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%
116.69 7349373410737187375473652736050.21
216.387292472889729060.04
单位质量响应值RSD%判断
4410.134450.920.66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%
5min136878-3687884.08885.604.0684.0985.604.06
237930-3793086.48686.49
340302-4030291.89591.89
437375-3737585.22185.22
536944-3694484.23884.24
635808-3580881.64881.65
10min143386-4338698.92798.372.7999.8699.322.79
243408-4340898.97799.94
345110-45110102.858103.88
443178-4317898.45399.40
541842-4184295.40696.34
641918-4191895.58096.49
15min143322-4332298.78197.783.78100.8199.823.77
243040-4304098.138100.20
345434-45434103.597105.76
443205-4320598.514100.56
541498-4149894.62296.62
640797-4079793.02494.99
20min141774-4177495.25196.423.0098.3899.553.02
242762-4276297.504100.66
344405-44405101.250104.57
442619-4261997.178100.31
540969-4096993.41696.46
641182-4118293.90196.90
30min141896-4189695.53096.102.7099.72100.302.72
242305-4230596.462100.70
344291-44291100.990105.43
441786-4178695.27999.49
541607-4160794.87198.96
640987-4098793.45797.50
45min138935-3893588.77892.873.7494.0398.143.67
240453-4045392.23997.55
343476-4347699.132104.69
440705-4070592.81498.09
540912-4091293.28698.43
639902-3990290.98396.07
60min139331-3933189.68192.363.8095.9298.663.73
241845-4184595.413101.74
342542-4254297.002103.67
441058-4105893.61999.92
538680-3868088.19794.37
639577-3957790.24296.34
90min139959-3995991.11392.312.4398.3599.642.47
240936-4093693.341100.73
342085-4208595.960103.70
440454-4045492.24299.59
540305-4030591.90299.06
639168-3916889.30996.41
极限139038-3903889.01388.522.5197.2696.882.51
239903-3990390.98599.41
340006-4000691.220100.03
438153-3815386.99595.37
538077-3807786.82295.00
637764-3776486.10894.20
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%
116.25 9669396816966549658396377966250.17
216.219648896443964660.04
单位质量响应值RSD%判断
5946.155951.020.06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%
5min117630-1763030.40830.614.5630.4130.614.55
216730-1673028.85628.86
317829-1782930.75130.75
418901-1890132.60032.60
517040-1704029.39029.39
618362-1836231.67031.67
10min128850-2885049.76050.873.9050.1051.223.90
228250-2825048.72549.05
329692-2969251.21251.55
431075-3107553.59853.96
528531-2853149.21049.54
630576-3057652.73753.09
15min134240-3424059.05660.843.6459.9561.753.65
234134-3413458.87459.74
335745-3574561.65262.56
437244-3724464.23865.20
534212-3421259.00859.88
636068-3606862.20963.15
20min136822-3682263.51065.804.1265.0667.384.11
236518-3651862.98664.50
338842-3884266.99468.59
440775-4077570.32872.00
537482-3748264.64866.18
638452-3845266.32167.95
30min139289-3928967.76570.634.3970.0272.944.36
238804-3880466.92869.14
342141-4214172.68475.02
443632-4363275.25677.71
540680-4068070.16472.41
641168-4116871.00673.37
45min141801-4180172.09875.515.6075.1078.615.52
240852-4085270.46173.42
343818-4381875.57678.72
447881-4788182.58485.87
543750-4375075.45978.49
644587-4458776.90380.06
60min142780-4278073.78677.614.9177.5981.544.88
242700-4270073.64877.39
345042-4504277.68881.67
448521-4852183.68887.89
544655-4465577.02080.89
646285-4628579.83183.84
90min147895-4789582.60881.554.2887.2386.344.24
244491-4449176.73781.30
346511-4651180.22185.07
450510-5051087.11992.26
546368-4636879.97584.70
647897-4789782.61287.51
极限149118-4911884.71885.333.7590.2691.043.77
246715-4671580.57385.99
350093-5009386.39992.14
452424-5242490.42096.52
548877-4887784.30289.91
649614-4961485.57391.39
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%
