氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091378721380841380571381321378421379970.10
214.051375831375611375720.02
单位质量响应值RSD%判断
9793.979791.600.02数据可信
供试品溶液-2025011111批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150669-5066933.54640.6012.4833.5540.6012.48
254675-5467536.19836.20
372103-7210347.73747.74
462783-6278341.56641.57
565241-6524143.19343.19
662463-6246341.35441.35
10min1106843-10684370.73677.445.1570.9277.665.17
2112752-11275274.64974.85
3122302-12230280.97181.24
4121214-12121480.25180.48
5120631-12063179.86580.10
6118061-11806178.16378.39
15min1128629-12862985.16086.422.2185.7487.072.25
2127130-12713084.16884.78
3134868-13486889.29190.01
4131256-13125686.89987.58
5132507-13250787.72888.41
6128773-12877385.25585.92
20min1134489-13448989.04089.052.4890.0990.192.49
2130284-13028486.25687.34
3139803-13980392.55893.77
4135588-13558889.76790.93
5135190-13519089.50490.67
6131707-13170787.19888.34
30min1142721-14272194.49095.752.6596.0497.382.66
2142613-14261394.41895.98
3150242-15024299.469101.19
4145393-14539396.25997.92
5147252-14725297.49099.16
6139481-13948192.34593.97
45min1153463-153463101.60297.363.20103.6799.523.13
2144005-14400595.34097.43
3149583-14958399.033101.31
4142759-14275994.51596.71
5150393-15039399.569101.78
6142152-14215294.11396.25
60min1154976-154976102.603100.462.96105.24103.162.92
2148568-14856898.361100.98
3158543-158543104.965107.79
4152608-152608101.036103.75
5148947-14894798.612101.37
6146750-14675097.15799.82
极限1154859-154859102.526100.122.78105.73103.382.73
2151882-151882100.555103.72
3157009-157009103.949107.36
4149128-14912898.732102.01
5148858-14885898.553101.86
6145638-14563896.42199.62
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871335048133661313369461336941133735913365810.07
29.891329606133014013298730.03
单位质量响应值RSD%判断
135418.54134466.430.50数据可信
供试品溶液-2025011111批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142338-423382.8244.4821.682.824.4821.74
261660-616604.1124.11
385696-856965.7165.72
468005-680054.5364.54
574632-746324.9784.98
670862-708624.7264.73
10min1132068-1320688.80811.3312.538.8211.3612.57
2157547-15754710.50810.53
3185695-18569512.38512.42
4179772-17977211.99012.02
5186058-18605812.40912.44
6178531-17853111.90711.93
15min1181793-18179312.12514.418.7912.1914.508.82
2205655-20565513.71613.80
3229018-22901815.27515.38
4224995-22499515.00615.10
5229368-22936815.29815.39
6225701-22570115.05315.15
20min1206611-20661113.78015.717.1513.9115.887.21
2223959-22395914.93715.09
3247472-24747216.50516.69
4243133-24313316.21616.39
5249662-24966216.65116.83
6242308-24230816.16116.34
30min1228510-22851015.24117.426.9415.4517.686.99
2251622-25162216.78217.02
3272030-27203018.14318.42
4271764-27176418.12618.39
5275768-27576818.39318.67
6267330-26733017.83018.10
45min1248687-24868716.58617.965.1816.8818.315.25
2256407-25640717.10117.43
3276610-27661018.44918.83
4269991-26999118.00718.37
5284236-28423618.95719.33
6279348-27934818.63119.00
60min1255759-25575917.05818.785.9217.4419.245.99
2265371-26537117.69918.13
3294709-29470919.65620.14
4292407-29240719.50219.97
5291724-29172419.45719.94
6289806-28980619.32919.80
极限1260473-26047317.37219.015.0417.8519.575.12
2274868-27486818.33318.86
3296271-29627119.76020.35
4292872-29287219.53320.11
5295133-29513319.68420.27
6290682-29068219.38719.96
