氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566156961290611006131961166612890.30
212.556094561127610360.22
单位质量响应值RSD%判断
4879.704863.430.24数据可信
供试品溶液-2025020511批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min137854-3785450.37949.314.6450.3849.314.64
235707-3570747.52147.52
337676-3767650.14250.14
436708-3670848.85448.85
539596-3959652.69752.70
634752-3475246.25046.25
10min167925-6792590.40085.565.8990.9686.105.85
257869-5786977.01677.54
366264-6626488.18988.75
465881-6588187.67988.22
561610-6161081.99582.58
666160-6616088.05188.56
15min174171-7417198.71294.412.74100.2895.902.75
269068-6906891.92193.30
371433-7143395.06896.61
470696-7069694.08795.60
568845-6884591.62493.12
671400-7140095.02496.52
20min173134-7313497.33293.993.4399.9996.543.39
270129-7012993.33395.74
372154-7215496.02898.62
471154-7115494.69797.26
566153-6615388.04190.56
671026-7102694.52797.07
30min173063-7306397.23895.101.21100.9898.701.26
270795-7079594.21997.66
371044-7104494.55198.21
471627-7162795.32698.94
570769-7076994.18597.68
671458-7145895.10198.70
45min173194-7319497.41295.641.43102.23100.291.40
271910-7191095.703100.19
371663-7166395.374100.09
472113-7211395.973100.65
572230-7223096.129100.67
670058-7005893.23897.89
60min171831-7183195.59893.511.53101.5099.221.49
270587-7058793.94299.49
370232-7023293.47099.24
469511-6951192.51098.25
570715-7071594.11399.72
668709-6870991.44397.13
极限171343-7134394.94894.432.06101.92101.181.92
272361-7236196.303102.90
371411-7141195.039101.85
470721-7072194.121100.89
571708-7170895.434102.09
668183-6818390.74397.45
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011351596135027213517911349990134782613502950.12
29.051349215134942513493200.02
单位质量响应值RSD%判断
149866.26149096.130.37数据可信
供试品溶液-2025020511批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1426384-42638425.67228.065.9325.6728.065.93
2472918-47291828.47428.47
3461321-46132127.77627.78
4485519-48551929.23229.23
5503444-50344430.31230.31
6446317-44631726.87226.87
10min1958431-95843157.70659.828.0557.9960.138.01
2858917-85891751.71452.03
31007211-100721160.64360.95
41080528-108052865.05765.38
5993171-99317159.79760.13
61062773-106277363.98864.29
15min11205111-120511172.55874.143.0573.4875.113.08
21187409-118740971.49272.38
31236718-123671874.46175.44
41292936-129293677.84678.89
51216036-121603673.21674.22
61250072-125007275.26576.27
20min11306235-130623578.64779.763.1180.3881.563.13
21281536-128153677.16078.84
31350751-135075181.32783.14
41390874-139087483.74385.66
51290342-129034277.69079.50
61328674-132867479.99881.84
30min11434350-143435086.36085.692.6788.9788.382.66
21396690-139669084.09386.64
31436580-143658086.49589.21
41486052-148605289.47392.32
51379314-137931483.04785.72
61406236-140623684.66887.40
45min11499312-149931290.27290.061.7793.8493.701.75
21510655-151065590.95494.43
31502488-150248890.46394.14
41531491-153149192.20996.05
51471543-147154388.60092.20
61458870-145887087.83791.51
60min11491778-149177889.81890.041.2194.3994.681.23
21496490-149649090.10294.59
31512691-151269191.07795.76
41518445-151844591.42496.29
51481730-148173089.21393.80
61471241-147124188.58193.23
极限11512113-151211391.04291.641.5696.6197.281.51
21537137-153713792.54998.04
31545914-154591493.07798.77
41538393-153839392.62598.50
51516356-151635691.29896.87
61482134-148213489.23794.87
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566088260741607526042160572606740.30
