奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063615236339363263632136323362920.22
2 16.013648636211363480.54
单位质量响应值RSD%判断
2259.782270.330.33数据可信
供试品溶液-410453批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130942-3094288.56889.791.2788.5789.781.27
231513-3151390.20290.20
331708-3170890.76090.76
431444-3144490.00590.00
530821-3082188.22188.22
631776-3177690.95590.96
10min132388-3238892.70795.261.4692.8595.411.46
233444-3344495.72995.88
333812-3381296.78396.93
433232-3323295.12395.27
533276-3327695.24995.40
633524-3352495.95896.11
15min132687-3268793.56395.641.3593.8695.951.36
233684-3368496.41696.73
334019-3401997.37597.69
433407-3340795.62495.93
533204-3320495.04295.35
633479-3347995.83096.14
20min132581-3258193.25995.561.4693.7296.021.46
233696-3369696.45196.92
334024-3402497.39097.86
433293-3329395.29795.77
533245-3324595.16095.62
633462-3346295.78196.25
30min132776-3277693.81795.361.1494.4395.991.14
233719-3371996.51797.15
333745-3374596.59197.23
433342-3334295.43796.06
533053-3305394.61095.23
633254-3325495.18695.82
45min132663-3266393.49494.940.9794.2695.730.97
233573-3357396.09996.89
333366-3336695.50696.30
433219-3321995.08595.87
532951-3295194.31895.10
633244-3324495.15795.95
60min132626-3262693.38894.781.5094.3195.721.50
233580-3358096.11997.07
333823-3382396.81497.77
433148-3314894.88295.83
532710-3271093.62894.57
632781-3278193.83294.78
极限132437-3243792.84794.621.4693.9395.721.45
233724-3372496.53197.64
333530-3353095.97697.09
432955-3295594.33095.43
532806-3280693.90395.00
632892-3289294.14995.25
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药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250
标示量(mg)40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%
1 11.044427844439534434644429234430264432300.11
2 11.084439494413284426380.42
单位质量响应值RSD%判断
40147.6439949.280.36数据可信
供试品溶液-410453批-奥美沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364479-36447981.74582.282.6481.7582.282.64
2356210-35621079.89179.89
3384422-38442286.21886.22
4368758-36875882.70582.70
5360958-36095880.95680.96
6366319-36631982.15882.16
10min1410741-41074192.12193.672.0392.2693.812.03
2408409-40840991.59891.73
3432328-43232896.96297.11
4419635-41963594.11694.25
5415704-41570493.23493.37
6419158-41915894.00994.15
15min1417151-41715193.55895.012.0893.8595.302.08
2413872-41387292.82393.11
3438753-43875398.40398.71
4424046-42404695.10595.40
5420684-42068494.35194.64
6427157-42715795.80396.10
20min1416614-41661493.43895.292.1193.8895.742.11
2415042-41504293.08593.53
3439510-43951098.57399.04
4424771-42477195.26795.72
5423920-42392095.07795.52
6429272-42927296.27796.73
30min1419707-41970794.13295.311.8494.7395.921.84
2414115-41411592.87893.47
3436478-43647897.89398.53
4427022-42702295.77296.38
5423224-42322494.92195.53
6429144-42914496.24896.86
45min1418190-41819093.79295.252.0194.5596.022.01
2412866-41286692.59793.35
3437059-43705998.02398.82
4425653-42565395.46596.24
5424441-42444195.19395.96
6429828-42982896.40297.18
60min1417227-41722793.57695.062.1594.4995.992.15
2412690-41269092.55893.46
3439318-43931898.53099.49
4425688-42568895.47396.40
5423134-42313494.90095.82
6425101-42510195.34296.28
极限1426623-42662395.68397.381.5996.7598.471.60
2428051-42805196.00397.06
3445650-44565099.950101.07
4433386-43338697.20098.29
5434139-43413997.36998.45
6437404-43740498.10199.19
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.067272772894725387283972900727800.21
