替米沙坦左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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237638457631627634167631897640657635350.06
211.327610947611897611420.01
单位质量响应值RSD%判断
67990.6567238.690.79数据可信
供试品溶液-E21595批-pH1.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1102821-10282113.68712.967.9113.6912.977.90
297113-9711312.92712.93
382985-8298511.04611.05
4104788-10478813.94813.95
597204-9720412.93912.94
699468-9946813.24013.24
10min1188420-18842025.08124.378.9625.1624.448.95
2179710-17971023.92123.99
3152326-15232620.27620.34
4198683-19868326.44726.52
5185851-18585124.73924.81
6193465-19346525.75225.83
15min1246805-24680532.85334.108.0933.0734.318.08
2247346-24734632.92533.13
3223756-22375629.78429.96
4277685-27768536.96337.19
5266017-26601735.41035.62
6275326-27532636.64936.87
20min1310259-31025941.29942.068.4041.7042.468.39
2306158-30615840.75341.14
3270718-27071836.03636.38
4333248-33324844.35944.79
5331061-33106144.06844.47
6344539-34453945.86246.28
30min1404665-40466553.86555.389.1254.4956.029.10
2401182-40118253.40254.02
3355113-35511347.27047.81
4426332-42633256.75057.43
5449838-44983859.87960.53
6459343-45934361.14461.82
45min1511805-51180568.12768.435.1169.0569.365.10
2537006-53700671.48272.39
3480556-48055663.96764.77
4484502-48450264.49365.48
5531834-53183470.79371.78
6538671-53867171.70372.72
60min1609657-60965781.15277.694.3382.4679.004.30
2582955-58295577.59878.91
3561434-56143474.73375.89
4546219-54621972.70874.06
5597153-59715379.48880.86
6604293-60429380.43881.85
极限1695438-69543892.57189.612.6894.3391.362.70
2667533-66753388.85690.60
3654590-65459087.13388.71
4656737-65673787.41989.17
5670208-67020889.21291.03
6694807-69480792.48794.35
替米沙坦左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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237629647621117608247605897605567614090.15
211.327646687626907636790.19
单位质量响应值RSD%判断
67801.3467462.810.36数据可信
供试品溶液-E21595批-pH7.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1174144-17414423.17424.799.6623.1724.799.67
2203384-20338427.06527.07
3174688-17468823.24623.25
4213190-21319028.37028.37
5168583-16858322.43422.43
6183738-18373824.45124.45
10min1332760-33276044.28247.349.0944.4147.489.10
2383582-38358251.04551.20
3332903-33290344.30144.43
4406785-40678554.13254.29
5327991-32799143.64743.77
6350568-35056846.65146.79
15min1469578-46957862.48966.858.7762.8667.258.77
2532618-53261870.87771.31
3462608-46260861.56161.94
4572472-57247276.18176.64
5468217-46821762.30762.67
6508762-50876267.70368.10
20min1572334-57233476.16381.397.7776.8882.167.78
2639466-63946685.09685.92
3570998-57099875.98576.70
4687681-68768191.51292.39
5574802-57480276.49177.20
6624273-62427383.07483.85
30min1713176-71317694.90596.772.2796.0598.002.31
2744622-74462299.090100.39
3708183-70818394.24195.38
4732125-73212597.42798.82
5718277-71827795.58496.72
6746925-74692599.396100.63
45min1754702-754702100.43199.111.69102.10100.871.63
2731920-73192097.39999.25
3733730-73373097.64099.30
4737350-73735098.122100.05
5747610-74761099.487101.16
6763214-763214101.564103.35
60min1752915-752915100.19398.411.43102.42100.721.38
2738254-73825498.242100.63
3731822-73182297.38699.59
4728827-72882796.98899.46
5732983-73298397.54199.76
6752130-752130100.089102.44
极限1745577-74557799.21797.681.92102.00100.531.87
2738140-73814098.227101.16
3725313-72531396.52099.27
4717863-71786395.52998.54
5723343-72334396.25899.02
6753732-753732100.302103.21
