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%
111.052975072961352968372970452966282968300.18
211.122971282975132973200.10
单位质量响应值RSD%判断
26862.4426737.410.33数据可信
供试品溶液-23081601批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min16724-67242.2512.7074.592.252.7074.65
23139-31391.0511.05
315815-158155.2955.30
413344-133444.4684.47
59332-93323.1253.12
6-0.0000.00
10min163607-6360721.29719.8627.5721.3119.8727.60
248357-4835716.19116.20
375372-7537225.23625.27
473061-7306124.46224.49
563213-6321321.16521.18
632200-3220010.78110.78
15min1117097-11709739.20637.9011.7539.3438.0211.82
2103731-10373134.73134.83
3126044-12604442.20242.37
4122167-12216740.90341.06
5119180-11918039.90340.04
690882-9088230.42930.49
20min1147242-14724249.29948.296.5349.6548.636.62
2137589-13758946.06746.36
3154655-15465551.78152.19
4148931-14893149.86550.25
5148286-14828649.64950.01
6128655-12865543.07643.30
30min1178680-17868059.82559.323.6960.4559.923.79
2171852-17185257.53958.08
3183252-18325261.35662.05
4181742-18174260.85061.52
5180792-18079260.53261.16
6166622-16662255.78856.26
45min1205767-20576768.89468.663.1969.8569.593.28
2199208-19920866.69867.56
3209849-20984970.26171.29
4210923-21092370.62071.62
5209565-20956570.16671.13
6195018-19501865.29566.07
60min1223575-22357574.85774.003.7476.1975.323.80
2211802-21180270.91572.15
3223793-22379374.93076.35
4230726-23072677.25178.65
5226178-22617875.72877.09
6210056-21005670.33071.47
极限1237546-23754679.53479.102.5581.2980.832.64
2229839-22983976.95478.58
3239363-23936380.14381.98
4242935-24293581.33983.16
5239955-23995580.34182.12
6227918-22791876.31177.84
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%
115.207194971571718857181771396717240.33
2 15.187177972299720390.52
单位质量响应值RSD%判断
4718.684745.650.41数据可信
供试品溶液-23081601批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.00013.5579.450.0013.5579.44
212705-1270517.40717.41
317527-1752724.01324.01
415820-1582021.67521.67
513273-1327318.18518.19
6-0.0000.00
10min145761-4576162.69671.6913.1862.7071.7713.24
260547-6054782.95483.05
357627-5762778.95479.09
454733-5473374.98975.11
552619-5261972.09272.19
642684-4268458.48158.48
15min162740-6274085.95988.425.5586.3188.895.62
269529-6952995.26095.82
366793-6679391.51292.08
463616-6361687.15987.70
565391-6539189.59190.09
659139-5913981.02581.35
20min167907-6790793.03894.104.8393.8695.064.89
273598-73598100.835101.92
370533-7053396.63697.72
466743-6674391.44392.46
569354-6935495.02196.02
663938-6393887.60088.38
30min169323-6932394.97895.703.5096.3297.193.56
274347-74347101.862103.51
370597-7059796.72498.34
468270-6827093.53695.06
569114-6911494.69296.22
667461-6746192.42793.69
45min170884-7088497.11797.822.7498.9999.842.79
275144-75144102.954105.17
370618-7061896.75398.91
469955-6995595.84497.89
571752-7175298.306100.36
670024-7002495.93997.71
60min171124-7112497.44697.242.4299.8699.802.41
273297-73297100.423103.21
368876-6887694.36697.06
469502-6950295.22497.80
572549-7254999.398102.00
670487-7048796.57398.88
极限170178-7017896.15097.052.4099.10100.152.42
273953-73953101.322104.66
370075-7007596.00999.22
468957-6895794.47797.59
571133-7113397.458100.61
670708-7070896.87699.72
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%
111.052961702961432971932969592968522966630.17
211.122968492978392973440.24
单位质量响应值RSD%判断
26847.3326739.570.29数据可信
供试品溶液-23100202批-阿齐沙坦-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min117964-179646.0164.1030.936.024.1031.02
211220-112203.7583.76
312523-125234.1944.19
49450-94503.1653.16
514930-149305.0005.00
67450-74502.4952.49
10min176775-7677525.71222.998.4325.7523.028.46
270309-7030923.54623.57
368794-6879423.03923.06
465345-6534521.88421.90
571097-7109723.81023.84
659611-5961119.96419.98
15min1113013-11301337.84835.964.1038.0236.114.12
2108934-10893436.48236.63
3107511-10751136.00536.16
4105770-10577035.42235.56
5109154-10915436.55536.72
699859-9985933.44233.57
20min1137892-13789246.18044.782.4346.5745.132.45
2136670-13667045.77046.12
3134048-13404844.89245.24
4132229-13222944.28344.62
5132474-13247444.36544.73
6128989-12898943.19843.51
30min1172906-17290657.90656.631.6758.5557.231.71
2169493-16949356.76357.37
3168852-16885256.54857.15
4165974-16597455.58456.17
5171458-17145857.42158.03
6165968-16596855.58256.13
45min1202708-20270867.88667.260.7168.8568.180.74
2200847-20084767.26368.19
3202071-20207167.67368.59
4200658-20065867.20068.09
5199925-19992566.95467.88
6198828-19882866.58767.45
60min1221006-22100674.01473.301.2575.3674.581.27
2218928-21892873.31874.62
3220776-22077673.93775.23
4214678-21467871.89573.16
5221274-22127474.10475.40
6216507-21650772.50773.74
极限1229687-22968776.92177.040.6678.6778.740.65
2232101-23210177.73079.43
3229820-22982076.96678.67
4227648-22764876.23977.90
5230001-23000177.02778.74
6231074-23107477.38679.02
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%
115.207194471357718487193071380716920.42
2 15.187140171392713960.01
单位质量响应值RSD%判断
4716.584703.290.20数据可信
供试品溶液-23100202批-氨氯地平-pH5.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131891-3189143.89948.9114.8643.9048.9114.85
241887-4188757.65957.66
338000-3800052.30952.31
436249-3624949.89849.90
527029-2702937.20737.21
638111-3811152.46152.46
10min165369-6536989.98389.434.5790.2389.704.59
268802-6880294.70995.03
361937-6193785.25985.55
464919-6491989.36489.64
561276-6127684.34984.56
667492-6749292.90693.20
15min170207-7020796.64395.981.6697.3996.751.69
271660-7166098.64399.49
368287-6828794.00094.76
469423-6942395.56496.34
568991-6899194.96995.64
669781-6978196.05696.86
20min171843-7184398.89597.681.77100.1898.981.80
272198-7219899.384100.78
370593-7059397.17498.46
469824-6982496.11697.42
569244-6924495.31796.52
672039-7203999.165100.51
30min171347-7134798.21298.711.01100.04100.561.01
271561-7156198.507100.45
372028-7202899.150100.98
470860-7086097.54299.38
571512-7151298.439100.17
672961-72961100.434102.33
45min171400-7140098.28599.022.05100.66101.412.05
272433-7243399.707102.20
372688-72688100.058102.44
472811-72811100.227102.61
569178-6917895.22697.51
673076-73076100.592103.04
60min171279-7127998.11998.741.41101.04101.681.43
272339-7233999.578102.63
373053-73053100.560103.49
470719-7071997.348100.28
570579-7057997.15599.96
672393-7239399.652102.66
极限170951-7095197.66798.992.01101.13102.482.01
272891-72891100.337103.94
372233-7223399.432102.92
470533-7053397.092100.57
570699-7069997.320100.67
674161-74161102.086105.65
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