缬沙坦氨氯地平片项目信息
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%
113.412484432481572483812482832483272483180.05
213.462524402525272524840.03
单位质量响应值RSD%判断
18517.3818758.100.92数据可信
加速1月-供试品溶液-2023112221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%
5min190615-9061531.51928.187.2131.5228.187.22
282743-8274328.78128.78
381102-8110228.21028.21
478911-7891127.44827.45
580166-8016627.88427.88
672630-7263025.26325.26
10min1132925-13292546.23545.992.3846.2946.042.38
2136190-13619047.37147.42
3131838-13183845.85745.90
4131601-13160145.77545.82
5134007-13400746.61246.66
6126820-12682044.11244.15
15min1166618-16661857.95558.322.0758.0858.442.07
2169695-16969559.02559.15
3164771-16477157.31257.44
4172567-17256760.02460.15
5169158-16915858.83858.96
6163188-16318856.76256.88
20min1189554-18955465.93365.841.3466.1666.061.33
2193247-19324767.21767.44
3186726-18672664.94965.17
4186368-18636864.82565.05
5189580-18958065.94266.16
6190292-19029266.18966.40
30min1212351-21235173.86275.701.9474.2076.031.93
2220050-22005076.54076.88
3213347-21334774.20974.54
4223589-22358977.77178.10
5218778-21877876.09876.43
6217616-21761675.69476.01
45min1227896-22789679.26981.162.1679.7381.622.15
2238064-23806482.80683.27
3228262-22826279.39779.85
4240065-24006583.50283.96
5234035-23403581.40581.86
6231673-23167380.58381.03
60min1235462-23546281.90184.241.9282.4984.841.91
2241557-24155784.02184.62
3238409-23840982.92683.51
4247772-24777286.18386.78
5244330-24433084.98685.58
6245663-24566385.44986.03
极限1243751-24375184.78486.291.4685.5187.021.46
2248184-24818486.32687.07
3248364-24836486.38987.11
4254132-25413288.39589.14
5248926-24892686.58487.32
6245066-24506685.24285.96
缬沙坦氨氯地平片项目信息
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%
116.134650786464945646537304656344465638046533390.07
216.174732796473585447343250.05
单位质量响应值RSD%判断
288489.71292784.481.05数据可信
加速1月-供试品溶液-2023112221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%
5min13715472-371547271.26668.953.5571.2768.953.55
23605042-360504269.14869.15
33612826-361282669.29769.30
43637200-363720069.76569.76
53651401-365140170.03770.04
63347212-334721264.20364.20
10min14373739-437373983.89284.541.1684.0184.651.15
24399416-439941684.38584.50
34362654-436265483.68083.80
44489739-448973986.11786.23
54447275-444727585.30385.42
64371566-437156683.85183.96
15min14694835-469483590.05190.951.0990.3191.211.09
24742596-474259690.96791.22
34675754-467575489.68589.94
44818855-481885592.43092.69
54766753-476675391.43191.69
64751698-475169891.14291.39
20min14871844-487184493.44694.181.0993.8694.591.09
24909017-490901794.15994.57
34840118-484011892.83893.24
44997031-499703195.84896.26
54913230-491323094.24094.65
64928983-492898394.54294.94
30min15023689-502368996.35997.051.0696.9297.621.06
25055677-505567796.97297.54
34986500-498650095.64696.20
45143322-514332298.65499.23
55072885-507288597.30297.87
65077598-507759897.39397.95
45min15083581-508358197.50898.041.0098.2398.771.00
25106423-510642397.94698.67
35041091-504109196.69397.41
45194489-519448999.635100.37
55123504-512350498.27399.00
65120311-512031198.21298.93
60min15089102-508910297.61498.070.9898.5098.960.98
25102971-510297197.88098.77
35041675-504167596.70497.58
45193011-519301199.607100.51
55127349-512734998.34799.24
65124607-512460798.29599.18
极限15178597-517859799.33098.620.81100.3899.670.81
25091963-509196397.66898.72
35110560-511056098.02599.07
45195831-519583199.661100.73
55156977-515697798.91599.97
65115809-511580998.12699.17
缬沙坦氨氯地平片项目信息
