叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
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%
117.26 7508574849752207522175173751100.21
217.217475774723747400.04
单位质量响应值RSD%判断
4351.684342.820.15数据可信
供试品溶液-24082901批-叶酸-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%
5min146687-46687108.491111.073.67108.49111.073.67
248222-48222112.058112.06
345758-45758106.332106.33
450772-50772117.983117.98
548341-48341112.334112.33
647005-47005109.230109.23
10min157802-57802134.320140.955.82135.52142.185.80
262065-62065144.226145.47
355564-55564129.119130.30
465621-65621152.489153.80
561058-61058141.886143.13
661809-61809143.631144.84
15min159231-59231137.640147.365.91140.34150.165.88
264730-64730150.419153.27
359775-59775138.904141.52
469510-69510161.526164.53
564013-64013148.753151.58
663211-63211146.889149.70
20min162314-62314144.804150.515.29149.03154.945.28
265555-65555152.336156.85
360720-60720141.100145.26
470520-70520163.873168.67
565851-65851153.024157.50
663650-63650147.909152.35
30min162251-62251144.658151.033.85150.49157.143.89
264349-64349149.533155.74
362912-62912146.194151.92
469206-69206160.820167.44
566118-66118153.644159.82
665129-65129151.346157.43
45min163720-63720148.072152.414.84155.52160.204.81
267286-67286156.358164.23
361326-61326142.509149.86
469501-69501161.505169.91
568112-68112158.278166.16
663577-63577147.739155.51
60min174281-74281172.613175.141.49181.70184.631.59
274469-74469173.050182.66
375413-75413175.244184.18
477120-77120179.210189.41
576226-76226177.133186.78
674713-74713173.617183.03
90min1-0.0000.00-11.0111.434.12
2-0.00011.53
3-0.00010.88
4-0.00012.19
5-0.00011.61
6-0.00011.34
极限1-0.0000.00-11.0111.434.12
2-0.00011.53
3-0.00010.88
4-0.00012.19
5-0.00011.61
6-0.00011.34
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.20 9517495466954579533195060952980.19
216.279377193727937490.04
单位质量响应值RSD%判断
5882.595762.081.47数据可信
供试品溶液-24082901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%
5min1113812-113812200.579199.701.93200.58199.711.93
2109782-109782193.476193.48
3115887-115887204.236204.24
4115150-115150202.937202.94
5112438-112438198.157198.16
6112828-112828198.844198.84
10min1115146-115146202.930202.621.68205.16204.841.68
2114021-114021200.947203.10
3118187-118187208.289210.56
4115998-115998204.431206.69
5113483-113483199.999202.20
6112980-112980199.112201.32
15min1113917-113917200.764200.901.69205.25205.371.68
2113313-113313199.699204.08
3117262-117262206.659211.24
4114795-114795202.311206.84
5113077-113077199.283203.71
6111599-111599196.679201.10
20min1112960-112960199.077198.281.82205.79204.981.81
2111878-111878197.170203.77
3115892-115892204.244211.12
4113076-113076199.282206.06
5111412-111412196.349202.99
6109817-109817193.538200.15
30min1111552-111552196.596195.621.93205.52204.521.91
2110314-110314194.414203.21
3114667-114667202.085211.23
4111237-111237196.041205.03
5109941-109941193.757202.58
6108277-108277190.824199.58
45min1110350-110350194.477193.902.47205.59204.982.43
2108846-108846191.827202.78
3115182-115182202.993214.39
4109792-109792193.494204.66
5108435-108435191.102202.08
6107525-107525189.499200.38
60min1109932-109932193.741193.752.60207.01206.982.53
2108435-108435191.102204.19
3114888-114888202.475216.13
4108775-108775191.702205.02
5111007-111007195.635208.73
6106573-106573187.821200.80
90min1-0.0000.00-15.4215.391.87
2-0.00015.21
3-0.00015.90
4-0.00015.45
5-0.00015.27
6-0.00015.07
极限1-0.0000.00-15.4215.391.87
2-0.00015.21
3-0.00015.90
4-0.00015.45
5-0.00015.27
6-0.00015.07
