阿齐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%
1 10.982903182899042900722900732899832900700.06
2 10.962900582906022903300.14
单位质量响应值RSD%判断
26418.0326489.960.20数据可信
中间条件18月-供试品溶液-2023101221批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127965-279659.48619.9451.219.4919.9451.19
2106114-10611435.99335.99
378519-7851926.63326.63
451112-5111217.33717.34
560088-6008820.38120.38
628940-289409.8169.82
10min1119787-11978740.63164.8125.2140.6864.9225.25
2249687-24968784.69284.89
3236391-23639180.18280.33
4183431-18343162.21962.31
5196615-19661566.69066.80
6160468-16046854.43054.48
15min1212243-21224371.99186.7610.1072.2787.2310.18
2272600-27260092.46493.13
3278595-27859594.49895.09
4274630-27463093.15393.59
5257460-25746087.32987.81
6239226-23922681.14481.50
20min1242494-24249482.25291.896.6982.9392.846.80
2281487-28148795.47896.66
3287281-28728197.44498.56
4287620-28762097.55998.52
5268589-26858991.10492.07
6258014-25801487.51788.32
30min1270190-27019091.64795.563.1192.7897.033.21
2280737-28073795.22496.94
3291039-29103998.718100.38
4292919-29291999.356100.86
5276230-27623093.69595.17
6279336-27933694.74996.04
45min1285385-28538596.80197.812.2098.4599.812.24
2283207-28320796.06298.31
3296774-296774100.664102.87
4295800-295800100.333102.39
5282420-28242095.79597.79
6286609-28660997.21699.04
60min1287690-28769097.58298.311.4399.76100.841.43
2284566-28456696.52399.30
3293302-29330299.486102.25
4294674-29467499.951102.56
5286385-28638597.14099.67
6292320-29232099.153101.51
极限1299173-299173101.477101.061.12104.20104.151.06
2296025-296025100.410103.72
3294367-29436799.847103.17
4303483-303483102.939106.11
5299032-299032101.430104.50
6295633-295633100.277103.19
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127178471831717117175471738717640.07
215.117195271907719300.05
单位质量响应值RSD%判断
4746.304760.420.22数据可信
中间条件18月-供试品溶液-2023101221批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min132806-3280644.74662.0224.4844.7562.0224.48
253219-5321972.58972.59
356958-5695877.68977.69
456191-5619176.64376.64
537962-3796251.77951.78
635691-3569148.68148.68
10min160532-6053282.56484.285.5682.8184.625.62
262156-6215684.77985.18
364529-6452988.01588.45
466339-6633990.48490.91
556524-5652477.09777.38
660652-6065282.72783.00
15min167890-6789092.60089.963.0593.3190.783.02
262572-6257285.34686.22
366812-6681291.12992.05
467599-6759992.20393.13
564734-6473488.29589.01
666143-6614390.21790.95
20min170144-7014495.67492.452.5996.9093.762.53
264936-6493688.57189.92
367778-6777892.44793.87
468678-6867893.67595.12
568188-6818893.00694.21
666957-6695791.32792.56
30min172866-7286699.38794.653.80101.1496.483.70
265240-6524088.98590.83
368190-6819093.00994.95
470751-7075196.50298.46
570644-7064496.35698.08
668669-6866993.66295.40
45min172090-7209098.32895.163.45100.6397.513.38
265997-6599790.01892.35
369752-6975295.13997.60
471023-7102396.87399.37
571826-7182697.968100.23
667897-6789792.60994.87
60min171678-7167897.76694.833.56100.6297.713.47
265864-6586489.83692.67
368313-6831393.17796.16
471123-7112397.009100.04
572071-7207198.302101.11
668107-6810792.89695.67
极限172859-7285999.37795.634.28102.7799.044.17
265563-6556389.42692.76
369034-6903494.16097.66
471705-7170597.803101.38
573228-7322899.881103.23
668299-6829993.15896.45
阿齐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%
