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%
117.307412773905738117412573761739460.24
217.247531874996751570.31
单位质量响应值RSD%判断
4274.344359.451.40数据可信
供试品溶液-24091401批-2.5mg0.8mg-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%
5min137254-3725487.18889.322.3787.1989.322.37
237858-3785888.60188.60
339611-3961192.70492.70
438852-3885290.92790.93
538012-3801288.96188.96
637409-3740987.55087.55
10min140022-4002293.66696.993.2094.6397.983.19
241571-4157197.29198.28
343523-43523101.859102.89
442306-4230699.011100.02
540232-4023294.15795.15
640993-4099395.93896.91
15min142517-4251799.50597.792.96101.5199.862.93
241023-4102396.00898.07
343096-43096100.860103.02
442647-4264799.809101.92
539780-3978093.09995.13
641649-4164997.47399.51
20min141702-4170297.59797.222.16100.71100.382.15
240577-4057794.96498.10
343102-43102100.874104.16
441238-4123896.51199.73
540857-4085795.62098.69
641778-4177897.775100.90
30min141963-4196398.20896.672.46102.41100.912.42
240762-4076295.39799.58
341997-4199798.288102.69
442166-4216698.683102.98
539526-3952692.50596.64
641428-4142896.956101.16
45min141619-4161997.40394.412.28102.6999.722.17
239539-3953992.53597.78
340497-4049794.777100.27
440600-4060095.018100.41
540736-4073695.337100.50
639047-3904791.38496.67
60min137888-3788888.67191.092.3895.0497.452.25
238026-3802688.99495.27
339388-3938892.18298.73
439060-3906091.41497.86
538783-3878390.76696.98
640386-4038694.517100.82
90min138578-3857890.28689.202.0197.6496.571.85
236933-3693386.43693.70
338290-3829089.61297.18
437418-3741887.57195.03
538804-3880490.81598.04
638667-3866790.49497.85
极限139174-3917491.68190.432.10100.0498.792.01
237165-3716586.97995.20
339438-3943892.299100.87
438756-3875690.70399.14
538923-3892391.09499.33
638370-3837089.79998.16
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%
116.039757797372974509754097369974620.10
216.039721997378972980.12
单位质量响应值RSD%判断
6079.986069.740.12数据可信
供试品溶液-24091401批-2.5mg0.8mg-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%
5min15378-53789.08315.0929.059.0815.1029.06
211460-1146019.35519.36
311166-1116618.85918.86
48047-804713.59113.59
510888-1088818.38918.39
66683-668311.28711.29
10min117742-1774229.96536.349.7330.0736.519.79
223341-2334139.42139.64
322813-2281338.53038.74
420545-2054534.69934.85
522745-2274538.41538.62
621923-2192337.02637.15
15min125867-2586743.68847.324.8844.1247.894.97
228647-2864748.38349.04
329338-2933849.55050.19
426796-2679645.25745.79
528605-2860548.31248.94
628861-2886148.74449.28
20min130415-3041551.36953.784.2452.2954.884.31
231995-3199554.03755.23
333691-3369156.90258.09
430135-3013550.89651.94
532207-3220754.39555.56
632606-3260655.06956.15
30min135229-3522959.49961.284.9460.9962.974.92
235401-3540159.79061.58
338452-3845264.94366.76
434002-3400257.42759.03
536257-3625761.23663.01
638341-3834164.75566.45
45min140063-4006367.66466.681.5769.8169.061.55
239565-3956566.82269.28
340066-4006667.66970.21
438646-3864665.27067.51
538811-3881165.54968.00
639739-3973967.11669.53
60min142721-4272172.15370.322.3675.0673.442.11
241192-4119269.57072.77
341558-4155870.18973.48
442868-4286872.40175.37
540337-4033768.12671.31
641157-4115769.51172.67
90min144563-4456375.26474.042.5578.9777.942.39
244028-4402874.36078.33
344875-4487575.79179.86
444618-4461875.35779.13
542138-4213871.16875.11
642801-4280172.28876.22
极限145924-4592477.56276.351.8582.1081.071.74
245207-4520776.35181.15
345997-4599777.68682.60
445684-4568477.15781.77
543933-4393374.20078.93
644500-4450075.15779.89
