厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.023223432203322113221232165322050.08
214.073213132110321200.05
单位质量响应值RSD%判断
2297.082282.870.44数据可信
加速3月-供试品溶液-24032502批-左氨氯地平-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%
5min122815-2281562.90563.405.6562.9063.405.64
221241-2124158.56558.57
322433-2243361.85261.85
424609-2460967.85167.85
522435-2243561.85761.86
624434-2443467.36967.37
10min130619-3061984.42283.802.2784.7784.162.27
230673-3067384.57184.90
329680-2968081.83382.18
430885-3088585.15585.53
529404-2940481.07281.42
631107-3110785.76786.14
15min132368-3236889.24489.283.2490.0690.103.23
231957-3195788.11188.91
331220-3122086.07986.88
433572-3357292.56493.41
531477-3147786.78887.58
633691-3369192.89293.74
20min133442-3344292.20591.492.1193.5292.802.12
233252-3325291.68292.97
332183-3218388.73490.01
433432-3343292.17893.54
532608-3260889.90691.18
634176-3417694.22995.60
30min133685-3368592.87593.962.9494.7095.782.93
234731-3473195.75997.55
333389-3338992.05993.83
435407-3540797.62399.50
532682-3268290.11091.89
634572-3457295.32197.21
45min133799-3379993.19093.353.0495.5395.703.03
232854-3285490.58492.91
333017-3301791.03493.31
434737-3473795.77698.19
533308-3330891.83694.11
635435-3543597.700100.12
60min135238-3523897.15794.973.32100.0297.833.29
234797-3479795.94198.77
333252-3325291.68294.47
435686-3568698.393101.34
532820-3282090.49093.28
634870-3487096.14399.11
90min133777-3377793.12993.282.9996.5396.682.95
232218-3221888.83192.19
333411-3341192.12095.42
435130-3513096.860100.36
533846-3384693.31996.61
634619-3461995.45198.95
120min132684-3268490.11691.723.7694.0395.633.71
232186-3218688.74292.60
332222-3222288.84292.65
435033-3503396.592100.63
532836-3283690.53594.34
634645-3464595.52299.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限135083-3508396.73095.791.49101.15100.211.44
235408-3540897.626101.97
334672-3467295.59799.90
434779-3477995.892100.46
533879-3387993.41097.72
634629-3462995.478100.04
厄贝沙坦左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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.372084777208507720864502085874208560320855560.04
215.322075069207480420749360.01
单位质量响应值RSD%判断
135690.05135439.690.14数据可信
加速3月-供试品溶液-24032502批-厄贝沙坦-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%
5min1499028-49902822.08721.744.4922.0921.744.48
2456291-45629120.19520.20
3492456-49245621.79621.80
4518304-51830422.94022.94
5476225-47622521.07721.08
6504862-50486222.34522.34
10min1955996-95599642.31242.330.8742.4342.450.87
2964632-96463242.69442.81
3951930-95193042.13242.25
4959808-95980842.48042.61
5942702-94270241.72341.84
6963671-96367142.65142.78
15min11220190-122019054.00554.491.8654.3654.851.86
21210930-121093053.59553.94
31218396-121839653.92554.28
41265753-126575356.02156.38
51217641-121764153.89254.24
61254342-125434255.51655.88
20min11413022-141302262.53962.930.8163.2063.590.81
21418777-141877762.79463.44
31408332-140833262.33262.99
41433927-143392763.46564.14
51420499-142049962.87063.52
61437042-143704263.60264.27
30min11653780-165378073.19574.021.4274.2075.021.40
21699527-169952775.22076.22
31679129-167912974.31775.32
41699408-169940875.21576.24
51647799-164779972.93073.93
61654245-165424573.21674.24
45min11851617-185161781.95182.961.6883.3684.381.65
21822721-182272180.67282.09
31892823-189282383.77585.19
41878560-187856083.14484.59
51901741-190174184.17085.57
61899084-189908484.05285.48
60min11985161-198516187.86288.350.6489.7390.240.65
