替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7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%
114.125211452198520585215951948520950.19
214.105211252226521690.16
单位质量响应值RSD%判断
3689.453699.930.21数据可信
供试品溶液-F94945批-氢氯噻嗪-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%
5min138218-3821874.25469.329.5574.2569.329.55
235220-3522068.42968.43
335148-3514868.28968.29
436580-3658071.07171.07
539320-3932076.39576.39
629593-2959357.49657.50
10min146899-4689991.12086.076.6691.5386.466.67
244069-4406985.62286.00
344904-4490487.24487.62
443148-4314883.83284.23
547474-4747492.23792.66
639310-3931076.37576.69
15min146780-4678090.88990.364.6291.8191.224.64
246789-4678990.90691.76
347200-4720091.70592.57
445665-4566588.72389.58
549587-4958796.34397.28
643017-4301783.57884.32
20min147995-4799593.25093.194.5194.6794.564.50
251450-5145099.962101.32
346592-4659290.52491.90
447375-4737592.04593.40
549161-4916195.51596.99
645223-4522387.86489.07
30min147959-4795993.18092.622.9695.1294.512.99
246791-4679190.91092.83
347590-4759092.46394.34
447231-4723191.76593.63
550260-5026097.65099.65
646206-4620689.77491.47
45min150887-5088798.86895.583.15101.3397.983.16
247586-4758692.45594.88
349486-4948696.14698.54
448351-4835193.94196.32
551097-5109799.276101.82
647747-4774792.76894.96
60min149188-4918895.56795.001.9398.5897.931.96
248014-4801493.28696.22
348636-4863694.49597.42
448314-4831493.86996.77
550640-5064098.389101.49
648588-4858894.40297.11
极限150492-5049298.10195.042.25101.6498.502.27
247685-4768592.64796.10
348492-4849294.21597.66
448737-4873794.69198.11
549993-4999397.131100.77
648109-4810993.47196.71
替米沙坦氢氯噻嗪片项目信息
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对照品来源中检所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%
111.201772241785641778871769341776911776600.36
211.121779051776871777960.09
单位质量响应值RSD%判断
15862.5015988.850.57数据可信
供试品溶液-F94945批-替米沙坦-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%
5min113445-134457.5988.5820.647.608.5820.65
217623-176239.9599.96
311914-119146.7336.73
414967-149678.4588.46
520139-2013911.38111.38
612993-129937.3437.34
10min136105-3610520.40420.466.3720.4520.516.39
238835-3883521.94722.00
334059-3405919.24819.29
436678-3667820.72820.77
538482-3848221.74721.81
633106-3310618.70918.75
15min141995-4199523.73324.062.9423.8924.222.98
244317-4431725.04525.22
342641-4264124.09824.24
442048-4204823.76323.92
543622-4362224.65224.84
640822-4082223.07023.21
20min143444-4344424.55225.203.9824.8425.503.98
247997-4799727.12527.44
343020-4302024.31224.59
444550-4455025.17725.47
544516-4451625.15825.48
644030-4403024.88325.16
30min142769-4276924.17024.892.0524.5925.322.05
243474-4347424.56925.04
343883-4388324.80025.21
444403-4440325.09425.53
545417-4541725.66726.13
644314-4431425.04325.45
45min145846-4584625.90925.341.4926.4725.911.44
244050-4405024.89425.50
345145-4514525.51326.06
444564-4456425.18525.76
545139-4513925.51026.11
644263-4426325.01525.56
60min144114-4411424.93025.110.8225.6325.820.82
244757-4475725.29426.04
344568-4456825.18725.88
443864-4386424.78925.50
544486-4448625.14125.89
644755-4475525.29325.98
极限144746-4474625.28725.330.5226.1326.180.42
244500-4450025.14826.03
345105-4510525.49026.32
444840-4484025.34126.19
544654-4465425.23526.12
645034-4503425.45026.28
