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%
112.566473665172652266490565619651320.52
212.556606366155661090.10
单位质量响应值RSD%判断
5185.675267.651.11数据可信
供试品溶液-2025020311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%
5min123187-2318728.76425.259.1728.7625.259.16
219984-1998424.79124.79
321615-2161526.81426.81
418677-1867723.16923.17
520510-2051025.44325.44
618163-1816322.53222.53
10min147621-4762159.07559.154.5459.3959.434.54
248400-4840060.04160.32
348118-4811859.69259.99
448077-4807759.64159.90
550218-5021862.29762.58
643667-4366754.17054.42
15min162799-6279977.90477.012.0178.8877.952.04
262255-6225577.22978.17
361728-6172876.57577.54
462130-6213077.07477.99
563637-6363778.94379.92
659931-5993174.34675.20
20min165673-6567381.46983.261.8383.3185.051.80
268097-6809784.47686.28
365955-6595581.81983.63
466896-6689682.98684.76
568869-6886985.43487.29
667193-6719383.35585.03
30min169322-6932285.99688.382.0388.7491.091.97
270963-7096388.03190.77
370577-7057787.55390.27
470904-7090487.95890.66
573532-7353291.21894.02
672143-7214389.49592.10
45min172198-7219889.56489.891.9993.2793.591.93
273600-7360091.30395.02
370919-7091987.97791.67
470612-7061287.59691.27
573636-7363691.34795.16
673813-7381391.56795.17
60min172438-7243889.86190.352.0094.5695.051.95
272674-7267490.15494.89
373293-7329390.92295.59
470415-7041587.35292.00
574868-7486892.87697.71
673290-7329090.91895.53
极限171272-7127288.41594.9613.2294.11100.6612.49
296798-96798120.080125.81
373113-7311390.69996.38
469342-6934286.02191.64
574886-7488692.89898.76
673880-7388091.65097.28
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%
19.011343750134589113433121339146134834313440880.26
29.051359817136329013615540.19
单位质量响应值RSD%判断
149177.36150447.960.60数据可信
供试品溶液-2025020311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%
5min1618786-61878637.17431.6111.6537.1731.6011.65
2531368-53136831.92331.92
3563000-56300033.82333.82
4491340-49134029.51829.52
5512036-51203630.76130.76
6440087-44008726.43926.44
10min11192449-119244971.63871.102.7272.0571.462.75
21215377-121537773.01573.37
31199813-119981372.08072.46
41178500-117850070.80071.13
51192400-119240071.63571.98
61122611-112261167.44267.74
15min11421631-142163185.40684.390.9386.6285.540.95
21402104-140210484.23385.40
31399129-139912984.05485.23
41419969-141996985.30686.42
51390422-139042283.53184.67
61395466-139546683.83484.88
20min11453212-145321287.30388.361.6389.4690.441.54
21467739-146773988.17690.28
31445379-144537986.83388.94
41496505-149650589.90491.97
51458214-145821487.60489.67
61503683-150368390.33592.31
30min11489235-148923589.46791.272.2092.6094.342.08
21493445-149344589.72092.80
31504634-150463490.39393.47
41550792-155079293.16696.23
51507057-150705790.53893.58
61570537-157053794.35297.33
45min11546865-154686592.93091.412.1997.0595.492.09
21498639-149863990.03294.11
31487404-148740489.35793.44
41536775-153677592.32396.42
51492488-149248889.66393.71
61567331-156733194.15998.19
60min11529057-152905791.86090.781.7397.0195.871.66
21480726-148072688.95694.04
31496551-149655189.90794.98
41524022-152402291.55796.68
51489255-148925589.46994.51
61546988-154698892.93798.01
极限11535011-153501192.21790.182.3898.3996.282.27
21439770-143977086.49692.56
31489219-148921989.46695.54
41524963-152496391.61497.75
51491598-149159889.60995.64
61526514-152651491.70797.81