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
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%
117.26 7505074689746237479774611747540.25
217.217390773913739100.01
单位质量响应值RSD%判断
4331.054294.600.60数据可信
供试品溶液-24082901批-叶酸-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min142683-4268399.98099.321.6699.9899.321.66
242881-42881100.443100.44
343412-43412101.687101.69
442014-4201498.41398.41
541737-4173797.76497.76
641672-4167297.61197.61
15min143070-43070100.88698.352.57102.0099.452.54
242052-4205298.50299.62
341786-4178697.87899.01
442187-4218798.81899.91
542803-42803100.261101.35
640020-4002093.74294.83
20min142061-4206198.52396.521.44100.7598.721.44
240901-4090195.80598.02
341292-4129296.72198.94
440969-4096995.96598.16
541636-4163697.52799.73
640378-4037894.58096.71
30min141314-4131496.77396.642.11100.1099.912.01
240945-4094595.90999.18
340971-4097195.96999.26
441122-4112296.32399.58
540309-4030994.41997.70
642895-42895100.476103.65
45min141142-4114296.37094.591.57100.7798.931.53
239885-3988593.42697.77
340631-4063195.17399.53
440863-4086395.716100.04
540325-4032594.45698.79
639446-3944692.39796.69
60min139846-3984693.33492.581.8598.8197.981.75
240379-4037994.58399.96
339046-3904691.46096.88
438326-3832689.77495.17
539913-3991393.49198.87
639636-3963692.84298.16
90min139713-3971393.02391.661.3199.5398.091.27
239082-3908291.54597.97
339026-3902691.41497.85
439482-3948292.48298.87
539266-3926691.97698.40
638229-3822989.54795.90
极限139889-3988993.43591.351.43100.9898.791.37
238622-3862290.46797.91
338936-3893691.20398.65
439441-3944192.38699.80
538620-3862090.46397.91
638488-3848890.15397.50
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.20 9346994891935929319293398937080.73
216.279623895905960720.25
单位质量响应值RSD%判断
5784.445904.861.46数据可信
供试品溶液-24082901批-左氨氯地平-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
10min113934-1393424.46322.7511.2924.4622.7511.29
214332-1433225.16225.16
311237-1123719.72819.73
414141-1414124.82624.83
513027-1302722.87122.87
611091-1109119.47219.47
15min123155-2315540.65237.1717.3640.9237.4217.30
224008-2400842.14942.43
314204-1420424.93725.16
423392-2339241.06841.34
522137-2213738.86539.12
620134-2013435.34835.56
20min124390-2439042.82042.444.5943.5443.104.72
225307-2530744.43045.18
322580-2258039.64240.14
424553-2455343.10643.84
525133-2513344.12444.81
623072-2307240.50641.12
30min127317-2731747.95948.123.4749.1649.263.59
228588-2858850.19051.43
326005-2600545.65546.59
427378-2737848.06649.28
528316-2831649.71350.89
626858-2685847.15348.21
45min130113-3011352.86852.743.2854.6054.423.37
231559-3155955.40657.21
329199-2919951.26352.71
429709-2970952.15853.90
530737-3073753.96355.69
628939-2893950.80652.39
60min130963-3096354.36053.085.1256.6855.345.12
232630-3263057.28659.70
329248-2924851.34953.36
429434-2943451.67554.00
530839-3083954.14256.47
628304-2830449.69251.84
90min130979-3097954.38852.136.3957.3154.986.15
232236-3223656.59559.65
330104-3010452.85255.44
429347-2934751.52354.42
526748-2674846.96049.89
628742-2874250.46153.16
极限136775-3677564.56463.122.5268.0966.542.66
236921-3692164.82068.50
334984-3498461.41964.59
436237-3623763.61967.09
536040-3604063.27366.72
634747-3474761.00364.26
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100546-202105 对照品来源中检院对照品使用方法直接使用
对照品含量(%)97.3对照品水分(%)0对照品稀释倍数5000
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%
117.26 7434174742744167442874215744280.27
217.217500375435752190.41
单位质量响应值RSD%判断
4312.174370.660.96数据可信