212.556061360990608020.44
单位质量响应值RSD%判断
4830.734844.780.21数据可信
供试品溶液-2025020511批-氨氯地平-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min136856-3685649.39352.233.3449.3952.233.35
238036-3803650.97550.97
339625-3962553.10453.10
439123-3912352.43252.43
539834-3983453.38453.38
640357-4035754.08554.09
10min162195-6219583.35287.374.0983.9087.954.08
264021-6402185.79986.37
363543-6354385.15985.75
464565-6456586.52887.11
567599-6759990.59491.19
669225-6922592.77393.37
15min169548-6954893.20696.033.1294.6897.583.12
270806-7080694.89296.41
372152-7215296.69698.23
469417-6941793.03194.57
572683-7268397.40899.01
675326-75326100.950102.58
20min168203-6820391.40496.834.8893.9199.454.84
271388-7138895.67298.25
371442-7144295.74598.36
470018-7001893.83696.41
574278-7427899.545102.23
678172-78172104.764107.52
30min171141-7114195.34196.043.0098.8799.733.01
270129-7012993.98597.62
371084-7108495.26598.94
469209-6920992.75296.37
573450-7345098.436102.22
674966-74966100.467104.38
45min170359-7035994.29395.612.7898.88100.372.81
269785-6978593.52498.21
370464-7046494.43499.17
469831-6983193.58698.24
573080-7308097.940102.82
674536-7453699.891104.92
60min168775-6877592.17094.652.7897.80100.472.80
270948-7094895.082100.80
370240-7024094.13499.92
468291-6829191.52297.21
572019-7201996.518102.49
673477-7347798.472104.62
极限169245-6924592.80093.722.6299.46100.592.62
269133-6913392.65099.43
371044-7104495.211102.04
467093-6709389.91696.62
570757-7075794.827101.87
672303-7230396.898104.14
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011346081134690413466491344864134338513455770.11
29.051349991135050113502460.03
单位质量响应值RSD%判断
149342.62149198.450.07数据可信
供试品溶液-2025020511批-厄贝沙坦-shui(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1459739-45973927.71928.782.9727.7228.782.97
2470627-47062728.37628.38
3499736-49973630.13130.13
4477194-47719428.77228.77
5486676-48667629.34329.34
6469768-46976828.32428.32
10min1936058-93605856.43859.273.1056.7559.593.09
2975337-97533758.80659.12
3972142-97214258.61458.95
4999788-99978860.28060.60
5987589-98758959.54559.87
61027185-102718561.93262.25
15min11189108-118910871.69573.131.8572.6374.111.85
21200829-120082972.40273.37
31221417-122141773.64374.63
41198276-119827672.24873.24
51216316-121631673.33674.32
61251670-125167075.46776.47
20min11280744-128074477.22080.706.8578.9582.506.74
21289987-128998777.77779.55
31313207-131320779.17780.98
41293459-129345977.98779.78
51332065-133206580.31482.12
61521780-152178091.75393.59
30min11424003-142400385.85884.942.1488.4587.632.12
21385868-138586883.55886.20
31394220-139422084.06286.75
41368803-136880382.53085.19
51438949-143894986.75989.45
61441170-144117086.89389.75
45min11488595-148859589.75288.682.0993.3092.312.08
21438189-143818986.71390.28
31442804-144280486.99190.61
41448949-144894987.36290.94
51504815-150481590.73094.39
61501173-150117390.51194.34
60min11490640-149064089.87590.022.1094.4294.642.10
21488266-148826689.73294.26
31467856-146785688.50293.09
41453297-145329787.62492.17
51524846-152484691.93896.60
61533774-153377492.47697.31
极限11515720-151572091.38891.001.8596.9396.621.82
21494346-149434690.09995.63
31531705-153170592.35197.92
41459659-145965988.00893.53
51529961-152996192.24697.93
61524219-152421991.90097.76
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566183561612619886165561750617680.25
212.556162361567615950.07