1 10.982915362918432917992920352920902918610.08
2 10.962899582896642898110.08
单位质量响应值RSD%判断
26581.1526442.610.37数据可信
中间条件18月-供试品溶液-2024010621批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1161170-16117054.54945.5416.0754.5545.5416.08
2158421-15842153.61853.62
3118966-11896640.26540.26
4139391-13939147.17747.18
5114472-11447238.74438.74
6114817-11481738.86038.86
10min1270559-27055991.57285.255.9191.8785.515.92
2247330-24733083.71084.01
3231290-23129078.28178.50
4268153-26815390.75891.02
5247438-24743883.74683.96
6246590-24659083.45983.68
15min1288382-28838297.60492.744.3298.4293.474.33
2262609-26260988.88189.64
3258950-25895087.64388.30
4283841-28384196.06796.83
5270811-27081191.65792.34
6279489-27948994.59495.27
20min1287959-28795997.46193.963.7298.8295.213.72
2265764-26576489.94991.21
3263736-26373689.26390.41
4284473-28447396.28197.58
5280025-28002594.77695.97
6283814-28381496.05897.26
30min1288917-28891797.78595.072.7399.6896.842.73
2268551-26855190.89292.65
3275416-27541693.21694.86
4283570-28357095.97697.81
5281999-28199995.44497.16
6286996-28699697.13598.87
45min1287264-28726497.22694.463.0299.6696.753.02
2266337-26633790.14392.40
3270930-27093091.69793.86
4284251-28425196.20698.57
5282016-28201695.45097.70
6283756-28375696.03898.32
60min1287349-28734997.25594.563.16100.2397.383.15
2266233-26623390.10892.87
3271714-27171491.96394.63
4283470-28347095.94298.84
5279366-27936694.55397.33
6288186-28818697.538100.35
极限1291477-29147798.65298.441.52102.17101.781.44
2286264-28626496.887100.15
3298892-298892101.161104.34
4288583-28858397.672101.11
5288430-28843097.620100.92
6291463-29146398.647102.00
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127210172154720607222872253721590.12
215.117180571867718360.07
单位质量响应值RSD%判断
4772.424754.200.28数据可信
中间条件18月-供试品溶液-2024010621批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min160261-6026182.02273.088.5482.0273.078.54
255325-5532575.30475.30
354193-5419373.76373.76
446487-4648763.27463.27
554649-5464974.38474.38
651218-5121869.71469.71
10min168805-6880593.65288.203.4794.1188.603.47
262235-6223584.70985.13
364037-6403787.16287.57
463872-6387286.93787.29
565637-6563789.34089.75
664191-6419187.37287.76
15min170213-7021395.56891.363.3396.5492.263.33
263224-6322486.05586.94
367432-6743291.78392.68
467289-6728991.58892.42
567291-6729191.59192.50
667289-6728991.58892.46
20min170552-7055296.03092.352.7097.5493.752.71
264982-6498288.44889.82
368469-6846993.19494.60
467921-6792192.44993.79
568167-6816792.78394.20
666983-6698391.17292.55
30min171476-7147697.28793.792.5199.3395.712.51
266695-6669590.78092.64
370255-7025595.62597.55
468943-6894393.84095.70
568208-6820892.83994.77
667882-6788292.39594.28
45min170458-7045895.90294.441.8698.4896.881.87
267166-6716691.42193.78
370276-7027695.65498.11
470250-7025095.61998.00
569583-6958394.71197.16
668576-6857693.34095.74
60min169690-6969094.85695.161.3497.9798.121.31
268203-6820392.83295.70
370203-7020395.55598.54
470387-7038795.80598.71
570091-7009195.40298.38
670923-7092396.53599.45
极限170946-7094696.56696.701.88100.21100.191.85
269170-6917094.14997.53
373331-7333199.812103.33
470790-7079096.35499.80
570862-7086296.45299.96
671163-7116396.861100.32
阿齐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%
1 10.982909062908742908592911582909662909530.05
