培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.743958539809398723989839914398160.34
29.783993639894399150.08
单位质量响应值RSD%判断
4087.894081.290.12数据可信
长期18月-供试品溶液-2022081201批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145749-4574995.56295.252.7895.5695.252.78
245825-4582595.72195.72
345820-4582095.71095.71
443656-4365691.19091.19
545005-4500594.00894.01
647533-4753399.28899.29
10min147574-4757499.37498.970.89100.44100.030.90
246837-4683797.83598.90
347172-4717298.53499.60
447136-4713698.45999.47
547542-4754299.307100.35
648026-48026100.318101.42
15min147455-4745599.12597.641.40101.2999.801.36
247174-4717498.538100.69
347218-4721898.630100.79
446050-4605096.19198.30
546657-4665797.45999.61
645898-4589895.87398.09
20min145514-4551495.07196.651.0798.3499.901.02
246738-4673897.628100.87
346404-4640496.930100.18
446779-4677997.713100.89
545885-4588595.84699.08
646305-4630596.723100.01
30min145236-4523694.49094.310.2698.8198.620.28
245164-4516494.34098.67
345145-4514594.30098.63
444992-4499293.98198.24
545043-4504394.08798.38
645306-4530694.63798.99
45min144993-4499393.98393.551.8899.3698.911.80
243920-4392091.74197.12
344733-4473393.44098.82
444654-4465493.27598.58
544114-4411492.14797.49
646292-4629296.696102.11
极限145048-4504894.09893.321.00100.5299.730.97
244833-4483393.648100.05
345194-4519494.403100.82
444116-4411692.15198.49
544174-4417492.27298.64
644693-4469393.35699.84
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.171676311673061671161677541678921675400.20
214.181681111680641680880.02
单位质量响应值RSD%判断
11823.5711853.880.19数据可信
长期18月-供试品溶液-2022081201批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1166813-16681391.34292.102.6591.3492.102.65
2167973-16797391.97791.98
3168576-16857692.30792.31
4162211-16221188.82288.82
5167569-16756991.75691.76
6176003-17600396.37496.37
10min1178733-17873397.86997.640.8498.8898.660.85
2176549-17654996.67397.69
3177691-17769197.29898.32
4176987-17698796.91397.90
5180162-18016298.65199.67
6179817-17981798.46299.53
15min1176813-17681396.81796.201.4098.9298.301.36
2177977-17797797.45599.55
3177606-17760697.25299.36
4173967-17396795.25997.32
5176128-17612896.44298.56
6171580-17158093.95296.12
20min1170310-17031093.25795.421.3096.4398.601.25
2176680-17668096.74599.92
3175033-17503395.84399.03
4175983-17598396.36399.49
5173767-17376795.14998.34
6173802-17380295.16998.38
30min1169648-16964892.89492.780.3697.1197.020.36
2169163-16916392.62896.88
3170359-17035993.28397.54
4168532-16853292.28396.48
5169599-16959992.86797.11
6169373-16937392.74397.01
45min1168052-16805292.02091.480.5497.2796.750.51
2165497-16549790.62195.90
3167573-16757391.75897.05
4167116-16711691.50896.73
5166697-16669791.27896.55
6167445-16744591.68896.98
极限1168177-16817792.08991.640.9898.3697.930.93
2168686-16868692.36798.66
3169258-16925892.68098.99
4165708-16570890.73796.97
5165239-16523990.48096.77
6167092-16709291.49497.81
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.743981139787397553984639764397930.10
29.783980139720397600.15
单位质量响应值RSD%判断
4085.524065.440.35数据可信
长期18月-供试品溶液-2022081201批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145521-4552195.29996.162.9795.3096.162.97
247349-4734999.12599.13
346624-4662497.60897.61
443431-4343190.92390.92
546181-4618196.68096.68
646494-4649497.33697.34
10min146103-4610396.51798.242.7497.5899.312.74
248121-48121100.742101.84
347800-47800100.070101.15
445209-4520994.64595.66
546085-4608596.47997.55
648234-48234100.978102.06
15min145745-4574595.76896.942.4897.9099.102.48
247832-47832100.137102.36
347291-4729199.004101.20
444936-4493694.07496.14
545344-4534494.92897.07
646679-4667997.72399.93
20min144513-4451393.18895.722.5396.3898.962.53
247518-4751899.479102.81
346153-4615396.62299.92
444600-4460093.37096.48
545248-4524894.72797.93
646298-4629896.925100.21
30min144782-4478293.75193.882.4097.9898.182.40
