苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172426392448362430892420122421652429480.47
214.092413912418082416000.13
单位质量响应值RSD%判断
17145.2417146.910.01数据可信
加速6月-供试品溶液-2023112521批-苯磺酸氨氯地平-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%
5min179633-7963330.10732.045.1030.1132.045.09
283130-8313031.42931.43
388609-8860933.50133.50
484492-8449231.94431.94
581587-8158730.84630.85
691017-9101734.41134.41
10min1128936-12893648.74850.313.1448.8050.373.14
2131976-13197649.89749.95
3133978-13397850.65450.71
4133598-13359850.51050.56
5129511-12951148.96549.02
6140475-14047553.11053.17
15min1160955-16095560.85362.822.0460.9862.952.05
2165693-16569362.64462.78
3168684-16868463.77563.92
4165521-16552162.57962.72
5165150-16515062.43962.57
6170884-17088464.60764.75
20min1179795-17979567.97670.862.5268.2171.102.53
2187328-18732870.82471.06
3187842-18784271.01871.27
4188734-18873471.35671.60
5186294-18629470.43370.67
6194500-19450073.53673.79
30min1209869-20986979.34680.882.2879.6981.242.28
2213240-21324080.62180.98
3211473-21147379.95380.32
4211080-21108079.80480.16
5214676-21467681.16481.52
6223259-22325984.40984.78
45min1232730-23273087.99088.411.5588.4788.911.56
2229567-22956786.79487.29
3234313-23431388.58889.09
4232683-23268387.97288.47
5233255-23325588.18888.68
6240483-24048390.92191.44
60min1241312-24131291.23491.971.4891.8692.611.48
2241222-24122291.20091.84
3243484-24348492.05592.70
4244571-24457192.46693.11
5239416-23941690.51791.15
6249562-24956294.35395.02
极限1257422-25742297.32596.252.4998.1097.052.49
2249641-24964194.38395.17
3248710-24871094.03194.83
4255537-25553796.61297.41
5250749-25074994.80295.59
6265452-265452100.361101.19
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.044622710461748346823244606980461345946285910.67
216.064597408460772046025640.16
单位质量响应值RSD%判断
288565.52286585.550.49数据可信
加速6月-供试品溶液-2023112521批-缬沙坦-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%
5min13677536-367753671.28673.192.8271.2973.192.82
23662254-366225470.99070.99
33905059-390505975.69775.70
43761211-376121172.90872.91
53746285-374628572.61972.62
63902099-390209975.63975.64
10min14445835-444583586.17987.691.9686.3087.811.96
24436088-443608885.99086.11
34574607-457460788.67588.80
44523191-452319187.67987.80
54490931-449093187.05387.17
64671039-467103990.54590.67
15min14763779-476377992.34293.101.7592.6093.371.75
24711834-471183491.33591.60
34818543-481854393.40493.68
44804568-480456893.13393.40
54764192-476419292.35092.62
64955790-495579096.06496.34
20min14928102-492810295.52895.961.6195.9496.381.61
24856816-485681694.14694.56
34948521-494852195.92396.35
44957396-495739696.09596.52
54915133-491513395.27695.70
65095383-509538398.77099.21
30min15096755-509675598.79798.761.4499.3799.351.44
25001708-500170896.95497.53
35069614-506961498.27198.86
45109045-510904599.03599.62
55069591-506959198.27098.85
65223433-5223433101.252101.85
45min15184289-5184289100.494100.341.33101.23101.081.33
25097158-509715898.80599.54
35142619-514261999.686100.44
45184384-5184384100.495101.24
55148729-514872999.804100.55
65299886-5299886102.734103.50
60min15228704-5228704101.355100.561.57102.26101.481.57
25072523-507252398.32799.22
35151965-515196599.867100.79
45193581-5193581100.674101.59
55164571-5164571100.111101.02
65315198-5315198103.031103.97
极限15202160-5202160100.840100.901.32101.92101.981.32
25126670-512667099.377100.44
35149965-514996599.828100.91
45221796-5221796101.221102.30
55206925-5206925100.932102.01
65323335-5323335103.189104.30
苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172422742419042421792423902420282421550.08
214.092448402451642450020.10
单位质量响应值RSD%判断
17089.2717388.361.23数据可信
加速6月-供试品溶液-2023112521批-苯磺酸氨氯地平-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%
5min182496-8249631.02431.653.7331.0231.653.73
280569-8056930.30030.30
384977-8497731.95731.96
488097-8809733.13133.13
587338-8733832.84532.85
681498-8149830.64930.65
10min1132389-13238949.78850.872.8149.8450.932.81
2130839-13083949.20549.26
3135090-13509050.80350.86
4139505-13950552.46452.52
5140142-14014252.70352.76
6133688-13368850.27650.33
15min1164602-16460261.90263.092.3462.0463.232.34
2163051-16305161.31961.45
3166716-16671662.69762.83
4172367-17236764.82264.96
5172444-17244464.85164.99
6167405-16740562.95663.09
20min1186817-18681770.25671.292.3970.4971.532.39
2183854-18385469.14269.38
3188499-18849970.88971.13
4196795-19679574.00974.26
5192487-19248772.38972.64
6188930-18893071.05171.29
30min1211866-21186679.67680.792.3080.0381.152.30
2206933-20693377.82178.17
3217200-21720081.68282.04
4219629-21962982.59682.97
5219418-21941882.51682.89
6213903-21390380.44280.80
45min1235304-23530488.49188.721.8588.9889.211.85
2229060-22906086.14386.62
3237238-23723889.21889.71
4239720-23972090.15190.66
5240835-24083590.57191.08
6233301-23330187.73788.23
60min1243313-24331391.50391.571.2292.1492.221.23
2240954-24095490.61691.24
3246201-24620192.58993.23
4247732-24773293.16593.83
5242662-24266291.25891.92
6240091-24009190.29190.93
极限1251256-25125694.49095.011.8595.2895.801.85
2246698-24669892.77693.55
3255801-25580196.19997.00
4255985-25598596.26897.09
5258015-25801597.03297.84
6248033-24803393.27894.07
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.044613571461266146131544616491461616346144080.04
216.064667651466652846670900.02
单位质量响应值RSD%判断
287681.30290603.360.72数据可信
加速6月-供试品溶液-2023112521批-缬沙坦-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%
5min13779566-377956672.86873.501.9972.8773.501.99
23740514-374051472.11572.12
33916413-391641375.50675.51
43866409-386640974.54274.54
53844711-384471174.12474.12
63725312-372531271.82271.82
10min14550106-455010687.72488.001.5787.8588.121.57
24469368-446936886.16786.29
34664847-466484789.93690.06
44580413-458041388.30888.43
54615349-461534988.98289.11
64506118-450611886.87687.00
15min14851801-485180193.54093.451.3793.8193.721.37
24759064-475906491.75292.02
34937629-493762995.19595.47
44857387-485738793.64893.92
54890669-489066994.29094.56
64784911-478491192.25192.52
20min15013174-501317496.65196.131.2497.0896.561.24
24907245-490724594.60995.03
35071502-507150297.77698.21
44986961-498696196.14696.57
55015860-501586096.70397.13
64923253-492325394.91895.34
30min15167932-516793299.63598.811.13100.2299.401.13
25050160-505016097.36597.94
35202092-5202092100.294100.89
45115844-511584498.63199.22
55142717-514271799.14999.74
65072323-507232397.79298.37
45min15245503-5245503101.131100.191.09101.88100.941.09
25123793-512379398.78499.52
35268198-5268198101.568102.33
45172518-517251899.724100.48
55216736-5216736100.576101.33
65152272-515227299.333100.07
60min15251803-5251803101.252100.862.02102.17101.782.01
25136557-513655799.03099.93
35419817-5419817104.491105.43
45172459-517245999.722100.64
55258186-5258186101.375102.30
65151566-515156699.320100.22
极限15250410-5250410101.225100.301.20102.31101.381.20
25124759-512475998.80399.87
35288324-5288324101.956103.06
45172634-517263499.726100.81
55224486-5224486100.725101.82
65154140-515414099.369100.44
苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172425092426952428542423942424532425810.08
