培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661540021530441520831545421521391531620.72
215.661549751529551539650.93
单位质量响应值RSD%判断
9780.469831.740.37数据可信
长期12月-供试品溶液-2023110721批-培哚普利-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min147153-4715329.99332.179.5229.9932.179.53
242580-4258027.08527.08
351753-5175332.91932.92
453248-5324833.87033.87
555608-5560835.37235.37
653105-5310533.77933.78
10min1151525-15152596.38394.315.7496.4794.405.74
2132599-13259984.34584.43
3156451-15645199.51799.62
4154219-15421998.09798.20
5146469-14646993.16793.27
6148308-14830894.33794.44
15min1156344-15634499.44998.731.2699.8399.111.26
2154151-15415198.05498.39
3155854-15585499.13799.53
4158187-158187100.621101.02
5152925-15292597.27497.66
6153805-15380597.83498.22
20min1156729-15672999.69399.131.56100.3799.811.55
2156417-15641799.495100.12
3158694-158694100.943101.64
4157035-15703599.888100.59
5151769-15176996.53897.22
6154430-15443098.23198.91
30min1155493-15549398.90799.201.0999.88100.171.08
2158150-158150100.597101.52
3157058-15705899.903100.90
4156547-15654799.578100.58
5153308-15330897.51798.48
6155120-15512098.67099.64
45min1155664-15566499.01699.081.13100.29100.351.13
2156478-15647899.534100.76
3158138-158138100.590101.89
4156713-15671399.683100.98
5153276-15327697.49798.76
6154288-15428898.14199.41
60min1156039-15603999.25598.860.97100.82100.420.97
2155514-15551498.921100.45
3156271-15627199.402101.00
4157286-157286100.048101.64
5153159-15315997.42398.97
6154219-15421998.09799.66
极限1154737-15473798.42698.811.36100.29100.681.35
2156715-15671599.685101.51
3156249-15624999.388101.29
4158242-158242100.656102.55
5152770-15277097.17599.02
6153353-15335397.54699.40
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222856872841882851662870152833082850730.50
212.152882842869912876380.32
单位质量响应值RSD%判断
23328.4023673.911.04数据可信
长期12月-供试品溶液-2023110721批-吲达帕胺-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133365-3336511.15412.5114.2411.1512.5114.24
230369-3036910.15210.15
340279-4027913.46513.47
436216-3621612.10712.11
545420-4542015.18415.18
638822-3882212.97812.98
10min1122761-12276141.03942.628.4941.0742.668.50
2109806-10980636.70836.74
3140210-14021046.87246.91
4126834-12683442.40142.44
5136835-13683545.74445.79
6128447-12844742.94042.98
15min1184859-18485961.79862.573.4461.9562.743.46
2177374-17737459.29659.44
3196753-19675365.77465.96
4186138-18613862.22662.39
5190752-19075263.76863.95
6187162-18716262.56862.74
20min1215505-21550572.04372.662.6472.3973.012.65
2210653-21065370.42170.74
3227913-22791376.19176.57
4215506-21550672.04472.39
5217905-21790572.84673.22
6216574-21657472.40172.76
30min1247062-24706282.59383.532.4883.1584.102.48
2247250-24725082.65683.19
3262337-26233787.69988.31
4247196-24719682.63883.20
5246260-24626082.32582.92
6249092-24909283.27183.84
45min1271880-27188090.88990.942.9791.7091.762.97
2267518-26751889.43190.21
3288046-28804696.29497.16
4269967-26996790.25091.06
5266554-26655489.10989.95
6268264-26826489.68190.50
60min1283762-28376294.86294.152.6895.9495.252.68
2277415-27741592.74093.79
3296122-29612298.993100.15
4277048-27704892.61793.70
5278120-27812092.97594.08
6277383-27738392.72993.82
极限1289838-28983896.89396.852.6798.2698.222.67
2288243-28824396.36097.68
3304779-304779101.887103.34
4286787-28678795.87397.24
5285164-28516495.33096.72
6283401-28340194.74196.11