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%
113.412480672483842482872482932483662482790.06
213.462480092481382480740.04
单位质量响应值RSD%判断
18514.4718430.460.33数据可信
加速1月-供试品溶液-2023112221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%
5min178399-7839927.51329.325.0427.5129.325.04
283906-8390629.44529.45
378457-7845727.53327.53
487991-8799130.87930.88
585337-8533729.94729.95
687126-8712630.57530.58
10min1125918-12591844.18845.452.7544.2345.502.76
2132574-13257446.52446.57
3124293-12429343.61843.66
4132735-13273546.58146.63
5130821-13082145.90945.96
6130783-13078345.89645.95
15min1159135-15913555.84556.912.3255.9657.032.32
2164809-16480957.83657.96
3157036-15703655.10955.23
4166131-16613158.30058.43
5165284-16528458.00358.13
6160617-16061756.36556.49
20min1186427-18642765.42364.761.8165.6464.981.80
2181493-18149363.69163.91
3183051-18305164.23864.45
4189739-18973966.58566.81
5181028-18102863.52863.75
6185469-18546965.08765.31
30min1216005-21600575.80374.602.2276.1274.922.21
2213979-21397975.09275.42
3204786-20478671.86672.18
4214670-21467075.33475.67
5209006-20900673.34773.68
6216970-21697076.14176.47
45min1232806-23280681.69981.141.0282.1581.591.02
2234462-23446282.28082.73
3228552-22855280.20680.64
4231426-23142681.21481.68
5228497-22849780.18680.64
6231491-23149181.23781.69
60min1241343-24134384.69584.761.3285.2885.341.32
2244373-24437385.75886.35
3237494-23749483.34483.91
4238168-23816883.58084.18
5242470-24247085.09085.67
6245282-24528286.07786.67
极限1242837-24283785.21986.562.1685.9487.292.14
2242188-24218884.99185.73
3253753-25375389.05089.76
4241079-24107984.60285.34
5251072-25107288.10988.84
6249093-24909387.41488.15
缬沙坦氨氯地平片项目信息
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%
116.134682600469427746891104688998469152146893010.10
216.174672691467586746742790.05
单位质量响应值RSD%判断
290719.22289071.060.41数据可信
加速1月-供试品溶液-2023112221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%
5min13665944-366594470.49370.702.7870.4970.702.78
23737607-373760771.87171.87
33475245-347524566.82666.83
43720533-372053371.54271.54
53726858-372685871.66471.66
63733667-373366771.79571.80
10min14440122-444012285.38084.971.5985.5085.091.60
24466946-446694685.89586.02
34287904-428790482.45282.56
44396256-439625684.53684.66
54443526-444352685.44585.56
64479043-447904386.12886.25
15min14763134-476313491.59191.071.4991.8591.331.49
24783584-478358491.98492.25
34611983-461198388.68488.93
44702542-470254290.42690.69
54748933-474893391.31891.58
64806220-480622092.41992.68
20min14940561-494056195.00294.341.3895.4194.741.38
24960858-496085895.39395.81
34796613-479661392.23592.63
44857086-485708693.39793.81
54909666-490966694.40894.82
64970450-497045095.57795.99
30min15085717-508571797.79497.101.5298.3697.671.52
25132626-513262698.69699.27
34944909-494490995.08695.64
44980426-498042695.76996.34
55033887-503388796.79797.37
65121173-512117398.47699.05
45min15140158-514015898.84198.191.4699.5798.921.46
25202852-5202852100.046100.79
35032761-503276196.77597.48
45012937-501293796.39497.12
55091292-509129297.90198.63
65157696-515769699.17899.92
60min15139298-513929898.82498.261.5099.7299.151.50
25202867-5202867100.046100.95
35046539-504653997.04097.91
45004311-500431196.22897.12
55092078-509207897.91698.81
65174732-517473299.505100.41
极限15122907-512290798.50998.491.4799.5799.551.46
25183233-518323399.669100.74
35184161-518416199.687100.72
44988524-498852495.92596.97
55089895-508989597.87498.93
65164299-516429999.305100.38
缬沙坦氨氯地平片项目信息
