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%
113.872417082409932400892404402406632407790.26
213.942443342440342441840.09
单位质量响应值RSD%判断
17359.7017516.790.64数据可信
加速3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%
5min174429-7442927.66931.017.5327.6731.017.53
282835-8283530.79430.79
388604-8860432.93832.94
489439-8943933.24933.25
587628-8762832.57632.58
677496-7749628.80928.81
10min1129963-12996348.31450.213.4448.3650.263.44
2134933-13493350.16150.21
3141054-14105452.43752.49
4140214-14021452.12452.18
5132810-13281049.37249.43
6131334-13133448.82348.87
15min1159790-15979059.40260.371.9459.5360.501.94
2166537-16653761.91062.04
3164769-16476961.25361.39
4164181-16418161.03461.18
5159895-15989559.44159.58
6159175-15917559.17359.30
20min1176474-17647465.60466.742.3465.8366.972.33
2184590-18459068.62168.86
3175425-17542565.21465.46
4184789-18478968.69568.94
5179161-17916166.60366.84
6176687-17668765.68365.91
30min1200031-20003174.36175.831.8174.7076.181.82
2208044-20804477.34077.69
3206772-20677276.86777.22
4207122-20712276.99777.36
5200620-20062074.58074.93
6201339-20133974.84775.18
45min1200833-20083374.65980.924.4675.1281.404.45
2226389-22638984.16084.64
3225179-22517983.71084.19
4223856-22385683.21883.70
5214029-21402979.56580.04
6215803-21580380.22480.69
60min1226303-22630384.12885.751.7784.7186.361.77
2233096-23309686.65387.27
3234420-23442087.14587.77
4231874-23187486.19986.82
5233536-23353686.81787.42
6224830-22483083.58084.18
极限1247584-24758492.03992.101.5292.7692.851.51
2254155-25415594.48295.25
3243839-24383990.64791.41
4244395-24439590.85491.62
5247050-24705091.84092.59
6249392-24939292.71193.45
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%
116.014699372470113746998664700879470673347015970.07
216.004783291477486447790780.13
单位质量响应值RSD%判断
293666.27298692.381.20数据可信
加速3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%
5min13487931-348793165.65167.903.5965.6567.903.58
23602951-360295167.81667.82
33676219-367621969.19569.19
43792274-379227471.37971.38
53647676-364767668.65868.66
63438309-343830964.71764.72
10min14172646-417264678.53980.702.7178.6580.812.71
24366510-436651082.18882.30
34323036-432303681.36981.48
44440247-444024783.57683.69
54286397-428639780.68080.79
64134619-413461977.82377.93
15min14495985-449598584.62586.482.2184.8786.732.21
24705695-470569588.57288.82
34609498-460949886.76187.01
44715261-471526188.75289.01
54563667-456366785.89986.15
64478060-447806084.28784.52
20min14654569-465456987.61089.411.9687.9989.801.96
24875287-487528791.76492.16
34748392-474839289.37689.77
44843268-484326891.16191.57
54722026-472202688.87989.27
64656660-465666087.64988.03
30min14812393-481239390.58092.491.5891.1193.041.58
25029263-502926394.66295.21
34929303-492930392.78193.33
44958592-495859293.33293.89
54905685-490568592.33692.88
64849453-484945391.27891.80
45min14903357-490335792.29294.581.6192.9795.271.61
25140479-514047996.75697.46
35039471-503947194.85495.55
45043434-504343494.92995.64
55053872-505387295.12595.82
64968529-496852993.51994.20
60min14961608-496160893.38995.581.6294.2296.431.62
25199843-519984397.87398.74
35096597-509659795.93096.79
45076793-507679395.55796.43
55113484-511348496.24897.10
65018364-501836494.45795.29
极限15178218-517821897.46698.942.0298.4599.952.01
25453423-5453423102.646103.68
35185676-518567697.60698.62
45183091-518309197.55898.59
55255734-525573498.92599.94
65283855-528385599.454100.44