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661539741534051542161538041531011537000.30
215.661555681549791552740.27
单位质量响应值RSD%判断
9814.819915.330.73数据可信
长期12月-供试品溶液-2023110721批-培哚普利-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151409-5140932.50631.878.5032.5131.878.50
244883-4488328.37928.38
345221-4522128.59328.59
454194-5419434.26734.27
554231-5423134.29034.29
652443-5244333.16033.16
10min1135595-13559585.73693.934.7385.8394.034.73
2149847-14984794.74894.83
3153926-15392697.32797.41
4146278-14627892.49192.59
5154548-15454897.72097.82
6151173-15117395.58695.69
15min1149417-14941794.47697.692.0594.8398.072.05
2158296-158296100.090100.46
3156302-15630298.82999.21
4155518-15551898.33498.71
5155176-15517698.11798.51
6152292-15229296.29496.68
20min1151060-15106095.51598.491.7996.1599.161.79
2158297-158297100.091100.76
3158820-158820100.422101.10
4155686-15568698.44099.12
5155849-15584998.54399.23
6154854-15485497.91498.59
30min1150708-15070895.29297.253.0496.2298.223.02
2160471-160471101.465102.44
3157732-15773299.734100.71
4148207-14820793.71194.68
5154657-15465797.78998.78
6151015-15101595.48696.46
45min1150996-15099695.47498.471.9396.6999.731.93
2158922-158922100.486101.76
3159018-159018100.547101.82
4155116-15511698.08099.33
5155706-15570698.45399.73
6154685-15468597.80799.06
60min1151800-15180095.98398.311.5097.4899.861.50
2158212-158212100.037101.61
3157544-15754499.615101.19
4155776-15577698.497100.04
5155403-15540398.26199.84
6154169-15416997.48199.03
极限1150734-15073495.30997.981.6497.0999.831.64
2158014-15801499.912101.79
3156550-15655098.986100.86
4154923-15492397.95799.80
5155836-15583698.535100.40
6153724-15372497.19999.04
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222874162853222883192863872857432866370.43
212.152882212877252879730.13
单位质量响应值RSD%判断
23456.3823701.480.74数据可信
长期12月-供试品溶液-2023110721批-吲达帕胺-pH2.0(内含0.19%EDTA)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min134133-3413311.37311.529.5211.3711.529.50
229758-297589.9159.92
332485-3248510.82410.82
438908-3890812.96412.96
537303-3730312.42912.43
634791-3479111.59211.59
10min1112721-11272137.55739.437.8237.5939.477.82
2104355-10435534.77034.80
3115558-11555838.50338.53
4126246-12624642.06442.10
5129122-12912243.02243.06
6122119-12211940.68940.72
15min1172122-17212257.34959.443.0857.5059.603.09
2172440-17244057.45557.59
3176551-17655158.82558.97
4183339-18333961.08661.25
5184638-18463861.51961.69
6181364-18136460.42860.59
20min1201737-20173767.21669.732.2467.5470.062.25
2205912-20591268.60768.91
3209926-20992669.94570.27
4213767-21376771.22571.57
5213629-21362971.17971.53
6210670-21067070.19370.53
30min1233518-23351877.80579.402.5978.3379.942.57
2242730-24273080.87581.39
3242992-24299280.96281.50
4228791-22879176.23076.79
5244149-24414981.34781.91
6237608-23760879.16879.72
45min1257431-25743185.77388.741.8786.5389.521.86
2270235-27023590.03990.79
3269301-26930189.72890.50
4270458-27045890.11390.90
5266146-26614688.67789.49
6264505-26450588.13088.92
60min1269497-26949789.79392.471.5890.8093.511.58
2279311-27931193.06394.09
3281097-28109793.65894.70
4281357-28135793.74594.81
5276907-27690792.26293.34
6276965-27696592.28193.33
极限1279328-27932893.06995.431.8494.3596.751.82
2289392-28939296.42297.73
3290627-29062796.83398.16
4292628-29262897.50098.84
5282148-28214894.00895.36
6284390-28439094.75596.08
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661528891507341519071520001528641520790.59
