891250-289125064.39264.57
62657148-265714859.17859.33
20min13164662-316466270.48168.971.9970.8269.272.01
23093706-309370668.90169.20
33070480-307048068.38468.68
43127893-312789369.66369.96
53132664-313266469.76970.09
62990379-299037966.60066.88
30min13419934-341993476.16775.181.2976.6675.641.31
23393789-339378975.58476.04
33348095-334809574.56775.01
43407377-340737775.88776.34
53381562-338156275.31275.78
63302743-330274373.55773.98
45min13636448-363644880.98980.530.9281.6581.150.93
23639196-363919681.05081.67
33585162-358516279.84780.46
43646821-364682181.22081.84
53620790-362079080.64081.28
63565592-356559279.41180.00
60min13761391-376139183.77183.560.9984.6284.370.99
23785778-378577884.31585.11
33715899-371589982.75883.55
43794357-379435784.50685.31
53752788-375278883.58084.40
63702449-370244982.45983.23
极限13878398-387839886.37786.080.7987.4187.070.80
23891345-389134586.66687.65
33833964-383396485.38886.36
43894886-389488686.74587.73
53868742-386874286.16287.17
63822560-382256085.13486.08
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.654311292431052343089234307293430693643089930.05
210.774388500438651343875060.04
单位质量响应值RSD%判断
404600.28407382.170.49数据可信
供试品溶液-250602批-shui(内含0.2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11075425-107542523.81624.7518.6923.8224.7518.69
21215000-121500026.90726.91
31351341-135134129.92729.93
41119843-111984324.80024.80
51205768-120576826.70326.70
6737761-73776116.33816.34
10min12203475-220347548.79850.779.7048.8550.839.71
22358560-235856052.23352.29
32562829-256282956.75756.82
42370752-237075252.50352.56
52357144-235714452.20152.26
61903343-190334342.15242.19
15min12782372-278237261.61962.005.6961.7862.175.71
22824442-282444262.55062.73
32944246-294424665.20365.40
42895023-289502364.11364.29
52856855-285685563.26863.44
62495425-249542555.26455.39
20min13102168-310216868.70168.392.4569.0068.702.48
23103594-310359468.73269.05
33145612-314561269.66370.00
43140820-314082069.55769.87
53096813-309681368.58268.90
62940378-294037865.11865.37
30min13388497-338849775.04274.900.7875.4975.360.81
23365597-336559774.53575.00
33400251-340025175.30275.79
43415419-341541975.63876.11
53382967-338296774.91975.39
63340629-334062973.98274.38
45min13621565-362156580.20380.120.4980.8280.740.50
23597349-359734979.66780.30
33623061-362306180.23780.90
43648023-364802380.78981.43
53609567-360956779.93880.57
63607358-360735879.88980.45
60min13730741-373074182.62182.760.5483.4283.560.54
23715433-371543382.28283.09
33745158-374515882.94083.78
43771877-377187783.53284.35
53722578-372257882.44083.25
63736228-373622882.74383.48
极限13861442-386144285.51685.300.5886.5086.290.55
23832212-383221284.86885.86
33840257-384025785.04786.07
43875965-387596585.83786.84
53825631-382563184.72385.72
63875280-387528085.82286.75
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