替米沙坦左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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237622827631147627197636047633027630040.07
211.327554857545887550360.09
单位质量响应值RSD%判断
67943.3766699.291.31数据可信
供试品溶液-E21595批-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%
5min1166562-16656222.26922.222.0622.2722.222.06
2160871-16087121.50821.51
3170713-17071322.82422.82
4165547-16554722.13322.13
5164767-16476722.02922.03
6168862-16886222.57722.58
10min1335920-33592044.91242.023.5945.0442.143.58
2304397-30439740.69740.82
3314841-31484142.09442.22
4311120-31112041.59641.72
5312490-31249041.77941.90
6306901-30690141.03241.16
15min1484906-48490664.83160.254.1265.2060.614.11
2437439-43743958.48558.83
3449732-44973260.12960.49
4455186-45518660.85861.21
5443220-44322059.25859.61
6433462-43346257.95358.31
20min1599723-59972380.18274.973.5580.9275.663.55
2544333-54433372.77773.45
3549079-54907973.41174.11
4559107-55910774.75275.44
5554002-55400274.06974.75
6558028-55802874.60875.28
30min1710434-71043494.98493.511.1796.1694.611.18
2688318-68831892.02793.10
3694221-69422192.81693.92
4702930-70293093.98195.09
5695429-69542992.97894.07
6704947-70494794.25095.34
45min1702029-70202993.86098.222.6595.5799.852.57
2743978-74397899.469101.05
3745987-74598799.737101.36
4721116-72111696.41298.04
5754552-754552100.883102.49
6740290-74029098.976100.59
60min1721439-72143996.45598.531.6598.68100.701.60
2735079-73507998.279100.42
3744881-74488199.590101.76
4724270-72427096.83499.00
5751317-751317100.450102.62
6744546-74454699.545101.71
极限1727624-72762497.28298.491.58100.05101.211.54
2731218-73121897.763100.45
3734662-73466298.223100.95
4725162-72516296.95399.66
5745912-74591299.727102.46
6755174-755174100.966103.68
替米沙坦左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100629-202204对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1250
标示量(mg)80供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.237615257635557624327635007611037624230.15
211.327568837561597565210.07
单位质量响应值RSD%判断
67891.6366830.481.12数据可信
供试品溶液-E21595批-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%
5min130266-302664.0444.649.024.044.649.02
238420-384205.1345.13
332643-326434.3624.36
437652-376525.0315.03
535713-357134.7724.77
633512-335124.4784.48
10min189391-8939111.94412.363.5611.9712.393.56
296012-9601212.82912.86
388843-8884311.87111.90
496653-9665312.91412.94
592848-9284812.40612.43
691318-9131812.20212.23
15min1128705-12870517.19717.994.2517.2918.084.25
2141456-14145618.90119.00
3130308-13030817.41117.50
4141359-14135918.88818.99
5130513-13051317.43917.53
6135396-13539618.09118.18
20min1159682-15968221.33621.802.8321.5221.992.83
2167929-16792922.43822.64
3161197-16119721.53921.73
4169177-16917722.60522.81
5157583-15758321.05621.25
6163155-16315521.80021.99
30min1181619-18161924.26724.631.7224.5724.941.75
2187590-18759025.06525.39
3181240-18124024.21724.52
4188570-18857025.19625.53
5184628-18462824.66924.98
6182232-18223224.34924.66
45min1193122-19312225.80425.401.4226.2425.861.39
2191945-19194525.64726.12
3190590-19059025.46625.91
4189688-18968825.34525.82
5190036-19003625.39225.84
6185290-18529024.75825.21
60min1193173-19317325.81125.202.3826.3925.802.31
2191941-19194125.64726.26
3189302-18930225.29425.88
4184963-18496324.71425.33
5190694-19069425.48026.07
6181550-18155024.25824.85
极限1194270-19427025.95825.552.0326.6826.282.00
2194395-19439525.97426.73
3192194-19219425.68026.40
4191187-19118725.54626.29
5191363-19136325.56926.30
6183812-18381224.56025.28
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