供试品溶液-24082901批-叶酸-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min141417-4141796.37895.650.7596.3895.650.75
240967-4096795.33195.33
341303-4130396.11396.11
441401-4140196.34196.34
540721-4072194.75894.76
640818-4081894.98494.98
10min142563-4256399.04599.641.79100.12100.701.78
242365-4236598.58499.64
343726-43726101.751102.82
443784-43784101.886102.96
542552-4255299.019100.07
641913-4191397.53298.59
15min142510-4251098.92198.461.84101.09100.631.80
241817-4181797.30999.46
342051-4205197.853100.05
442258-4225898.335100.54
543733-43733101.767103.92
641503-4150396.57898.72
20min140598-4059894.47296.952.9097.74100.212.83
241788-4178897.241100.48
341815-4181597.304100.59
443305-43305100.771104.07
542466-4246698.819102.10
640002-4000293.08596.30
30min139778-3977892.56496.412.3996.88100.752.27
241769-4176997.197101.51
342471-4247198.831103.20
441181-4118195.829100.24
541078-4107895.58999.97
642301-4230198.435102.68
45min141565-4156596.72295.412.54102.07100.822.39
241097-4109795.633101.03
341607-4160796.820102.29
441334-4133496.185101.66
538908-3890890.54095.98
641487-4148796.541101.88
60min138370-3837089.28892.752.6795.7199.222.53
239466-3946691.83898.30
341564-4156496.720103.26
439543-3954392.01798.57
540385-4038593.977100.43
639815-3981592.65099.06
90min139736-3973692.46694.411.4799.88101.911.41
241258-4125896.008103.49
341159-4115995.778103.39
440552-4055294.365101.94
540637-4063794.563102.06
640075-4007593.255100.70
极限138671-3867189.98891.781.6798.43100.341.59
239293-3929391.43599.98
339867-3986792.771101.45
440460-4046094.151102.77
538873-3887390.45899.00
639493-3949391.901100.38
叶酸左氨氯地平片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号100074-202217 对照品来源中检院对照品使用方法直接使用
对照品含量(%)91.2对照品水分(%)0对照品稀释倍数20000
标示量(mg)0.8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%
116.20 9556495836955929580695771957140.14
216.279480594833948190.03
单位质量响应值RSD%判断
5908.275827.840.97数据可信
供试品溶液-24082901批-左氨氯地平-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min114664-1466425.64028.205.5825.6428.205.58
216521-1652128.88728.89
316810-1681029.39329.39
415724-1572427.49427.49
517160-1716030.00530.00
615893-1589327.78927.79
10min120496-2049635.83837.134.0136.1237.444.02
221253-2125337.16237.48
321754-2175438.03838.36
420305-2030535.50435.81
522607-2260739.52939.86
620993-2099336.70737.02
15min123266-2326640.68141.013.9941.3641.733.98
223121-2312140.42841.16
323706-2370641.45142.20
422473-2247339.29539.99
525176-2517644.02144.79
622983-2298340.18640.90
20min125048-2504843.79743.303.8444.9344.483.82
224421-2442142.70143.88
324892-2489243.52444.73
423724-2372441.48242.62
526424-2642446.20347.46
624080-2408042.10543.27
30min127461-2746148.01646.753.8049.6448.423.77
226674-2667446.64048.30
326666-2666646.62648.32
425358-2535844.33945.94
528233-2823349.36651.14
626043-2604345.53747.17
45min129749-2974952.01750.063.7754.1752.243.73
228157-2815749.23351.41
328616-2861650.03652.25
427113-2711347.40849.50
529980-2998052.42154.74
628171-2817149.25851.39
60min131289-3128954.71051.864.0757.4454.604.00
229142-2914250.95653.68
329507-2950751.59454.36
428196-2819649.30251.92
530927-3092754.07756.98
628894-2889450.52253.21
90min133783-3378359.07154.335.3062.4157.645.14
230424-3042453.19756.49
330698-3069853.67657.02
429224-2922451.09954.26
532197-3219756.29759.80
630093-3009352.61955.86
极限142499-4249974.31174.811.6078.3178.731.67
242441-4244174.20978.09
342847-4284774.91978.86
442148-4214873.69777.43
544088-4408877.08981.22
642692-4269274.64878.48
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