单位质量响应值RSD%判断
4917.834907.970.15数据可信
供试品溶液-2025020511批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125079-2507933.09636.4316.3233.1036.4316.32
232882-3288243.39343.39
323294-2329430.74030.74
422477-2247729.66229.66
530880-3088040.75140.75
631014-3101440.92840.93
10min148882-4888264.50878.469.2664.8878.879.24
264865-6486585.60186.08
360706-6070680.11280.45
461617-6161781.31481.64
559201-5920178.12678.58
661471-6147181.12281.58
15min162957-6295783.08386.552.6484.1787.832.71
268088-6808889.85491.29
365520-6552086.46587.70
466727-6672788.05889.29
565173-6517386.00787.33
665050-6505085.84587.20
20min164034-6403484.50487.292.3686.5189.532.42
268085-6808589.85092.28
365585-6558586.55188.74
467740-6774089.39591.61
565140-6514085.96388.24
666287-6628787.47789.79
30min166362-6636287.57688.432.3190.5291.642.35
269688-6968891.96595.40
365701-6570186.70489.86
467865-6786589.56092.76
565643-6564386.62789.86
666812-6681288.17091.45
45min166853-6685388.22488.632.0392.1492.822.05
269654-6965491.92096.37
366296-6629687.48991.61
467703-6770389.34693.55
566513-6651387.77591.97
665959-6595987.04491.31
60min165938-6593887.01787.592.7691.9292.772.72
269225-6922591.35496.83
366512-6651287.77492.86
467555-6755589.15094.34
564618-6461885.27590.44
664398-6439884.98490.21
极限165430-6543086.34686.613.0792.2192.763.01
268546-6854690.45896.95
364406-6440684.99591.06
467035-6703588.46494.65
562773-6277382.84088.96
665585-6558586.55192.72
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011354581135419213552781356287135499013550660.06
29.051354225135405013541380.01
单位质量响应值RSD%判断
150395.78149628.510.37数据可信
供试品溶液-2025020511批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1214726-21472612.88315.1315.6512.8815.1315.65
2299000-29900017.93917.94
3234542-23454214.07114.07
4205283-20528312.31612.32
5288772-28877217.32517.33
6270409-27040916.22316.22
10min1592424-59242435.54345.5611.5735.6945.7311.54
2801153-80115348.06648.26
3850033-85003350.99851.15
4782646-78264646.95547.09
5772336-77233646.33746.53
6757949-75794945.47445.65
15min1926487-92648755.58560.254.5956.1260.924.64
21015379-101537960.91861.65
31064177-106417763.84664.57
41025671-102567161.53662.19
51008470-100847060.50461.21
6984819-98481959.08559.77
20min11064465-106446563.86367.803.4465.0269.153.50
21134203-113420368.04769.46
31178642-117864270.71372.15
41157662-115766269.45570.80
51122819-112281967.36468.74
61123186-112318667.38668.73
30min11245262-124526274.71076.671.9276.5878.772.00
21288625-128862577.31279.48
31311524-131152478.68680.90
41293332-129333277.59479.71
51257704-125770475.45777.58
61271242-127124276.26978.36
45min11363397-136339781.79882.621.3384.4985.571.39
21383139-138313982.98286.01
31408425-140842584.49987.59
41382583-138258382.94985.92
51361309-136130981.67284.64
61363940-136394081.83084.77
60min11398090-139809083.87984.792.3387.4888.662.33
21425409-142540985.51889.47
31465927-146592787.94991.98
41427090-142709085.61989.52
51375473-137547382.52286.40
61388044-138804483.27687.12
极限11423005-142300585.37485.782.3189.9190.592.24
21441999-144199986.51491.41
31448430-144843086.89991.91
41446669-144666986.79491.64
51365856-136585681.94586.74
61452321-145232187.13391.91
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
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%
112.566196961826618656141861423617000.43
212.556155861598615780.05
单位质量响应值RSD%判断
4912.424906.610.09数据可信