116.69 7362973143730667341073156732810.32
216.387228972850725700.55
单位质量响应值RSD%判断
4390.714430.400.64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%
5min137092-3709284.95886.642.1584.9686.642.15
238451-3845188.07188.07
339156-3915689.68689.69
437196-3719685.19785.20
537461-3746185.80485.80
637595-3759586.11086.11
10min142794-4279498.01997.771.7398.9698.731.72
244053-44053100.902101.88
342144-4214496.53097.53
442570-4257097.50698.45
541968-4196896.12797.08
642583-4258397.53598.49
15min142608-4260897.59399.641.1799.63101.691.16
243673-43673100.032102.13
344118-44118101.051103.12
443403-4340399.414101.44
543460-4346099.544101.57
643749-43749100.206102.25
20min143608-4360899.88399.131.25103.00102.291.19
242556-4255697.474100.68
343002-4300298.495101.69
443216-4321698.985102.12
543170-4317098.880102.01
644136-44136101.092104.25
30min141011-4101193.93596.021.4898.16100.281.43
242533-4253397.421101.72
341355-4135594.72399.01
441936-4193696.053100.29
542233-4223396.734100.96
642468-4246897.272101.55
45min140886-4088693.64894.592.5698.9299.922.44
242524-4252497.400102.78
339534-3953490.55295.89
442048-4204896.310101.61
541077-4107794.08699.39
641725-4172595.570100.93
60min140890-4089093.65895.261.9799.97101.641.87
241634-4163495.362101.82
341637-4163795.369101.71
440811-4081193.47799.85
541488-4148895.027101.37
643079-4307998.671105.09
90min140153-4015391.97093.421.8999.32100.851.79
240514-4051492.796100.31
340384-4038492.49999.90
441618-4161895.325102.74
540157-4015791.97999.38
641891-4189195.950103.47
极限139127-3912789.61989.342.6397.9997.822.42
237560-3756086.03094.58
339493-3949390.45898.89
439251-3925189.90398.37
538147-3814787.37595.80
640461-4046192.675101.26
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%
116.25 9637696589963989635496252963940.13
216.219634295942961420.30
单位质量响应值RSD%判断
5931.945931.030.02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%
5min117237-1723729.81628.928.3029.8228.928.30
214071-1407124.33924.34
317822-1782230.82830.83
416981-1698129.37329.37
517715-1771530.64330.64
616472-1647228.49228.49
10min128621-2862149.50747.615.2549.8447.935.27
224755-2475542.82043.09
328104-2810448.61348.96
428390-2839049.10849.43
528117-2811748.63548.98
627162-2716246.98447.30
15min134533-3453359.73457.824.9260.6158.664.92
230294-3029452.40153.15
334324-3432459.37260.25
433093-3309357.24358.11
533671-3367158.24259.12
634633-3463359.90760.75
20min138940-3894067.35763.155.5768.9064.645.55
233117-3311757.28458.61
336142-3614262.51764.06
435684-3568461.72463.23
537359-3735964.62266.15
637802-3780265.38866.89
30min139589-3958968.47968.124.7970.7770.314.77
236310-3631062.80764.77
339410-3941068.17070.41
438421-3842166.45968.65
541017-4101770.94973.20
641538-4153871.85074.08
45min141694-4169472.12072.464.3675.1775.414.34
239426-3942668.19770.86
341533-4153371.84274.84
440680-4068070.36673.30
543918-4391875.96779.00
644083-4408376.25379.28
60min142683-4268373.83175.224.0977.6978.984.08
240842-4084270.64774.07
343473-4347375.19878.99
443010-4301074.39778.11
545194-4519478.17482.05
645718-4571879.08182.96
90min144705-4470577.32979.245.1582.0083.845.00
242361-4236173.27477.48
345166-4516678.12682.75
449316-4931685.30489.85
546187-4618779.89284.64
647138-4713881.53786.29
极限147414-4741482.01483.342.0287.5588.822.10
246644-4664480.68385.70
348424-4842483.76289.26
449118-4911884.96290.45
548461-4846183.82689.46
649033-4903384.81590.48
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