左氨氯地平叶酸片项目信息
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%
116.387405374214742767413474123741600.12
216.697423074196742130.04
单位质量响应值RSD%判断
4527.474446.551.28数据可信
供试品溶液-24091401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%
5min139382-3938288.67286.632.5888.6786.632.58
236800-3680082.85882.86
338805-3880587.37387.37
439473-3947388.87788.88
538097-3809785.77985.78
638282-3828286.19586.20
10min143290-4329097.47197.532.2198.4698.492.22
241936-4193694.42395.34
343732-4373298.46699.44
444844-44844100.970101.96
542944-4294496.69297.65
643140-4314097.13398.09
15min143856-4385698.74696.882.94100.8198.932.92
240699-4069991.63793.61
342850-4285096.48098.55
444345-4434599.847101.96
543167-4316797.19499.22
643253-4325397.38899.42
20min142961-4296196.73097.382.8699.90100.512.84
241160-4116092.67595.66
344533-44533100.270103.41
444434-44434100.047103.27
543471-4347197.879100.99
642942-4294296.68899.81
30min142809-4280996.38895.553.23100.6399.763.20
239789-3978989.58893.61
343240-4324097.359101.61
443673-4367398.334102.66
542427-4242795.52899.72
642685-4268596.109100.30
45min142154-4215494.91395.662.42100.22100.932.38
241140-4114092.63097.64
343957-4395798.973104.31
442412-4241295.494100.92
541877-4187794.29099.55
643372-4337297.656102.92
60min141990-4199094.54494.842.77100.91101.172.72
240320-4032090.78496.83
341859-4185994.249100.68
443694-4369498.381104.86
541810-4181094.139100.44
643061-4306196.956103.30
90min140374-4037490.90691.802.3798.3299.182.36
239214-3921488.29495.34
340766-4076691.78899.27
442103-4210394.799102.38
540889-4088992.06599.42
641286-4128692.959100.38
极限139954-3995489.96089.762.5698.3998.172.41
239910-3991089.86197.89
339957-3995789.96798.47
440759-4075991.772100.40
537937-3793785.41893.79
640683-4068391.601100.06
左氨氯地平叶酸片项目信息
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%
116.21 9668296598966669665896844966900.10
216.259685197005969280.12
单位质量响应值RSD%判断
5964.845964.800.01数据可信
供试品溶液-24091401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%
5min112669-1266921.79222.624.2721.7922.624.27
212637-1263721.73721.74
313494-1349423.21123.21
413894-1389423.89923.90
513554-1355423.31423.31
612655-1265521.76821.77
10min123471-2347140.37241.864.7240.6142.114.72
223488-2348840.40140.64
325341-2534143.58943.85
425785-2578544.35244.62
524885-2488542.80443.06
623034-2303439.62039.86
15min130010-3001051.62052.454.4552.3153.174.44
229892-2989251.41752.11
330703-3070352.81253.55
432579-3257956.03956.80
531205-3120553.67554.41
628577-2857749.15549.84
20min133552-3355257.71258.233.8158.9859.533.82
233379-3337957.41558.68
334264-3426458.93760.27
435685-3568561.38162.76
534419-3441959.20460.53
631822-3182254.73755.96
30min136757-3675763.22564.173.8465.1366.113.85
235739-3573961.47463.37
338019-3801965.39667.38
439378-3937867.73469.80
538074-3807465.49167.48
635863-3586361.68763.52
45min139686-3968668.26370.392.9770.8773.042.97
241836-4183671.96274.54
340746-4074670.08772.80
441982-4198272.21375.03
541993-4199372.23274.95
639277-3927767.56070.08
60min140544-4054469.73972.943.2473.1176.383.19
243905-4390575.52078.90
341970-4197072.19275.68
443619-4361975.02878.65
543170-4317074.25677.78
641208-4120870.88174.15
90min142237-4223772.65175.743.2076.7979.993.11
246222-4622279.50683.73
343331-4333174.53378.82
444787-4478777.03781.49
544388-4438876.35180.70
643218-4321874.33978.40
极限146662-4666280.26381.902.9385.2187.002.91
246500-4650079.98485.09
348005-4800582.57387.69
448642-4864283.66888.98
549694-4969485.47890.67
646185-4618579.44284.33
左氨氯地平叶酸片项目信息