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%
113.872435072435442436262439812437632436840.08
213.942464532467542466040.09
单位质量响应值RSD%判断
17569.1417690.390.49数据可信
加速3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%
5min193257-9325734.29132.495.0734.2932.495.07
284965-8496531.24231.24
392518-9251834.02034.02
482352-8235230.28130.28
586155-8615531.68031.68
690876-9087633.41633.42
10min1147525-14752554.24651.364.0654.3051.414.06
2131891-13189148.49748.55
3142314-14231452.33052.39
4134388-13438849.41549.47
5141085-14108551.87851.93
6140786-14078651.76851.82
15min1176480-17648064.89362.532.8565.0462.682.85
2165605-16560560.89461.03
3169123-16912362.18862.33
4164023-16402360.31260.45
5170810-17081062.80862.95
6174341-17434164.10664.25
20min1190925-19092570.20469.782.6170.4670.022.60
2184361-18436167.79168.03
3183612-18361267.51567.76
4190154-19015469.92170.15
5193549-19354971.16971.41
6196004-19600472.07272.32
30min1217338-21733879.91778.603.2980.2978.963.28
2203847-20384774.95675.30
3206390-20639075.89176.25
4215801-21580179.35279.70
5217432-21743279.95180.31
6221709-22170981.52481.89
45min1236583-23658386.99384.743.0087.5085.232.99
2222406-22240681.78082.25
3221438-22143881.42481.91
4230970-23097084.92985.41
5235541-23554186.61087.11
6235744-23574486.68587.19
60min1243208-24320889.42988.732.0890.0889.362.09
2236400-23640086.92687.53
3235788-23578886.70187.32
4238795-23879587.80788.43
5247308-24730890.93791.58
6246341-24634190.58191.23
极限1251492-25149292.47592.241.0193.2893.020.99
2254491-25449193.57894.33
3248479-24847991.36792.13
4252903-25290392.99493.76
5249207-24920791.63592.43
6248468-24846891.36392.16
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%
116.014758750475782247627804771098477052647641950.14
216.004834092483888648364890.08
单位质量响应值RSD%判断
297576.20302280.561.11数据可信
加速3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%
5min13819624-381962470.99567.963.8170.9967.963.80
23519069-351906965.40865.41
33778281-377828170.22670.23
43583476-358347666.60566.61
53500638-350063865.06665.07
63738048-373804869.47869.48
10min14499602-449960283.63382.412.1183.7582.522.11
24276376-427637679.48479.59
34389227-438922781.58281.70
44449188-444918882.69682.81
54446114-444611482.63982.75
64542936-454293684.43984.55
15min14773802-477380288.73088.232.0588.9988.482.05
24603427-460342785.56385.80
34657968-465796886.57786.83
44793191-479319189.09089.34
54787077-478707788.97789.22
64865623-486562390.43790.69
20min14897786-489778691.03490.982.0991.4491.372.08
24759741-475974188.46888.85
34785953-478595388.95689.35
44962807-496280792.24392.64
54946927-494692791.94892.34
65015082-501508293.21493.62
30min15043100-504310093.73593.721.8394.2994.271.83
24925459-492545991.54992.08
34935752-493575291.74092.29
45104755-510475594.88195.43
55106976-510697694.92295.47
65138439-513843995.50796.07
45min15143274-514327495.59795.481.3696.3196.191.36
25073368-507336894.29894.98
35033187-503318793.55194.25
45169952-516995296.09396.80
55204180-520418096.72997.44
65198698-519869896.62797.35
60min15184084-518408496.35696.151.0297.2397.021.02
25135971-513597195.46196.30
35085482-508548294.52395.38
45198074-519807496.61697.49
55212368-521236896.88197.75
65222194-522219497.06497.95
极限15217678-521767896.98097.661.2998.0198.681.28
25363925-536392599.698100.70
35181350-518135096.30597.32
45299782-529978298.50699.54
55207594-520759496.79397.82
65254746-525474697.66998.71