214.092429062423942426500.15
单位质量响应值RSD%判断
17119.3417221.430.43数据可信
长期6月-供试品溶液-2023112521批-苯磺酸氨氯地平-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%
5min192177-9217734.80131.5813.8534.8031.5813.85
261908-6190823.37323.37
389454-8945433.77333.77
479242-7924229.91729.92
590508-9050834.17134.17
688644-8864433.46733.47
10min1135691-13569151.22947.789.9851.2947.839.98
2103458-10345839.06039.10
3132491-13249150.02150.08
4120192-12019245.37845.43
5134553-13455350.80050.86
6132870-13287050.16450.22
15min1162888-16288861.49759.257.0761.6459.387.08
2138188-13818852.17252.28
3165264-16526462.39462.53
4148395-14839556.02656.15
5163973-16397361.90762.05
6162927-16292761.51261.65
20min1184447-18444769.63766.864.3569.8867.094.37
2167268-16726863.15163.34
3184600-18460069.69569.94
4168130-16813063.47663.70
5179948-17994867.93868.18
6178129-17812967.25167.49
30min1209802-20980279.20976.902.6279.5777.252.62
2201785-20178576.18376.48
3209608-20960879.13679.50
4198063-19806374.77775.10
5198003-19800374.75575.11
6204909-20490977.36277.72
45min1228015-22801586.08683.872.5686.5884.342.55
2226018-22601885.33285.75
3227606-22760685.93186.42
4215431-21543181.33581.78
5218467-21846782.48182.96
6217306-21730682.04282.53
60min1235246-23524688.81686.482.5689.4587.092.54
2234834-23483488.66089.23
3232107-23210787.63188.27
4224588-22458884.79285.38
5221144-22114483.49184.11
6226364-22636485.46286.08
极限1245194-24519492.57194.771.3093.3695.521.26
2254111-25411195.93896.65
3252481-25248195.32396.10
4252920-25292095.48896.21
5251925-25192595.11395.87
6249414-24941494.16594.93
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.044637780464025446368874631095463311846358270.08
216.064641717464182546417710.01
单位质量响应值RSD%判断
289016.65289026.840.01数据可信
长期6月-供试品溶液-2023112521批-缬沙坦-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%
5min13861014-386101474.46866.3212.8674.4766.3212.86
22605123-260512350.24550.25
33655082-365508270.49670.50
43332875-333287564.28164.28
53611720-361172069.65969.66
63564994-356499468.75868.76
10min14506535-450653586.91880.048.4287.0480.158.42
23519347-351934767.87867.96
34356061-435606184.01684.13
44012983-401298377.39977.51
54287727-428772782.69882.81
64217441-421744181.34281.46
15min14724320-472432091.11887.014.3891.3987.264.40
24233339-423333981.64981.85
34705103-470510390.74891.01
44334331-433433183.59683.83
54568441-456844188.11288.37
64503097-450309786.85187.10
20min14837387-483738793.29990.702.7893.7291.092.80
24617860-461786089.06589.40
34868677-486867793.90294.31
44527319-452731987.31987.69
54703499-470349990.71791.12
64660811-466081189.89390.29
30min14942364-494236495.32493.872.4395.9094.412.42
24963245-496324595.72696.21
34996477-499647796.36796.93
44697036-469703690.59291.11
54820785-482078592.97993.53
64782941-478294192.24992.79
45min14992364-499236496.28895.382.4797.0296.082.45
25101312-510131298.38999.03
35054166-505416697.48098.21
44808055-480805592.73393.41
54889730-488973094.30895.02
64826143-482614393.08293.78
60min15004093-500409396.51495.852.3697.4196.712.34
25127475-512747598.89499.70
35074738-507473897.87798.77
44854632-485463293.63294.46
54910218-491021894.70495.57
64847803-484780393.50094.35
极限15126949-512694998.884100.141.2499.94101.151.22
25219745-5219745100.673101.64
35224650-5224650100.768101.82
45180135-518013599.909100.89
55284523-5284523101.923102.94
65116468-511646898.68299.69
苯磺酸氨氯地平缬沙坦片项目信息
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%
114.172433242433792431712430292430902431990.07
214.092454362450112452240.13
单位质量响应值RSD%判断