2 10.962962002933812947900.68
单位质量响应值RSD%判断
26498.4526896.901.06数据可信
中间条件18月-供试品溶液-2024010721批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min195233-9523332.00941.5622.7132.0141.5622.71
2160487-16048753.94253.94
3145928-14592849.04949.05
4135293-13529345.47445.47
591282-9128230.68130.68
6113729-11372938.22638.23
10min1225093-22509375.65783.5110.8175.8483.7510.84
2282451-28245194.93695.24
3244252-24425282.09782.37
4273670-27367091.98592.24
5213282-21328271.68771.86
6252068-25206884.72484.94
15min1253460-25346085.19289.937.9085.7990.627.94
2289840-28984097.42098.25
3263916-26391688.70689.43
4289247-28924797.22097.98
5235648-23564879.20579.77
6273187-27318791.82292.51
20min1267608-26760889.94792.266.1691.0293.456.22
2289205-28920597.20698.57
3271119-27111991.12792.35
4291884-29188498.10799.41
5246051-24605182.70283.71
6281032-28103294.45995.65
30min1274162-27416292.15093.104.0293.7294.804.11
2287078-28707896.49198.40
3273886-27388692.05793.78
4288835-28883597.08298.93
5258277-25827786.81188.28
6279649-27964993.99495.71
45min1277756-27775693.35893.983.3295.4496.203.43
2288005-28800596.80399.25
3277834-27783493.38495.62
4290080-29008097.50099.89
5264006-26400688.73690.69
6279919-27991994.08596.33
60min1280221-28022194.18793.833.4996.7996.583.58
2290335-29033597.586100.57
3276170-27617092.82595.58
4288334-28833496.91399.84
5263442-26344288.54790.99
6276529-27652992.94695.71
极限1292197-29219798.21299.811.96101.34103.072.02
2297530-297530100.004103.53
3294467-29446798.975102.25
4299774-299774100.759104.23
5290934-29093497.787100.72
6306721-306721103.094106.37
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127203671983720097207272002720200.05
215.117137672219717980.84
单位质量响应值RSD%判断
4763.234751.690.18数据可信
中间条件18月-供试品溶液-2024010721批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155356-5535675.43978.367.5075.4478.367.50
262134-6213484.67684.68
362893-6289385.71085.71
456617-5661777.15777.16
551513-5151370.20170.20
656484-5648476.97676.98
10min167379-6737991.82390.583.2692.2491.023.27
269557-6955794.79295.26
367431-6743191.89492.37
466347-6634790.41790.85
564493-6449387.89088.28
663595-6359586.66787.09
15min169227-6922794.34293.623.1395.2794.563.14
271617-7161797.59998.60
369951-6995195.32996.32
468671-6867193.58494.52
567248-6724891.64592.52
665455-6545589.20190.11
20min170842-7084296.54395.442.0398.0096.902.05
272087-7208798.24099.78
370449-7044996.00797.52
469859-6985995.20396.65
568764-6876493.71195.10
668210-6821092.95694.36
30min169868-6986895.21595.492.4697.2197.482.48
272896-7289699.342101.43
370893-7089396.61298.66
469489-6948994.69996.68
569537-6953794.76496.67
667722-6772292.29194.21
45min171938-7193898.03697.441.59100.5699.951.62
273177-7317799.725102.36
372225-7222598.428101.01
470258-7025895.74798.25
570517-7051796.10098.53
670868-7086896.57899.01
60min173062-7306299.56897.402.25102.63100.462.25
273303-7330399.897103.09
372144-7214498.317101.45
469365-6936594.53097.57
570216-7021695.69098.66
670725-7072596.38399.35
极限172884-7288499.32698.412.51102.94102.012.43
273232-7323299.800103.55
371245-7124597.092100.77
469734-6973495.03398.60
571312-7131297.183100.68
674854-74854102.010105.52
阿齐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%
1 10.982901842901132902612903772903732902620.04
2 10.962908812910462909640.05