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091371341368811374591372041372191371790.16
214.051388611388751388680.01
单位质量响应值RSD%判断
9735.919883.841.07数据可信
供试品溶液-2025011211批-氨氯地平-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min166398-6639843.88538.939.1143.8938.949.11
251212-5121233.84833.85
355966-5596636.99036.99
457920-5792038.28238.28
563244-6324441.80141.80
658700-5870038.79738.80
10min1124539-12453982.31378.814.2482.5679.024.24
2118284-11828478.17978.37
3116148-11614876.76776.97
4114065-11406575.39175.60
5126396-12639683.54183.77
6115961-11596176.64476.86
15min1135551-13555189.59286.342.0890.2986.992.09
2130526-13052686.27086.89
3129786-12978685.78186.41
4127380-12738084.19184.82
5130930-13093086.53787.23
6129593-12959385.65486.30
20min1142084-14208493.91088.723.9195.1189.863.90
2136941-13694190.51091.61
3128042-12804284.62985.74
4130191-13019186.04987.15
5136719-13671990.36491.54
6131428-13142886.86787.98
30min1153107-153107101.19594.574.14102.9296.204.13
2145118-14511895.91597.52
3138201-13820191.34392.92
4138468-13846891.52093.10
5145170-14517095.94997.63
6138471-13847191.52293.12
45min1154834-154834102.33798.722.78104.62100.872.79
2150757-15075799.642101.78
3146142-14614296.59298.68
4145888-14588896.42498.51
5153246-153246101.287103.50
6145306-14530696.03998.15
60min1151925-151925100.414100.172.17103.27102.872.15
2157464-157464104.075106.77
3148795-14879598.345100.97
4148184-14818497.941100.56
5151532-151532100.154102.93
6151426-151426100.084102.73
极限1150187-15018799.265100.171.09102.67103.431.07
2154215-154215101.927105.20
3151769-151769100.311103.48
4150384-15038499.395102.56
5152613-152613100.869104.20
6150165-15016599.251102.45
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871328256132915513293831327572132583413280400.11
29.891342442134517913438100.15
单位质量响应值RSD%判断
134553.19135875.630.70数据可信
供试品溶液-2025011211批-厄贝沙坦-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min199281-992816.6084.2529.706.614.2429.71
257380-573803.8193.82
343530-435302.8972.90
456193-561933.7403.74
566611-666114.4344.43
659687-596873.9733.97
10min1224229-22422914.92511.5415.6314.9611.5715.64
2172078-17207811.45411.48
3147230-1472309.8009.82
4156813-15681310.43810.46
5177384-17738411.80711.83
6162840-16284010.83910.86
15min1272251-27225118.12214.6612.2718.2414.7512.31
2220045-22004514.64714.73
3196103-19610313.05313.12
4202812-20281213.50013.58
5217048-21704814.44714.54
6213288-21328814.19714.28
20min1292318-29231819.45715.9611.8819.6816.1311.93
2242041-24204116.11116.28
3209242-20924213.92814.07
4223520-22352014.87815.03
5240907-24090716.03516.21
6230306-23030615.33015.49
30min1319869-31986921.29117.5211.1521.6217.7811.19
2261956-26195617.43617.69
3237490-23749015.80816.03
4246880-24688016.43316.67
5263063-26306317.51017.77
6250469-25046916.67216.92
45min1331445-33144522.06218.4010.2122.5118.7610.27
2273470-27347018.20318.56
3254039-25403916.90917.22
4260522-26052217.34117.67
5276714-27671418.41918.78
6262775-26277517.49117.83
60min1336485-33648522.39718.889.8222.9719.349.90
2288440-28844019.19919.65
3258246-25824617.19017.59
4266000-26600017.70618.13
5277938-27793818.50018.96
6274935-27493518.30018.74
极限1335807-33580722.35219.088.7423.0519.658.84
2286172-28617219.04819.61
3266912-26691217.76618.26
4272500-27250018.13818.66
5282992-28299218.83719.40
6275969-27596918.36918.91