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%
113.872412412406412408732409032406522408620.11
213.942415262414852415060.02
单位质量响应值RSD%判断
17365.6817324.680.17数据可信
加速3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%
5min189051-8905133.28234.475.1133.2834.475.11
290367-9036733.77333.77
395482-9548235.68535.69
487115-8711532.55832.56
591402-9140234.16034.16
699962-9996237.35937.36
10min1127388-12738847.60949.964.0347.6650.024.03
2136789-13678951.12351.18
3138211-13821151.65451.71
4127113-12711347.50747.56
5133249-13324949.80049.86
6139302-13930252.06252.12
15min1160990-16099060.16860.551.4860.3060.691.49
2160227-16022759.88360.02
3162602-16260260.77060.92
4160564-16056460.00960.14
5161095-16109560.20760.35
6166619-16661962.27262.42
20min1171922-17192264.25367.533.7464.4967.773.73
2187348-18734870.01970.26
3184072-18407268.79469.04
4177487-17748766.33366.57
5175178-17517865.47065.71
6188054-18805470.28370.54
30min1199634-19963474.61076.112.8774.9576.462.87
2207258-20725877.46077.82
3206276-20627677.09377.45
4195867-19586773.20373.55
5200974-20097475.11175.46
6211796-21179679.15679.53
45min1215008-21500880.35682.072.0880.8282.562.08
2225259-22525984.18784.67
3217645-21764581.34281.83
4214361-21436180.11480.58
5222254-22225483.06483.54
6223111-22311183.38583.89
60min1227612-22761285.06786.223.0385.6786.843.02
2236021-23602188.21088.84
3228327-22832785.33485.96
4224776-22477684.00784.61
5225165-22516584.15284.77
6242294-24229490.55491.19
极限1243909-24390991.15892.041.6791.9092.801.67
2249169-24916993.12393.90
3243664-24366491.06691.83
4241276-24127690.17490.91
5247202-24720292.38893.14
6252373-25237394.32195.11
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%
116.014741998474917847471224748903474466547463730.07
216.004742211474189747420540.01
单位质量响应值RSD%判断
296463.02296378.380.03数据可信
加速3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%
5min13744626-374462670.42070.022.9070.4270.022.89
23813479-381347971.71571.71
33787666-378766671.22971.23
43512046-351204666.04666.05
53740738-374073870.34770.35
63740446-374044670.34170.34
10min14466347-446634783.99282.752.1384.1182.862.14
24511819-451181984.84884.97
34425000-442500083.21583.33
44249254-424925479.91080.02
54340259-434025981.62181.74
64408088-440808882.89783.01
15min14683684-468368488.08087.711.7388.3487.961.73
24773550-477355089.77090.03
34678441-467844187.98188.24
44539412-453941285.36685.61
54610346-461034686.70086.95
64698822-469882288.36488.62
20min14812066-481206690.49490.381.5490.9090.781.54
24892682-489268292.01092.42
34808890-480889090.43490.84
44673796-467379687.89488.28
54797323-479732390.21790.61
64850767-485076791.22291.62
30min15002903-500290394.08392.901.7094.6493.451.70
25006898-500689894.15894.72
34922368-492236892.56893.12
44799875-479987590.26590.80
54897517-489751792.10192.65
65009802-500980294.21294.77
45min15028064-502806494.55694.201.5895.2794.901.58
25078056-507805695.49696.22
34985974-498597493.76494.47
44878963-487896391.75292.43
54985538-498553893.75694.46
65097348-509734895.85996.57
60min15034480-503448094.67794.841.8895.5595.711.87
25123276-512327696.34697.23
35007313-500731394.16695.03
44907668-490766892.29293.13
55012174-501217494.25795.11
65175163-517516397.32298.19
极限15128078-512807896.43796.500.3997.4697.520.39
25152541-515254196.89797.94
35142014-514201496.69997.72
45102608-510260895.95896.95
55147845-514784596.80897.82
65115350-511535096.19797.23
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%
