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%
114.023267632682327243272432709327030.07
214.073268932678326840.03
单位质量响应值RSD%判断
2332.602322.960.30数据可信
长期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%
5min124840-2484067.37662.619.2667.3862.619.26
219297-1929752.34152.34
322376-2237660.69260.69
422788-2278861.81061.81
524253-2425365.78365.78
624942-2494267.65267.65
10min132509-3250988.17786.162.1588.5586.502.17
230478-3047882.66882.96
331923-3192386.58786.92
432010-3201086.82387.17
531731-3173186.06786.43
631935-3193586.62087.00
15min133353-3335390.46691.121.6291.3391.951.63
232876-3287689.17289.92
333334-3333490.41591.23
433682-3368291.35992.18
534455-3445593.45594.30
633868-3386891.86392.72
20min135397-3539796.01092.882.2897.3894.222.28
233798-3379891.67392.92
333883-3388391.90493.22
433186-3318690.01391.35
534587-3458793.81395.18
634612-3461293.88195.25
30min138150-38150103.47795.614.11105.3897.464.07
234509-3450993.60295.36
335002-3500294.93996.77
434305-3430593.04894.88
534540-3454093.68695.57
634980-3498094.87996.77
45min135599-3559996.55894.782.4099.0397.162.39
234241-3424192.87595.15
334390-3439093.27995.64
433947-3394792.07794.43
535792-3579297.08299.49
635684-3568496.78999.20
60min136292-3629298.43895.561.72101.4598.471.71
235277-3527795.68598.48
335169-3516995.39298.27
434429-3442993.38596.25
535022-3502294.99397.94
635207-3520795.49598.45
90min135350-3535095.88394.641.6099.4498.081.62
234462-3446293.47496.80
334513-3451393.61397.02
434240-3424092.87296.25
535205-3520595.48998.96
635592-3559296.539100.02
120min136277-3627798.39795.101.90102.4999.061.91
234535-3453593.67297.51
334709-3470994.14498.07
434669-3466994.03697.93
535383-3538395.97299.97
634785-3478594.35098.37
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137436-37436101.54197.082.84106.18101.572.77
236220-3622098.243102.60
335564-3556496.463100.91
434361-3436193.20097.62
535776-3577697.038101.57
635391-3539195.994100.54
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%
115.372111533211101521101942109935210876421102880.06
215.322102182210226821022250.01
单位质量响应值RSD%判断
137299.15137220.950.05数据可信
长期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%
5min1582388-58238825.45823.5310.0525.4623.5310.05
2441451-44145119.29719.30
3515870-51587022.55022.55
4539275-53927523.57323.57
5571443-57144324.97924.98
6579623-57962325.33725.34
10min11068680-106868046.71546.592.5246.8646.722.54
21012738-101273844.26944.38
31068226-106822646.69546.82
41081528-108152847.27647.41
51083359-108335947.35647.50
61079919-107991947.20647.35
15min11352542-135254259.12359.581.8759.5259.971.89
21322827-132282757.82458.18
31366416-136641659.73060.11
41371538-137153859.95460.35
51400833-140083361.23461.64
61363645-136364559.60960.01
20min11538777-153877767.26467.561.7067.9968.281.71
21511209-151120966.05966.73
31524326-152432666.63267.35
41550637-155063767.78268.51
51581222-158122269.11969.86
61566718-156671868.48569.22
30min11806781-180678178.97978.421.0380.0879.521.05
21760745-176074576.96778.01
31784845-178484578.02079.11
41809626-180962679.10480.21
51801682-180168278.75679.88
61800403-180040378.70079.82
45min11951246-195124685.29485.732.0086.8487.261.99
21908158-190815883.41184.88
31935034-193503484.58586.11
41966508-196650885.96187.50
52019097-201909788.26089.82
61986856-198685686.85188.40
60min11990955-199095587.03089.151.3589.0591.161.33
22030162-203016288.74490.68
32045313-204531389.40691.40
42073052-207305290.61992.64
52051305-205130589.66891.72
62045483-204548389.41391.45
90min12070964-207096490.52793.622.2293.0396.122.20
22102473-210247391.90594.33
32134493-213449393.30495.79
42177028-217702895.16497.69
52174489-217448995.05397.60
62190481-219048195.75298.28
120min12141484-214148493.61095.071.5896.6198.101.59
22137699-213769993.44496.38
32155939-215593994.24297.25
42203094-220309496.30399.36
52218472-221847296.975100.06
62193231-219323195.87298.94
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12162607-216260794.53396.161.1698.0699.721.16
22182379-218237995.39898.85
32197109-219710996.04199.57
42217918-221791896.951100.54
52233695-223369597.641101.26
62205555-220555596.411100.01