215.661519251524771522010.26
单位质量响应值RSD%判断
9711.309719.090.06数据可信
长期12月-供试品溶液-2023110721批-培哚普利-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min151265-5126532.91436.3219.5532.9136.3219.55
243763-4376328.09728.10
352217-5221733.52533.53
474884-7488448.07848.08
553371-5337134.26634.27
663958-6395841.06341.06
10min1154763-15476399.363100.213.3799.46100.323.38
2146823-14682394.26694.35
3160816-160816103.250103.35
4160614-160614103.120103.26
5154923-15492399.46699.57
6158555-158555101.798101.92
15min1158347-158347101.664101.851.27102.06102.261.29
2154779-15477999.37499.74
3159718-159718102.545102.95
4160422-160422102.997103.45
5159068-159068102.127102.53
6159454-159454102.375102.80
20min1158972-158972102.066101.691.32102.77102.411.34
2154380-15438099.11799.78
3159628-159628102.487103.20
4160344-160344102.947103.71
5158457-158457101.735102.44
6158563-158563101.803102.54
30min1157589-157589101.178102.211.74102.19103.241.76
2154682-15468299.311100.27
3161085-161085103.422104.45
4162514-162514104.340105.41
5160028-160028102.744103.76
6159321-159321102.290103.33
45min1159328-159328102.294102.261.70103.61103.591.72
2154065-15406598.915100.18
3161271-161271103.542104.88
4161463-161463103.665105.05
5159513-159513102.413103.73
6160025-160025102.742104.09
60min1157556-157556101.157101.721.19102.77103.351.21
2155164-15516499.621101.18
3158679-158679101.878103.52
4160535-160535103.069104.76
5159227-159227102.229103.86
6159435-159435102.363104.02
极限1158629-158629101.845101.821.94103.77103.761.94
2152589-15258997.96899.82
3161284-161284103.550105.50
4159425-159425102.356104.36
5159499-159499102.404104.34
6160082-160082102.778104.74
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222860982853542848672829582821872842930.59
212.152862812856782859800.15
单位质量响应值RSD%判断
23264.5723537.450.83数据可信
长期12月-供试品溶液-2023110721批-吲达帕胺-pH4.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min133273-3327311.17112.8821.3711.1712.8821.36
228529-285299.5789.58
336102-3610212.12012.12
450819-5081917.06117.06
536122-3612212.12712.13
645288-4528815.20415.20
10min1119573-11957340.14342.9911.7640.1843.0311.77
2106204-10620435.65535.68
3130731-13073143.88943.93
4149058-14905850.04250.09
5123841-12384141.57641.61
6138895-13889546.63046.68
15min1181679-18167960.99461.374.9561.1561.544.98
2170239-17023957.15357.29
3183592-18359261.63661.80
4198009-19800966.47666.68
5178830-17883060.03760.20
6184394-18439461.90562.09
20min1211828-21182871.11670.793.3871.4571.143.40
2198765-19876566.73067.04
3215137-21513772.22772.58
4219460-21946073.67874.08
5207462-20746269.65069.99
6212413-21241371.31271.68
30min1246962-24696282.91182.081.9983.4682.642.01
2237245-23724579.64980.16
3249084-24908483.62384.19
4249519-24951983.76984.39
5242767-24276781.50382.05
6241360-24136081.03081.62
45min1273485-27348591.81589.981.7692.6190.801.77
2262063-26206387.98188.73
3273011-27301191.65692.48
4269491-26949190.47491.35
5264475-26447588.79089.59
6265648-26564889.18490.01
60min1284536-28453695.52593.991.7396.6095.071.73
2277016-27701693.00194.01
3287080-28708096.37997.47
4279119-27911993.70794.85
5274457-27445792.14293.20
6277537-27753793.17694.27
极限1294247-29424798.78697.201.94100.1598.561.92
2287138-28713896.39997.69
3298628-298628100.256101.64
4285792-28579295.94797.37
5286754-28675496.27097.61
6284634-28463495.55896.93
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