单位质量响应值RSD%判断
26435.5226547.810.30数据可信
中间条件18月-供试品溶液-2024010921批-阿齐沙坦-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1148441-14844150.27946.1916.5850.2846.1916.58
2158339-15833953.63153.63
3147836-14783650.07450.07
4109813-10981337.19537.19
5148197-14819750.19650.20
6105575-10557535.76035.76
10min1254772-25477286.29487.676.3186.5787.936.33
2279917-27991794.81195.11
3272405-27240592.26792.54
4255062-25506286.39386.60
5257984-25798487.38287.66
6232904-23290478.88779.09
15min1278076-27807694.18893.675.3694.9594.415.38
2289460-28946098.04498.87
3291079-29107998.59299.38
4277015-27701593.82894.51
5273703-27370392.70693.47
6249925-24992584.65385.29
20min1279553-27955394.68895.254.3195.9796.514.33
2290692-29069298.46199.83
3290808-29080898.50099.84
4289063-28906397.90999.12
5277699-27769994.06095.34
6259425-25942587.87088.98
30min1287693-28769397.44597.104.3399.2598.894.32
2289131-28913197.93299.85
3294531-29453199.761101.65
4302728-302728102.538104.29
5278622-27862294.37396.17
6267271-26727190.52892.12
45min1284600-28460096.39795.894.0098.7598.224.02
2291160-29116098.619101.08
3295474-295474100.081102.52
4288411-28841197.688100.01
5272547-27254792.31594.64
6266385-26638590.22892.33
60min1287899-28789997.51596.313.36100.4099.173.40
2289817-28981798.164101.17
3293971-29397199.571102.57
4287069-28706997.234100.10
5279983-27998394.83497.67
6267247-26724790.52093.12
极限1303989-303989102.965101.590.87106.39104.990.84
2298043-298043100.951104.50
3297720-297720100.841104.39
4302286-302286102.388105.79
5298531-298531101.116104.48
6299014-299014101.280104.38
阿齐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4000
标示量(mg)5供试品稀释倍数2系数0.7211
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
115.127175971537716537165271614716430.12
215.117206072141721000.08
单位质量响应值RSD%判断
4738.294771.670.50数据可信
中间条件18月-供试品溶液-2024010921批-氨氯地平-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min158724-5872480.07176.826.1080.0776.826.10
253415-5341572.83272.83
360548-6054882.55882.56
455546-5554675.73875.74
558232-5823279.40079.40
651564-5156470.30870.31
10min164856-6485688.43286.822.8188.8887.242.83
263680-6368086.82987.23
365212-6521288.91889.38
464403-6440387.81488.24
563624-6362486.75287.19
660257-6025782.16182.55
15min167098-6709891.48990.362.6092.4391.272.62
266436-6643690.58691.47
368092-6809292.84493.80
466941-6694191.27592.18
566002-6600289.99590.92
663063-6306385.98786.83
20min167866-6786692.53692.232.1093.9893.642.09
268427-6842793.30194.69
367936-6793692.63294.10
469542-6954294.82296.24
566572-6657290.77292.19
665524-6552489.34390.67
30min170389-7038995.97694.662.8697.9396.592.85
269732-6973295.08196.99
369741-6974195.09397.08
472039-7203998.226100.17
568550-6855093.46995.40
666112-6611290.14591.97
45min169844-6984495.23393.382.3397.7395.832.33
269219-6921994.38196.82
370212-7021295.73598.25
468475-6847593.36795.85
566653-6665390.88293.33
666495-6649590.66792.99
60min170875-7087596.63994.572.1399.6697.542.13
270149-7014995.64998.61
369230-6923094.39697.44
470187-7018795.70198.71
569026-6902694.11897.07
666690-6669090.93393.76
极限169680-6968095.01095.192.0298.5798.682.02
271244-7124497.142100.63
371175-7117597.048100.62
469719-6971995.06398.60
569661-6966194.98498.46
667377-6737791.87095.20
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