氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.979361993298928779272992571930190.47
214.979170591475915900.18
单位质量响应值RSD%判断
6213.696118.241.10数据可信
供试品溶液-24072201批-氨氯地平-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%
5min181692-8169285.89183.154.6685.8983.144.66
272809-7280976.55176.55
378550-7855082.58882.59
478013-7801382.02382.02
583489-8348987.78087.78
679931-7993184.03984.04
10min188750-8875093.31293.333.3293.4593.473.33
286774-8677491.23491.36
389921-8992194.54394.68
484653-8465389.00489.14
593351-9335198.14998.30
689156-8915693.73993.88
15min190550-9055095.20496.193.4395.5096.483.43
291571-9157196.27896.56
392466-9246697.21997.51
486275-8627590.71090.99
595918-95918100.848101.16
692121-9212196.85697.15
20min191100-9110095.78397.193.5696.2497.643.55
293552-9355298.36198.80
393191-9319197.98198.44
487037-8703791.51191.95
597021-97021102.008102.49
692724-9272497.49097.95
30min191437-9143796.13798.053.7996.7598.663.78
295864-95864100.791101.40
393676-9367698.49199.11
487476-8747691.97292.56
597548-97548102.562103.21
693513-9351398.32098.94
45min191235-9123595.92598.074.1096.7098.854.09
296134-96134101.075101.85
393524-9352498.33199.12
487135-8713591.61492.36
598044-98044103.084103.90
693591-9359198.40299.19
极限191385-9138596.08298.684.5297.0299.624.50
298855-98855103.936104.88
393827-9382798.65099.60
487274-8727491.76092.65
597751-97751102.775103.77
694040-9404098.87499.82
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.653615493611673608943602133602703608190.16
211.663611673613993612830.05
单位质量响应值RSD%判断
30971.5930984.820.04数据可信
供试品溶液-24072201批-阿托伐他汀钙-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%
5min1138317-13831736.88134.3310.4436.8834.3310.44
2106007-10600728.26628.27
3126775-12677533.80333.80
4144784-14478438.60538.61
5132356-13235635.29135.29
6124218-12421833.12133.12
10min1221583-22158359.08356.297.7959.1456.357.79
2180014-18001447.99948.05
3217205-21720557.91557.97
4225741-22574160.19160.26
5214429-21442957.17557.23
6207772-20777255.40055.46
15min1266993-26699371.19168.717.0771.3568.867.07
2221336-22133659.01759.14
3264461-26446170.51670.67
4270408-27040872.10172.27
5263862-26386270.35670.51
6259053-25905369.07469.22
20min1290900-29090077.56575.497.2777.8475.757.27
2241694-24169464.44564.67
3291332-29133277.68177.95
4296423-29642379.03879.32
5292326-29232677.94678.22
6285990-28599076.25676.52
30min1315664-31566484.16882.317.1684.5882.707.17
2264146-26414670.43270.76
3317101-31710184.55284.95
4323728-32372886.31986.74
5318228-31822884.85285.25
6313277-31327783.53283.92
45min1328790-32879087.66886.217.3388.2286.747.33
2275733-27573373.52173.97
3330480-33048088.11988.66
4339261-33926190.46091.02
5336243-33624389.65690.20
6329432-32943287.83988.37
极限1345947-34594792.24391.394.4692.9492.064.48
2312173-31217383.23883.81
3346478-34647892.38593.07
4354398-35439894.49695.21
5348478-34847892.91893.61
6348982-34898293.05293.73
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.979124491232913329129691267912740.05
214.979116091093911260.06
单位质量响应值RSD%判断
6097.136087.240.12数据可信
供试品溶液-24072202批-氨氯地平-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%
5min180853-8085386.03382.303.8186.0382.303.81
271909-7190976.51676.52
377683-7768382.66082.66
478056-7805683.05783.06
577307-7730782.26082.26
678236-7823683.24983.25
10min192209-9220998.11793.184.7198.2693.324.71
281098-8109886.29486.42
390987-9098796.81796.95
489485-8948595.21895.36
585865-8586591.36691.50
685797-8579791.29491.43
15min194663-94663100.72896.694.32101.0496.994.32
285108-8510890.56190.83
394384-94384100.431100.73
493548-9354899.54299.84
589378-8937895.10595.39
688149-8814993.79794.09
20min195384-95384101.49598.254.39101.9798.704.39
286839-8683992.40392.83
396511-96511102.695103.16
495537-95537101.658102.12
591010-9101096.84197.29
688715-8871594.39994.85
30min196385-96385102.56099.474.65103.20100.094.64