供试品溶液-2025020511批-氨氯地平-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min128656-2865637.84336.627.4537.8436.627.45
224095-2409531.81931.82
327842-2784236.76836.77
430404-3040440.15140.15
527904-2790436.84936.85
627468-2746836.27436.27
10min156602-5660274.74779.616.1275.1780.016.10
255542-5554273.34873.70
362699-6269982.79983.21
459287-5928778.29378.74
563192-6319283.45083.86
664362-6436284.99585.40
15min166633-6663387.99487.692.4889.2588.982.51
263165-6316583.41484.58
366783-6678388.19289.52
466711-6671188.09789.41
567522-6752289.16890.50
667602-6760289.27490.62
20min166760-6676088.16288.612.4290.3990.872.45
264615-6461585.32987.42
367637-6763789.32091.63
466222-6622287.45189.75
568015-6801589.81992.15
669329-6932991.55593.89
30min166117-6611787.31388.882.9290.5292.132.92
265035-6503585.88488.93
368576-6857690.56093.86
465852-6585286.96390.23
568039-6803989.85193.18
670207-7020792.71496.07
45min167447-6744789.06989.093.0593.2593.333.01
265549-6554986.56390.56
368902-6890290.99195.30
464476-6447685.14689.38
569607-6960791.92296.25
668805-6880590.86395.25
60min168357-6835790.27187.562.7695.4492.792.71
263972-6397284.48089.44
366985-6698588.45993.78
465096-6509685.96591.14
565148-6514886.03391.38
668260-6826090.14395.54
极限165382-6538286.34287.462.2292.5193.662.24
264615-6461585.32991.23
367154-6715488.68294.98
465015-6501585.85891.99
566826-6682688.24994.55
668400-6840090.32896.73
氨氯地平厄贝沙坦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100607-202305对照品来源中检所对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数200
标示量(mg)100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%
19.011357337135731113579251355122135651813568430.08
29.051357786135828213580340.03
单位质量响应值RSD%判断
150593.01150059.010.26数据可信
供试品溶液-2025020511批-厄贝沙坦-pH4.5(内含0.4%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1255500-25550015.29715.417.4015.3015.407.40
2226710-22671013.57313.57
3267384-26738416.00816.01
4284666-28466617.04317.04
5252946-25294615.14415.14
6256711-25671115.36915.37
10min1696398-69639841.69345.985.4241.8646.155.41
2744461-74446144.57144.72
3788868-78886847.23047.41
4771434-77143446.18646.38
5801415-80141547.98148.15
6805570-80557048.23048.40
15min1984031-98403158.91460.712.4459.5561.402.46
2984875-98487558.96559.61
31017943-101794360.94461.65
41027175-102717561.49762.20
51045417-104541762.58963.29
61025138-102513861.37562.08
20min11098554-109855465.77168.192.1067.0669.552.11
21131271-113127167.72969.03
31147704-114770468.71370.09
41133005-113300567.83369.22
51161051-116105169.51270.91
61162445-116244569.59670.98
30min11233498-123349873.85076.942.3775.8779.062.37
21287074-128707477.05779.11
31302858-130285878.00280.15
41266848-126684875.84677.99
51306542-130654278.22380.39
61313929-131392978.66580.83
45min11355826-135582681.17383.042.1384.0186.012.12
21389290-138929083.17786.09
31404673-140467384.09887.11
41352769-135276980.99083.97
51430443-143044385.64188.68
61389147-138914783.16886.20
60min11418194-141819484.90784.591.0688.6588.481.02
21409689-140968984.39888.23
31432311-143231185.75389.70
41395261-139526183.53487.42
51397003-139700383.63987.63
61424707-142470785.29789.26
极限11398977-139897783.75786.211.6188.4491.041.62
21443907-144390786.44791.22
31452876-145287686.98491.88
41429763-142976385.60090.41
51464812-146481287.69892.62
61449286-144928686.76991.68
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