阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195157951767515205155551757516360.23
212.235145251397514240.08
单位质量响应值RSD%判断
4235.934204.740.53数据可信
中间条件3月-供试品溶液-24051501批-左氨氯地平-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%
5min149555-4955594.89696.292.8594.9096.302.85
248402-4840292.68892.69
351838-5183899.26899.27
450293-5029396.30996.31
552073-5207399.71899.72
649549-4954994.88494.88
10min151156-5115697.96298.242.3198.4998.772.31
249663-4966395.10395.62
352715-52715100.947101.50
451373-5137398.37798.91
552503-52503100.541101.10
650391-5039196.49797.02
15min149979-4997995.70896.952.6896.7898.032.67
248672-4867293.20594.25
352394-52394100.332101.44
451256-5125698.15399.23
551560-5156098.73599.85
649903-4990395.56296.63
20min150024-5002495.79496.072.5297.4097.702.53
248479-4847992.83594.40
351628-5162898.865100.54
450549-5054996.79998.43
551362-5136298.356100.02
648978-4897893.79195.38
30min149885-4988595.52895.072.2297.6697.222.23
247955-4795591.83293.91
350929-5092997.52799.75
449862-4986295.48497.65
550475-5047596.65898.87
648772-4877293.39695.51
45min148007-4800791.93193.372.7194.6096.052.69
246661-4666189.35491.94
350230-5023096.18898.95
448746-4874693.34796.04
549993-4999395.73598.48
648907-4890793.65596.29
60min148450-4845092.78092.852.2995.9696.052.29
246668-4666889.36792.45
349308-4930894.42397.72
448629-4862993.12396.34
549859-4985995.47898.75
647998-4799891.91495.07
极限148444-4844492.76892.932.8796.4696.652.85
246161-4616188.39691.98
349956-4995695.66499.48
448830-4883093.50797.24
549798-4979895.36199.17
647989-4798991.89795.56
阿齐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%
111.293967233966083967283956913967883965080.12
211.343943183942633942900.01
单位质量响应值RSD%判断
35120.2834769.840.71数据可信
中间条件3月-供试品溶液-24051501批-阿齐沙坦-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%
5min14360-43601.1201.1522.471.121.1522.50
24266-42661.0951.10
35389-53891.3841.38
44953-49531.2721.27
55313-53131.3641.36
62667-26670.6850.68
10min116270-162704.1784.1210.604.184.1210.64
216902-169024.3404.35
317853-178534.5844.59
415703-157034.0324.04
516612-166124.2664.27
612891-128913.3103.31
15min124692-246926.3406.296.746.376.326.79
225848-258486.6376.67
326318-263186.7586.79
424178-241786.2086.24
524256-242566.2286.26
621620-216205.5525.57
20min130737-307377.8937.775.527.967.845.53
231835-318358.1758.24
331947-319478.2038.27
429708-297087.6287.69
529961-299617.6937.76
627433-274337.0447.10
30min138859-388599.9789.774.5210.099.874.54
239888-3988810.24210.35
339556-3955610.15710.27
437353-373539.5929.70
537199-371999.5529.66
635354-353549.0789.17
45min145706-4570611.73611.772.8511.9011.942.86
246863-4686312.03412.20
347285-4728512.14212.31
444696-4469611.47711.64
546600-4660011.96612.13
643977-4397711.29211.44
60min153899-5389913.84013.413.2514.0713.633.25
252962-5296213.60013.84
351671-5167113.26813.51
450060-5006012.85413.08
554053-5405313.88014.11
650586-5058612.99013.19
极限158839-5883915.10914.881.6515.4115.181.69
257991-5799114.89115.20
358071-5807114.91215.23
457598-5759814.79015.08
558956-5895615.13915.44
656333-5633314.46514.74
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195143151407513615135351462514030.09
212.235152051460514900.09
单位质量响应值RSD%判断
4216.824210.140.12数据可信
中间条件3月-供试品溶液-24051501批-左氨氯地平-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%
5min149240-4924094.44595.841.5294.4495.841.53
250720-5072097.28497.28
350077-5007796.05096.05
449656-4965695.24395.24
549146-4914694.26594.26
650968-5096897.75997.76
10min150907-5090797.64297.952.4298.1798.482.42
251916-5191699.578100.12
351103-5110398.01898.55
451780-5178099.31799.85
548716-4871693.44093.96
651976-5197699.693100.24
15min150619-5061997.09097.351.6598.1698.421.65
251106-5110698.02499.12
351264-5126498.32799.41
450713-5071397.27098.35
549215-4921594.39795.44
651596-5159698.964100.06
20min150175-5017596.23896.432.1897.8498.052.17
251288-5128898.373100.01
350587-5058797.02898.65
450674-5067497.19598.82
548164-4816492.38193.95
650766-5076697.37299.02
30min148378-4837892.79195.612.5394.9397.762.51
251042-5104297.901100.09
350264-5026496.40998.57
450219-5021996.32398.48
548196-4819692.44294.52
650992-5099297.80599.99