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%
112.566558665759657856561265411656310.23
212.556517865077651280.11
单位质量响应值RSD%判断
5225.405189.480.49数据可信
供试品溶液-2025020411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%
5min113999-1399917.42920.6522.9617.4320.6422.97
213060-1306016.26016.26
321221-2122126.42126.42
420792-2079225.88725.89
512934-1293416.10316.10
617489-1748921.77521.77
10min135735-3573544.49250.229.5344.6950.459.57
237931-3793147.22647.41
343598-4359854.28154.57
443982-4398254.75955.05
536994-3699446.05946.24
643755-4375554.47754.72
15min150370-5037062.71365.745.6363.4066.535.71
250415-5041562.76963.47
354720-5472068.12969.03
455487-5548769.08469.98
549625-4962561.78562.48
656194-5619469.96470.81
20min155549-5554969.16171.925.9170.5573.445.97
256083-5608369.82671.23
361716-6171676.83978.49
459552-5955274.14575.81
552980-5298065.96267.34
660718-6071875.59777.22
30min159822-5982274.48178.264.3176.6380.584.41
260719-6071975.59877.78
366172-6617282.38784.89
464305-6430580.06282.55
560864-6086475.77877.89
665254-6525481.24483.71
45min161155-6115576.14178.863.3979.1282.053.53
262085-6208577.29880.32
365694-6569481.79285.21
464874-6487480.77184.15
561039-6103975.99678.95
665193-6519381.16884.54
60min160936-6093675.86879.085.2879.6983.145.31
262524-6252477.84581.72
367372-6737283.88188.21
465061-6506181.00485.28
558755-5875573.15376.95
666427-6642782.70486.97
极限161438-6143876.49380.334.1581.1685.274.21
263088-6308878.54783.29
366327-6632782.58087.84
464994-6499480.92086.09
562615-6261577.95882.57
668650-6865085.47290.66
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%
19.011352125135322613531381352225134397013509370.30
29.051348222135043613493290.12
单位质量响应值RSD%判断
149937.51149097.130.40数据可信
供试品溶液-2025020411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%
5min1380247-38024722.88928.0217.1222.8928.0217.12
2393329-39332923.67623.68
3575412-57541234.63634.64
4526845-52684531.71331.71
5417957-41795725.15925.16
6499476-49947630.06630.07
10min11041392-104139262.68665.183.6762.9465.503.72
21076412-107641264.79465.06
31124719-112471967.70268.09
41106602-110660266.61166.96
51031508-103150862.09162.37
61116742-111674267.22167.56
15min11349549-134954981.23579.401.7382.1980.441.66
21317220-131722079.28980.27
31309220-130922078.80779.94
41282844-128284477.22078.31
51321450-132145079.54480.51
61334599-133459980.33581.42
20min11433370-143337086.28184.482.1488.1386.402.04
21398240-139824084.16686.03
31401697-140169784.37486.39
41353205-135320581.45583.41
51435202-143520286.39188.24
61398829-139882984.20186.17
30min11500696-150069690.33388.162.6193.1591.022.50
21473348-147334888.68791.49
31450998-145099887.34290.29
41403908-140390884.50787.36
51507573-150757390.74793.56
61450975-145097587.34090.25
45min11531678-153167892.19888.283.0596.0192.112.91
21467618-146761888.34292.13
31444659-144465986.96090.88
41408422-140842284.77988.57
51502998-150299890.47294.29
61443970-144397086.91990.80
60min11525876-152587691.84988.312.9496.6993.132.81
21473795-147379588.71493.48
31443215-144321586.87391.76
41408728-140872884.79789.53
51504249-150424990.54795.37
61447053-144705387.10491.95
极限11528245-152824591.99188.513.2197.8594.313.06
21470256-147025688.50194.25
31426399-142639985.86191.71
41404195-140419584.52490.20
51501831-150183190.40196.23
61491559-149155989.78395.60
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%