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%
113.412460872462742463112461632463112462290.05
213.462477362482852480100.16
单位质量响应值RSD%判断
18361.6018425.710.25数据可信
加速1月-供试品溶液-2023112421批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min183033-8303329.26428.664.3029.2628.664.29
277602-7760227.35027.35
384053-8405329.62329.62
481491-8149128.72028.72
585128-8512830.00230.00
676612-7661227.00127.00
10min1132215-13221546.59745.822.7146.6545.872.71
2130557-13055746.01346.06
3127440-12744044.91444.96
4130856-13085646.11846.17
5134428-13442847.37747.43
6124541-12454143.89243.94
15min1164114-16411457.83957.221.4157.9757.341.41
2159446-15944656.19456.32
3161445-16144556.89957.02
4162870-16287057.40157.53
5165577-16557758.35558.48
6160672-16067256.62656.74
20min1174566-17456661.52363.484.3961.7563.704.38
2177493-17749362.55462.77
3168865-16886559.51459.73
4187985-18798566.25266.47
5188976-18897666.60166.83
6182846-18284664.44164.65
30min1208436-20843673.46074.261.3173.7974.581.32
2208335-20833573.42473.74
3209817-20981773.94674.26
4213203-21320375.14075.47
5214988-21498875.76976.11
6209401-20940173.80074.12
45min1229675-22967580.94581.212.0681.3981.662.06
2222738-22273878.50078.94
3231654-23165481.64382.08
4234444-23444482.62683.08
5235886-23588683.13483.60
6228227-22822780.43580.88
60min1236989-23698983.52385.061.9784.1185.641.96
2235577-23557783.02583.60
3239681-23968184.47285.05
4243796-24379685.92286.52
5244038-24403886.00786.61
6248009-24800987.40787.98
极限1245272-24527286.44287.732.3987.1688.452.37
2246705-24670586.94787.66
3244539-24453986.18486.90
4257052-25705290.59491.33
5244065-24406586.01786.76
6255891-25589190.18490.91
缬沙坦氨氯地平片项目信息
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%
116.134640391464764546470394644528464763646454480.07
216.174668595468137946749870.20
单位质量响应值RSD%判断
288000.50289114.840.28数据可信
加速1月-供试品溶液-2023112421批-缬沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13729377-372937772.04570.353.4172.0470.353.41
23651737-365173770.54570.54
33660077-366007770.70670.71
43695491-369549171.39071.39
53716870-371687071.80371.80
63395941-339594165.60365.60
10min14436364-443636485.70285.421.1785.8285.541.17
24435858-443585885.69385.81
34419633-441963385.37985.50
44443837-444383785.84785.97
54472238-447223886.39586.51
64322766-432276683.50883.62
15min14707512-470751290.94091.470.7491.2091.730.74
24745934-474593491.68391.94
34722288-472228891.22691.49
44764406-476440692.03992.30
54780232-478023292.34592.61
64688983-468898390.58290.83
20min14847547-484754793.64694.540.6894.0694.950.68
24904934-490493494.75495.17
34870854-487085494.09694.51
44930456-493045695.24795.66
54927872-492787295.19795.61
64882024-488202494.31294.71
30min14971286-497128696.03697.500.9796.6198.070.96
25099729-509972998.51799.09
35012770-501277096.83797.41
45089122-508912298.31298.89
55066127-506612797.86898.44
65044011-504401197.44198.00
45min15028042-502804297.13298.710.9897.8699.440.98
25128270-512827099.06999.80
35075699-507569998.05398.78
45169901-516990199.873100.61
55129392-512939299.09099.83
65125662-512566299.01899.74
60min15035809-503580997.28298.951.0998.1799.851.08
25138534-513853499.267100.17
35083051-508305198.19599.09
45195656-5195656100.370101.27
55138761-513876199.271100.18
65142170-514217099.337100.22
极限15031255-503125597.19498.981.2398.25100.041.22
25179245-5179245100.053101.12
35075622-507562298.05299.11
45198943-5198943100.434101.51
55126803-512680399.040100.11
65129634-512963499.095100.14
缬沙坦氨氯地平片项目信息
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%
