阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.482783492780352793052791382781982786050.21
210.532775952778462777200.07
单位质量响应值RSD%判断
26584.4526374.170.57数据可信
长期6月-供试品溶液-2023101221批-阿齐沙坦-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%
5min174702-7470225.31531.3613.7025.3131.3613.71
290248-9024830.58330.58
396312-9631232.63832.64
4110398-11039837.41137.41
583281-8328128.22228.22
6100365-10036534.01134.01
10min1232946-23294678.93983.394.5179.0883.564.52
2234604-23460479.50179.67
3253230-25323085.81385.99
4260360-26036088.22988.44
5252627-25262785.60985.77
6242706-24270682.24782.44
15min1272602-27260292.37894.332.2292.9694.972.22
2273554-27355492.70093.31
3283491-28349196.06896.73
4279169-27916994.60395.30
5287630-28763097.47098.10
6273776-27377692.77593.42
20min1284227-28422796.31797.041.9997.4198.211.98
2280410-28041095.02496.15
3290745-29074598.52699.72
4281878-28187895.52196.74
5295395-295395100.102101.28
6285578-28557896.77597.94
30min1287477-28747797.41898.562.4599.05100.262.43
2284180-28418096.30197.96
3292913-29291399.261101.00
4287348-28734897.37599.13
5304143-304143103.066104.80
6288969-28896997.92499.62
45min1291138-29113898.65999.801.65100.83102.051.64
2290849-29084998.561100.75
3292534-29253499.132101.42
4293801-29380199.561101.86
5303854-303854102.968105.27
6294924-29492499.942102.18
60min1290146-29014698.32399.292.22101.04102.092.21
2284649-28464996.46099.20
3294220-29422099.703102.54
4293041-29304199.304102.15
5304361-304361103.140106.01
6291591-29159198.813101.61
极限1298543-298543101.168101.540.91104.43104.890.88
2300022-300022101.670104.94
3296499-296499100.476103.87
4297473-297473100.806104.21
5301375-301375102.128105.58
6303843-303843102.964106.31
阿齐沙坦氨氯地平片项目信息
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4000
标示量(mg)5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%
115.267422074182741427425173811741210.25
215.327376973798737840.03
单位质量响应值RSD%判断
4857.214816.190.60数据可信
长期6月-供试品溶液-2023101221批-氨氯地平-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%
5min160130-6013080.60376.3212.3080.6076.3212.30
250348-5034867.49167.49
362222-6222283.40883.41
462117-6211783.26783.27
545932-4593261.57161.57
660850-6085081.56981.57
10min169515-6951593.18486.799.4393.6387.219.44
261683-6168382.68583.06
369070-6907092.58793.05
469366-6936692.98493.45
554069-5406972.47972.82
664767-6476786.81987.27
15min169330-6933092.93688.677.5093.9089.587.52
264911-6491187.01287.85
369870-6987093.66094.64
469534-6953493.20994.19
556889-5688976.25977.00
666372-6637288.97189.91
20min170736-7073694.82190.296.7496.3091.696.77
266859-6685989.62490.94
371405-7140595.71797.22
469195-6919592.75594.25
558917-5891778.97780.15
667043-6704389.87091.30
30min169919-6991993.72593.044.4095.7394.944.48
268544-6854491.88293.70
373117-7311798.012100.04
471877-7187796.35098.36
564406-6440686.33587.94
668564-6856491.90993.84
45min172813-7281397.60595.153.66100.1397.563.75
271351-7135195.64597.97
373071-7307197.951100.53
472779-7277997.559100.11
566509-6650989.15491.24
669358-6935892.97395.41
60min173025-7302597.88996.554.01100.9699.504.04
270953-7095395.11297.97
373447-7344798.455101.57
476533-76533102.591105.68
569200-6920092.76295.34
669012-6901292.51095.47
极限172894-7289497.71396.981.73101.33100.461.71
273500-7350098.526101.91
373370-7337098.351102.02
471948-7194896.445100.10
572238-7223896.83499.93
670117-7011793.99197.46
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.482781112779082780172781132786772781650.11