112.566469665043652406510065134650430.32
212.556595765838658980.13
单位质量响应值RSD%判断
5178.585250.840.98数据可信
供试品溶液-2025020511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%
5min120473-2047325.45526.279.4325.4626.279.43
222672-2267228.18928.19
319721-1972124.52024.52
424142-2414230.01730.02
521065-2106526.19126.19
618691-1869123.23923.24
10min148923-4892360.82960.383.0361.1160.683.05
250503-5050362.79363.11
347000-4700058.43858.71
448923-4892360.82961.16
549379-4937961.39561.69
646654-4665458.00758.27
15min161802-6180276.84276.622.7577.8077.582.76
262918-6291878.22979.24
359335-5933573.77474.70
462880-6288078.18279.19
563074-6307478.42379.40
659712-5971274.24375.15
20min166434-6643482.60183.271.6084.4185.081.62
267821-6782184.32586.21
366282-6628282.41284.15
466725-6672582.96384.84
568699-6869985.41787.26
665880-6588081.91283.64
30min169024-6902485.82188.582.6688.5591.322.63
272248-7224889.83092.65
369569-6956986.49989.16
471100-7110088.40291.20
574275-7427592.35095.14
671248-7124888.58691.22
45min173348-7334891.19790.622.4694.8894.342.44
274424-7442492.53596.35
371433-7143388.81692.43
471635-7163589.06892.85
575406-7540693.75697.58
671033-7103388.31991.94
60min176903-7690395.61893.583.66100.3198.313.53
280151-8015199.656104.50
373827-7382791.79396.40
474011-7401192.02296.79
572940-7294090.69095.55
673744-7374491.69096.29
极限169382-6938286.26688.661.6092.0394.441.49
271779-7177989.24795.20
371637-7163789.07094.70
470579-7057987.75593.55
572010-7201089.53495.40
672480-7248090.11895.74
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%
19.011339969134676013466391344446134654213448710.22
29.051349363133974713445550.51
单位质量响应值RSD%判断
149264.26148569.610.33数据可信
供试品溶液-2025020511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%
5min1560920-56092033.90032.856.8133.9032.856.80
2572898-57289834.62434.62
3508973-50897330.76130.76
4586580-58658035.45135.45
5539075-53907532.58032.58
6492545-49254529.76829.77
10min11182198-118219871.44870.333.2271.8270.703.22
21219510-121951073.70374.09
31151985-115198569.62269.96
41145428-114542869.22669.62
51173690-117369070.93471.30
61109375-110937567.04767.38
15min11373823-137382383.02982.571.7784.2083.721.79
21387731-138773183.87085.07
31355880-135588081.94583.06
41357748-135774882.05883.22
51393888-139388884.24285.39
61328299-132829980.27881.35
20min11441726-144172687.13386.801.7589.2388.871.76
21457534-145753488.08990.22
31441866-144186687.14289.17
41409867-140986785.20887.28
51464362-146436288.50190.59
61402331-140233184.75286.72
30min11447478-144747887.48190.002.0990.5493.022.04
21507250-150725091.09394.21
31481845-148184589.55892.55
41476826-147682689.25492.28
51539001-153900193.01296.08
61482175-148217589.57892.49
45min11505464-150546490.98590.791.9895.0294.821.96
21514962-151496291.55995.69
31497143-149714390.48294.47
41479548-147954889.41993.43
51550692-155069293.71997.82
61465915-146591588.59592.50
60min11449563-144956387.60790.152.2092.6595.192.12
21548347-154834793.57798.72
31477528-147752889.29794.29
41482352-148235289.58894.60
51491474-149147490.14095.28
61500529-150052990.68795.58
极限11453726-145372687.85889.270.9093.8895.310.83
21475765-147576589.19095.37
31482389-148238989.59195.58
41474007-147400789.08495.09
51484758-148475889.73495.88
61491966-149196690.17096.07
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