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%
116.387227472631721817249172292723740.26
216.697357773420734980.16
单位质量响应值RSD%判断
4418.444403.710.24数据可信
供试品溶液-24091402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%
5min140455-4045592.64995.322.8392.6595.322.84
241124-4112494.18194.18
342537-4253797.41797.42
440200-4020092.06592.06
542440-4244097.19597.19
642960-4296098.38698.39
10min140854-4085493.56396.783.1094.5997.843.09
240549-4054992.86493.91
343270-4327099.096100.18
442082-4208296.37597.40
543433-4343399.469100.55
643357-4335799.295100.39
15min141437-4143794.89897.144.7796.9799.274.71
238936-3893689.17091.25
344651-44651102.258104.44
442928-4292898.312100.41
543821-43821100.357102.54
642716-4271697.827100.02
20min140338-4033892.38196.842.9795.50100.052.91
242922-4292298.299101.37
342938-4293898.335101.65
442483-4248397.293100.48
543757-43757100.211103.51
641273-4127394.52297.81
30min141012-4101293.92496.091.8998.07100.381.89
241250-4125094.46998.63
343123-4312398.759103.17
442447-4244797.211101.48
541707-4170795.51699.93
642197-4219796.638100.97
45min141102-4110294.13094.901.4699.32100.261.42
241341-4134194.67899.89
341542-4154295.138100.65
441019-4101993.94099.29
541024-4102493.95299.43
642592-4259297.543102.95
60min139659-3965990.82693.012.4697.0799.422.39
240765-4076593.35999.62
341242-4124294.451101.02
439666-3966690.84297.23
542201-4220196.647103.17
640133-4013391.91198.40
90min139070-3907089.47792.602.9096.73100.052.78
239687-3968790.89098.19
341179-4117994.307101.92
441897-4189795.951103.35
541326-4132694.643102.24
639453-3945390.35497.87
极限139194-3919489.76191.542.6898.00100.012.56
239824-3982491.20499.51
341703-4170395.507104.17
438684-3868488.59397.06
539817-3981791.18899.83
640598-4059892.976101.49
左氨氯地平叶酸片项目信息
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%
116.21 9695896925969799687597049969570.07
216.259677396811967920.03
单位质量响应值RSD%判断
5981.315956.430.30数据可信
供试品溶液-24091402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%
5min114802-1480225.44423.477.9825.4423.487.97
213117-1311722.54722.55
315208-1520826.14126.14
413432-1343223.08923.09
512740-1274021.89921.90
612640-1264021.72721.73
10min125140-2514043.21441.854.2543.5042.114.28
224101-2410141.42841.68
325948-2594844.60344.89
424131-2413141.47941.74
523669-2366940.68540.93
623086-2308639.68339.92
15min131191-3119153.61552.203.4154.3852.933.43
230035-3003551.62852.34
332006-3200655.01655.80
430081-3008151.70752.42
529212-2921250.21350.91
629696-2969651.04551.73
20min134161-3416158.72058.163.5660.0859.463.57
233848-3384858.18259.47
335922-3592261.74763.14
433253-3325357.15958.45
532304-3230455.52856.78
633521-3352157.62058.87
30min139709-3970968.25765.734.4670.2767.694.43
236829-3682963.30665.24
340411-4041169.46471.55
437095-3709563.76465.69
536329-3632962.44764.32
639077-3907767.17069.06
45min143930-4393075.51272.864.4778.2875.554.41
240309-4030969.28871.92
344011-4401175.65278.51
440578-4057869.75172.39
541163-4116370.75673.32
644345-4434576.22678.86
60min146447-4644779.83976.395.3383.4579.885.20
241640-4164071.57674.98
345783-4578378.69882.39
441465-4146571.27574.69
544534-4453476.55179.90
646785-4678580.42083.90
90min149781-4978185.57079.815.7590.0784.155.60
243437-4343774.66578.86
347128-4712881.01085.58
443183-4318374.22878.43
546550-4655080.01684.22
648511-4851183.38787.76
极限151352-5135288.27084.244.1093.7289.474.07
246006-4600679.08184.11
350326-5032686.50791.98
448768-4876883.82988.86
547419-4741981.51086.60
650171-5017186.24091.54
左氨氯地平叶酸片项目信息
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%