17162.9517404.120.99数据可信
长期6月-供试品溶液-2023112521批-苯磺酸氨氯地平-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%
5min184882-8488231.83831.537.1431.8431.547.14
284618-8461831.73931.74
386341-8634132.38532.39
489950-8995033.73933.74
572461-7246127.17927.18
686182-8618232.32632.33
10min1123504-12350446.32548.116.5746.3848.166.57
2135019-13501950.64450.70
3129598-12959848.61148.66
4136111-13611151.05351.11
5113712-11371242.65242.70
6131609-13160949.36549.42
15min1157899-15789959.22660.323.0559.3660.453.05
2161207-16120760.46760.60
3157993-15799359.26159.40
4169786-16978663.68563.83
5156174-15617458.57958.70
6161823-16182360.69860.83
20min1178864-17886467.09068.361.9167.3268.601.92
2182757-18275768.55068.79
3178497-17849766.95267.19
4186432-18643269.92870.18
5180808-18080867.81968.03
6186145-18614569.82170.06
30min1202277-20227775.87177.633.0476.2177.973.03
2203300-20330076.25576.61
3198639-19863974.50774.85
4211830-21183079.45579.82
5213089-21308979.92780.25
6212598-21259879.74380.10
45min1213926-21392680.24184.664.0780.7185.144.05
2217273-21727381.49681.98
3223021-22302183.65284.12
4230819-23081986.57787.07
5237721-23772189.16689.63
6231499-23149986.83287.32
60min1227230-22723085.23188.503.7285.8389.123.70
2227289-22728985.25385.87
3232404-23240487.17287.78
4238377-23837789.41290.05
5249827-24982793.70794.32
6240585-24058590.24090.87
极限1248120-24812093.06794.612.5493.8195.382.52
2249262-24926293.49594.25
3250135-25013593.82294.58
4245487-24548792.07992.87
5259190-25919097.21997.98
6261212-26121297.97798.76
苯磺酸氨氯地平缬沙坦片项目信息
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100651-202307对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.1对照品水分(%)0对照品稀释倍数200
标示量(mg)80供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.044655866465380746506904644928464639746503380.11
216.064687851468838446881180.01
单位质量响应值RSD%判断
289921.32291912.700.49数据可信
长期6月-供试品溶液-2023112521批-缬沙坦-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%
5min13561389-356138968.24266.986.4868.2466.986.48
23590394-359039468.79868.80
33578516-357851668.57068.57
43682382-368238270.56070.56
53047506-304750658.39558.40
63513915-351391567.33267.33
10min14282088-428208882.05281.984.2982.1782.094.29
24359740-435974083.54083.65
34296327-429632782.32582.44
44446717-444671785.20685.32
53923722-392372275.18575.28
64361802-436180283.57983.69
15min14582542-458254287.80989.251.7188.0689.501.72
24652696-465269689.15389.41
34615269-461526988.43688.69
44781732-478173291.62691.89
54590509-459050987.96288.18
64722412-472241290.48990.74
20min14711142-471114290.27392.651.8290.6793.051.81
24797931-479793191.93692.34
34777631-477763191.54791.95
44942922-494292294.71495.13
54875083-487508393.41493.78
64906750-490675094.02194.42
30min14823377-482337792.42495.532.3992.9796.082.37
24918550-491855094.24794.80
34913974-491397494.16094.71
45049554-504955496.75897.33
55137916-513791698.45198.98
65070537-507053797.16097.72
45min14861268-486126893.15096.862.7393.8597.572.71
24980753-498075395.43996.15
34987853-498785395.57596.28
45100127-510012797.72798.46
55238286-5238286100.374101.06
65162515-516251598.92299.64
60min14885881-488588193.62197.322.6494.4898.192.61
25011631-501163196.03196.90
35019492-501949296.18297.05
45111267-511126797.94098.83
55250004-5250004100.599101.45
65195567-519556799.555100.44
极限15099915-509991597.72399.771.4998.74100.811.48
25198546-519854699.613100.64
35181194-518119499.280100.31
45171375-517137599.092100.15
55272238-5272238101.025102.05
65317780-5317780101.897102.95
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