246663-4666397.689102.13
345249-4524994.72999.10
443542-4354291.15695.30
544069-4406992.25996.51
644750-4475093.68498.05
45min143959-4395992.02993.572.1597.3098.922.16
245984-4598496.268101.79
345399-4539995.043100.47
443739-4373991.56896.73
543861-4386191.82397.10
645239-4523994.708100.12
极限143862-4386291.82592.611.7898.1299.001.81
245446-4544695.142101.74
344606-4460693.38399.86
443403-4340390.86597.04
543522-4352291.11497.41
644586-4458693.34199.80
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.171669851672501678241676511670741673570.22
214.181673651675191674420.07
单位质量响应值RSD%判断
11810.6611808.320.02数据可信
长期18月-供试品溶液-2022081201批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1168760-16876092.63693.482.3392.6493.482.33
2174866-17486695.98895.99
3173522-17352295.25095.25
4163665-16366589.84089.84
5169782-16978293.19793.20
6171168-17116893.95893.96
10min1174958-17495896.03996.892.2897.0797.932.28
2180021-18002198.81899.88
3179998-17999898.80599.86
4171369-17136994.06995.07
5172662-17266294.77895.81
6180049-18004998.83399.88
15min1173471-17347195.22295.812.1997.3297.922.18
2179235-17923598.386100.55
3178352-17835297.902100.06
4171067-17106793.90395.95
5169831-16983193.22495.31
6175251-17525196.19998.34
20min1170364-17036493.51794.821.8796.6798.001.87
2178206-17820697.822101.08
3173522-17352295.25098.49
4170335-17033593.50196.59
5169906-16990693.26596.39
6174146-17414695.59398.80
30min1169417-16941792.99792.802.0697.1997.032.04
2174825-17482595.966100.31
3169899-16989993.26297.56
4166274-16627491.27295.40
5164767-16476790.44594.61
6169157-16915792.85497.13
45min1167107-16710791.72992.291.5996.9697.561.60
2171564-17156494.17699.59
3170129-17012993.38898.73
4167029-16702991.68696.83
5164039-16403990.04595.21
6168935-16893592.73298.04
极限1166097-16609791.17591.042.1897.4297.332.15
2169658-16965893.12999.59
3166992-16699291.66698.04
4164872-16487290.50296.66
5159305-15930587.44693.61
6168203-16820392.33198.67
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.743974939894400033992039842398820.24
29.784003839898399680.25
单位质量响应值RSD%判断
4094.664086.710.14数据可信
长期18月-供试品溶液-2022081501批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min144349-4434992.49993.702.1392.5093.702.13
244741-4474193.31793.32
345343-4534394.57394.57
446006-4600695.95595.96
545681-4568195.27895.28
643414-4341490.54990.55
10min146810-4681097.63296.891.5798.6697.921.55
246786-4678697.58298.62
345396-4539694.68395.73
447479-4747999.028100.09
546078-4607896.10697.16
646164-4616496.28597.29
15min147365-4736598.79096.661.55100.9098.781.52
246358-4635896.69098.81
345158-4515894.18796.29
446353-4635396.67998.85
546195-4619596.35098.48
646647-4664797.29299.37
20min147064-4706498.16297.292.19101.37100.482.14
246205-4620596.37199.57
344776-4477693.39096.54
447556-4755699.188102.43
547006-4700698.041101.24
647266-4726698.583101.74
30min145776-4577695.47693.771.4599.7898.041.44
244528-4452892.87397.14
344064-4406491.90596.09
445522-4552294.94699.29
545191-4519194.25698.54
644657-4465793.14297.39
45min144383-4438392.57092.071.5797.9397.391.52
245122-4512294.11299.41
343018-4301889.72394.93
444306-4430692.41097.81
544161-4416192.10797.44
643878-4387891.51796.80
极限143702-4370291.15091.611.1997.5497.961.18
244389-4438992.58398.93
343046-4304689.78295.99
444423-4442392.65499.08
544171-4417192.12898.49
643818-4381891.39297.70
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.178417484118839808410184138841020.09
214.188441984223843210.17
单位质量响应值RSD%判断
5935.225946.470.14数据可信
长期18月-供试品溶液-2022081501批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183988-8398891.64690.762.6291.6590.762.62
282406-8240689.92089.92
383358-8335890.95890.96
485453-8545393.24493.24
584588-8458892.30192.30
679269-7926986.49786.50
10min190013-9001398.22095.032.6699.2496.042.65
287067-8706795.00696.00
383885-8388591.53392.54
