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%
117.307481174729746677473474688747260.08
217.247444374257743500.18
单位质量响应值RSD%判断
4319.424312.650.12数据可信
供试品溶液-2024092121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%
5min139468-3946892.37994.642.5392.3894.642.53
241000-4100095.96495.96
341542-4154297.23397.23
440826-4082695.55795.56
538890-3889091.02691.03
640877-4087795.67695.68
10min138862-3886290.96096.343.3191.9997.393.29
241167-4116796.35597.42
342361-4236199.150100.23
442701-4270199.946101.01
541113-4111396.22997.24
640753-4075395.38696.45
15min140059-4005993.76295.223.2195.8097.343.15
241833-4183397.914100.05
342105-4210598.551100.73
438820-3882090.86293.03
539840-3984093.24995.33
641430-4143096.97199.09
20min138226-3822689.47293.592.4092.5596.772.38
240401-4040194.56297.79
340201-4020194.09497.37
440551-4055194.91398.10
539642-3964292.78695.90
640897-4089795.72398.92
30min137619-3761988.05191.312.8292.1295.532.76
239549-3954992.56896.84
340643-4064395.12999.45
439162-3916291.66295.90
539125-3912591.57695.72
637970-3797088.87293.14
45min138862-3886290.96091.043.2496.0196.273.04
240097-4009793.85199.15
336702-3670285.90491.28
438957-3895791.18396.44
538599-3859990.34595.51
640151-4015193.97799.23
60min136276-3627684.90788.402.4990.9794.642.43
239137-3913791.60497.95
337956-3795688.84095.17
438105-3810589.18895.46
537399-3739987.53693.70
637730-3773088.31194.61
90min136968-3696886.52788.912.0493.5396.141.98
238754-3875490.70798.07
338257-3825789.54496.87
438558-3855890.24997.51
538326-3832689.70696.85
637060-3706086.74294.02
极限136970-3697086.53287.522.4494.5095.742.31
237884-3788488.67197.04
337737-3773788.32796.64
437639-3763988.09896.36
535776-3577683.73791.88
638350-3835089.76298.00
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%
116.039868498705987269871898603986870.06
216.039822198443983320.16
单位质量响应值RSD%判断
6156.396134.250.26数据可信
供试品溶液-2024092121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%
5min110177-1017716.99116.328.0316.9916.328.03
210342-1034217.26717.27
310510-1051017.54717.55
48593-859314.34714.35
59003-900315.03115.03
610018-1001816.72616.73
10min117065-1706528.49129.286.9428.6829.466.94
218209-1820930.40130.59
318729-1872931.26931.46
415973-1597326.66826.83
516428-1642827.42827.59
618814-1881431.41131.60
15min121257-2125735.49037.336.4036.0037.836.40
223562-2356239.33839.87
323761-2376139.67140.21
420842-2084234.79735.25
521074-2107435.18435.66
623642-2364239.47240.01
20min124866-2486641.51542.458.0442.4243.378.01
227128-2712845.29246.26
327542-2754245.98346.97
423786-2378639.71240.55
522474-2247437.52238.38
626766-2676644.68845.66
30min129927-2992749.96549.006.1351.3350.406.15
230950-3095051.67353.14
330751-3075151.34152.84
427502-2750245.91647.20
526697-2669744.57245.85
630278-3027850.55152.02
45min133878-3387856.56255.167.6258.4857.097.58
235682-3568259.57461.62
333924-3392456.63858.70
430098-3009850.25152.04
529720-2972049.62051.39
634911-3491158.28660.32
60min136419-3641960.80458.4310.9363.3560.9810.73
239069-3906965.22867.93
336169-3616960.38763.08
429304-2930448.92551.28
531341-3134152.32654.65
637698-3769862.93965.62
90min141203-4120368.79164.139.3372.0167.339.22
241488-4148869.26772.70
339554-3955466.03869.40
435242-3524258.83961.73
532734-3273454.65257.56
640240-4024067.18370.56
极限141547-4154769.36667.297.7373.3571.207.72
243497-4349772.62176.82
342090-4209070.27274.37
435853-3585359.85963.41
536955-3695561.69965.21
641897-4189769.95074.07