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7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%
114.125204752124521125221752129521260.12
214.105231652379523480.09
单位质量响应值RSD%判断
3691.643712.620.41数据可信
供试品溶液-F57850批-氢氯噻嗪-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%
5min134822-3482267.52069.674.2967.5269.674.29
234727-3472767.33667.34
337443-3744372.60272.60
437642-3764272.98872.99
536814-3681471.38371.38
634146-3414666.20966.21
10min141495-4149580.45983.052.1180.8383.442.12
242204-4220481.83482.21
343839-4383985.00485.41
443715-4371584.76485.17
543082-4308283.53683.93
642666-4266682.73083.10
15min145207-4520787.65789.101.7288.4889.951.72
244831-4483186.92887.76
346495-4649590.15491.03
446902-4690290.94391.82
546211-4621189.60390.46
646078-4607889.34590.17
20min144987-4498787.23090.161.9188.5491.511.90
246069-4606989.32890.64
346422-4642290.01391.39
446913-4691390.96592.35
547285-4728591.68693.04
647319-4731991.75293.08
30min145616-4561688.45092.432.1590.2494.272.14
247933-4793392.94294.75
348339-4833993.73095.61
448247-4824793.55195.44
547897-4789792.87394.74
647971-4797193.01694.85
45min146512-4651290.18793.802.2592.4796.162.24
248231-4823193.52095.84
348913-4891394.84397.24
449543-4954396.06498.47
549125-4912595.25497.64
647926-4792692.92995.28
60min146716-4671690.58393.691.7093.3796.571.70
248282-4828293.61996.46
348686-4868694.40297.33
448632-4863294.29897.24
549009-4900995.02997.94
648582-4858294.20197.07
极限148912-4891294.84194.862.5798.1398.262.49
248616-4861694.26797.63
347485-4748592.07495.52
448792-4879294.60898.07
551268-5126899.409102.85
648454-4845493.95397.34
替米沙坦氢氯噻嗪片项目信息
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对照品来源中检所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%
111.201774781768911770941768771772121771100.15
211.121775011782101778560.29
单位质量响应值RSD%判断
15813.3915994.240.81数据可信
供试品溶液-F57850批-替米沙坦-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%
5min115400-154008.7159.088.048.729.088.02
213800-138007.8107.81
317467-174679.8859.88
416541-165419.3619.36
516229-162299.1849.18
616778-167789.4959.50
10min131601-3160117.88418.684.3317.9318.734.35
231344-3134417.73817.78
334805-3480519.69719.75
433637-3363719.03619.09
532398-3239818.33518.39
634214-3421419.36219.42
15min141866-4186623.69323.461.7523.8423.611.75
240527-4052722.93523.08
342194-4219423.87824.04
440919-4091923.15723.31
541018-4101823.21323.37
642200-4220023.88224.04
20min144246-4424625.04024.861.1825.3225.141.18
243301-4330124.50524.77
343694-4369424.72725.02
443601-4360124.67524.96
544019-4401924.91125.19
644741-4474125.32025.61
30min144236-4423625.03425.340.8325.4525.760.83
245015-4501525.47525.88
344836-4483625.37425.81
444661-4466125.27525.70
544570-4457025.22325.64
645303-4530325.63826.07
45min144302-4430225.07125.220.7325.6325.780.72
244380-4438025.11625.66
344260-4426025.04825.62
444985-4498525.45826.02
544951-4495125.43926.00
644503-4450325.18525.76
60min144728-4472825.31224.981.4226.0125.691.41
243506-4350624.62125.31
344659-4465925.27325.99
444119-4411924.96825.67
543284-4328424.49525.20
644602-4460225.24125.96
极限145850-4585025.94725.542.3326.7826.392.25
244940-4494025.43226.26
343849-4384924.81525.67
444191-4419125.00925.85
546685-4668526.42027.26
645316-4531625.64526.50
替米沙坦氢氯噻嗪片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100309-202205对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.7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%
