培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.764496544919449444494644883449310.08
210.834524745130451880.19
单位质量响应值RSD%判断
4175.744172.480.06数据可信
供试品溶液-2022081401批-培哚普利-pH6.8磷酸盐溶液
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min135038-3503871.61979.267.7571.6279.267.75
240772-4077283.33983.34
338043-3804377.76177.76
437461-3746176.57176.57
543642-4364289.20589.21
637699-3769977.05877.06
10min140758-4075883.31089.715.1483.4389.845.14
244269-4426990.48790.63
342746-4274687.37487.50
442719-4271987.31987.45
546416-4641694.87695.02
646414-4641494.87195.00
15min142743-4274387.36890.874.0187.6391.164.02
244805-4480591.58391.87
343541-4354188.99989.27
442614-4261487.10487.38
546330-4633094.70095.01
646711-4671195.47995.77
20min143155-4315588.21091.732.9088.6192.162.91
245123-4512392.23392.67
344084-4408490.10990.53
444224-4422490.39590.81
546065-4606594.15894.62
646597-4659795.24695.69
30min143232-4323288.36791.332.2588.9291.922.26
245191-4519192.37292.97
344139-4413990.22190.80
444137-4413790.21790.79
545767-4576793.54994.17
645633-4563393.27593.88
45min144546-4454691.05391.631.6391.7592.371.64
244857-4485791.68992.44
344766-4476691.50392.23
443726-4372689.37790.10
545952-4595293.92794.70
645125-4512592.23793.00
极限145120-4512092.22777.2548.4293.0878.1447.84
245021-4502192.02492.93
345334-4533492.66493.54
445227-4522792.44593.31
5447-4470.9141.85
645620-4562093.24994.16
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.764437844375445184450544507444570.17
210.834453544490445120.08
单位质量响应值RSD%判断
4131.694110.060.38数据可信
供试品溶液-2022081501批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131924-3192466.09776.278.0766.1076.288.07
235094-3509472.66072.66
338455-3845579.61979.62
439541-3954181.86881.87
539478-3947881.73781.74
636541-3654175.65675.66
10min140215-4021583.26388.933.6183.3789.063.62
242118-4211887.20387.32
344219-4421991.55391.69
444222-4422291.55991.70
543356-4335689.76689.90
643591-4359190.25390.38
15min141703-4170386.34491.282.7286.5991.552.73
244543-4454392.22492.49
344281-4428191.68191.97
444842-4484292.84393.13
544257-4425791.63291.92
644882-4488292.92693.20
20min142569-4256988.13791.621.9688.5392.051.97
244554-4455492.24792.67
344471-4447192.07592.51
444291-4429191.70292.15
544546-4454692.23092.67
645076-4507693.32793.76
30min142163-4216387.29690.521.8887.8491.101.89
243836-4383690.76091.33
343695-4369590.46891.06
444382-4438291.89192.49
543842-4384290.77391.36
644408-4440891.94492.53
45min143241-4324189.52891.311.1690.2192.041.18
243862-4386290.81491.54
344491-4449192.11692.86
444202-4420291.51892.27
544688-4468892.52493.27
644114-4411491.33692.08
极限144891-4489192.94493.321.1593.7894.211.13
245468-4546894.13995.02
345644-4564494.50395.40
444230-4423091.57692.48
544887-4488792.93693.83
645321-4532193.83594.73
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.764479444756447494462244638447120.18
210.834481644844448300.05
单位质量响应值RSD%判断
4155.394139.430.28数据可信
供试品溶液-2022081501批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min125486-2548652.43061.3212.6052.4361.3212.60
225560-2556052.58252.58
332776-3277667.42767.43
428752-2875259.14859.15
532216-3221666.27566.27
634052-3405270.05270.05
10min132611-3261167.08759.9248.8967.1760.0248.80
232512-3251266.88466.97
337034-3703476.18676.30
434987-3498771.97572.07
5367-3670.7550.87
637238-3723876.60676.72
15min135602-3560273.24077.223.4873.4477.433.47
236272-3627274.61974.82
338484-3848479.16979.41
437682-3768277.51977.74
538557-3855779.31979.43
638637-3863779.48479.73
20min137621-3762177.39479.552.0077.7279.881.98
237895-3789577.95778.28
339310-3931080.86881.24
438719-3871979.65380.00
539563-3956381.38981.63
638898-3889880.02180.40
30min139328-3932880.90584.333.1481.3684.793.12
239529-3952981.31981.77
340996-4099684.33784.84
441818-4181886.02886.51
542217-4221786.84987.23
642069-4206986.54487.05
45min141708-4170885.80287.792.5186.3988.402.48
243245-4324588.96389.55
341205-4120584.76785.41
444149-4414990.82391.45
542988-4298888.43588.96
642763-4276387.97288.63
极限145422-4542293.44295.042.9294.1795.792.87
245046-4504692.66893.41
345277-4527793.14493.93
447720-4772098.16998.94
548103-4810398.95799.63
645623-4562393.85594.66
培哚普利氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号DJ468-220103对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.8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1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.764502744963450604503745011450200.09
210.834461644577445960.07
单位质量响应值RSD%判断
4184.014117.821.13数据可信
供试品溶液-2022081401批-培哚普利
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min142377-4237787.10978.4011.7887.1178.4011.78
229864-2986461.38861.39
336478-3647874.98374.98
439889-3988981.99582.00
540713-4071383.68983.69
639525-3952581.24781.25
10min146674-4667495.94292.503.0296.0992.633.02
245678-4567893.89594.00
343671-4367189.76989.89
443430-4343089.27489.41
544393-4439391.25391.39
646161-4616194.88895.02
15min145732-4573294.00692.582.3794.3192.872.36
246425-4642595.43095.69
345258-4525893.03193.31
445262-4526293.04093.33
543894-4389490.22890.52
643669-4366989.76590.06
20min145903-4590394.35792.861.2094.8293.301.21
245106-4510692.71993.14
344342-4434291.14991.58
445288-4528893.09393.53
544874-4487492.24292.68
645541-4554193.61394.06
30min145403-4540393.32990.542.9993.9591.132.98
244791-4479192.07192.64
343664-4366489.75590.34
444250-4425090.95991.56
544534-4453491.54392.14
641630-4163085.57486.17
45min144816-4481692.12391.841.6592.9092.591.63
245523-4552393.57694.30
344541-4454191.55892.29
444383-4438391.23391.98
545331-4533193.18193.93
643479-4347989.37590.12
极限144241-4424190.94191.681.2091.8792.581.19
244567-4456791.61192.49
344370-4437091.20692.09
444799-4479992.08892.99
545562-4556293.65694.56
644070-4407090.58991.48
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