培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941493981493051490151496521491601493060.17
216.041484561487411485980.14
单位质量响应值RSD%判断
9366.759264.210.78数据可信
长期24月-供试品溶液-2023110721批-培哚普利-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%
5min149051-4905132.84530.856.5132.8430.856.51
244739-4473929.95729.96
341968-4196828.10228.10
443967-4396729.44129.44
547199-4719931.60531.60
649500-4950033.14533.15
10min1132751-13275188.89186.493.4089.0286.623.39
2128133-12813385.79885.92
3125070-12507083.74783.86
4129745-12974586.87887.00
5135337-13533790.62290.75
6123993-12399383.02683.16
15min1151316-151316101.32298.522.11101.8198.992.11
2148468-14846899.41599.88
3148685-14868599.560100.01
4142876-14287695.67096.14
5147168-14716898.54499.03
6144242-14424296.58597.05
20min1155055-155055103.826100.812.42104.72101.672.41
2153816-153816102.996103.86
3151997-151997101.778102.62
4145992-14599297.75798.60
5147404-14740498.70299.59
6149006-14900699.775100.63
30min1151905-151905101.716100.741.53103.02102.011.52
2151632-151632101.533102.81
3152171-152171101.894103.15
4147367-14736798.67899.92
5147608-14760898.839100.12
6151996-151996101.777103.03
45min1151074-151074101.160100.471.44102.87102.141.43
2151372-151372101.359103.04
3151896-151896101.710103.37
4147900-14790099.035100.67
5146759-14675998.27099.94
6151284-151284101.300102.96
60min1149823-149823100.32299.831.59102.44101.901.57
2150219-150219100.587102.67
3151298-151298101.310103.38
4146286-14628697.95499.98
5145929-14592997.71599.78
6150938-150938101.069103.13
极限1148912-14891299.71299.331.65102.23101.801.63
2150411-150411100.716103.20
3150359-150359100.681103.15
4145692-14569297.55699.98
5144892-14489297.02099.48
6149826-149826100.324102.79
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.692838822838872831322841842842762838720.16
212.622835692836752836220.03
单位质量响应值RSD%判断
22369.7422474.010.33数据可信
长期24月-供试品溶液-2023110721批-吲达帕胺-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%
5min134494-3449412.08611.988.8212.0911.988.82
232062-3206211.23411.23
330670-3067010.74610.75
432377-3237711.34411.34
537856-3785613.26413.26
637606-3760613.17613.18
10min1115638-11563840.51739.734.6840.5639.784.69
2109241-10924138.27538.32
3107907-10790737.80837.85
4109907-10990738.50938.55
5121707-12170742.64342.70
6115980-11598040.63640.69
15min1170803-17080359.84559.703.0360.0659.913.04
2168326-16832658.97759.18
3168399-16839959.00359.20
4164034-16403457.47357.67
5179508-17950862.89563.12
6171297-17129760.01860.23
20min1202865-20286571.07971.092.2671.5371.542.27
2203158-20315871.18171.62
3204230-20423071.55771.99
4194800-19480068.25368.68
5209017-20901773.23473.71
6203306-20330671.23371.69
30min1237778-23777883.31183.371.8884.0584.101.89
2238529-23852983.57484.29
3240397-24039784.22984.95
4229425-22942580.38581.09
5242363-24236384.91885.69
6239168-23916883.79884.54
45min1261168-26116891.50692.031.5592.5793.091.56
2263523-26352392.33293.38
3266427-26642793.34994.40
4255185-25518589.41090.43
5264791-26479192.77693.88
6264912-26491292.81893.89
60min1270945-27094594.93296.022.0196.3797.462.00
2274871-27487196.30897.73
3279906-27990698.07299.50
4264793-26479392.77794.16
5275387-27538796.48897.97
6278436-27843697.55799.00
极限1277046-27704697.07099.731.9698.88101.551.94
2283530-28353099.342101.15
3293162-293162102.716104.54
4282132-28213298.852100.60
5283368-28336899.285101.15
6288665-288665101.141102.98
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941487481485211487081486611486641486600.06