45min146764-4676489.69693.713.1992.3596.393.14
249850-4985095.61598.34
350395-5039596.66099.36
449107-4910794.19096.89
547086-4708690.31392.91
649938-4993895.78498.51
60min145551-4555187.36992.543.2590.5295.753.20
249656-4965695.24398.50
348919-4891993.82997.07
448501-4850193.02796.25
547338-4733890.79793.89
649528-4952894.99798.26
极限144833-4483385.99291.503.8689.6395.223.78
248852-4885293.70197.49
349220-4922094.40698.16
448098-4809892.25495.99
546062-4606288.34991.95
649177-4917794.32498.11
阿齐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%
111.293942673941883943063943923946453943600.05
211.343949023949613949320.02
单位质量响应值RSD%判断
34930.0334826.460.21数据可信
中间条件3月-供试品溶液-24051501批-阿齐沙坦-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%
5min13884-38840.9991.119.111.001.119.13
24315-43151.1101.11
33846-38460.9890.99
44308-43081.1081.11
54846-48461.2471.25
64591-45911.1811.18
10min115009-150093.8614.053.423.874.063.44
215776-157764.0594.06
315378-153783.9563.96
415575-155754.0074.01
516396-163964.2184.23
616302-163024.1944.20
15min123559-235596.0616.152.436.096.182.44
223828-238286.1306.16
323676-236766.0916.12
423186-231865.9655.99
524803-248036.3816.41
624328-243286.2596.29
20min129488-294887.5867.591.727.657.651.74
229701-297017.6417.70
329166-291667.5037.56
428729-287297.3917.45
530177-301777.7647.83
629762-297627.6577.72
30min137497-374979.6479.621.809.759.731.78
237656-376569.6889.79
336910-369109.4969.60
436361-363619.3549.46
538265-382659.8449.95
637723-377239.7059.81
45min144274-4427411.39011.572.5811.5511.732.55
244582-4458211.46911.63
345077-4507711.59711.75
443823-4382311.27411.43
547149-4714912.13012.29
644973-4497311.57011.73
60min149750-4975012.79912.972.8013.0213.202.79
249655-4965512.77513.00
349267-4926712.67512.89
450325-5032512.94713.16
553170-5317013.67913.91
650416-5041612.97013.20
极限154940-5494014.13414.401.7114.4314.701.71
255395-5539514.25114.55
355702-5570214.33014.62
456025-5602514.41314.70
557725-5772514.85115.16
656048-5604814.41914.72
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195153851571515525150651484515300.07
212.235170051628516640.10
单位质量响应值RSD%判断
4227.244224.370.05数据可信
中间条件3月-供试品溶液-24051502批-左氨氯地平-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%
5min148865-4886593.45295.542.1093.4595.532.10
249221-4922194.13394.13
349251-4925194.19094.19
450095-5009595.80595.80
550701-5070196.96396.96
651593-5159398.66998.67
10min150927-5092797.39697.881.1897.9198.411.19
250688-5068896.93997.46
350820-5082097.19197.71
450809-5080997.17097.70
551645-5164598.76999.31
652194-5219499.819100.37
15min149822-4982295.28296.471.6396.3497.541.63
249702-4970295.05396.11
349858-4985895.35196.41
450469-5046996.52097.59
551039-5103997.61098.70
651755-5175598.979100.08
20min150142-5014295.89497.021.2897.4898.631.28
250835-5083597.22098.81
350070-5007095.75797.35
450437-5043796.45998.07
551164-5116497.84999.48
651741-5174198.952100.61
30min149694-4969495.03896.501.7597.1698.651.73
249804-4980495.24897.38
350312-5031296.22098.34
451213-5121397.943100.09
549889-4988995.41197.58
651847-5184799.155101.36
45min147662-4766291.15292.621.5593.8095.311.54
247652-4765291.13293.79
348073-4807391.93894.60
448660-4866093.06095.75
549269-4926994.22596.93
649270-4927094.22796.98
60min147748-4774891.31692.131.3794.4795.331.37
247638-4763891.10694.27
347449-4744990.74493.91
448483-4848392.72295.93
548626-4862692.99596.22
649106-4910693.91397.19
极限147163-4716390.19791.521.6093.8695.231.59
247339-4733990.53494.21
347180-4718090.23093.90
448068-4806891.92895.65
548303-4830392.37796.12
649066-4906693.83797.64
阿齐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%
111.293947543950543949513948993945053948330.06
211.343962913963123963020.01
单位质量响应值RSD%判断
34971.9234947.270.05数据可信
中间条件3月-供试品溶液-24051502批-阿齐沙坦-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%
5min17129-71291.8301.766.961.831.766.96
26805-68051.7471.75
37348-73481.8861.89
46300-63001.6171.62
56321-63211.6221.62
67334-73341.8821.88
10min117735-177354.5524.424.634.564.424.58
216648-166484.2734.28
318485-184854.7454.75
416318-163184.1884.20
516832-168324.3204.33
617197-171974.4144.42
15min124804-248046.3666.352.766.406.382.75