2 16.017348073777736280.29
单位质量响应值RSD%判断
4531.764598.881.04数据可信
供试品溶液-410314批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158197-5819782.65386.774.7082.6586.764.71
262160-6216088.28188.28
358765-5876583.45983.46
460905-6090586.49986.50
560366-6036685.73385.73
666163-6616393.96693.97
10min163098-6309889.61394.553.9789.7594.693.97
267300-6730095.58195.73
364974-6497492.27792.42
466364-6636494.25294.40
566694-6669494.72094.86
671003-71003100.840101.00
15min163768-6376890.56595.143.5490.8595.443.54
267697-6769796.14596.45
366002-6600293.73794.03
466547-6654794.51194.81
566938-6693895.06795.37
670984-70984100.813101.14
20min164383-6438391.43895.153.0291.8895.613.03
267668-6766896.10496.57
366029-6602993.77694.22
466278-6627894.12994.59
567212-6721295.45695.92
670410-7041099.998100.49
30min165029-6502992.35695.192.8992.9595.812.90
266755-6675594.80795.43
366404-6640494.30894.91
465976-6597693.70194.32
567327-6732795.61996.24
670647-70647100.334100.99
45min164715-6471591.91095.252.7692.6596.032.76
267396-6739695.71796.50
366798-6679894.86895.63
466017-6601793.75994.53
567225-6722595.47496.25
670259-7025999.783100.61
60min165451-6545192.95595.082.5293.8596.012.53
266892-6689295.00195.95
366201-6620194.02094.94
465769-6576993.40794.33
567275-6727595.54596.48
670084-7008499.535100.53
极限165835-6583593.50095.192.4294.5596.282.43
266482-6648294.41995.52
366605-6660594.59495.67
465672-6567293.26994.35
567507-6750795.87596.97
670048-7004899.484100.64
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药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250
标示量(mg)40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%
1 11.044465704475254460584471514476844469980.16
2 11.084510654524224517440.22
单位质量响应值RSD%判断
40488.9540771.120.50数据可信
供试品溶液-410314批-奥美沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338466-33846674.82578.164.6574.8278.164.65
2352203-35220377.86277.86
3345841-34584176.45576.46
4352709-35270977.97477.97
5346824-34682476.67376.67
6385364-38536485.19385.19
10min1391200-39120086.48390.814.1386.6190.944.13
2405838-40583889.71989.85
3405738-40573889.69789.82
4407115-40711590.00190.13
5412643-41264391.22391.35
6442188-44218897.75597.90
15min1401195-40119588.69292.623.6988.9692.903.69
2413720-41372091.46191.74
3416899-41689992.16492.44
4413856-41385691.49191.77
5420648-42064892.99393.27
6447482-44748298.92599.23
20min1406000-40600089.75592.953.2990.1793.393.29
2415446-41544691.84392.27
3418258-41825892.46592.90
4413492-41349291.41191.84
5423548-42354893.63494.07
6446044-44604498.60799.08
30min1408916-40891690.39993.303.1890.9793.893.18
2414190-41419091.56592.15
3421231-42123193.12293.71
4416162-41616292.00192.59
5424744-42474493.89894.49
6446923-44692398.80299.44
45min1405207-40520789.57993.243.1390.3093.983.13
2416643-41664392.10892.84
3423047-42304793.52394.26
4415800-41580091.92192.66
5425353-42535394.03394.78
6444479-44447998.26199.06
60min1409798-40979890.59493.112.9591.4694.012.95
2414669-41466991.67192.56
3418227-41822792.45893.35
4415556-41555691.86792.76
5424298-42429893.80094.70
6444531-44453198.27399.24
极限1428966-42896694.83296.402.7695.8597.462.77
2425856-42585694.14495.19
3435834-43583496.35097.40
4426653-42665394.32095.36
5442018-44201897.71798.78
6457098-457098101.051102.18
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063688637014368423704436903369380.24
2 16.013726937185372270.16