21991469-199146988.14190.00
31995484-199548488.31990.20
42021036-202103689.45091.36
51989050-198905088.03489.90
61995521-199552188.32090.22
90min12046018-204601890.55593.221.8392.9195.591.80
22076975-207697591.92594.28
32133173-213317394.41396.78
42126984-212698494.13996.54
52148158-214815895.07697.44
62105454-210545493.18695.57
120min12061224-206122491.22893.901.4894.0996.791.45
22118240-211824093.75296.61
32141210-214121094.76897.66
42144788-214478894.92797.85
52125862-212586294.08996.98
62138321-213832194.64197.55
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12136936-213693694.57995.460.9097.9498.870.88
22142775-214277594.83898.22
32183605-218360596.645100.07
42160896-216089695.64099.09
52174571-217457196.24599.66
62142442-214244294.82398.25
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.023213632146320953194731825320300.44
214.073201932006320120.03
单位质量响应值RSD%判断
2284.592275.200.30数据可信
加速3月-供试品溶液-24032502批-左氨氯地平-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%
5min121773-2177360.29760.214.0560.3060.214.05
221272-2127258.91058.91
320565-2056556.95256.95
422386-2238661.99561.99
523056-2305663.85063.85
621392-2139259.24259.24
10min129034-2903480.40580.762.2980.7481.092.29
228144-2814477.94178.27
328910-2891080.06280.38
429871-2987182.72383.07
529934-2993482.89883.25
629076-2907680.52280.85
15min130899-3089985.57087.362.1886.3588.142.18
230709-3070985.04485.80
331226-3122686.47687.24
432121-3212188.95489.76
532011-3201188.65089.46
632307-3230789.46990.25
20min131705-3170587.80289.812.4689.0691.082.45
231918-3191888.39289.62
331728-3172887.86689.11
433725-3372593.39694.69
532799-3279990.83292.14
632709-3270990.58391.86
30min133037-3303791.49192.221.2593.2493.991.26
233125-3312591.73593.46
332695-3269590.54492.27
433711-3371193.35895.17
533546-3354692.90194.71
633697-3369793.31995.10
45min132848-3284890.96892.882.4493.2295.162.43
232707-3270790.57792.81
333012-3301291.42293.65
434024-3402494.22496.56
534780-3478096.31898.65
633865-3386593.78496.08
60min133684-3368493.28394.032.6196.0496.822.58
233740-3374093.43896.17
332417-3241789.77492.51
434452-3445295.41098.27
534640-3464095.93098.79
634791-3479196.34899.16
90min133372-3337292.41995.022.1395.7098.342.11
234388-3438895.23298.49
333546-3354692.90196.14
434457-3445795.42398.81
535233-3523397.572100.97
634872-3487296.57399.92
120min133188-3318891.90994.201.8395.7098.041.83
233925-3392593.95097.73
333373-3337392.42196.18
434490-3449095.51599.43
534566-3456695.72599.66
634551-3455195.68499.57
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132972-3297291.31196.203.4895.61100.573.40
234716-3471696.141100.45
333868-3386893.79298.06
434801-3480196.376100.83
535847-3584799.273103.74
636216-36216100.295104.71
厄贝沙坦左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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.372077286207715620759042073051207208220750960.12
215.322072956207276420728600.01
单位质量响应值RSD%判断
135009.50135304.180.16数据可信
加速3月-供试品溶液-24032502批-厄贝沙坦-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%
5min1468648-46864820.80519.675.5120.8019.675.51
2441702-44170219.60819.61
3414747-41474718.41218.41
4441661-44166119.60719.61
5473442-47344221.01721.02
6418656-41865618.58518.59
10min1921975-92197540.92940.223.1941.0440.333.19
2883160-88316039.20639.31
3897164-89716439.82839.93
4902014-90201440.04340.15
5955308-95530842.40942.53
6876857-87685738.92639.03
15min11207639-120763953.61153.071.6953.9553.401.71