210.532771172769262770220.05
单位质量响应值RSD%判断
26542.4626307.880.63数据可信
长期6月-供试品溶液-2024010621批-阿齐沙坦-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%
5min1144404-14440449.03546.4115.0649.0446.4215.05
2162145-16214555.05955.06
3127922-12792243.43843.44
4108034-10803436.68536.69
5154645-15464552.51352.51
6122951-12295141.75041.75
10min1260246-26024688.37285.634.5688.6485.884.58
2259498-25949888.11888.42
3245329-24532983.30683.55
4232087-23208778.81079.01
5254309-25430986.35686.65
6261484-26148488.79289.02
15min1277307-27730794.16591.414.1894.9392.154.19
2271913-27191392.33393.13
3268172-26817291.06391.77
4247765-24776584.13384.78
5271122-27112292.06592.84
6278955-27895594.72595.45
20min1284400-28440096.57495.142.8697.8696.382.88
2282130-28213095.80397.11
3285614-28561496.98698.20
4264522-26452289.82490.93
5279444-27944494.89196.17
6284880-28488096.73697.99
30min1289686-28968698.36897.322.18100.1999.092.20
2284679-28467996.66898.51
3291052-29105298.832100.58
4274959-27495993.36894.98
5287758-28775897.71499.52
6291515-29151598.990100.78
45min1291096-29109698.84798.102.49101.22100.412.50
2288163-28816397.851100.23
3296606-296606100.718103.02
4275433-27543393.52995.66
5290084-29008498.504100.86
6291939-29193999.134101.47
60min1288391-28839197.92998.101.59100.85100.951.61
2287439-28743997.605100.53
3295740-295740100.424103.28
4281659-28165995.64398.29
5289670-28967098.363101.26
6290412-29041298.615101.50
极限1294868-294868100.128101.701.23103.59105.101.20
2303828-303828103.171106.63
3303980-303980103.222106.64
4298237-298237101.272104.45
5298510-298510101.365104.81
6297475-297475101.013104.45
阿齐沙坦氨氯地平片项目信息
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4000
标示量(mg)5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%
115.267321873658739107357173557735830.34
215.327316773288732280.12
单位质量响应值RSD%判断
4821.954779.900.62数据可信
长期6月-供试品溶液-2024010621批-氨氯地平-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%
5min157790-5779078.04479.056.2078.0479.046.21
259997-5999781.02581.02
358457-5845778.94578.94
453990-5399072.91272.91
564656-6465687.31687.32
656299-5629976.03076.03
10min165692-6569288.71592.002.0089.1592.432.01
269222-6922293.48393.93
368695-6869592.77193.21
467551-6755191.22691.63
569344-6934493.64794.13
668220-6822092.12992.55
15min166660-6666090.02392.392.0290.9593.342.02
268602-6860292.64593.61
369457-6945793.80094.75
466727-6672790.11391.03
569559-6955993.93894.94
669470-6947093.81894.75
20min168017-6801791.85594.722.1793.2896.182.17
270991-7099195.87297.36
372071-7207197.33098.81
468656-6865692.71894.13
570363-7036395.02496.55
670717-7071795.50296.96
30min170355-7035595.01396.871.2796.9598.861.29
271842-7184297.02199.04
372688-7268898.163100.18
470972-7097295.84697.77
572508-7250897.92099.98
672029-7202997.27399.26
45min171990-7199097.22196.931.3699.6999.461.35
272980-7298098.558101.11
372714-7271498.199100.76
470409-7040995.08697.55
571199-7119996.15398.75
671364-7136496.37598.90
60min171646-7164696.75696.440.9699.7699.510.97
271270-7127096.24899.35
372485-7248597.889101.00
470387-7038795.05698.04
571489-7148996.54499.68
671211-7121196.16999.23
极限172551-7255197.97897.121.28101.52100.721.27
272224-7222497.537101.17
372630-7263098.085101.74
470148-7014894.73398.25
571806-7180696.972100.64
672123-7212397.400101.00
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.482773552774372770992775252772902773410.06
210.532781132780392780760.02