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%
114.023264632653325893258932623326200.10
214.073250532461324830.10
单位质量响应值RSD%判断
2326.682308.670.55数据可信
长期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%
5min122353-2235360.89564.945.2860.8964.945.28
224713-2471367.32467.32
324714-2471467.32767.33
425403-2540369.20469.20
523085-2308562.88962.89
622761-2276162.00662.01
10min130064-3006481.90185.603.0782.2485.963.07
231483-3148385.76786.14
332276-3227687.92788.30
432716-3271689.12689.51
531079-3107984.66785.02
630909-3090984.20384.55
15min132894-3289489.61191.401.5890.4092.231.60
233291-3329190.69391.54
333770-3377091.99792.86
434266-3426693.34994.23
533124-3312490.23891.06
633955-3395592.50193.31
20min132922-3292289.68793.072.3590.9894.412.36
234689-3468994.50195.86
334430-3443093.79595.17
435219-3521995.94597.34
533741-3374191.91893.24
633974-3397492.55393.88
30min133325-3332590.78594.552.5592.5796.402.54
235571-3557196.90498.78
335424-3542496.50398.40
435295-3529596.15298.08
534471-3447193.90795.74
634146-3414693.02294.86
45min133155-3315590.32295.032.8992.6297.422.88
236050-3605098.209100.63
335184-3518495.85098.28
435582-3558296.93499.40
534507-3450794.00596.36
634815-3481594.84497.20
60min133682-3368291.75894.252.6994.5597.162.68
235785-3578597.487100.45
335196-3519695.88298.85
435261-3526196.05999.06
533633-3363391.62494.50
634026-3402692.69595.58
90min133818-3381892.12896.402.5495.4399.842.54
236507-3650799.454102.96
335759-3575997.416100.91
435745-3574597.378100.92
535293-3529396.14699.53
635194-3519495.87799.28
120min133116-3311690.21693.922.4694.0397.892.46
235423-3542396.501100.56
334548-3454894.11798.15
435301-3530196.168100.25
534381-3438193.66297.58
634083-3408392.85096.78
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133313-3331390.75396.343.1795.07100.843.13
236627-3662799.781104.37
335631-3563197.067101.63
435862-3586297.697102.31
535655-3565597.133101.57
635098-3509895.615100.06
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%
115.372104304210492121038392104223210345021041470.03
215.322110302211010621102040.01
单位质量响应值RSD%判断
136899.61137741.780.44数据可信
长期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%
5min1531073-53107323.20523.835.2623.2023.835.26
2560714-56071424.50024.50
3564283-56428324.65624.66
4583459-58345925.49425.49
5526662-52666223.01223.01
6506567-50656722.13422.13
10min11014749-101474944.33845.392.6944.4745.522.69
21020889-102088944.60644.74
31034037-103403745.18145.32
41090917-109091747.66647.81
51046606-104660645.73045.86
61025427-102542744.80544.93
15min11315950-131595057.49957.882.0557.8758.262.04
21284746-128474656.13556.52
31305227-130522757.03057.42
41353390-135339059.13559.54
51347982-134798258.89859.28
61340614-134061458.57658.95
20min11486916-148691664.96965.701.7665.6666.411.75
21471962-147196264.31665.01
31481340-148134064.72565.43
41526303-152630366.69067.42
51524383-152438366.60667.32
61531059-153105966.89867.60
30min11721973-172197375.23976.081.2976.3077.151.29
21714969-171496974.93375.99
31750054-175005476.46677.53
41772257-177225777.43778.54
51757840-175784076.80777.89
61729798-172979875.58176.65
45min11877367-187736782.02984.301.4583.5085.791.45
21918025-191802583.80685.28
31945472-194547285.00586.49
41949532-194953285.18286.72
51947761-194776185.10586.61
61937231-193723184.64586.13
60min12014162-201416288.00688.680.9989.9490.650.98
22030161-203016188.70590.64
32042264-204226489.23491.20
42028118-202811888.61690.62
52059711-205971189.99791.98
62003638-200363887.54689.51
90min12101573-210157391.82693.991.4194.2496.441.40
22147263-214726393.82296.25
32195255-219525595.91998.38
42145815-214581593.75996.26
52163216-216321694.51997.00
62153343-215334394.08896.53
120min12103622-210362291.91593.621.4294.8496.601.40
22144196-214419693.68896.64
32194405-219440595.88298.87
42145075-214507593.72696.75
52145384-214538493.74096.74
62123468-212346892.78295.75
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12121869-212186992.71295.542.1396.1599.032.07
22204164-220416496.30899.78
32248378-224837898.240101.76
42141765-214176593.58297.12
52197919-219791996.03599.56
62204807-220480796.33699.82
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%