21173946-117394652.11552.44
31192483-119248352.93853.26
41190260-119026052.83953.17
51228922-122892254.55554.91
61178936-117893652.33652.66
20min11382985-138298561.39561.611.1762.0462.241.17
21379355-137935561.23461.85
31393107-139310761.84462.46
41405059-140505962.37563.00
51403407-140340762.30162.96
61362580-136258060.48961.10
30min11672475-167247574.24673.381.4275.2374.351.42
21636500-163650072.64973.61
31660399-166039973.71074.67
41638621-163862172.74373.71
51684840-168484074.79575.80
61624907-162490772.13473.08
45min11903516-190351684.50383.781.9385.9085.161.93
21865796-186579682.82884.19
31905275-190527584.58185.95
41866783-186678382.87284.25
51941587-194158786.19387.61
61840322-184032281.69783.04
60min12000336-200033688.80188.271.2390.6690.121.24
21984233-198423388.08689.91
31994586-199458688.54690.39
41967005-196700587.32189.16
52025984-202598489.93991.84
61958204-195820486.93088.73
90min12137905-213790594.90893.671.4997.2796.011.49
22109274-210927493.63795.95
32118699-211869994.05596.39
42079168-207916892.30094.62
52147124-214712495.31797.71
62068263-206826391.81694.10
120min12167383-216738396.21695.341.2299.1098.201.23
22143782-214378295.16998.00
32166005-216600596.15599.01
42135814-213581494.81597.65
52170724-217072496.36599.29
62102811-210281193.35096.14
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12169935-216993596.33096.921.1399.75100.301.13
22195740-219574097.475100.83
32205592-220559297.913101.30
42163851-216385196.06099.42
52211997-221199798.197101.66
62151813-215181395.52598.84
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.023220432188320493212331894320920.40
214.073214132146321440.02
单位质量响应值RSD%判断
2289.022284.580.14数据可信
加速3月-供试品溶液-2024042411批-左氨氯地平-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%
5min112969-1296935.80747.1013.0435.8147.1013.04
216472-1647245.47945.48
317038-1703847.04247.04
419051-1905152.59952.60
518323-1832350.58950.59
618505-1850551.09251.09
10min128148-2814877.71683.594.9277.9283.864.94
229054-2905480.21880.47
330305-3030583.67283.93
432281-3228189.12789.42
531231-3123186.22886.51
630643-3064384.60584.89
15min131439-3143986.80390.343.3287.4391.073.34
231868-3186887.98788.69
332549-3254989.86790.59
434465-3446595.15795.94
533367-3336792.12692.89
632637-3263790.11090.86
20min132588-3258889.97591.891.8891.0993.121.92
232927-3292790.91192.10
332695-3269590.27091.50
433745-3374593.16994.49
534090-3409094.12295.39
633645-3364592.89394.15
30min132673-3267390.21092.093.2991.8293.833.30
232363-3236389.35491.05
332509-3250989.75791.48
435264-3526497.36399.20
533619-3361992.82194.62
633699-3369993.04294.81
45min131507-3150786.99090.563.7189.1092.813.72
231509-3150986.99689.18
332261-3226189.07291.30
434411-3441195.00897.38
533493-3349392.47494.78
633622-3362292.83095.12
60min132712-3271290.31792.332.1392.9195.092.17
232649-3264990.14392.82
333712-3371293.07895.80
434320-3432094.75797.66
534106-3410694.16696.99
633156-3315691.54394.35
90min131921-3192188.13390.452.4491.2393.722.47
231932-3193288.16491.34
332699-3269990.28193.52
434049-3404994.00997.44
532887-3288790.80094.15
633083-3308391.34294.65
120min132150-3215088.76690.782.0692.3594.552.11
232038-3203888.45692.12
332876-3287690.77094.51
433491-3349192.46896.42
533682-3368292.99596.85
633036-3303691.21295.03
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限132787-3278790.52493.072.6194.6197.342.63
232938-3293890.94195.10
333166-3316691.57195.81
434997-3499796.626101.09