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091371181378361378581375811378921376570.24
214.051368941366011367480.16
单位质量响应值RSD%判断
9769.849732.950.27数据可信
供试品溶液-2025011111批-氨氯地平-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%
5min189642-8964259.60060.3413.5559.6060.3313.54
2100808-10080867.02467.02
379165-7916552.63552.63
4108118-10811871.88571.88
576028-7602850.54950.55
690719-9071960.31760.32
10min1159047-159047105.746101.673.20106.08102.013.22
2154624-154624102.805103.18
3144426-14442696.02596.32
4155292-155292103.249103.65
5151991-151991101.055101.34
6152149-152149101.160101.49
15min1168330-168330111.918104.304.14112.84105.204.12
2157897-157897104.981105.92
3149402-14940299.333100.16
4154188-154188102.515103.49
5158163-158163105.158106.00
6153273-153273101.907102.80
20min1165097-165097109.768104.273.18111.31105.753.17
2155629-155629103.473105.00
3150995-150995100.392101.77
4153454-153454102.027103.57
5159729-159729106.199107.63
6156041-156041103.747105.21
30min1157910-157910104.990102.312.67107.14104.372.66
2154001-154001102.391104.49
3147147-14714797.83499.77
4151484-151484100.718102.83
5157892-157892104.978106.99
6154844-154844102.951104.99
45min1160935-160935107.001102.472.62109.73105.102.62
2155176-155176103.172105.84
3149152-14915299.167101.65
4152164-152164101.170103.84
5155199-155199103.188105.79
6152097-152097101.125103.74
60min1159281-159281105.902101.382.92109.23104.582.92
2153486-153486102.049105.29
3145686-14568696.86399.89
4150678-150678100.182103.41
5153817-153817102.269105.44
6151972-151972101.042104.22
极限1158171-158171105.16499.683.30109.08103.443.27
2149842-14984299.626103.44
3144395-14439596.00499.57
4146271-14627197.252101.04
5152642-152642101.487105.23
6148253-14825398.569102.30
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871324480133419413339671331814133314613315200.31
29.891324900132028513225920.25
单位质量响应值RSD%判断
134905.78133730.230.62数据可信
供试品溶液-2025011111批-厄贝沙坦-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%
5min122876-228761.5331.7018.781.531.7018.69
230916-309162.0722.07
321888-218881.4671.47
431329-313292.0992.10
520084-200841.3461.35
624734-247341.6571.66
10min164985-649854.3544.525.754.364.535.75
269618-696184.6654.68
363103-631034.2284.24
473703-737034.9394.95
565054-650544.3594.37
667900-679004.5504.56
15min189518-895185.9986.083.686.036.123.71
294358-943586.3236.36
386795-867955.8165.85
495349-953496.3896.43
590117-901176.0386.07
688739-887395.9465.98
20min1104744-1047447.0197.131.517.087.201.57
2108416-1084167.2657.34
3104670-1046707.0147.08
4107947-1079477.2337.31
5107002-1070027.1707.24
6105784-1057847.0887.16
30min1118223-1182237.9228.182.308.038.292.26
2121786-1217868.1608.27
3119727-1197278.0228.13
4123431-1234318.2718.39
5125956-1259568.4408.54
6123419-1234198.2708.38
45min1134873-1348739.0379.181.419.199.331.42
2138907-1389079.3089.47
3135413-1354139.0749.22
4138422-1384229.2759.44
5138818-1388189.3029.45
6135432-1354329.0759.23
60min1144126-1441269.6579.741.339.869.951.31
2145573-1455739.7549.96
3142815-1428159.5709.77
4145175-1451759.7289.94
5148463-1484639.94810.15
6146356-1463569.80710.01
极限1150974-15097410.11610.041.4910.3710.291.43
2149195-1491959.99710.26
3149505-14950510.01810.27
4148228-1482289.93210.20
5153501-15350110.28610.54
6147216-1472169.86410.12
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.091356441357461358421357861360401358120.11