单位质量响应值RSD%判断
26463.8426407.980.15数据可信
长期6月-供试品溶液-2024010721批-阿齐沙坦-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%
5min1140959-14095947.84547.6820.9947.8547.6820.99
2168295-16829557.12457.12
394400-9440032.04232.04
4151116-15111651.29351.29
5118476-11847640.21440.21
6169670-16967057.59057.59
10min1260086-26008688.28089.477.4888.5589.747.50
2271317-27131792.09292.41
3226664-22666476.93577.11
4283621-28362196.26896.55
5273460-27346092.81993.04
6266445-26644590.43890.76
15min1280368-28036895.16495.864.9495.9296.624.96
2284134-28413496.44297.27
3257541-25754187.41688.02
4295320-295320100.239101.06
5295700-295700100.368101.11
6281413-28141395.51996.34
20min1291010-29101098.77697.563.74100.0698.863.80
2291702-29170299.011100.38
3266328-26632890.39891.49
4296453-296453100.624102.00
5291879-29187999.071100.37
6287206-28720697.48598.84
30min1291936-29193699.09098.291.98100.92100.132.04
2289642-28964298.312100.23
3279314-27931494.80696.40
4294452-29445299.944101.88
5294534-29453499.972101.82
6287599-28759997.61899.51
45min1290444-29044498.58498.961.69100.97101.351.76
2293718-29371899.695102.16
3283920-28392096.37098.49
4297275-297275100.903103.39
5295372-295372100.257102.66
6288640-28864097.972100.41
60min1293048-29304899.46899.081.68102.40102.021.75
2292216-29221699.185102.20
3284215-28421596.47099.13
4298007-298007101.151104.20
5295351-295351100.250103.21
6288675-28867597.984100.96
极限1304824-304824103.465102.161.49106.95105.641.35
2302684-302684102.739106.30
3307056-307056104.223107.41
4297381-297381100.939104.55
5297662-297662101.034104.55
6296309-296309100.575104.10
阿齐沙坦氨氯地平片项目信息
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4000
标示量(mg)5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%
115.267314273367728757306272865730620.29
215.327339673548734720.15
单位质量响应值RSD%判断
4787.814795.820.12数据可信
长期6月-供试品溶液-2024010721批-氨氯地平-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%
5min163437-6343785.83180.974.4785.8380.974.47
261971-6197183.84883.85
358635-5863579.33479.33
457433-5743377.70877.71
556695-5669576.70976.71
660876-6087682.36682.37
10min169416-6941693.92192.001.7894.4092.451.78
268441-6844192.60293.07
368373-6837392.51092.95
468337-6833792.46192.89
567556-6755691.40491.83
665839-6583989.08189.54
15min170020-7002094.73893.832.6595.7494.792.62
268236-6823692.32593.30
369029-6902993.39794.35
469387-6938793.88294.83
572434-7243498.00598.94
666997-6699790.64891.60
20min168424-6842492.57993.921.3494.1095.401.32
270220-7022095.00996.50
369732-6973294.34995.82
470525-7052595.42296.89
569310-6931093.77895.26
668268-6826892.36893.82
30min170256-7025695.05897.005.1197.1099.005.00
269496-6949694.02996.05
371227-7122796.37198.37
478999-78999106.887108.88
570851-7085195.86397.86
669308-6930893.77595.74
45min172190-7219097.67498.222.68100.24100.762.63
271974-7197497.38299.93
372650-7265098.297100.83
473707-7370799.727102.32
575429-75429102.057104.59
669601-6960194.17196.66
60min173129-7312998.94597.711.33102.05100.791.32
272556-7255698.170101.25
372773-7277398.463101.54
472583-7258398.206101.35
571731-7173197.053100.15
670507-7050795.39798.41
极限173251-7325199.11097.612.25102.77101.242.20
272193-7219397.678101.31
374142-74142100.315103.94
472667-7266798.320102.01
570962-7096296.01399.65
669650-6965094.23897.78
阿齐沙坦氨氯地平片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号68522100802对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.70对照品水分(%)0对照品稀释倍数1000