116.387246572000722947244972016722450.32
216.697479074899748440.11
单位质量响应值RSD%判断
4410.564484.361.18数据可信
供试品溶液-2024092121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%
5min142866-4286697.37496.923.3297.3796.913.32
240568-4056892.15492.15
344024-44024100.004100.00
442769-4276997.15397.15
541531-4153194.34194.34
644227-44227100.465100.47
10min144138-44138100.26399.832.42101.34100.902.43
242521-4252196.59097.61
344311-44311100.656101.77
443933-4393399.797100.88
543147-4314798.01299.06
645623-45623103.636104.75
15min143243-4324398.23096.772.87100.4398.962.83
242031-4203195.47797.57
341071-4107193.29695.53
443223-4322398.185100.37
541672-4167294.66196.80
644363-44363100.774103.04
20min143022-4302297.72898.362.83101.02101.632.81
242127-4212795.69598.85
343675-4367599.211102.48
443004-4300497.687100.97
542436-4243696.39799.59
645547-45547103.464106.85
30min142897-4289797.44496.403.46101.82100.763.41
241532-4153294.34398.56
342470-4247096.474100.84
441470-4147094.20298.57
541153-4115393.48297.74
645109-45109102.469107.01
45min141987-4198795.37796.182.55100.83101.602.55
241441-4144194.13799.41
342513-4251396.572102.01
441964-4196495.325100.74
541715-4171594.759100.06
644414-44414100.890106.57
60min141497-4149794.26495.381.85100.78101.881.88
241010-4101093.15899.47
342458-4245896.447102.96
442216-4221695.897102.37
541601-4160194.500100.85
643161-4316198.044104.84
90min141462-4146294.18493.062.85101.75100.622.79
240337-4033791.62998.98
340268-4026891.47299.06
440012-4001290.89198.43
540608-4060892.24499.65
643116-4311697.941105.83
极限139737-3973790.26692.233.7598.88100.823.61
240083-4008391.05299.42
341729-4172994.791103.39
439865-3986590.55799.10
539074-3907488.76097.19
643130-4313097.973106.95
左氨氯地平叶酸片项目信息
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%
116.21 9661596652967939680896917967570.13
216.259646796474964700.01
单位质量响应值RSD%判断
5968.975936.620.39数据可信
供试品溶液-2024092121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%
5min114426-1442624.86424.176.1624.8624.176.17
213865-1386523.89723.90
314027-1402724.17724.18
414972-1497225.80525.81
514395-1439524.81124.81
612442-1244221.44521.44
10min124512-2451242.24842.914.4742.5243.184.48
225428-2542843.82744.09
325088-2508843.24143.51
425748-2574844.37944.67
525759-2575944.39844.67
622836-2283639.36039.60
15min130630-3063052.79353.144.1653.5453.884.17
231653-3165354.55655.31
331180-3118053.74154.49
431867-3186754.92555.70
531285-3128553.92254.69
628365-2836548.88949.56
20min134007-3400758.61459.584.7759.9560.914.76
235056-3505660.42261.78
335228-3522860.71862.06
436833-3683363.48464.87
534441-3444159.36260.73
631838-3183854.87556.09
30min138212-3821265.86166.824.8267.8468.824.79
239234-3923467.62369.65
340675-4067570.10672.13
440726-4072670.19472.29
537952-3795265.41367.44
635814-3581461.72863.56
45min140988-4098870.64672.775.6473.3675.515.58
242421-4242173.11675.90
345308-4530878.09280.89
444345-4434576.43279.31
541513-4151371.55174.31
638730-3873066.75469.27
60min142571-4257173.37475.926.5476.8779.476.44
244461-4446176.63280.23
347761-4776182.32085.99
446671-4667180.44184.17
542902-4290273.94577.49
639913-3991368.79372.05
90min146068-4606879.40279.296.9383.7283.686.81
245917-4591779.14183.59
350119-5011986.38490.97
448639-4863983.83388.45
544079-4407975.97380.34
641193-4119370.99975.02
极限148747-4874784.01985.084.1389.2290.354.18
250070-5007086.29991.62
352242-5224290.04395.58
450576-5057687.17192.72
548085-4808582.87888.09
646452-4645280.06384.87
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