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%
110.482787692782832791582787362789612787810.12
210.532772222769912771060.06
单位质量响应值RSD%判断
26601.2426315.860.77数据可信
中间条件6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%
5min174380-7438025.22633.6025.9425.2333.6025.94
287657-8765729.72829.73
396088-9608832.58832.59
4106735-10673536.19936.20
583172-8317228.20728.21
6146420-14642049.65749.66
10min1211249-21124971.64483.039.9971.7883.2210.02
2249030-24903084.45784.62
3253105-25310585.83986.02
4261797-26179788.78788.99
5219723-21972374.51874.67
6274080-27408092.95393.23
15min1272742-27274292.49995.084.4293.0495.724.46
2283502-28350296.14896.78
3286840-28684097.28097.94
4292475-29247599.19199.89
5258944-25894487.81988.39
6287541-28754197.51898.31
20min1279421-27942194.76495.892.7995.8297.072.85
2287778-28777897.59898.77
3280585-28058595.15996.36
4288389-28838997.80599.05
5269603-26960391.43492.49
6290747-29074798.60599.94
30min1285387-28538796.78797.741.6698.3799.441.74
2288030-28803097.68499.39
3290550-29055098.538100.27
4292033-29203399.041100.83
5280211-28021195.03296.60
6292878-29287899.328101.21
45min1286238-28623897.07697.022.0199.1999.272.04
2281215-28121595.37297.63
3287737-28773797.58499.86
4295315-295315100.154102.49
5278869-27886994.57796.67
6287000-28700097.33499.77
60min1291060-29106098.71197.641.79101.37100.431.82
2288074-28807497.699100.48
3287219-28721997.409100.23
4292461-29246199.186102.08
5278197-27819794.34996.97
6290362-29036298.475101.45
极限1294506-29450699.880100.500.68103.08103.840.73
2296133-296133100.432103.76
3298350-298350101.184104.54
4299260-299260101.492104.94
5295015-295015100.053103.20
6294793-29479399.977103.50
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%
115.267337873161735207346973396733850.19
215.327331873689735040.36
单位质量响应值RSD%判断
4808.984797.910.17数据可信
中间条件6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%
5min159487-5948780.29278.335.5680.2978.335.56
254250-5425073.22473.22
361591-6159183.13283.13
460910-6091082.21382.21
554233-5423373.20173.20
657729-5772977.91977.92
10min167428-6742891.01188.381.7491.4688.821.75
264830-6483087.50487.91
364973-6497387.69788.16
466306-6630689.49689.95
564678-6467887.29987.71
664654-6465487.26687.70
15min170563-7056395.24293.463.6896.1994.393.64
272725-7272598.16099.05
366960-6696090.37991.33
471070-7107095.92696.88
567579-6757991.21492.11
666566-6656689.84790.76
20min169645-6964594.00393.491.6895.4894.931.66
269244-6924493.46294.90
370177-7017794.72196.17
469203-6920393.40694.89
570246-7024694.81496.21
667077-6707790.53791.95
30min170812-7081295.57893.972.7397.5895.942.68
269730-6973094.11896.08
367370-6737090.93292.91
470706-7070695.43597.44
571835-7183596.95998.88
667287-6728790.82092.74
45min169121-6912193.29693.093.6095.8395.583.53
267735-6773591.42593.91
366750-6675090.09592.58
472478-7247897.827100.36
571295-7129596.23098.69
666422-6642289.65392.08
60min172434-7243497.76793.842.97100.8296.842.92
269672-6967294.03997.03
367707-6770791.38794.37
469792-6979294.20197.28
570800-7080095.56298.56
666735-6673590.07593.00
极限171512-7151296.52394.182.95100.1297.702.91
269591-6959193.93097.44
367631-6763191.28594.78
471806-7180696.920100.52
571090-7109095.95399.48
667011-6701190.44893.87
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%
110.482783582776932775992740212783662772070.66
210.532777142777812777480.02
单位质量响应值RSD%判断
26451.0526376.830.20数据可信
中间条件6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%
5min1178768-17876860.72953.3216.0060.7353.3216.01
2128713-12871343.72543.72
3158273-15827353.76753.77
4184686-18468662.73962.74
5125000-12500042.46342.46
6166231-16623156.47056.47
10min1264837-26483789.96784.756.4490.3085.046.47
2226270-22627076.86677.11
3249180-24918084.64884.95
4270309-27030991.82692.17
5243040-24304082.56382.80
6243168-24316882.60682.92
15min1278273-27827394.53190.344.9995.3791.115.02
2252480-25248085.76986.44
3270545-27054591.90692.68
4283420-28342096.28097.14
5256295-25629587.06587.76
6254675-25467586.51587.29
20min1282008-28200895.80091.764.1397.1693.034.17
2254955-25495586.61087.76
3270070-27007091.74593.02
4283881-28388196.43797.83
5266321-26632190.47191.65
6263459-26345989.49990.75
30min1283782-28378296.40393.074.4598.3094.854.47
2250967-25096785.25586.88
3278776-27877694.70296.49
4283192-28319296.20298.13
5275364-27536493.54395.22