113.412492532491632492762492322492352492320.02
213.462498092498062498080.01
单位质量响应值RSD%判断
18585.5318559.290.10数据可信
加速1月-供试品溶液-2023112421批-氨氯地平
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min181505-8150528.44929.684.2428.4529.684.24
288376-8837630.84730.85
380857-8085728.22228.22
488772-8877230.98530.98
583146-8314629.02129.02
687561-8756130.56230.56
10min1127629-12762944.54845.782.8544.6045.832.85
2129860-12986045.32645.38
3128133-12813344.72444.77
4135914-13591447.43947.49
5129613-12961345.24045.29
6135783-13578347.39447.44
15min1165623-16562357.80957.512.9157.9357.642.92
2165487-16548757.76257.89
3159523-15952355.68055.80
4168101-16810158.67458.80
5158838-15883855.44155.56
6171087-17108759.71659.85
20min1187761-18776165.53663.991.6465.7564.211.63
2182356-18235663.65063.87
3181009-18100963.17963.39
4186159-18615964.97765.21
5180157-18015762.88263.10
6182492-18249263.69763.93
30min1211811-21181173.93173.992.5174.2674.322.50
2203976-20397671.19671.53
3209885-20988573.25873.58
4214466-21446674.85775.19
5211603-21160373.85874.18
6220111-22011176.82877.16
45min1235542-23554282.21481.072.2582.6681.522.24
2230801-23080180.55981.01
3232605-23260581.18881.63
4223507-22350778.01378.47
5231994-23199480.97581.42
6239097-23909783.45483.92
60min1241544-24154484.30983.791.1184.9084.381.11
2237401-23740182.86283.44
3236626-23662682.59283.17
4240109-24010983.80884.40
5241007-24100784.12184.70
6243696-24369685.06085.66
极限1249821-24982187.19887.021.0987.9387.741.09
2245657-24565785.74486.46
3247574-24757486.41387.13
4250347-25034787.38188.11
5248829-24882986.85187.57
6253618-25361888.52389.27
缬沙坦氨氯地平片项目信息
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%
116.134708102471083747132854715041471485747124240.07
216.174724979472740047261900.04
单位质量响应值RSD%判断
292152.76292281.390.04数据可信
加速1月-供试品溶液-2023112421批-缬沙坦
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min13569302-356930268.08970.361.7668.0970.361.76
23714118-371411870.85170.85
33666245-366624569.93869.94
43750295-375029571.54171.54
53727236-372723671.10171.10
63703267-370326770.64470.64
10min14450686-445068684.90285.020.3685.0285.140.36
24450106-445010684.89185.01
34436922-443692284.63984.76
44484597-448459785.54985.67
54462114-446211485.12085.24
64457053-445705385.02385.14
15min14796954-479695491.50790.700.4991.7690.960.49
24733548-473354890.29890.56
34758448-475844890.77391.03
44758349-475834990.77191.03
54746179-474617990.53990.80
64735818-473581890.34190.60
20min14970029-497002994.80993.710.6595.2294.120.64
24890032-489003293.28393.69
34924221-492422193.93594.34
44908096-490809693.62894.04
54887663-488766393.23893.65
64893074-489307493.34193.75
30min15141707-514170798.08496.470.9298.6597.040.91
25027076-502707695.89796.46
35078882-507888296.88597.45
45040428-504042896.15296.72
55024679-502467995.85296.42
65029394-502939495.94196.51
45min15220272-522027299.58397.831.03100.3198.561.02
25098349-509834997.25797.98
35156689-515668998.37099.10
45123324-512332497.73398.46
55094306-509430697.18097.91
65078703-507870396.88297.61
60min15230710-523071099.78298.011.07100.6898.901.07
25116188-511618897.59798.48
35174965-517496598.71899.61
45116773-511677397.60898.50
55108664-510866497.45498.34
65080238-508023896.91197.80
极限15245865-5245865100.07198.131.20101.1399.181.19
25116102-511610297.59698.65
35174299-517429998.70699.76
45148104-514810498.20699.26
55113601-511360197.54898.60
65066429-506642996.64897.70
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