288809-8880994.49995.08
397736-97736103.998104.64
498013-98013104.293104.93
590613-9061396.41997.03
689340-8934095.06495.67
45min196127-96127102.28699.964.15103.10100.754.15
289517-8951795.25295.99
397935-97935104.210105.02
497976-97976104.253105.06
592225-9222598.13498.90
689894-8989495.65496.42
极限196684-96684102.879100.304.55103.86101.254.54
290496-9049696.29497.19
399039-99039105.385106.37
498486-98486104.796105.78
591349-9134997.20298.14
689501-8950195.23596.16
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.653600633600853603373604023604173602610.05
211.663607613610893609250.07
单位质量响应值RSD%判断
30923.6930954.120.07数据可信
供试品溶液-24072202批-阿托伐他汀钙-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%
5min1138579-13857936.99836.146.1937.0036.146.19
2139474-13947437.23637.24
3121968-12196832.56332.56
4128092-12809234.19834.20
5142478-14247838.03838.04
6141713-14171337.83437.83
10min1222684-22268459.45256.796.3559.5156.846.35
2214347-21434757.22657.29
3189161-18916150.50250.56
4206032-20603255.00655.06
5217626-21762658.10158.16
6226326-22632660.42460.49
15min1268023-26802371.55668.347.6271.7268.507.62
2255634-25563468.24968.41
3220269-22026958.80758.95
4251993-25199367.27767.43
5263959-26395970.47170.63
6276024-27602473.69273.86
20min1294510-29451078.62875.028.2778.9175.298.27
2279196-27919674.53974.81
3238099-23809963.56763.80
4277307-27730774.03574.30
5293645-29364578.39778.67
6303296-30329680.97381.26
30min1324736-32473686.69781.648.7087.1182.048.69
2302395-30239580.73381.13
3256322-25632268.43268.77
4305059-30505981.44481.83
5315779-31577984.30684.71
6330558-33055888.25288.67
45min1338521-33852190.37886.028.8790.9386.558.86
2317353-31735384.72685.26
3269239-26923971.88172.34
4321770-32177085.90586.43
5335959-33595989.69490.24
6350407-35040793.55194.12
极限1350777-35077793.65091.015.3694.3691.685.38
2341114-34111491.07091.74
3306883-30688381.93182.51
4338502-33850290.37391.04
5348227-34822792.96993.67
6359726-35972696.03996.76
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.979078690826907549061890585907140.12
214.979040490441904220.03
单位质量响应值RSD%判断
6059.726040.210.23数据可信
供试品溶液-24072203批-氨氯地平-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%
5min187942-8794294.23091.322.5194.2391.322.50
283481-8348189.45089.45
383546-8354689.51989.52
487666-8766693.93493.93
583360-8336089.32089.32
685361-8536191.46491.46
10min194807-94807101.58698.502.91101.7498.652.91
289962-8996296.39496.54
388852-8885295.20595.35
495383-95383102.203102.36
590486-9048696.95697.10
692090-9209098.67498.83
15min195629-95629102.46699.902.93102.79100.212.93
291224-9122497.74698.06
389824-8982496.24696.55
497006-97006103.942104.27
592043-9204398.62498.93
693653-93653100.349100.67
20min196021-96021102.886100.232.82103.38100.712.82
291718-9171898.27698.75
390088-9008896.52997.00
496952-96952103.884104.38
592367-9236798.97199.45
694087-94087100.814101.30
30min196216-96216103.095100.582.95103.76101.232.95
291964-9196498.53999.18
390212-9021296.66297.29
497583-97583104.560105.23
592649-9264999.27399.91
694601-94601101.365102.02
45min196363-96363103.253100.632.91104.09101.442.91
292184-9218498.77599.58
390411-9041196.87597.67
497473-97473104.442105.29
592309-9230998.90999.71
694738-94738101.512102.33
极限196605-96605103.512101.282.65104.52102.262.65
293153-9315399.813100.78
390745-9074597.23398.18
497538-97538104.512105.53
593621-93621100.315101.28
695458-95458102.283103.27
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.653583403583763585043582793588093584620.06
211.663585833589393587610.08
单位质量响应值RSD%判断
30769.2730768.520.01数据可信
供试品溶液-24072203批-阿托伐他汀钙-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%
5min1159307-15930742.76642.905.0342.7742.905.03
2147888-14788839.70139.70
3172072-17207246.19346.19
4164029-16402944.03444.03
5159057-15905742.69942.70
6156467-15646742.00442.00
10min1239592-23959264.31962.725.6064.3962.805.60
