替米沙坦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22AD265对照品来源工作对照品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)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.643058030560304663043530706305490.35
215.633052230698306100.41
单位质量响应值RSD%判断
1953.261958.410.19数据可信
供试品溶液-1批-氨氯地平-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%
5min129224-2922496.66896.042.1696.6796.042.17
228881-2888195.53395.53
329579-2957997.84297.84
427865-2786592.17292.17
529512-2951297.62097.62
629153-2915396.43396.43
10min130121-3012199.63598.193.15100.1798.723.14
230133-3013399.674100.21
329739-2973998.37198.91
427809-2780991.98792.50
530225-3022599.979100.52
630075-3007599.482100.02
15min130613-30613101.26299.152.65102.35100.232.65
229747-2974798.39899.48
330105-3010599.582100.67
428489-2848994.23695.26
530398-30398100.551101.65
630501-30501100.892101.98
20min129922-2992298.97697.993.55100.6399.623.53
230229-3022999.992101.62
329656-2965698.09799.74
427629-2762991.39292.94
529644-2964498.05799.71
630664-30664101.431103.08
30min129757-2975798.43195.913.08100.6398.083.07
229021-2902195.99698.18
328935-2893595.71297.90
427313-2731390.34692.40
529225-2922596.67198.87
629712-2971298.282100.49
45min128023-2802392.69593.003.1595.4495.703.14
227850-2785092.12394.84
328347-2834793.76796.49
426570-2657087.88990.44
528939-2893995.72598.46
628963-2896395.80498.56
60min127699-2769991.62393.263.5394.8996.493.49
227945-2794592.43795.67
328566-2856694.49197.73
426608-2660888.01491.06
529325-2932597.002100.27
629027-2902796.01699.31
90min127029-2702989.40789.762.4293.1893.502.43
227046-2704689.46393.21
327317-2731790.36094.13
425959-2595985.86889.40
527729-2772991.72295.53
627731-2773191.72995.55
120min126835-2683588.76589.163.1493.0493.403.12
226483-2648387.60191.84
327469-2746990.86295.13
425555-2555584.53188.54
527556-2755691.15095.47
627826-2782692.04396.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限127231-2723190.07589.323.1494.8494.063.12
227100-2710089.64294.37
326941-2694189.11693.89
425436-2543684.13888.62
527339-2733990.43295.26
627978-2797892.54697.39
替米沙坦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100320240115对照品来源工作对照品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625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.458945158938758932928942378939738939780.06
2 11.438907708919088913390.10
单位质量响应值RSD%判断
78076.6877982.410.09数据可信
供试品溶液-1批-替米沙坦-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%
5min192245-9224510.64011.599.0610.6411.599.05
2105780-10578012.20112.20
387466-8746610.08810.09
4112271-11227112.94912.95
5101712-10171211.73211.73
6103238-10323811.90811.91
10min1190258-19025821.94523.087.0222.0023.157.03
2207827-20782723.97124.04
3175784-17578420.27520.33
4208315-20831524.02724.10
5209815-20981524.20024.27
6208823-20882324.08624.15
15min1310507-31050735.81436.384.5336.0036.584.54
2311147-31114735.88836.09
3291371-29137133.60733.78
4329481-32948138.00338.21
5322275-32227537.17237.37
6327858-32785837.81538.02
20min1400813-40081346.23047.434.1046.6147.824.11
2407996-40799647.05947.46
3384952-38495244.40144.76
4422201-42220148.69749.11
5419397-41939748.37448.78
6431774-43177449.80150.21
30min1557162-55716264.26464.182.0664.9064.842.08
2548144-54814463.22363.89
3538143-53814362.07062.67
4566063-56606365.29065.98
5568026-56802665.51766.19
6560986-56098664.70565.39
45min1657848-65784875.87777.832.4876.8778.852.47
2655891-65589175.65176.66
3678207-67820778.22579.17
4677971-67797178.19879.25
5701768-70176880.94381.98
6677180-67718078.10779.15
60min1717388-71738882.74487.143.1484.1688.583.11
2738337-73833785.16186.59
3769543-76954388.76090.14
4762824-76282487.98589.47
5783402-78340290.35891.85
6761257-76125787.80489.28
90min1779291-77929189.88492.271.5591.7694.201.57
2795509-79550991.75593.66
3797002-79700291.92793.80
4812461-81246193.71095.68
5811705-81170593.62395.61
6803999-80399992.73494.70
120min1799507-79950792.21694.091.7794.5996.541.75
2798436-79843692.09294.51
3828232-82823295.52997.91
4825582-82558295.22397.72
5812873-81287393.75896.27
6830133-83013395.74898.23
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1813364-81336493.81494.300.9896.7097.261.00
2814645-81464593.96296.89
3809493-80949393.36896.28
4819606-81960694.53497.56
5815770-81577094.09297.12
6832402-83240296.01099.03