6271776-27177692.32494.07
45min1290933-29093398.83294.762.99101.2697.053.04
2268064-26806491.06393.16
3277872-27787294.39596.71
4285221-28522196.89299.36
5279168-27916894.83697.04
6272385-27238592.53194.79
60min1282846-28284696.08592.743.4099.0695.563.41
2263794-26379489.61392.22
3276333-27633393.87296.71
4278992-27899294.77697.78
5276743-27674394.01296.74
6259339-25933988.09990.88
极限1293115-29311599.57398.520.89103.09101.860.94
2289729-28972998.423101.53
3285795-28579597.087100.45
4292185-29218599.257102.79
5289782-28978298.441101.69
6289439-28943998.325101.59
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%
115.267335773205729317265472675729640.43
215.327381773681737490.14
单位质量响应值RSD%判断
4781.394813.900.48数据可信
中间条件6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%
5min162852-6285284.93780.954.8884.9480.954.88
259951-5995181.01781.02
356756-5675676.69976.70
461176-6117682.67382.67
556040-5604075.73275.73
662650-6265084.66484.66
10min172003-7200397.30491.884.5197.7892.334.51
269673-6967394.15594.61
363850-6385086.28686.71
468280-6828092.27392.73
564937-6493787.75588.18
669171-6917193.47793.95
15min171045-7104596.00993.564.5397.0294.524.52
273633-7363399.507100.48
366086-6608689.30890.21
469540-6954093.97694.95
565230-6523088.15189.06
669857-6985794.40495.39
20min171971-7197197.26194.424.1198.8195.904.11
273376-7337699.159100.69
365933-6593389.10190.50
469687-6968794.17495.67
567152-6715290.74892.15
671104-7110496.08997.60
30min172286-7228697.68695.362.1299.7797.362.14
270724-7072495.57697.65
368327-6832792.33694.23
469832-6983294.37096.39
570110-7011094.74696.65
672107-7210797.44599.49
45min173325-7332599.09196.472.97101.7299.002.97
274248-74248100.338102.95
369079-6907993.35395.76
469198-6919893.51396.05
570827-7082795.71598.14
671618-7161896.78499.37
60min169161-6916193.46393.131.8596.6496.201.84
271313-7131396.37299.54
368358-6835892.37895.31
468388-6838892.41995.48
568592-6859292.69495.65
667658-6765891.43294.56
极限170815-7081595.69995.082.6999.4098.672.64
273178-7317898.892102.59
369698-6969894.18997.63
467357-6735791.02594.60
570826-7082695.71399.19
670284-7028494.98198.62
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%
110.482757212775742760642772852768062766900.29
210.532788082775902781990.31
单位质量响应值RSD%判断
26401.7226419.660.05数据可信
中间条件6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%
5min1174718-17471859.36054.786.1259.3654.786.12
2162046-16204655.05555.05
3170731-17073158.00658.01
4149351-14935150.74250.74
5156353-15635353.12153.12
6154291-15429152.42052.42
10min1269408-26940891.53194.653.1191.8694.953.10
2278142-27814294.49894.80
3286760-28676097.42697.75
4283604-28360496.35496.64
5266983-26698390.70791.00
6286585-28658597.36797.66
15min1285891-28589197.131100.122.8397.97100.952.81
2302360-302360102.726103.56
3297330-297330101.018101.88
4298530-298530101.425102.24
5282683-28268396.04196.84
6301319-301319102.373103.20
20min1293321-29332199.655100.382.09101.03101.772.09
2297509-297509101.078102.48
3295664-295664100.452101.88
4297158-297158100.959102.34
5285133-28513396.87498.21
6303923-303923103.257104.66
30min1281078-28107895.49698.882.5597.43100.822.53
2294899-294899100.192102.15
3294506-294506100.058102.04
4286539-28653997.35199.29
5287424-28742497.65299.52
6301805-301805102.538104.51
45min1291311-29131198.973100.332.23101.43102.832.21
2299102-299102101.620104.14
3290626-29062698.740101.28
4293280-29328099.642102.12
5290575-29057598.723101.14
6307011-307011104.307106.85
60min1290292-29029298.626101.152.17101.64104.202.14
2297527-297527101.084104.17
3297101-297101100.940104.03
4295761-295761100.484103.52
5295896-295896100.530103.49
6309755-309755105.239108.36
极限1297886-297886101.206102.431.40104.77106.041.37
2304932-304932103.600107.25
3298745-298745101.498105.15
4296556-296556100.755104.35
5304539-304539103.467106.99
6306184-306184104.026107.73
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%
115.267330473544733457343072637732520.49
215.327381873237735280.56
单位质量响应值RSD%判断
4800.264799.480.02数据可信
中间条件6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%
5min162386-6238684.26884.845.0584.2784.845.05
266036-6603689.19889.20
363693-6369386.03386.03
459272-5927280.06180.06
559101-5910179.83179.83
666357-6635789.63289.63
10min169644-6964494.07192.773.6694.5493.243.66
271155-7115596.11296.61
367227-6722790.80791.28
466922-6692290.39590.84