489326-8932697.47198.51
586806-8680694.72195.75
685423-8542393.21294.17
15min191301-9130199.62694.942.66101.7497.002.64
286279-8627994.14696.20
384584-8458492.29694.32
487415-8741595.38597.50
586697-8669794.60296.68
685766-8576693.58695.58
20min190262-9026298.49295.512.78101.7198.632.76
286339-8633994.21197.31
383704-8370491.33694.39
489818-8981898.007101.19
588166-8816696.20599.33
686890-8689094.81297.85
30min187550-8755095.53391.582.5899.8495.762.57
282748-8274890.29394.44
382137-8213789.62693.69
485042-8504292.79697.06
584254-8425491.93696.13
681849-8184989.31293.40
45min185041-8504192.79589.922.4098.1795.122.37
283826-8382691.46996.62
379955-7995587.24592.31
483000-8300090.56895.87
582212-8221289.70894.93
680395-8039587.72592.81
极限183328-8332890.92689.261.8997.3395.451.91
281634-8163489.07795.24
379748-7974887.01993.05
483370-8337090.97197.28
582460-8246089.97996.19
680255-8025587.57293.63
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10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%
19.743986639832399033992139837398720.10
29.783987939999399390.22
单位质量响应值RSD%判断
4093.634083.740.18数据可信
长期18月-供试品溶液-2022081501批-培哚普利-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min145928-4592895.84093.782.6195.8493.782.60
243407-4340790.57990.58
343824-4382491.44991.45
446107-4610796.21396.21
545813-4581395.60095.60
644573-4457393.01293.01
10min146102-4610296.20396.631.6497.2797.671.60
247373-4737398.85599.86
345536-4553695.02296.04
445899-4589995.77996.85
545806-4580695.58596.65
647121-4712198.32999.36
15min146254-4625496.52096.641.8698.6598.761.82
247565-4756599.256101.36
345555-4555595.06197.13
445230-4523094.38396.52
546354-4635496.72998.85
646913-4691397.895100.02
20min146486-4648697.00496.011.91100.2199.201.87
246826-4682697.713100.92
344724-4472493.32796.46
446089-4608996.17699.36
545160-4516094.23797.44
646761-4676197.578100.79
30min144272-4427292.38492.810.9796.6797.070.95
244960-4496093.82098.11
344297-4429792.43696.60
443927-4392791.66495.91
544391-4439192.63296.88
645024-4502493.95398.25
45min143820-4382091.44192.561.1396.7597.841.09
245207-4520794.33599.67
344307-4430792.45797.65
443942-4394291.69596.96
544274-4427492.38897.66
644577-4457793.02098.36
极限143597-4359790.97592.312.3697.3098.622.25
246048-4604896.090102.47
343818-4381891.43797.66
443152-4315290.04796.33
543991-4399191.79898.10
644812-4481293.51199.89
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100374-202106对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数2系数0.721
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.178415884293839918424283922841210.19
214.188440084379843900.02
单位质量响应值RSD%判断
5936.565951.340.18数据可信
长期18月-供试品溶液-2022081501批-氨氯地平-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183839-8383991.43689.811.9091.4489.801.90
280544-8054487.84287.84
380408-8040887.69487.69
483643-8364391.22291.22
583471-8347191.03491.03
682161-8216189.60589.61
10min185797-8579793.57193.622.0594.5994.622.02
288235-8823596.23097.21
384924-8492492.61993.59
483602-8360291.17792.19
584929-8492992.62493.64
687576-8757695.51196.51
15min186591-8659194.43793.902.5996.4995.942.55
288967-8896797.02899.07
384577-8457792.24094.24
482693-8269390.18692.21
586123-8612393.92695.97
687629-8762995.56997.63
20min186226-8622694.03992.862.3097.1495.942.26
287675-8767595.61998.74
383245-8324590.78893.82
483590-8359091.16494.19
583423-8342390.98294.07
686724-8672494.58297.70
30min181759-8175989.16789.561.8993.3293.671.86
283670-8367091.25195.44
382034-8203489.46793.50
479544-7954486.75190.79
581938-8193889.36293.46
683768-8376891.35895.53
45min181994-8199489.42389.401.8894.5694.501.86
284163-8416391.78996.99
381617-8161789.01294.04
479504-7950486.70891.71
581694-8169489.09694.18
682851-8285190.35895.54
极限180794-8079488.11588.562.7494.2594.662.66
284317-8431791.95798.18
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