114.125179352011520275211352034519960.24
214.105179451927518600.19
单位质量响应值RSD%判断
3682.443678.010.09数据可信
供试品溶液-23K2033批-氢氯噻嗪-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%
5min136659-3665971.50571.513.3571.5071.513.35
238303-3830374.71174.71
336655-3665571.49771.50
434981-3498168.23268.23
537694-3769473.52373.52
635690-3569069.61569.61
10min140961-4096179.89682.191.5080.2982.581.49
242557-4255783.00983.42
342622-4262283.13683.53
442276-4227682.46182.84
542475-4247582.84983.26
641928-4192881.78282.17
15min146026-4602689.77590.392.0890.6291.252.06
245659-4565989.05989.94
347322-4732292.30393.16
446950-4695091.57892.41
547177-4717792.02092.89
644923-4492387.62488.46
20min146220-4622090.15491.783.5291.4993.143.49
247185-4718592.03693.41
347853-4785393.33994.71
444540-4454086.87788.22
549511-4951196.57397.95
647023-4702391.72093.05
30min146416-4641690.53695.402.7992.3897.272.75
248426-4842694.45796.34
350149-5014997.81799.71
449824-4982497.18399.01
549066-4906695.70597.62
649584-4958496.71598.55
45min148646-4864694.88698.582.0997.23100.982.06
251750-51750100.940103.35
351129-5112999.729102.16
450535-5053598.570100.94
550349-5034998.207100.66
650844-5084499.173101.55
60min148690-4869094.97198.152.6797.84101.102.63
250803-5080399.093102.06
351674-51674100.792103.78
450910-5091099.302102.22
551270-51270100.004103.00
648580-4858094.75797.68
极限148582-4858294.76198.132.0798.16101.622.05
250489-5048998.480102.00
351254-5125499.973103.52
450858-5085899.200102.67
551113-5111399.698103.25
649571-4957196.690100.14
替米沙坦氢氯噻嗪片项目信息
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对照品来源中检所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%
111.208968089464893668966089760895860.19
211.128901289290891510.23
单位质量响应值RSD%判断
7998.758017.180.17数据可信
供试品溶液-23K2033批-替米沙坦-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%
5min117717-1771719.91221.7022.0419.9121.7022.04
218159-1815920.40920.41
314468-1446816.26016.26
422905-2290525.74325.74
516712-1671218.78218.78
625908-2590829.11829.12
10min125077-2507728.18428.157.5828.2928.267.64
224390-2439027.41227.52
322880-2288025.71425.80
425518-2551828.67928.82
523970-2397026.93927.04
628438-2843831.96132.12
15min133267-3326737.38836.293.0137.6636.573.06
231880-3188035.82936.10
330674-3067434.47434.71
432490-3249036.51536.82
532183-3218336.17036.42
633245-3324537.36337.70
20min134793-3479339.10338.914.5339.5839.394.49
235047-3504739.38939.85
333476-3347637.62338.05
432146-3214636.12836.63
536312-3631240.81041.27
635953-3595340.40740.95
30min137488-3748842.13242.212.0042.8242.902.06
237035-3703541.62342.31
336862-3686241.42942.06
437521-3752142.16942.88
537461-3746142.10242.78
638980-3898043.80944.58
45min138951-3895143.77644.492.9244.7045.422.94
240641-4064145.67646.59
337978-3797842.68343.55
439461-3946144.35045.29
539320-3932044.19145.11
641152-4115246.25047.26
60min139585-3958544.48944.881.6645.6646.061.70
240493-4049345.50946.68
338969-3896943.79744.90
439567-3956744.46945.66
540310-4031045.30446.46
640667-4066745.70546.98
极限139984-3998444.93745.822.1946.3547.242.22
240556-4055645.58047.00
339506-3950644.40045.74
441343-4134346.46547.90
541610-4161046.76548.18
641596-4159646.74948.27
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