214.051366061382491374280.85
单位质量响应值RSD%判断
9638.899781.351.04数据可信
供试品溶液-2025011211批-氨氯地平-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%
5min187125-8712558.17661.8310.1758.1861.8310.18
299930-9993066.72666.73
393826-9382662.65162.65
4104122-10412269.52669.53
592946-9294662.06362.06
677598-7759851.81551.81
10min1151027-151027100.846103.712.11101.17104.062.13
2159392-159392106.431106.80
3153862-153862102.739103.09
4157934-157934105.458105.84
5156966-156966104.811105.16
6152749-152749101.995102.28
15min1161539-161539107.865107.310.97108.75108.230.93
2160240-160240106.997107.96
3160110-160110106.911107.83
4158153-158153105.604106.58
5161661-161661107.946108.87
6162524-162524108.522109.38
20min1163663-163663109.283106.921.34110.77108.441.31
2159881-159881106.758108.31
3160184-160184106.960108.47
4156985-156985104.824106.38
5160541-160541107.198108.73
6159533-159533106.525107.98
30min1158830-158830106.056106.062.34108.15108.182.27
2154905-154905103.435105.58
3158665-158665105.946108.05
4157031-157031104.855107.00
5157784-157784105.357107.48
6165842-165842110.738112.79
45min1157883-157883105.424105.661.09108.10108.361.05
2155780-155780104.019106.74
3157961-157961105.476108.17
4157407-157407105.106107.83
5160351-160351107.071109.78
6160060-160060106.877109.54
60min1163367-163367109.085106.231.50112.35109.521.44
2157279-157279105.020108.32
3157717-157717105.313108.59
4158606-158606105.906109.21
5157335-157335105.058108.36
6160245-160245107.001110.26
极限1160898-160898107.437105.801.68111.31109.681.61
2157335-157335105.058108.94
3157879-157879105.421109.29
4155874-155874104.082107.98
5156256-156256104.337108.22
6162452-162452108.474112.33
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100供试品稀释倍数2系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.871312764131536513139101315967131545513146920.11
29.891333850134845413411520.77
单位质量响应值RSD%判断
133200.81135606.881.27数据可信
供试品溶液-2025011211批-厄贝沙坦-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%
5min126407-264071.7681.9413.591.771.9413.56
231074-310742.0812.08
328460-284601.9061.91
431804-318042.1302.13
533317-333172.2312.23
622714-227141.5211.52
10min166599-665994.4604.715.824.474.725.86
274917-749175.0175.03
367950-679504.5504.56
474916-749165.0175.03
571978-719784.8204.83
665944-659444.4164.42
15min192857-928576.2186.351.496.256.391.55
296154-961546.4396.48
393552-935526.2656.30
495972-959726.4276.47
596002-960026.4296.47
694827-948276.3506.38
20min1113536-1135367.6037.431.577.677.511.54
2112029-1120297.5027.58
3111384-1113847.4597.53
4110679-1106797.4127.49
5109895-1098957.3597.43
6108512-1085127.2677.34
30min1129287-1292878.6588.601.818.778.721.74
2124849-1248498.3618.48
3129038-1290388.6418.75
4127460-1274608.5368.65
5128219-1282198.5878.70
6131898-1318988.8338.94
45min1143654-1436549.6209.530.859.789.690.83
2140894-1408949.4359.60
3143235-1432359.5929.75
4141126-1411269.4519.61
5143134-1431349.5859.75
6141569-1415699.4819.64
60min1156011-15601110.44810.062.0010.6610.281.94
2147978-1479789.91010.13
3150012-15001210.04610.26
4149970-14997010.04310.26
5147812-1478129.89910.12
6149440-14944010.00810.22
极限1157990-15799010.58010.401.3710.8510.661.31
2154561-15456110.35110.62
3154638-15463810.35610.62
4152660-15266010.22310.50
5153921-15392110.30810.58
6157607-15760710.55510.82
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