厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.309151791366913099141491131913470.16
212.379151591502915080.02
单位质量响应值RSD%判断
7426.597397.570.28数据可信
供试品溶液-FA4444批-氢氯噻嗪-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%
5min124025-2402525.85321.8215.3625.8521.8215.36
217227-1722718.53818.54
320242-2024221.78221.78
416805-1680518.08418.08
523817-2381725.62925.63
619534-1953421.02021.02
10min174634-7463480.31382.803.9880.4482.903.98
273318-7331878.89678.99
381144-8114487.31887.43
475201-7520180.92381.01
579551-7955185.60485.73
677808-7780883.72883.83
15min185363-8536391.85892.732.3992.3993.252.40
282827-8282789.12989.62
388415-8841595.14295.69
485407-8540791.90592.40
587713-8771394.38794.94
687297-8729793.93994.46
20min188022-8802294.71994.853.5395.7195.843.53
283190-8319089.52090.45
392831-9283199.894100.92
487338-8733893.98394.94
589178-8917895.96396.99
688295-8829595.01396.01
30min190505-9050597.39196.122.4198.8597.582.42
285487-8548791.99193.37
391883-9188398.874100.39
488862-8886295.62397.05
589697-8969796.52298.03
689510-8951096.32097.79
45min187807-8780794.48898.753.9396.44100.693.89
290450-9045097.33299.17
398191-98191105.662107.68
489480-8948096.28898.19
592609-9260999.655101.65
692079-9207999.085101.03
60min191029-9102997.95597.912.43100.38100.352.44
287332-8733293.97796.30
394257-94257101.429103.97
491457-9145798.416100.80
590686-9068697.586100.07
691187-9118798.125100.57
极限193620-93620100.743101.192.10103.66104.122.11
291961-9196198.958101.75
397736-97736105.172108.22
493005-93005100.081102.96
594146-94146101.309104.29
693761-93761100.895103.83
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
114.812588012583522585162583532584172584880.08
214.842582822580712581760.06
单位质量响应值RSD%判断
17453.6117397.300.23数据可信
供试品溶液-FA4444批-厄贝沙坦-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%
5min132335-3233512.37110.6314.1412.3710.6314.14
223602-236029.0309.03
328372-2837210.85510.85
423441-234418.9688.97
532115-3211512.28712.29
626823-2682310.26210.26
10min1113265-11326543.33344.184.3543.4044.234.35
2109325-10932541.82641.87
3120849-12084946.23546.29
4111157-11115742.52742.57
5121245-12124546.38646.45
6116950-11695044.74344.79
15min1156834-15683460.00260.982.7860.2861.252.79
2153039-15303958.55058.80
3162714-16271462.25262.54
4156858-15685860.01160.27
5164162-16416262.80663.10
6162658-16265862.23062.51
20min1183904-18390470.35971.003.1370.9471.583.13
2176274-17627467.43967.99
3193537-19353774.04474.64
4184023-18402370.40470.96
5188990-18899072.30472.91
6186800-18680071.46772.05
30min1215666-21566682.51082.081.9883.4483.021.99
2205989-20598978.80879.69
3215926-21592682.61083.58
4215742-21574282.53983.45
5217152-21715283.07984.05
6216774-21677482.93483.88
45min1240824-24082492.13595.352.4593.4896.692.44
2245763-24576394.02595.30
3258558-25855898.920100.30
4247133-24713394.54995.87
5252320-25232096.53397.92
6250710-25071095.91797.28
60min1245578-24557893.95493.701.9095.7695.521.90
2235681-23568190.16891.92
3246638-24663894.36096.23
4248471-24847195.06196.86
5245811-24581194.04395.91
6247352-24735294.63396.47
极限1257579-25757998.54597.841.09100.82100.131.11
2250270-25027095.74997.95
3257783-25778398.623100.97
4256337-25633798.070100.34
5255893-25589397.900100.24
6256500-25650098.133100.44
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5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%