115.661543561536551524671527981529561532460.50
215.661542291552451547370.47
单位质量响应值RSD%判断
9785.829881.030.69数据可信
长期12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%
5min149281-4928131.26036.6914.6431.2636.6814.64
253151-5315133.71533.72
353144-5314433.71133.71
456138-5613835.61035.61
572426-7242645.94245.94
662861-6286139.87539.87
10min1135912-13591286.21390.325.8986.3190.435.89
2150821-15082195.67095.77
3147902-14790293.81993.92
4131093-13109383.15683.26
5150339-15033995.36595.50
6138226-13822687.68187.80
15min1153176-15317697.16496.431.4697.5296.811.44
2154163-15416397.79098.18
3148802-14880294.39094.77
4154290-15429097.87198.23
5150556-15055695.50295.93
6151125-15112595.86396.25
20min1153121-15312197.12996.571.9097.7797.241.89
2156104-15610499.02299.70
3147940-14794093.84394.51
4154328-15432897.89598.54
5151163-15116395.88796.60
6150793-15079395.65396.32
30min1152139-15213996.50696.371.4697.4497.331.45
2155931-15593198.91299.89
3149473-14947394.81595.76
4152241-15224196.57197.51
5151064-15106495.82596.82
6150698-15069895.59296.55
45min1152368-15236896.65296.341.3997.8897.581.38
2154608-15460898.07399.35
3148550-14855094.23095.46
4153233-15323397.20098.43
5150659-15065995.56896.85
6151798-15179896.29097.53
60min1153651-15365197.46696.651.2398.9898.191.22
2155154-15515498.41999.99
3149954-14995495.12096.63
4152346-15234696.63898.16
5150892-15089295.71597.29
6152209-15220996.55198.08
极限1152775-15277596.91096.552.2198.7298.382.18
2157049-15704999.621101.49
3148022-14802293.89595.69
4154799-15479998.194100.01
5149641-14964194.92296.78
6150964-15096495.76197.58
培哚普利吲达帕胺片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
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%
112.222864922864052877652872102871972870140.20
212.152843082863022853050.50
单位质量响应值RSD%判断
23487.2323481.890.02数据可信
长期12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%
5min136691-3669112.27414.8113.3112.2714.8113.32
241644-4164413.93113.93
342745-4274514.29914.30
442947-4294714.36714.37
553923-5392318.03818.04
647734-4773415.96815.97
10min1119771-11977140.06645.378.5740.1045.418.57
2136864-13686445.78345.83
3147656-14765649.39449.44
4124942-12494241.79541.84
5148352-14835249.62649.68
6136125-13612545.53645.58
15min1182135-18213560.92763.462.1461.0863.642.15
2188353-18835363.00763.19
3192619-19261964.43464.63
4191897-19189764.19364.36
5192609-19260964.43164.63
6190660-19066063.77963.96
20min1208326-20832669.68972.271.8670.0372.641.87
2218928-21892873.23573.60
3217524-21752472.76673.15
4219265-21926573.34873.71
5216332-21633272.36772.76
6215884-21588472.21772.59
30min1242253-24225381.03882.501.1781.5983.091.17
2246999-24699982.62683.21
3248681-24868183.18883.79
4250501-25050183.79784.38
5244908-24490881.92682.54
6246483-24648382.45383.05
45min1264780-26478088.57489.971.2089.3790.801.20
2272396-27239691.12191.96
3271572-27157290.84691.70
4270900-27090090.62191.45
5265522-26552288.82289.68
6268497-26849789.81790.66
60min1276759-27675992.58193.621.1293.6494.731.12
2282873-28287394.62695.74
3283162-28316294.72395.85
4281085-28108594.02895.13
5275664-27566492.21493.34
6279731-27973193.57594.68
极限1284196-28419695.06995.921.2196.4097.301.20
2291419-29141997.48598.88
3288711-28871196.57997.99
4288665-28866596.56497.95
5282128-28212894.37795.78
6285281-28528195.43296.82
点击查看处理图标(人工保存)
 
原始图谱下载图谱(谢鑫慧 于 2024-12-03 16:08:32 完成)
生成报告数据部分(等待生成报告)
Current page cost:74 ms