565472-6547288.43688.88
671674-7167496.81397.31
15min170553-7055395.29994.942.7696.2995.922.76
272843-7284398.39299.42
368609-6860992.67393.66
469801-6980194.28395.23
567853-6785391.65292.59
672054-7205497.32798.36
20min170698-7069895.49597.113.3497.0298.633.28
272107-7210797.39898.97
369195-6919593.46594.96
470515-7051595.24896.72
576043-76043102.715104.16
672819-7281998.36099.94
30min170483-7048395.20595.562.0697.2697.612.07
272439-7243997.84799.96
369173-6917393.43595.45
469685-6968594.12796.13
570059-7005994.63296.65
672623-7262398.095100.22
45min172303-7230397.66397.053.20100.2499.643.16
272905-7290598.476101.14
369065-6906593.28995.82
473120-7312098.767101.29
569061-6906193.28495.82
674649-74649100.832103.50
60min172961-7296198.55299.101.71101.67102.231.70
272578-7257898.035101.24
372251-7225197.593100.65
474274-74274100.325103.40
572663-7266398.149101.21
675482-75482101.957105.19
极限171184-7118496.15298.771.8899.82102.441.82
273910-7391099.834103.59
372153-7215397.460101.06
472979-7297998.576102.21
575120-75120101.468105.07
673386-7338699.126102.92
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%
110.482767032767882771112776742748202766190.39
210.532777962766012771980.31
单位质量响应值RSD%判断
26394.9426324.600.19数据可信
中间条件6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%
5min1161099-16109954.83954.9421.6654.8454.9421.65
298351-9835133.47933.48
3192742-19274265.61065.61
4150253-15025351.14751.15
5176012-17601259.91559.92
6189839-18983964.62264.62
10min1234939-23493979.97586.389.3180.2886.699.34
2215493-21549373.35573.54
3274056-27405693.29093.65
4262577-26257789.38389.67
5261209-26120988.91789.25
6274339-27433993.38793.75
15min1259459-25945988.32192.176.9489.0792.966.99
2238454-23845481.17181.76
3288394-28839498.17199.05
4280269-28026995.40596.19
5273865-27386593.22594.05
6284238-28423896.75697.63
20min1267245-26724590.97294.105.3692.2195.395.42
2250498-25049885.27186.32
3287349-28734997.81599.24
4288285-28828598.13499.44
5281382-28138295.78497.13
6283777-28377796.59998.01
30min1265611-26561190.41694.104.5792.1695.924.65
2256165-25616587.20088.72
3287935-28793598.01599.99
4285082-28508297.04498.90
5280787-28078795.58197.46
6282996-28299696.33398.29
45min1274180-27418093.33294.993.6995.5897.343.79
2260578-26057888.70290.70
3283610-28361096.54299.06
4285118-28511897.05699.45
5281965-28196595.98298.39
6288911-28891198.347100.83
60min1275489-27548993.77893.754.5596.5496.624.60
2256431-25643187.29189.79
3292017-29201799.404102.46
4281741-28174195.90698.84
5266299-26629990.65093.59
6280450-28045095.46798.50
极限1298608-298608101.648100.851.06104.93104.241.01
2295937-295937100.739103.72
3291445-29144599.210102.81
4298649-298649101.662105.13
5293798-293798100.011103.46
6299112-299112101.819105.38
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%
115.267333273448729477308473128731880.28
215.327269073561731260.85
单位质量响应值RSD%判断
4796.074773.240.34数据可信
中间条件6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%
5min155008-5500874.53975.936.8574.5475.936.85
251067-5106769.19869.20
356560-5656076.64276.64
452848-5284871.61271.61
560418-6041881.86981.87
660290-6029081.69681.70
10min162777-6277785.06687.492.1885.4887.912.17
266197-6619789.70090.08
363715-6371586.33786.76
464193-6419386.98587.38
564209-6420987.00687.46
666312-6631289.85690.31
15min166091-6609189.55789.941.6790.4490.851.65
267462-6746291.41492.30
366070-6607089.52890.43
466615-6661590.26791.15
564518-6451887.42588.36
667488-6748891.45092.40
20min166686-6668690.36391.531.7891.7592.941.74
269639-6963994.36495.75
366558-6655890.18991.59
468297-6829792.54693.93
566898-6689890.65092.07
667197-6719791.05592.52
30min166005-6600589.44090.842.6791.3392.752.60
269194-6919493.76195.68
366699-6669990.38192.28
468584-6858492.93594.83
567449-6744991.39793.32
664281-6428187.10489.07
45min166988-6698890.77292.972.2593.1695.402.21
270382-7038295.37197.81
366731-6673190.42492.83
469257-6925793.84796.26
568282-6828292.52694.96
670033-7003394.89897.35
60min165656-6565688.96791.732.7691.8594.672.68
267809-6780991.88594.85
369943-6994394.77697.68
468933-6893393.40896.34
565277-6527788.45491.40
668561-6856192.90495.88
极限167128-6712890.96292.712.1494.3496.152.09
269057-6905793.57697.05
366923-6692390.68494.12
469789-6978994.56898.02
567353-6735391.26794.71
670244-7024495.18498.68
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