单位质量响应值RSD%判断
2300.002325.230.78数据可信
供试品溶液-SD018YD批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131748-3174889.00884.234.8089.0184.234.81
230165-3016584.57084.57
327363-2736376.71476.71
430165-3016584.57084.57
530368-3036885.13985.14
630453-3045385.37785.38
10min133292-3329293.33791.523.8593.4991.663.85
233807-3380794.78194.92
330958-3095886.79386.92
431142-3114287.30987.45
533183-3318393.03193.17
633483-3348393.87294.01
15min133703-3370394.48992.613.9594.7992.903.95
234745-3474597.41097.71
331907-3190789.45489.73
431130-3113087.27587.56
533481-3348193.86794.16
633238-3323893.18593.48
20min133744-3374494.60493.054.0395.0793.504.03
235035-3503598.22398.68
332206-3220690.29290.71
431178-3117887.41087.84
533578-3357894.13994.59
633396-3339693.62894.08
30min133916-3391695.08693.094.1895.7193.704.18
235213-3521398.72299.35
332834-3283492.05392.62
430981-3098186.85887.44
533163-3316392.97593.59
633126-3312692.87193.48
45min133931-3393195.12892.974.4895.9193.734.48
235415-3541599.289100.08
332173-3217390.20090.93
431068-3106887.10287.82
533224-3322493.14693.91
633159-3315992.96493.73
60min133680-3368094.42593.244.1495.3694.154.13
235438-3543899.353100.31
333304-3330493.37094.25
431222-3122287.53388.40
533234-3323493.17494.09
632659-3265991.56292.48
极限133675-3367594.41093.534.5095.5094.604.48
235445-3544599.373100.49
334124-3412495.66996.70
430929-3092986.71287.73
533128-3312892.87793.95
632861-3286192.12893.20
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药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250
标示量(mg)40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%
1 11.042241812248372241042256392244822246490.28
2 11.082267442262152264800.17
单位质量响应值RSD%判断
20348.6420440.430.32数据可信
供试品溶液-SD018YD批-奥美沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1186061-18606181.94478.363.6681.9478.363.66
2176209-17620977.60577.60
3166980-16698073.54073.54
4176256-17625677.62677.63
5181580-18158079.97079.97
6180480-18048079.48679.49
10min1207347-20734791.31989.684.0091.4689.824.00
2210165-21016592.56092.69
3196751-19675186.65286.77
4190334-19033483.82683.96
5208027-20802791.61891.75
6209195-20919592.13292.26
15min1214068-21406894.27992.394.1894.5792.684.18
2219239-21923996.55696.84
3206652-20665291.01291.28
4193978-19397885.43185.70
5213606-21360694.07594.36
6211193-21119393.01293.30
20min1216137-21613795.19093.244.2895.6493.674.28
2220870-22087097.27497.72
3209749-20974992.37692.80
4194750-19475085.77186.18
5215166-21516694.76295.20
6213541-21354194.04794.49
30min1218112-21811296.06093.864.3196.6694.444.30
2222782-22278298.11698.72
3212291-21229193.49694.07
4195937-19593786.29386.85
5215667-21566794.98395.58
6213880-21388094.19694.79
45min1217714-21771495.88494.084.3096.6594.834.30
2224507-22450798.87699.65
3212570-21257093.61994.35
4196879-19687986.70887.41
5215686-21568694.99195.75
6214344-21434494.40095.15
60min1216992-21699295.56694.014.3196.4994.924.31
2225208-22520899.185100.12
3212960-21296093.79194.68
4197064-19706486.79087.63
5215243-21524394.79695.71
6213333-21333393.95594.87
极限1221979-22197997.76397.104.6498.8598.164.62
2233954-233954103.037104.14
3226181-22618199.613100.65
4203209-20320989.49690.48
5219319-21931996.59197.67
6218212-21821296.10497.17
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100374-202106对照品来源中检所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1000