224384-243846.2596.29
325925-259256.6546.69
423933-239336.1436.18
524905-249056.3926.43
624414-244146.2666.30
20min130471-304717.8217.812.127.897.882.12
230763-307637.8967.96
331293-312938.0328.11
429501-295017.5727.64
530644-306447.8657.93
629884-298847.6707.74
30min138311-383119.8339.971.809.9510.081.79
238902-389029.98510.10
340179-4017910.31310.43
438759-387599.94810.06
538313-383139.8349.95
638564-385649.89810.01
45min146257-4625711.87312.052.4012.0412.222.40
247570-4757012.21012.38
348667-4866712.49112.67
446029-4602911.81411.98
547421-4742112.17112.34
645751-4575111.74311.91
60min151191-5119113.13913.331.8413.3713.571.85
252313-5231313.42713.66
353039-5303913.61313.86
451202-5120213.14213.37
553004-5300413.60413.84
650958-5095813.07913.31
极限156154-5615414.41314.601.0914.7214.921.10
257471-5747114.75115.06
357290-5729014.70415.03
456314-5631414.45414.76
557569-5756914.77615.09
656610-5661014.53014.84
阿齐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100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数6250
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.195135951370514375141251409513970.07
212.235136851490514290.17
单位质量响应值RSD%判断
4216.324205.150.19数据可信
中间条件3月-供试品溶液-24051502批-左氨氯地平-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%
5min148323-4832392.74694.151.7092.7594.151.70
248533-4853393.14993.15
349017-4901794.07894.08
448961-4896193.97193.97
548828-4882893.71693.72
650664-5066497.23997.24
10min149728-4972895.44396.631.6795.9697.151.67
249622-4962295.24095.76
350070-5007096.09996.62
450439-5043996.80897.33
550291-5029196.52497.04
651932-5193299.673100.21
15min148262-4826292.62996.223.1193.6797.283.09
249947-4994795.86396.91
348839-4883993.73794.79
450379-5037996.69297.75
550672-5067297.25598.31
652688-52688101.124102.22
20min148862-4886293.78195.232.5495.3496.822.53
249360-4936094.73796.32
348096-4809692.31193.89
449761-4976195.50697.10
549787-4978795.55697.15
651826-5182699.470101.13
30min147087-4708790.37493.873.0392.4695.993.01
247972-4797292.07394.18
348437-4843792.96595.06
449026-4902694.09696.22
549541-4954195.08497.21
651386-5138698.625100.83
45min144611-4461185.62290.283.2988.2192.923.25
246838-4683889.89692.51
346408-4640889.07191.68
447503-4750391.17393.82
547562-4756291.28693.94
649297-4929794.61697.37
60min144207-4420784.84789.433.4687.9192.583.42
246633-4663389.50392.62
345379-4537987.09690.20
447353-4735390.88594.04
547207-4720790.60493.77
648785-4878593.63396.92
极限143097-4309782.71689.104.1386.2592.744.06
246987-4698790.18293.80
345344-4534487.02990.61
447202-4720290.59594.26
547452-4745291.07594.74
648459-4845993.00796.81
阿齐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%
111.293935483939613938293938913938083938070.04
211.343936873938803937840.04
单位质量响应值RSD%判断
34881.0534725.220.32数据可信
中间条件3月-供试品溶液-24051502批-阿齐沙坦-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%
5min17660-76601.9751.7610.681.971.7610.68
27006-70061.8061.81
37330-73301.8901.89
45595-55951.4431.44
56439-64391.6601.66
66861-68611.7691.77
10min117703-177034.5644.405.894.584.415.93
217302-173024.4614.47
318295-182954.7174.73
415675-156754.0414.05
516031-160314.1334.14
617301-173014.4614.47
15min125352-253526.5366.383.256.576.423.27
224714-247146.3726.41
325273-252736.5166.55
423698-236986.1106.14
523911-239116.1656.20
625640-256406.6116.65
20min130658-306587.9047.752.927.987.822.92
230137-301377.7707.84
330601-306017.8907.96
428970-289707.4697.53
529013-290137.4807.55
631000-310007.9938.06
30min139052-3905210.0699.803.0010.199.913.03
237547-375479.6809.79
338751-387519.99110.11
436635-366359.4459.55
536867-368679.5059.61
639204-3920410.10810.22
45min146751-4675112.05311.822.9212.2311.992.94
245068-4506811.62011.79
347315-4731512.19912.37
444698-4469811.52411.68
544220-4422011.40111.56
647034-4703412.12612.30
60min151480-5148013.27313.122.7913.5113.352.79
249909-4990912.86813.10
352934-5293413.64813.89
450089-5008912.91413.14
549130-4913012.66712.89
651773-5177313.34813.59
极限156088-5608814.46114.430.9414.7714.740.97
255824-5582414.39314.70
356678-5667814.61314.93
455599-5559914.33514.63
555276-5527614.25114.55
656436-5643614.55014.86
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