216.041482171482031482100.01
单位质量响应值RSD%判断
9326.229240.020.66数据可信
长期24月-供试品溶液-2023110821批-培哚普利-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%
5min141241-4124127.71128.037.4727.7128.037.47
239302-3930226.40826.41
337305-3730525.06625.07
442775-4277528.74228.74
543678-4367829.34929.35
645952-4595230.87730.88
10min1125040-12504084.01888.675.1884.1388.785.18
2129860-12986087.25787.36
3136453-13645391.68791.79
4124069-12406983.36683.48
5141426-14142695.02995.15
6134932-13493290.66590.79
15min1148723-14872399.93299.142.95100.3899.602.95
2145992-14599298.09798.55
3146441-14644198.39898.87
4141404-14140495.01495.46
5147945-14794599.40999.91
6154735-154735103.972104.46
20min1148972-148972100.09999.632.05100.95100.502.05
2147646-14764699.208100.06
3146187-14618798.22899.09
4145324-14532497.64898.48
5147622-14762299.192100.09
6153879-153879103.396104.30
30min1150230-150230100.944100.151.95102.19101.411.95
2148260-14826099.621100.86
3146532-14653298.46099.71
4146917-14691798.71899.94
5147989-14798999.439100.73
6154336-154336103.703105.02
45min1149649-149649100.554100.051.85102.20101.721.85
2148022-14802299.461101.10
3146387-14638798.362100.01
4147463-14746399.085100.70
5147821-14782199.326101.02
6154090-154090103.538105.27
60min1148648-14864899.881100.332.45101.93102.392.43
2154126-154126103.562105.60
3146058-14605898.141100.18
4146115-14611598.179100.19
5147324-14732498.992101.08
6153608-153608103.214105.36
极限1147164-14716498.88498.761.78101.34101.221.79
2146159-14615998.209100.66
3145166-14516697.54299.98
4145269-14526997.611100.01
5146026-14602698.120100.60
6152108-152108102.206104.76
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.692835382836462840322839182840012838270.08
212.622835632833452834540.06
单位质量响应值RSD%判断
22366.1922460.700.30数据可信
长期24月-供试品溶液-2023110821批-吲达帕胺-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%
5min127617-276179.68010.148.739.6810.148.72
227158-271589.5199.52
326301-263019.2199.22
430861-3086110.81710.82
532960-3296011.55311.55
628613-2861310.02910.03
10min198984-9898434.69436.845.5934.7336.885.59
2101434-10143435.55335.59
3105494-10549436.97637.01
4107318-10731837.61637.66
5115421-11542140.45640.50
6102001-10200135.75235.79
15min1169233-16923359.31759.572.6759.4959.762.67
2165687-16568758.07458.25
3167959-16795958.87159.06
4165820-16582058.12158.31
5175547-17554761.53061.74
6175560-17556061.53561.72
20min1205227-20522771.93371.502.2872.3571.932.27
2202789-20278971.07971.49
3199273-19927369.84670.27
4198947-19894769.73270.16
5206658-20665872.43572.89
6211033-21103373.96874.40
30min1243867-24386785.47783.992.3186.1884.702.30
2238451-23845183.57884.28
3233602-23360281.87982.58
4233306-23330681.77582.48
5241604-24160484.68485.43
6246897-24689786.53987.26
45min1268881-26888194.24492.441.9895.2993.491.98
2262781-26278192.10693.14
3257685-25768590.32091.35
4258126-25812690.47591.51
5264992-26499292.88193.96
6269970-26997094.62695.70
60min1280439-28043998.29595.962.1599.7297.382.14
2270751-27075194.90096.30
3267928-26792893.91095.30
4267737-26773793.84395.24
5275217-27521796.46597.92
6280519-28051998.32399.77
极限1290519-290519101.82899.181.90103.64100.981.89
2283662-28366299.425101.20
3277472-27747297.25599.02
4276779-27677997.01398.78
5282278-28227898.940100.78
6287076-287076100.622102.46
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数4000
标示量(mg)2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%
115.941478981481171481221481521482521481080.09
216.041484671483761484220.05
单位质量响应值RSD%判断
9291.599253.240.30数据可信