114.023265032592325383259432579325910.13
214.073241832416324170.01
单位质量响应值RSD%判断
2324.612303.980.64数据可信
长期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%
5min117068-1706846.56548.2912.1946.5748.2912.19
217871-1787148.75648.76
315649-1564942.69442.69
421757-2175759.35859.36
517628-1762848.09348.09
616235-1623544.29344.29
10min130395-3039582.92585.202.3183.1885.472.32
230596-3059683.47383.74
330924-3092484.36884.60
431999-3199987.30187.63
532116-3211687.62087.89
631351-3135185.53385.78
15min131861-3186186.92492.623.4987.6493.363.46
233738-3373892.04592.78
334923-3492395.27895.98
433572-3357291.59292.41
534602-3460294.40295.16
634993-3499395.46996.19
20min133803-3380392.22295.242.5593.4296.502.52
234192-3419293.28494.53
335832-3583297.75898.99
434647-3464794.52595.85
534936-3493695.31396.59
636046-3604698.34299.59
30min134086-3408692.99496.182.9194.7197.962.87
234272-3427293.50295.27
336296-3629699.024100.80
434659-3465994.55896.41
536011-3601198.246100.05
636198-3619898.756100.55
45min133951-3395192.62695.152.0094.8697.472.00
234067-3406792.94395.23
335383-3538396.53398.86
435226-3522696.10598.48
535598-3559897.11999.47
635024-3502495.55397.90
60min132919-3291989.81192.973.0892.5695.823.04
232844-3284489.60692.41
334329-3432993.65796.52
433964-3396492.66295.57
535095-3509595.74798.64
635305-3530596.32099.20
90min134447-3444793.97993.741.7197.2297.111.66
234090-3409093.00596.30
334123-3412393.09596.48
433551-3355191.53594.96
534697-3469794.66198.09
635258-3525896.19299.60
120min133660-3366091.83291.882.0795.6095.762.01
232964-3296489.93393.75
334772-3477294.86698.77
432958-3295889.91793.85
534115-3411593.07497.02
633586-3358691.63095.58
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132303-3230388.13093.173.1392.4197.573.04
234504-3450494.13598.45
334914-3491495.25399.68
433684-3368491.89896.33
534187-3418793.27097.74
635309-3530996.331100.79
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%
115.372107504210530021046412105513210578621057490.06
215.322092723209355720931400.03
单位质量响应值RSD%判断
137003.84136627.940.20数据可信
长期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%
5min1442066-44206619.38719.3312.6719.3919.3312.66
2443325-44332519.44219.44
3368720-36872016.17016.17
4539151-53915123.64423.64
5436937-43693719.16219.16
6414557-41455718.18018.18
10min11046389-104638945.88946.842.3746.0046.942.39
21054808-105480846.25846.37
31055379-105537946.28346.37
41106328-110632848.51848.65
51093509-109350947.95548.06
61051360-105136046.10746.21
15min11369073-136907360.04061.001.0660.4061.371.07
21399843-139984361.39061.75
31375756-137575660.33360.68
41398191-139819161.31761.72
51403543-140354361.55261.92
61399688-139968861.38361.74
20min11554504-155450468.17269.441.4268.8770.151.42
21558457-155845768.34669.05
31585564-158556469.53470.22
41596143-159614369.99870.74
51595772-159577269.98270.70
61610703-161070370.63771.33
30min11776201-177620177.89579.141.3378.9780.231.33
21788452-178845278.43279.52
31792805-179280578.62379.69
41802822-180282279.06280.19
51833501-183350180.40881.51
61833247-183324780.39681.49
45min11930305-193030584.65386.331.2386.1687.861.23
21978343-197834386.76088.28
31949784-194978485.50787.01
41973330-197333086.54088.11
51995176-199517687.49889.05
61984802-198480287.04388.58
60min12005700-200570087.95989.061.6189.9491.071.59
22022131-202213188.68090.68
31996519-199651987.55789.54
42018259-201825988.51090.56
52075697-207569791.02993.07
62066222-206622290.61392.63
90min12128506-212850693.34592.501.8395.8195.001.79
22148198-214819894.20896.70
32036871-203687189.32691.79
42105392-210539292.33194.87
52110686-211068692.56395.11
62125756-212575693.22495.75
120min12123151-212315193.11093.200.7996.1096.220.78
22112575-211257592.64695.67
32119091-211909192.93295.89
42107325-210732592.41695.47
52152663-215266394.40497.46
62136136-213613693.67996.72
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12078682-207868291.16093.421.8894.6696.961.81
22184175-218417595.78699.32
32140521-214052193.87297.35
42093501-209350191.81095.38
52124799-212479993.18296.76
62159986-215998694.72598.29
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%
114.023243932422324643243932437324400.05