替米沙坦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22AD265对照品来源工作对照品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)5供试品稀释倍数5系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.643055030649305733056030476305620.21
215.633045430218303360.56
单位质量响应值RSD%判断
1954.091940.880.48数据可信
供试品溶液-2批-氨氯地平-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%
5min122931-2293176.17774.0613.7976.1874.0613.80
216234-1623453.93053.93
324996-2499683.03783.04
423274-2327477.31777.32
523584-2358478.34778.35
622735-2273575.52675.53
10min128035-2803593.13393.770.5893.5694.180.58
228324-2832494.09394.39
328498-2849894.67195.13
428135-2813593.46593.89
528190-2819093.64894.08
628172-2817293.58894.01
15min128049-2804993.18094.711.9194.1295.641.87
229007-2900796.36297.18
328813-2881395.71896.70
429162-2916296.87797.83
528024-2802493.09794.05
627997-2799793.00793.95
20min127547-2754791.51293.531.9892.9794.981.94
228600-2860095.01096.37
328597-2859795.00096.52
428504-2850494.69196.18
527360-2736090.89192.36
628312-2831294.05395.51
30min127547-2754791.51292.211.5593.4894.191.49
228539-2853994.80796.69
327928-2792892.77894.82
427651-2765191.85793.87
527325-2732590.77492.75
627560-2756091.55593.53
45min127139-2713990.15792.271.6692.6394.761.63
227653-2765391.86494.28
328182-2818293.62196.18
427503-2750391.36693.89
528406-2840694.36696.85
627766-2776692.23994.73
60min126010-2601086.40689.802.3589.3892.812.31
227043-2704389.83892.76
327987-2798792.97496.06
426860-2686089.23092.26
527154-2715490.20693.21
627142-2714290.16693.17
90min126243-2624387.18087.191.4790.6490.701.45
226079-2607986.63590.06
326692-2669288.67292.27
426723-2672388.77592.30
525858-2585885.90189.41
625884-2588485.98789.49
120min126253-2625387.21386.732.0991.1590.722.00
226347-2634787.52591.43
325955-2595586.22390.31
426984-2698489.64293.66
525529-2552984.80888.79
625579-2557984.97488.95
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限125740-2574085.50985.980.9989.9390.450.97
226095-2609586.68891.08
326039-2603986.50291.07
426184-2618486.98491.50
525567-2556784.93489.39
625664-2566485.25789.71
替米沙坦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100320240115对照品来源工作对照品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625
标示量(mg)80供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
1 11.454478524477834473434470454473624474770.08
2 11.434456844454244455540.05
单位质量响应值RSD%判断
39080.9638981.100.19数据可信
供试品溶液-2批-替米沙坦-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%
5min156051-5605112.92514.0611.6112.9214.0611.60
249549-4954911.42511.43
363861-6386114.72514.73
463500-6350014.64214.64
569701-6970116.07216.07
663073-6307314.54414.54
10min1115841-11584126.71127.225.2126.7827.295.22
2110038-11003825.37325.44
3120942-12094227.88827.97
4115634-11563426.66426.74
5128300-12830029.58429.67
6117448-11744827.08227.16
15min1162136-16213637.38638.674.3137.6138.904.32
2159678-15967836.82037.02
3170844-17084439.39439.63
4164977-16497738.04138.27
5179791-17979141.45741.71
6168860-16886038.93739.17
20min1202233-20223346.63247.931.9947.0648.382.01
2205077-20507747.28847.70
3210668-21066848.57749.03
4205665-20566547.42347.86
5210787-21078748.60549.09
6212830-21283049.07649.52
30min1274935-27493563.39666.884.7964.0867.594.78
2282758-28275865.20065.87
3296297-29629768.32269.05
4278061-27806164.11764.82
5311273-31127371.77572.53
6296944-29694468.47169.19
45min1370260-37026085.37787.994.5186.4289.074.51
2358071-35807182.56683.60
3393438-39343890.72191.83
4375494-37549486.58487.64
5406023-40602393.62394.78
6386276-38627689.07090.17
60min1397397-39739791.63494.092.6593.1595.662.67
2395493-39549391.19592.69
3421216-42121697.12798.74
4404100-40410093.18094.72
5418516-41851696.50498.18
6411620-41162094.91496.51
90min1410338-41033894.61894.491.1996.6496.581.18
2405017-40501793.39195.39
3411418-41141894.86797.02
4416800-41680096.10898.17
5411540-41154094.89597.10
6403479-40347993.03795.16
120min1409657-40965794.46194.101.6697.0196.721.58
2407430-40743093.94896.47
3400954-40095492.45495.13
4420529-42052996.96899.56
5404285-40428593.22395.96
6405619-40561993.53096.17
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限1404135-40413593.18893.570.9096.2696.720.87
2407389-40738993.93896.98
3401381-40138192.55395.74
4411609-41160994.91198.04
5407061-40706193.86397.12
6403268-40326892.98896.15
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