长期24月-供试品溶液-2023110822批-培哚普利-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%
5min151806-5180634.85031.188.1234.8531.188.11
247848-4784832.18732.19
345543-4554330.63730.64
445125-4512530.35530.36
540399-4039927.17627.18
647398-4739831.88431.88
10min1128332-12833286.32988.274.2586.4788.404.25
2128152-12815286.20786.34
3130007-13000787.45587.58
4129265-12926586.95687.08
5129041-12904186.80586.91
6142513-14251395.86896.00
15min1152281-152281102.439101.461.50102.92101.941.49
2152426-152426102.536103.01
3152693-152693102.716103.19
4146737-14673798.71099.18
5150231-150231101.060101.52
6150550-150550101.275101.79
20min1154556-154556103.969102.930.92104.86103.820.93
2153366-153366103.169104.05
3154443-154443103.893104.78
4151843-151843102.144103.01
5151034-151034101.600102.46
6152837-152837102.813103.73
30min1153276-153276103.108102.280.99104.42103.581.00
2152825-152825102.805104.10
3153203-153203103.059104.36
4151332-151332101.801103.07
5149359-149359100.473101.74
6152272-152272102.433103.76
45min1152516-152516102.597102.442.18104.32104.152.15
2158306-158306106.492108.20
3152682-152682102.709104.42
4149193-149193100.362102.04
5149426-149426100.518102.19
6151604-151604101.984103.72
60min1152106-152106102.321101.500.92104.45103.620.92
2152088-152088102.309104.44
3151768-151768102.094104.22
4149543-149543100.597102.68
5148888-148888100.156102.23
6150941-150941101.538103.68
极限1151188-151188101.704100.840.90104.25103.360.91
2150967-150967101.555104.10
3150740-150740101.402103.93
4148826-148826100.115102.60
5147808-14780899.430101.90
6149905-149905100.841103.39
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)2补液体积(ml)2
对照品批号100275-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)98.2对照品水分(%)0对照品稀释倍数10000
标示量(mg)0.625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%
112.692836642837732836002834622834592835920.05
212.622837792836442837120.04
单位质量响应值RSD%判断
22347.6822481.140.43数据可信
长期24月-供试品溶液-2023110822批-吲达帕胺-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%
5min139617-3961713.88511.8013.1913.8911.8013.19
235032-3503212.27812.28
332705-3270511.46311.46
435210-3521012.34112.34
526068-260689.1379.14
633292-3329211.66911.67
10min1118117-11811741.39938.826.3741.4538.876.37
2111953-11195339.23939.29
3108842-10884238.14838.19
4113871-11387139.91139.96
597774-9777434.26934.31
6114021-11402139.96340.01
15min1177855-17785562.33759.942.6962.5660.142.71
2173472-17347260.80161.01
3169294-16929459.33659.53
4171199-17119960.00460.21
5163991-16399157.47857.65
6170272-17027259.67959.89
20min1208034-20803472.91471.871.4573.3872.311.46
2202286-20228670.90071.35
3205317-20531771.96272.40
4207512-20751272.73173.18
5200680-20068070.33770.74
6206505-20650572.37872.82
30min1244355-24435585.64484.601.5786.4185.341.58
2242497-24249784.99385.73
3241354-24135484.59385.32
4244948-24494885.85286.59
5234481-23448182.18482.87
6240665-24066584.35185.09
45min1268953-26895394.26692.711.3195.3793.781.32
2265239-26523992.96494.04
3266211-26621193.30594.37
4264954-26495492.86493.95
5258703-25870390.67391.69
6262945-26294592.16093.23
60min1281041-28104198.50397.031.5899.9898.471.59
2279327-27932797.90299.35
3278091-27809197.46998.90
4279772-27977298.05899.51
5270360-27036094.75996.14
6272445-27244595.49096.93
极限1291734-291734102.250100.141.94104.13101.971.94
2289433-289433101.444103.28
3286467-286467100.404102.23
4288827-288827101.232103.08
5278971-27897197.77799.53
6278895-27889597.75099.57
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