534179-3417994.36898.74
634180-3418094.37098.70
厄贝沙坦左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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.372073219207222520698222070553206926320710160.09
215.322074129207514620746380.04
单位质量响应值RSD%判断
134744.05135420.230.36数据可信
加速3月-供试品溶液-2024042411批-厄贝沙坦-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%
5min1295335-29533513.11816.5410.9713.1216.5410.97
2366416-36641616.27516.28
3373729-37372916.60016.60
4408148-40814818.12918.13
5393045-39304517.45817.46
6398126-39812617.68417.68
10min1875295-87529538.87942.244.4438.9542.334.46
2947319-94731942.07842.17
3948255-94825542.11942.21
41001646-100164644.49144.59
5973438-97343843.23843.33
6960299-96029942.65442.75
15min11220792-122079254.22556.803.0554.5157.123.07
21272484-127248456.52156.84
31255059-125505955.74756.07
41333310-133331059.22359.57
51288520-128852057.23357.57
61302484-130248457.85358.19
20min11441169-144116964.01365.091.3864.6065.731.40
21476944-147694465.60266.24
31440620-144062063.98964.62
41490090-149009066.18666.86
51472479-147247965.40466.06
61470773-147077365.32865.98
30min11668685-166868574.11975.442.3575.0676.442.36
21683488-168348874.77775.78
31665578-166557873.98174.97
41768574-176857478.55679.60
51682102-168210274.71575.73
61722363-172236376.50377.52
45min11861378-186137882.67883.071.7484.0484.491.74
21864308-186430882.80884.23
31819500-181950080.81882.22
41910058-191005884.84086.32
51864735-186473582.82784.26
61901002-190100284.43885.88
60min12007930-200793089.18888.671.2291.0090.551.21
22012770-201277089.40391.28
31957090-195709086.92988.78
42017193-201719389.59991.55
51975488-197548887.74789.64
62006689-200668989.13391.05
90min12089210-208921092.79892.991.9795.1195.371.96
22121920-212192094.25196.63
32042872-204287290.74093.07
42147727-214772795.39797.85
52049991-204999191.05693.44
62109701-210970193.70896.12
120min12151468-215146895.56394.421.1098.3997.321.08
22146060-214606095.32398.22
32091708-209170892.90995.75
42139021-213902195.01097.99
52115019-211501993.94496.83
62111355-211135593.78296.71
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12181745-218174596.90895.181.55100.2798.591.52
22155221-215522195.73099.16
32097310-209731093.15896.51
42171136-217113696.43799.94
52111927-211192793.80797.22
62139069-213906995.01398.46
厄贝沙坦左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100546-202105对照品来源中检院对照品使用方法左氨氯地平需分装,厄贝沙坦105℃烘干2小时
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数8000
标示量(mg)2.5供试品稀释倍数2系数0.7210
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.023208332077321283194632014320500.23
214.073219832205322020.02
单位质量响应值RSD%判断
2286.022288.700.09数据可信
加速3月-供试品溶液-2024042411批-左氨氯地平-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%
5min117632-1763248.67051.349.9248.6751.349.92
216266-1626644.89944.90
317098-1709847.19647.20
419673-1967354.30354.30
520082-2008255.43255.43
620837-2083757.51657.52
10min130859-3085985.18085.302.0085.4585.592.03
230190-3019083.33383.58
330253-3025383.50783.77
431072-3107285.76886.07
531228-3122886.19986.51
631820-3182087.83388.15
15min132996-3299691.07991.841.3591.8292.601.37
232640-3264090.09690.81
333187-3318791.60692.33
433855-3385593.45094.23
533690-3369092.99593.78
633268-3326891.83092.64
20min134384-3438494.91093.761.8896.1695.041.89
232839-3283990.64591.86
333749-3374993.15794.39
434475-3447595.16196.46
533885-3388593.53394.84
634481-3448195.17896.50
30min134581-3458195.45495.031.2797.2396.821.24