2215969-21596957.97858.04
3248798-24879866.79166.87
4245401-24540165.87965.95
5229604-22960461.63861.71
6222549-22254959.74459.81
15min1272364-27236473.11771.575.8973.3071.745.89
2245379-24537965.87366.04
3283752-28375276.17476.36
4283011-28301175.97576.16
5260484-26048469.92870.10
6254547-25454768.33468.50
20min1295105-29510579.22276.506.0979.5276.796.09
2261473-26147370.19370.47
3302241-30224181.13781.45
4302520-30252081.21281.52
5276652-27665274.26874.56
6271733-27173372.94873.23
30min1318207-31820785.42481.576.3885.8682.006.38
2277288-27728874.43974.83
3321382-32138286.27686.73
4322505-32250586.57787.02
5295428-29542879.30979.72
6288376-28837677.41577.82
45min1333175-33317589.44284.716.6690.0285.276.65
2286874-28687477.01277.53
3333184-33318489.44490.04
4335386-33538690.03590.62
5305432-30543281.99482.54
6299340-29934080.35980.89
极限1350130-35013093.99391.853.6194.7292.563.63
2324380-32438087.08187.72
3353633-35363394.93495.68
4352042-35204294.50795.25
5342934-34293492.06292.74
6329847-32984788.54889.22
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
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)5供试品稀释倍数1系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.979138191306913739136891301913460.05
214.979319093012931010.14
单位质量响应值RSD%判断
6101.946219.171.35数据可信
供试品溶液-24072204批-氨氯地平-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%
5min182115-8211586.41487.162.7386.4187.162.73
284859-8485989.30289.30
381160-8116085.40985.41
480122-8012284.31784.32
586103-8610390.61190.61
682569-8256986.89286.89
10min188670-8867093.31293.662.9493.4693.812.94
291152-9115295.92496.07
386136-8613690.64690.79
485809-8580990.30290.44
592100-9210096.92297.07
690158-9015894.87895.02
15min189733-8973394.43194.833.1694.7395.133.16
292592-9259297.44097.75
386755-8675591.29791.59
486831-8683191.37791.67
593349-9334998.23698.55
691398-9139896.18396.49
20min190054-9005494.76995.173.2795.2395.633.26
292913-9291397.77898.25
386748-8674891.29091.74
487193-8719391.75892.20
593685-9368598.59099.07
692026-9202696.84497.31
30min189936-8993694.64595.453.2695.2696.063.26
293441-9344198.33398.97
387396-8739691.97292.57
487208-8720891.77492.37
593802-9380298.71399.35
692396-9239697.23497.86
45min189989-8998994.70095.303.4295.4796.073.41
293226-9322698.10798.90
387038-8703891.59592.35
486853-8685391.40092.15
593863-9386398.77799.58
692369-9236997.20597.99
极限190313-9031395.04195.523.3995.9796.453.39
293443-9344398.33599.30
386860-8686091.40892.31
487404-8740491.98092.88
593877-9387798.79299.76
692694-9269497.54798.50
氨氯地平阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100590-202005 对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9对照品水分(%)0对照品稀释倍数500
标示量(mg)20供试品稀释倍数1系数0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.653629343630343631223633563631323631160.05
211.663699593698563699080.02
单位质量响应值RSD%判断
31168.7631724.531.25数据可信
供试品溶液-24072204批-阿托伐他汀钙-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%
5min1160018-16001842.03543.935.1742.0343.925.17
2161611-16161142.45342.45
3179260-17926047.08947.09
4167819-16781944.08444.08
5175782-17578246.17646.18
6158803-15880341.71641.72
10min1243418-24341863.94364.853.0564.0164.923.05
2244129-24412964.13064.20
3260289-26028968.37568.45
4240710-24071063.23263.31
5251033-25103365.94366.02
6241635-24163563.47563.54
15min1280090-28009073.57674.532.7273.7574.712.72
2282576-28257674.22974.41
3295842-29584277.71477.91
4272840-27284071.67271.85
5287862-28786275.61875.80
6283133-28313374.37674.55
20min1301944-30194479.31780.112.6579.6280.412.65
2309653-30965381.34281.64
3314646-31464682.65482.98
4291218-29121876.49976.80
5308192-30819280.95881.27
6304030-30403079.86580.16
30min1322850-32285084.80986.023.3985.2486.463.38
2338993-33899389.04989.49
3335920-33592088.24288.70
4308252-30825280.97481.40
5327008-32700885.90186.35
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