标示量(mg)20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%
110.482774772775222770192764072769742770800.17
210.532792712789802791260.08
单位质量响应值RSD%判断
26438.9326507.690.19数据可信
长期6月-供试品溶液-2024010921批-阿齐沙坦-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%
5min1162437-16243755.05756.2717.5355.0656.2717.53
2160160-16016054.28654.29
3132127-13212744.78444.78
4189685-18968564.29364.29
5209612-20961271.04771.05
6141994-14199448.12848.13
10min1273296-27329692.63391.236.4492.9491.546.45
2283580-28358096.11896.42
3240674-24067481.57581.82
4260723-26072388.37188.73
5288894-28889497.91998.31
6267756-26775690.75591.02
15min1282747-28274795.83695.114.0296.6695.934.06
2287314-28731497.38498.22
3260965-26096588.45389.15
4274683-27468393.10393.95
5292520-29252099.148100.09
6285474-28547496.76097.53
20min1282925-28292595.89696.492.3897.2597.842.41
2287513-28751397.45198.83
3274419-27441993.01394.21
4280378-28037895.03396.40
5290332-29033298.40799.90
6292503-29250399.143100.45
30min1285127-28512796.64397.862.3698.5399.742.39
2292589-29258999.172101.09
3277000-27700093.88895.60
4289466-28946698.113100.01
5292050-29205098.989101.03
6296041-296041100.342102.20
45min1292646-29264699.19198.831.76101.61101.251.76
2296825-296825100.608103.08
3283884-28388496.22198.45
4291559-29155998.823101.26
5287711-28771197.518100.10
6296819-296819100.606103.02
60min1288710-28871097.85798.681.94100.83101.651.98
2292750-29275099.226102.25
3283722-28372296.16698.93
4286965-28696597.266100.25
5298082-298082101.034104.16
6296579-296579100.524103.50
极限1299015-299015101.350102.951.99104.87106.481.90
2306761-306761103.975107.55
3304883-304883103.339106.64
4313738-313738106.340109.87
5297466-297466100.825104.51
6300586-300586101.882105.42
阿齐沙坦氨氯地平片项目信息
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4000
标示量(mg)5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%
115.267346473693730627328673272733550.33
215.327370073552736260.15
单位质量响应值RSD%判断
4807.014805.870.02数据可信
长期6月-供试品溶液-2024010921批-氨氯地平-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%
5min155491-5549174.85277.984.6374.8577.984.63
258731-5873179.22279.22
354049-5404972.90772.91
460830-6083082.05482.05
560296-6029681.33381.33
657475-5747577.52877.53
10min165438-6543888.26988.301.6688.6988.731.64
265282-6528288.05988.50
365517-6551788.37688.78
464788-6478887.39387.85
564278-6427886.70587.16
667453-6745390.98791.42
15min167539-6753991.10390.091.9192.0191.011.89
266306-6630689.44090.37
366462-6646289.65190.55
465861-6586188.84089.78
565571-6557188.44989.38
668987-6898793.05793.99
20min167916-6791691.61291.422.3693.0292.842.33
266946-6694690.30391.73
368763-6876392.75494.15
467427-6742790.95292.39
565460-6546088.29989.72
670133-7013394.60296.06
30min168463-6846392.35093.782.5794.2795.722.54
268037-6803791.77593.70
369703-6970394.02295.93
469802-6980294.15696.10
568315-6831592.15094.07
672836-7283698.248100.23
45min172639-7263997.98395.742.59100.4298.192.54
270843-7084395.56098.00
371577-7157796.55098.98
470774-7077495.46797.93
567586-6758691.16793.59
672434-7243497.706100.23
60min171170-7117096.00195.621.9798.9898.601.95
270604-7060495.23898.21
371181-7118196.01698.98
469673-6967393.98296.98
569396-6939693.60896.54
673289-7328998.860101.93
极限171643-7164396.63996.731.89100.15100.241.86
270906-7090695.64599.14
373274-7327498.839102.34
472492-7249297.784101.30
569491-6949193.73697.19
672452-7245297.730101.35
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