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%
117.307529675135753407538975246752810.13
217.247577775949758630.17
单位质量响应值RSD%判断
4351.504400.410.80数据可信
供试品溶液-24091401批-2.5mg0.8mg-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%
5min136040-3604083.20287.613.5283.2087.613.52
237354-3735486.23686.24
337798-3779887.26187.26
438325-3832588.47888.48
540123-4012392.62992.63
638061-3806187.86887.87
10min142569-4256998.27598.121.8699.2099.091.86
242120-4212097.23998.20
341628-4162896.10397.07
443417-43417100.233101.22
543445-43445100.298101.33
641828-4182896.56597.54
15min141773-4177396.43897.963.0698.45100.023.04
241099-4109994.88296.92
341049-4104994.76696.80
443810-43810101.140103.24
543860-43860101.256103.40
643003-4300399.277101.33
20min140873-4087394.36096.433.8897.4599.583.83
239844-3984491.98495.08
341066-4106694.80697.90
443011-4301199.296102.52
544319-44319102.315105.58
641502-4150295.81298.96
30min141795-4179596.48995.442.64100.6299.662.60
240251-4025192.92497.04
340403-4040393.27597.42
440702-4070293.96598.29
543076-4307699.446103.85
641808-4180896.519100.74
45min141436-4143695.66094.742.15100.87100.022.12
240075-4007592.51897.67
340255-4025592.93398.11
440458-4045893.40298.77
541980-4198096.916102.43
642021-4202197.010102.30
60min140045-4004592.44892.502.1698.7298.832.16
239170-3917090.42896.60
339386-3938690.92797.14
439696-3969691.64398.05
541489-4148995.782102.37
640606-4060693.744100.11
90min139534-3953491.26991.362.4398.5798.732.42
238521-3852188.93096.11
338727-3872789.40696.63
440070-4007092.50699.93
541159-4115995.020102.67
639434-3943491.03898.45
极限137352-3735286.23189.062.7994.5497.442.72
237778-3777887.21595.38
337912-3791287.52495.74
438764-3876489.49197.94
539928-3992892.178100.89
639737-3973791.737100.16
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%
116.039720297330972469699797384972320.16
216.039706197064970620.01
单位质量响应值RSD%判断
6065.636055.020.13数据可信
供试品溶液-24091401批-2.5mg0.8mg-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%
5min17979-797913.50811.5312.6213.5111.5412.61
26099-609910.32510.33
36370-637010.78410.78
46814-681411.53611.54
57709-770913.05113.05
65905-59059.99710.00
10min121324-2132436.10135.635.9736.2535.765.99
219928-1992833.73833.85
320897-2089735.37835.50
421288-2128836.04036.17
523173-2317339.23139.38
619650-1965033.26733.38
15min128557-2855748.34646.604.9148.9047.124.93
227210-2721046.06646.56
327395-2739546.37946.89
427578-2757846.68947.22
529175-2917549.39349.97
625239-2523942.72943.21
20min132021-3202154.21152.476.3255.3053.526.29
228390-2839048.06449.07
332763-3276355.46756.50
430758-3075852.07353.12
533029-3302955.91757.05
628998-2899849.09350.05
30min137217-3721763.00859.266.5964.7060.886.55
231422-3142253.19754.73
335513-3551360.12361.77
434786-3478658.89260.52
537524-3752463.52765.28
633542-3354256.78658.29
45min140558-4055868.66464.685.5771.0566.965.55
234841-3484158.98561.11
337607-3760763.66865.98
437800-3780063.99566.27
540468-4046868.51270.97
637946-3794664.24266.37
60min142895-4289572.62068.476.5075.7771.476.41
236288-3628861.43564.22
339264-3926466.47369.49
439458-3945866.80269.79
543204-4320473.14476.36
641556-4155670.35373.20
90min145863-4586377.64571.966.6081.6175.736.48
238119-3811964.53568.00
340756-4075668.99972.76
441998-4199871.10274.84
543903-4390374.32778.36
644394-4439475.15878.79
极限146451-4645178.64175.215.4983.4679.775.39
240462-4046268.50172.68
342802-4280272.46376.99
444727-4472775.72280.25
545071-4507176.30481.16
647019-4701979.60284.06