113.872462492459902461652467092470692464360.18
213.942467522469722468620.07
单位质量响应值RSD%判断
17767.5617708.900.24数据可信
加速3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%
5min194086-9408634.38431.486.9734.3831.486.96
276089-7608927.80727.81
386213-8621331.50731.51
483969-8396930.68730.69
589309-8930932.63832.64
687211-8721131.87231.87
10min1144750-14475052.90048.555.0452.9648.615.05
2126218-12621846.12746.17
3128090-12809046.81146.86
4130195-13019547.58047.63
5132202-13220248.31448.37
6135700-13570049.59249.65
15min1174944-17494463.93460.074.6064.0860.204.59
2164813-16481360.23260.36
3151859-15185955.49855.63
4161837-16183759.14459.27
5165480-16548060.47660.61
6167321-16732161.14861.28
20min1195609-19560971.48668.363.4971.7468.593.49
2188276-18827668.80669.03
3177086-17708664.71764.94
4182268-18226866.61166.84
5188289-18828968.81169.05
6190725-19072569.70169.94
30min1219492-21949280.21577.253.9280.5977.603.92
2216466-21646679.10979.45
3195670-19567071.50971.84
4211559-21155977.31577.66
5213326-21332677.96178.31
6211771-21177177.39377.75
45min1236310-23631086.36185.083.4986.8785.563.48
2235692-23569286.13586.61
3216431-21643179.09679.55
4236652-23665286.48686.95
5237716-23771686.87587.35
6234063-23406385.54086.02
60min1239476-23947687.51888.404.6888.1789.024.66
2248171-24817190.69591.31
3220236-22023680.48681.07
4247164-24716490.32790.94
5251180-25118091.79592.42
6245103-24510389.57490.20
极限1251955-25195592.07892.311.4092.8793.071.41
2254454-25445492.99293.76
3247811-24781190.56491.28
4250840-25084091.67192.43
5258290-25829094.39395.17
6252157-25215792.15292.93
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%
116.014865035487092948735734885692489367648777810.24
216.004840921484750748442140.10
单位质量响应值RSD%判断
304670.89302763.380.45数据可信
加速3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%
5min13958417-395841772.65365.076.5972.6565.076.59
23250090-325009059.65259.65
33493778-349377864.12564.12
43472916-347291663.74263.74
53605368-360536866.17366.17
63491037-349103764.07564.07
10min14654775-465477585.43480.814.0885.5580.914.07
24397633-439763380.71480.81
34225140-422514077.54877.66
44173075-417307576.59376.70
54490806-449080682.42482.53
64474245-447424582.12082.23
15min14921356-492135690.32787.313.9290.5987.553.92
24846227-484622788.94889.18
34521357-452135782.98583.22
44515636-451563682.88083.11
54882196-488219689.60889.86
64853729-485372989.08589.33
20min15057743-505774392.83090.393.8493.2490.783.84
25042745-504274592.55592.94
34665928-466592885.63986.01
44697311-469731186.21586.59
55054895-505489592.77893.17
65030872-503087292.33792.73
30min15179046-517904695.05693.743.1095.6394.283.10
25214353-521435395.70496.24
34807695-480769588.24188.76
45053567-505356792.75393.27
55202830-520283095.49396.04
65188093-518809395.22295.77
45min15225231-522523195.90495.232.9296.6395.932.92
25308383-530838397.43098.13
34899262-489926289.92190.59
45158616-515861694.68195.35
55290904-529090497.10997.82
65249170-524917096.34397.05
60min15226830-522683095.93395.452.6596.8296.302.65
25317797-531779797.60398.46
34941895-494189590.70491.52
45160900-516090094.72395.55
55280710-528071096.92297.79
65273774-527377496.79597.66
极限15210517-521051795.63496.251.2996.6897.261.29
25333178-533317897.88598.91
35201955-520195595.47796.44
45151291-515129194.54795.53
55274635-527463596.81197.84
65291697-529169797.12498.15
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