214.073220632223322140.04
单位质量响应值RSD%判断
2313.842289.550.75数据可信
长期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%
5min116763-1676345.98446.747.7945.9846.747.79
217197-1719747.17547.17
315181-1518141.64441.64
418449-1844950.60950.61
516072-1607244.08844.09
618564-1856450.92450.92
10min130482-3048283.61885.161.7783.8785.421.78
230904-3090484.77585.04
330415-3041583.43483.67
431648-3164886.81687.10
531161-3116185.48085.73
631664-3166486.86087.14
15min134602-3460294.92093.211.6795.6493.951.67
233262-3326291.24491.98
333460-3346091.78792.48
434563-3456394.81395.58
533787-3378792.68493.40
634205-3420593.83194.60
20min134837-3483795.56494.791.0696.8196.041.06
234678-3467895.12896.37
333933-3393393.08494.29
434762-3476295.35996.65
534819-3481995.51596.75
634291-3429194.06795.35
30min134624-3462494.98095.820.9596.7697.600.95
235264-3526496.73698.50
334512-3451294.67396.39
435253-3525396.70598.53
535140-3514096.39598.16
634784-3478495.41997.23
45min135163-3516396.45995.451.0898.7697.761.08
234827-3482795.53797.84
334224-3422493.88396.13
435179-3517996.50298.86
534882-3488295.68897.99
634502-3450294.64596.98
60min133927-3392793.06893.791.1195.9196.631.11
233808-3380892.74295.58
333819-3381992.77295.54
434566-3456694.82197.71
534595-3459594.90097.73
634434-3443494.45997.32
90min134843-3484395.58195.381.6298.9498.741.53
235407-3540797.128100.48
335227-3522796.63499.92
433801-3380192.72296.14
534716-3471695.23298.59
634635-3463595.01098.40
120min134158-3415893.70293.610.8297.5997.500.76
234127-3412793.61797.51
334561-3456194.80798.63
434213-3421393.85397.79
533953-3395393.13997.03
633732-3373292.53396.45
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135103-3510396.29494.012.47100.7098.422.34
232993-3299390.50694.92
335221-3522196.618100.97
433721-3372192.50396.96
534445-3444594.48998.90
634142-3414293.65898.09
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%
115.372092368209214620921112092102209233520922120.01
215.322086469208642820864480.01
单位质量响应值RSD%判断
136123.10136191.120.04数据可信
长期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%
5min1422380-42238018.61318.608.9118.6118.598.93
2435357-43535719.18519.18
3374287-37428716.49416.49
4460402-46040220.28820.29
5380168-38016816.75316.75
6459284-45928420.23920.24
10min11058020-105802046.62346.572.0546.7346.672.06
21055448-105544846.51046.62
31016309-101630944.78544.88
41075936-107593647.41347.53
51060202-106020246.72046.81
61074570-107457047.35347.47
15min11383435-138343560.96360.751.4361.3361.111.44
21369409-136940960.34560.71
31345871-134587159.30859.65
41401243-140124361.74862.12
51377310-137731060.69461.05
61393781-139378161.41961.79
20min11556531-155653168.59168.911.1569.2969.611.16
21563379-156337968.89369.59
31533756-153375667.58868.26
41570362-157036269.20169.92
51587492-158749269.95670.65
61570616-157061669.21269.93
30min11788588-178858878.81779.040.9079.9080.120.91
21807414-180741479.64780.73
31766164-176616477.82978.87
41805513-180551379.56380.67
51806162-180616279.59280.67
61788405-178840578.80979.91
45min11933170-193317085.18985.471.2086.7187.001.19
21928127-192812784.96686.49
31908930-190893084.12085.60
41967560-196756086.70488.25
51966793-196679386.67088.19
61933237-193323785.19186.73
60min11994529-199452987.89289.531.2689.8991.531.25
22040525-204052589.91991.92
32007422-200742288.46190.41
42043453-204345390.04892.08
52062424-206242490.88492.89
62041754-204175489.97391.99
90min12097306-209730692.42193.671.5094.9096.161.45
22181398-218139896.12798.62
32138937-213893794.25696.69
42095870-209587092.35894.89
52125123-212512393.64796.15
62115329-211532993.21695.73
120min12122999-212299993.55493.550.9796.5596.560.95
22105385-210538592.77795.81
32111809-211180993.06196.02
42151069-215106994.79197.83
52143943-214394394.47797.50
62101770-210177092.61895.65
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12118963-211896393.37692.971.3996.8996.501.35
22057182-205718290.65394.20
32102527-210252792.65296.13
42127396-212739693.74797.31
52142405-214240594.40997.96
62110350-211035092.99696.54
点击查看处理图标(自动生成)
 
原始图谱下载图谱(谢超君 于 2024-08-22 11:56:30 完成)
生成报告数据部分下载报告(谢超君 于 2024-08-22 11:56:56 完成)
Current page cost:1.417 s