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%
117.307397474166738977330773479737650.49
217.247317173121731460.05
单位质量响应值RSD%判断
4263.874242.810.36数据可信
供试品溶液-24091402批-2.5mg0.8mg-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%
5min137948-3794890.13191.952.5090.1391.952.50
237514-3751489.10089.10
338622-3862291.73191.73
440274-4027495.65595.66
539130-3913092.93892.94
638799-3879992.15292.15
10min140095-4009595.23097.672.9396.2398.692.93
239807-3980794.54695.54
340717-4071796.70797.73
443129-43129102.436103.50
541479-4147998.51799.55
641496-4149698.55799.58
15min139156-3915693.00097.002.7495.0699.112.73
240142-4014295.34297.38
340648-4064896.54398.64
442313-42313100.498102.70
541195-4119597.84399.97
641598-4159898.800100.92
20min138758-3875892.05495.052.9295.1598.232.89
239340-3934093.43796.54
340084-4008495.20498.37
441112-4111297.645100.96
539135-3913592.95096.16
641682-4168298.999102.22
30min139213-3921393.13593.303.4697.2597.543.38
238903-3890392.39996.54
336988-3698887.85092.07
440948-4094897.256101.66
539351-3935193.46397.71
640287-4028795.686100.00
45min137165-3716588.27189.480.8893.4294.760.83
238042-3804290.35495.52
338030-3803090.32595.53
437561-3756189.21194.69
537577-3757789.24994.54
637681-3768189.49694.88
60min137013-3701387.91090.243.0194.0496.512.92
236722-3672287.21993.39
338157-3815790.62796.83
439875-3987594.707101.18
538504-3850491.45197.73
637682-3768289.49995.87
90min136746-3674687.27686.731.5794.3894.001.47
236101-3610185.74492.88
335899-3589985.26492.47
436308-3630886.23593.76
537512-3751289.09596.39
636527-3652786.75694.12
极限136943-3694387.74488.003.6695.8296.243.44
237117-3711788.15796.25
336189-3618985.95394.11
439596-3959694.045102.53
536763-3676387.31695.60
635693-3569384.77593.11
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%
116.039724097403972289750697521973800.15
216.039701097100970550.07
单位质量响应值RSD%判断
6074.866054.590.24数据可信
供试品溶液-24091402批-2.5mg0.8mg-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%
5min15869-58699.92910.9913.939.9311.0013.93
26686-668611.31111.31
36488-648810.97610.98
47850-785013.28013.28
56896-689611.66611.67
65203-52038.8028.80
10min119460-1946032.92234.125.8233.0334.245.84
220036-2003633.89634.02
321042-2104235.59835.72
421006-2100635.53735.68
521245-2124535.94136.07
618238-1823830.85430.95
15min126003-2600343.99143.564.5244.4744.064.52
225056-2505642.38942.89
324775-2477541.91342.43
427719-2771946.89447.44
526238-2623844.38844.92
624682-2468241.75642.20
20min128614-2861448.40850.163.7149.3751.153.72
229334-2933449.62650.60
329161-2916149.33350.32
430419-3041951.46252.52
531502-3150253.29454.32
628871-2887148.84349.75
30min133823-3382357.22057.622.7558.7259.162.76
233506-3350656.68458.21
332890-3289055.64257.17
434691-3469158.68960.32
535547-3554760.13761.75
633884-3388457.32358.77
45min138032-3803264.34163.792.3466.4865.982.27
237520-3752063.47565.63
336127-3612761.11863.27
437590-3759063.59365.88
538476-3847665.09267.37
638499-3849965.13167.22
60min140150-4015067.92467.441.2270.7870.331.16
239866-3986667.44470.30
339136-3913666.20969.04
439462-3946266.76069.75
540122-4012267.87770.88
640433-4043368.40371.21
90min142442-4244271.80170.325.1075.4173.964.81
241722-4172270.58374.19
339266-3926666.42869.99
439276-3927666.44570.18
541805-4180570.72474.48
644887-4488775.93879.51
极限143653-4365373.85073.613.2378.2678.033.11
242801-4280172.40976.80
341377-4137770.00074.30
443503-4350373.59678.07
544118-4411874.63779.18
645606-4560677.15481.57
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