112.309138791531914119142791468914450.07
212.379123091261912460.03
单位质量响应值RSD%判断
7434.557376.390.56数据可信
供试品溶液-FA4444批-氢氯噻嗪-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%
5min122059-2205923.75921.879.6923.7621.879.69
217407-1740718.74818.75
321977-2197723.67023.67
421785-2178523.46423.46
518651-1865120.08820.09
619934-1993421.47021.47
10min176906-7690682.83283.512.4282.9583.622.41
277907-7790783.91084.00
374061-7406179.76879.89
478321-7832184.35684.47
578954-7895485.03885.14
679069-7906985.16285.27
15min186298-8629892.94892.201.6293.4892.731.61
285985-8598592.61193.12
383998-8399890.47190.99
483759-8375990.21390.75
586523-8652393.19093.72
687059-8705993.76894.30
20min190240-9024097.19494.582.1498.1995.572.13
286262-8626292.90993.89
386177-8617792.81893.79
486002-8600292.62993.62
589080-8908095.94496.94
689129-8912995.99797.00
30min192052-9205299.14595.312.29100.6396.772.27
287242-8724293.96595.41
387827-8782794.59596.03
486350-8635093.00494.46
589483-8948396.37897.85
687981-8798194.76196.24
45min192763-9276399.91196.722.06101.8998.662.04
287330-8733094.05995.97
389418-8941896.30898.21
488706-8870695.54197.46
590674-9067497.66199.61
689908-8990896.83698.79
60min190547-9054797.52496.441.06100.0098.871.07
289249-8924996.12698.51
387900-8790094.67397.06
489531-8953196.43098.83
589668-8966896.57899.02
690373-9037397.33799.78
极限193397-93397100.59498.001.47103.56100.901.47
289769-8976996.68699.55
390897-9089797.901100.76
489748-8974896.66499.54
591245-9124598.276101.20
690888-9088897.892100.82
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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对照品水分(%)0对照品稀释倍数1000
标示量(mg)150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%
114.812589242583232586062584132588532586240.11
214.842581382580192580780.04
单位质量响应值RSD%判断
17462.8017390.700.30数据可信
供试品溶液-FA4444批-厄贝沙坦-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%
5min128026-2802610.72110.268.4010.7210.268.39
223279-232798.9068.91
328527-2852710.91310.91
429190-2919011.16711.17
525157-251579.6249.62
626660-2666010.19910.20
10min1113449-11344943.40144.322.5443.4544.372.54
2116009-11600944.38044.42
3111300-11130042.57842.63
4117321-11732144.88244.94
5118629-11862945.38245.43
6118431-11843145.30645.36
15min1154438-15443859.08160.361.8059.3560.631.79
2158300-15830060.55960.82
3155424-15542459.45859.73
4156544-15654459.88760.17
5160209-16020961.28961.56
6161725-16172561.86962.15
20min1183939-18393970.36770.551.6370.9371.121.63
2181633-18163369.48570.05
3181440-18144069.41169.98
4183374-18337470.15170.73
5187598-18759871.76772.35
6188542-18854272.12872.71
30min1213825-21382581.80081.210.9782.7282.140.97
2210280-21028080.44481.36
3211945-21194581.08181.99
4209883-20988380.29281.22
5215257-21525782.34883.29
6212548-21254881.31182.26
45min1233747-23374789.42189.251.2990.7590.581.28
2228913-22891387.57288.89
3234365-23436589.65890.97
4230831-23083188.30689.64
5237411-23741190.82392.17
6234536-23453689.72391.08
60min1235867-23586790.23292.031.0692.0193.821.04
2241677-24167792.45594.21
3239873-23987391.76593.53
4241163-24116392.25894.03
5241836-24183692.51694.32
6243058-24305892.98394.79
极限1245338-24533893.85594.840.8696.0897.080.84
2246816-24681694.42196.64
3251466-25146696.20098.42
4246850-24685094.43496.67
5248365-24836595.01397.28
6248565-24856595.09097.36
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