标示量(mg)10供试品稀释倍数1系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 16.063735237192373363718337328372780.23
2 16.013783837925378820.17
单位质量响应值RSD%判断
2321.172366.151.36数据可信
供试品溶液-SD005YD批-氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min130894-3089485.47283.405.9385.4783.405.93
228422-2842278.63378.63
330170-3017083.46983.47
433241-3324191.96591.97
528550-2855078.98778.99
629601-2960181.89581.89
10min134244-3424494.74090.215.0194.8890.345.01
232506-3250689.93290.06
333724-3372493.30193.44
433876-3387693.72293.88
530485-3048584.34084.47
630797-3079785.20485.34
15min134663-3466395.89991.084.7196.2091.374.70
233150-3315091.71391.99
333565-3356592.86293.16
434048-3404894.19894.51
531343-3134386.71486.99
630748-3074885.06885.35
20min134593-3459395.70691.054.4696.1791.494.46
232618-3261890.24290.68
333386-3338692.36692.82
434329-3432994.97595.44
531590-3159087.39787.81
630946-3094685.61686.04
30min134356-3435695.05091.523.9495.6792.113.94
233157-3315791.73392.32
333615-3361593.00093.60
434251-3425194.75995.38
532049-3204988.66789.23
631053-3105385.91286.47
45min134010-3401094.09391.353.7094.8792.103.71
233317-3331792.17592.91
333305-3330592.14292.90
434174-3417494.54695.33
532451-3245189.78090.49
630862-3086285.38386.09
60min134241-3424194.73291.103.6195.6792.003.61
232800-3280090.74591.64
333153-3315391.72292.63
434074-3407494.27095.21
532220-3222089.14090.00
631076-3107685.97586.82
极限133999-3399994.06290.703.5295.1691.753.53
231906-3190688.27289.31
333073-3307391.50092.57
434005-3400594.07995.18
532610-3261090.21991.23
631111-3111186.07287.06
奥美沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100864-202205对照品来源原料药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250
标示量(mg)40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%
1 11.042265792261862271432262202268382265930.19
2 11.082304572307292305930.09
单位质量响应值RSD%判断
20524.7320811.640.99数据可信
供试品溶液-SD005YD批-奥美沙坦酯-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1181613-18161378.92977.865.7878.9377.865.77
2171441-17144174.50974.51
3177073-17707376.95676.96
4198848-19884886.42086.42
5173484-17348475.39675.40
6172485-17248574.96274.96
10min1210232-21023291.36788.464.2691.5088.594.26
2204856-20485689.03189.15
3209334-20933490.97791.11
4211273-21127391.82091.96
5194429-19442984.49984.62
6191195-19119583.09483.22
15min1215090-21509093.47990.564.0793.7690.844.07
2211398-21139891.87492.15
3212540-21254092.37092.65
4215189-21518993.52293.82
5201666-20166687.64487.91
6194364-19436484.47184.73
20min1215906-21590693.83391.243.6994.2791.673.69
2212223-21222392.23392.66
3213737-21373792.89193.32
4216269-21626993.99194.44
5204984-20498489.08689.50
6196538-19653885.41685.82
30min1216101-21610193.91891.943.8194.5192.523.81
2214595-21459593.26393.84
3215392-21539293.61094.20
4218671-21867195.03595.64
5207521-20752190.18990.75
6196963-19696385.60086.15
45min1217681-21768194.60592.063.9395.3692.793.93
2215049-21504993.46194.20
3215174-21517493.51594.26
4218090-21809094.78295.55
5208562-20856290.64191.35
6196351-19635185.33586.02
60min1216303-21630394.00692.123.5094.9293.013.50
2213894-21389492.95993.85
3216228-21622893.97394.87
4218046-21804694.76395.69
5209109-20910990.87991.74
6198223-19822386.14886.98
极限1222605-22260596.74594.213.4197.8195.253.42
2215275-21527593.55994.60
3217900-21790094.70095.76
4225134-22513497.84498.93
5215851-21585193.80994.82
6203931-20393188.62989.60
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