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%
117.307325672918732027255672556728980.47
217.247285172700727760.15
单位质量响应值RSD%判断
4213.764221.350.13数据可信
供试品溶液-2024092121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%
5min140094-4009496.03593.633.2396.0493.633.23
239591-3959194.83094.83
339932-3993295.64795.65
438853-3885393.06393.06
539396-3939694.36394.36
636672-3667287.83987.84
10min139599-3959994.84997.782.0695.9298.822.04
240497-4049797.00098.05
341709-4170999.903100.97
441588-4158899.614100.65
541281-4128198.87899.93
640250-4025096.40997.38
15min139176-3917693.83694.961.4195.9697.091.40
238996-3899693.40595.54
340107-4010796.06698.24
440396-4039696.75898.90
539855-3985595.46397.61
639352-3935294.25896.31
20min138268-3826891.66193.353.7794.8296.533.66
236501-3650187.42990.60
340400-4040096.768100.01
438688-3868892.66795.88
540008-4000895.82999.04
639967-3996795.73198.83
30min138269-3826991.66493.542.6895.8597.762.61
237387-3738789.55193.69
339706-3970695.10699.42
440256-4025696.423100.67
539351-3935194.25598.53
639351-3935194.25598.41
45min137011-3701188.65191.992.9593.8597.252.86
238097-3809791.25296.39
339452-3945294.49799.87
440050-4005095.930101.25
538109-3810991.28196.60
637713-3771390.33295.54
60min136769-3676988.07190.732.2394.2697.012.11
238430-3843092.04998.20
337108-3710888.88395.30
438828-3882893.00399.39
538548-3854892.33298.67
637590-3759090.03796.25
90min137303-3730389.35090.352.7596.5197.642.60
237762-3776290.44997.62
338921-3892193.225100.64
436820-3682088.19395.61
538969-3896993.340100.70
636555-3655587.55894.77
极限136932-3693288.46187.543.9496.6295.833.68
235754-3575485.64093.82
338563-3856392.368100.81
435974-3597486.16794.56
537550-3755089.94298.34
634512-3451282.66590.85
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%
116.039829598080986999835598375983610.23
216.039800797893979500.09
单位质量响应值RSD%判断
6136.066110.420.30数据可信
供试品溶液-2024092121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%
5min111467-1146719.21416.7111.7319.2116.7111.73
29924-992416.62916.63
310122-1012216.96016.96
410842-1084218.16718.17
59387-938715.72915.73
68107-810713.58413.58
10min118569-1856931.11429.965.5131.3330.155.54
217623-1762329.52929.71
317649-1764929.57329.76
419418-1941832.53732.74
517468-1746829.26929.44
616572-1657227.76827.92
15min122714-2271438.05937.485.6938.6238.005.70
221699-2169936.35936.87
322317-2231737.39437.91
424705-2470541.39541.96
521594-2159436.18336.68
621167-2116735.46735.93
20min127195-2719545.56843.374.7846.5544.304.80
225595-2559542.88743.80
325081-2508142.02642.96
427579-2757946.21147.23
525404-2540442.56743.47
624442-2444240.95541.81
30min132050-3205053.70349.305.8155.1950.715.79
228640-2864047.98949.38
329140-2914048.82750.23
430883-3088351.74753.28
528240-2824047.31948.69
627569-2756946.19447.50
45min137363-3736362.60555.228.2464.6957.188.14
232213-3221353.97655.90
332014-3201453.64255.58
434987-3498758.62460.74
531093-3109352.09954.00
630062-3006250.37252.19
60min140541-4054167.93059.677.9070.7162.257.76
233565-3356556.24158.77
333442-3344256.03558.57
436986-3698661.97364.74
533509-3350956.14758.63
635642-3564259.72162.10
90min143781-4378173.35963.088.5776.8966.328.37
234824-3482458.35161.50
336314-3631460.84764.01
437452-3745262.75466.21
535539-3553959.54962.65
637955-3795563.59766.64
极限144229-4422974.11065.786.4278.4669.726.35
237573-3757362.95766.76
338352-3835264.26268.10
438642-3864264.74868.90
537530-3753062.88566.65
639225-3922565.72569.48
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