234875-3487596.26597.98
333814-3381493.33795.09
434630-3463095.58997.42
534712-3471295.81697.64
633954-3395493.72395.57
45min134577-3457795.44393.722.1097.7596.042.05
234358-3435894.83897.09
332797-3279790.53092.80
434275-3427594.60996.97
534359-3435994.84197.20
633352-3335292.06294.43
60min133467-3346792.37993.561.0295.2296.400.98
234341-3434194.79197.57
333751-3375193.16395.94
433991-3399193.82596.71
533617-3361792.79395.68
634211-3421194.43397.31
90min134032-3403293.93994.001.3597.2997.361.33
233906-3390693.59196.90
333694-3369493.00696.30
434302-3430294.68498.09
534826-3482696.13099.53
633566-3356692.65296.06
120min133966-3396693.75693.191.3197.6397.071.29
234088-3408894.09397.92
332908-3290890.83694.64
433893-3389393.55597.48
534030-3403093.93397.86
633684-3368492.97896.90
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限134700-3470095.78293.381.83100.1897.781.78
233792-3379293.27697.62
332912-3291290.84795.16
433680-3368092.96797.42
534307-3430794.69899.15
633592-3359292.72497.16
厄贝沙坦左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100607-202305对照品来源中检院对照品使用方法105℃烘干2小时
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数200
标示量(mg)150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%
115.372075255207567020754432069773207109120734460.14
215.322079112207988020794960.03
单位质量响应值RSD%判断
134902.15135737.340.44数据可信
加速3月-供试品溶液-2024042411批-厄贝沙坦-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%
5min1384758-38475817.06017.767.4417.0617.767.43
2359884-35988415.95715.96
3382348-38234816.95316.95
4413417-41341718.33118.33
5424953-42495318.84218.84
6438482-43848219.44219.44
10min1948365-94836542.05042.942.8342.1543.042.84
2930910-93091041.27641.37
3956156-95615642.39642.49
4981737-98173743.53043.63
5992500-99250044.00744.11
61000408-100040844.35844.47
15min11268426-126842656.24257.021.6456.5757.351.65
21257119-125711955.74056.06
31296018-129601857.46557.79
41315433-131543358.32658.67
51295719-129571957.45257.80
61282786-128278656.87957.23
20min11544944-154494468.50366.252.3269.1466.902.30
21453117-145311764.43165.06
31474789-147478965.39266.04
41521680-152168067.47168.14
51470478-147047865.20165.87
61500028-150002866.51167.18
30min11703380-170338075.52876.290.6476.5577.310.63
21730597-173059776.73477.72
31720974-172097476.30877.32
41733819-173381976.87777.92
51718806-171880676.21277.24
61715377-171537776.06077.10
45min11897347-189734784.12883.861.0485.5785.311.03
21883464-188346483.51384.92
31899524-189952484.22585.66
41923111-192311185.27086.74
51876074-187607483.18584.64
61868736-186873682.85984.32
60min11984923-198492388.01188.720.7589.9290.640.75
22000894-200089488.71990.60
32001168-200116888.73190.64
42018795-201879589.51391.46
51983447-198344787.94689.86
62016353-201635389.40591.33
90min12093269-209326992.81592.640.9395.2195.050.92
22075775-207577592.04094.41
32086661-208666192.52294.92
42114025-211402593.73696.18
52105540-210554093.35995.76
62060932-206093291.38193.80
120min12109244-210924493.52493.721.0796.4496.641.06
22104718-210471893.32396.20
32082296-208229692.32995.24
42149943-214994395.32898.29
52111375-211137593.61896.54
62124583-212458394.20497.13
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限12139060-213906094.84694.160.5598.2897.600.55
22119171-211917193.96497.36
32105159-210515993.34296.77
42129873-212987394.43897.93
52128974-212897494.39897.84
62119881-211988193.99597.45
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