奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191013571021701020631020511022521019790.36
29.121021611035231028420.94
单位质量响应值RSD%判断
11096.7411276.541.14数据可信
加速6月-供试品溶液-2024041311批-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%
5min131022-3102262.27562.302.2062.2762.302.19
231981-3198164.20064.20
330325-3032560.87560.88
430191-3019160.60660.61
531370-3137062.97362.97
631327-3132762.88762.89
10min138374-3837477.03381.072.7677.3881.422.75
239983-3998380.26380.62
340972-4097282.24982.59
440666-4066681.63481.97
540740-4074081.78382.13
641581-4158183.47183.82
15min141712-4171283.73487.882.3884.5188.682.37
244153-4415388.63489.44
343982-4398288.29189.09
443887-4388788.10088.89
544494-4449489.31990.12
644426-4442689.18290.00
20min142447-4244785.21090.242.9586.4591.522.94
245881-4588192.10393.40
344953-4495390.24091.53
444998-4499890.33191.61
545243-4524390.82292.12
646196-4619692.73594.04
30min142614-4261485.54591.543.2487.2693.333.22
246176-4617692.69594.50
345998-4599892.33894.12
446002-4600292.34694.13
546528-4652893.40295.21
646291-4629192.92694.75
45min143146-4314686.61392.183.1688.8094.483.14
246507-4650793.36095.68
345683-4568391.70694.01
446220-4622092.78495.08
547187-4718794.72597.05
646776-4677693.90096.24
60min142994-4299486.30892.173.6788.9894.983.63
246861-4686194.07096.91
346221-4622192.78695.60
445576-4557691.49194.30
545801-4580191.94394.79
648039-4803996.43599.30
极限143165-4316586.65191.652.9689.8094.972.94
245484-4548491.30694.67
345708-4570891.75695.08
446129-4612992.60195.92
546308-4630892.96096.32
647144-4714494.63998.04
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191013211022171021171021141019431019420.36
29.121024061037351030700.92
单位质量响应值RSD%判断
11092.7111301.541.32数据可信
加速6月-供试品溶液-b批-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%
5min131980-3198064.13967.389.5864.1467.389.58
230125-3012560.41960.42
330473-3047361.11761.12
437891-3789175.99475.99
536331-3633172.86572.87
634769-3476969.73369.73
10min142010-4201084.25584.386.8884.6184.756.88
238409-3840977.03377.37
340596-4059681.41981.76
446981-4698194.22594.65
543229-4322986.70087.10
641196-4119682.62383.01
15min144169-4416988.58588.695.9289.4189.535.92
241495-4149583.22283.99
343915-4391588.07688.87
449116-4911698.50799.45
544049-4404988.34589.23
642582-4258285.40286.25
20min146521-4652193.30391.386.2594.6292.726.24
242686-4268685.61186.84
345664-4566491.58492.86
450462-50462101.207102.70
545142-4514290.53791.91
642900-4290086.04087.36
30min146384-4638493.02891.906.5294.8693.746.51
242798-4279885.83687.54
346394-4639493.04894.84
451117-51117102.520104.58
544798-4479889.84791.73
643440-4344087.12388.92
45min146707-4670793.67691.766.4096.0394.126.39
243295-4329586.83289.01
346054-4605492.36694.67
450718-50718101.720104.34
545305-4530590.86493.24
642446-4244685.13087.41
60min148072-4807296.41391.646.8099.2994.506.76
243137-4313786.51689.18
346228-4622892.71595.53
450092-50092100.465103.65
544892-4489290.03592.92
641719-4171983.67286.43
极限147936-4793696.14090.676.5199.5594.046.46
242676-4267685.59188.73
346078-4607892.41495.75
449098-4909898.471102.22
543510-4351087.26490.65
641957-4195784.14987.37
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191005061022071022951024321022561019390.80
29.121018661032281025470.94
单位质量响应值RSD%判断
11092.3811244.190.97数据可信
长期6月-供试品溶液-2024041311批-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%
5min137986-3798676.37873.606.8576.3873.606.85
237177-3717774.75274.75
339408-3940879.23879.24
434559-3455969.48869.49
537837-3783776.07976.08
632655-3265565.65965.66
10min143012-4301286.48487.316.6686.9187.726.66
245484-4548491.45591.87
347322-4732295.15095.59
440398-4039881.22881.61
544387-4438789.24989.67
639945-3994580.31780.68
15min143936-4393688.34290.916.4989.2591.806.49
247687-4768795.88496.81
348794-4879498.11099.08
442305-4230585.06385.90
546747-4674793.99494.91
641808-4180884.06384.87
20min145085-4508590.65292.436.9492.0593.836.93
248384-4838497.28698.74
350196-50196100.929102.44
442685-4268585.82787.14
547241-4724194.98796.43
642236-4223684.92486.20
30min144487-4448789.45092.106.9391.3594.026.92
247156-4715694.81696.81
350363-50363101.265103.34
442530-4253085.51587.30
547839-4783996.19098.16
642468-4246885.39087.14
45min144971-4497190.42391.607.0092.8294.036.99
247486-4748695.48098.00
349944-49944100.422103.06
442211-4221184.87487.14
546954-4695494.41096.91
641778-4177884.00386.23
60min144233-4423388.93989.996.3991.8492.926.39
246980-4698094.46397.52
348157-4815796.829100.02
441632-4163283.70986.44
546245-4624592.98596.01
641290-4129083.02285.71
极限143291-4329187.04590.268.0890.4493.698.02
247227-4722794.95998.54
350037-50037100.609104.34
441416-4141683.27586.47
546526-4652693.55097.09
640836-4083682.10985.26
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191025701033301033951032951034921032160.36
29.121010341016841013590.46
单位质量响应值RSD%判断
11231.3411113.930.75数据可信
长期6月-供试品溶液-b批-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%
5min132866-3286666.05771.195.8866.0671.205.87
235732-3573271.81771.82
333786-3378667.90667.91
437411-3741175.19275.19
538181-3818176.73976.74
634558-3455869.45769.46
10min140080-4008080.55687.544.6580.9287.934.66
244090-4409088.61589.01
342407-4240785.23385.61
445492-4549291.43391.85
545249-4524990.94591.37
644012-4401288.45988.84
15min142401-4240185.22190.894.3086.0491.784.31
244964-4496490.37291.26
343635-4363587.70188.55
447595-4759595.66096.59
546567-4656793.59494.53
646172-4617292.80093.68
20min142576-4257685.57392.644.4086.8694.024.40
247119-4711994.70396.10
344751-4475189.94491.28
447887-4788796.24797.70
547129-4712994.72496.18
647077-4707794.61996.01
30min142339-4233985.09692.324.6286.8694.224.62
247064-4706494.59396.51
344765-4476589.97291.81
447218-4721894.90296.89
548229-4822996.93498.91
645991-4599192.43694.35
45min141678-4167883.76891.925.5086.0094.335.47
246593-4659393.64696.09
343657-4365787.74590.08
448181-4818196.83899.36
547330-4733095.12797.64
646966-4696694.39696.83
60min141422-4142283.25391.245.0985.9594.175.08
246943-4694394.35097.31
343812-4381288.05790.88
447352-4735295.17298.23
546292-4629293.04196.09
646561-4656193.58296.54
极限141015-4101582.43590.285.3485.6093.715.32
246409-4640993.27696.77
342912-4291286.24889.56
447005-4700594.47498.06
546406-4640693.27096.83
645762-4576291.97695.45
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191007351019571020981015861017331016220.53
29.121017131027301022220.71
单位质量响应值RSD%判断
11057.8911208.550.96数据可信
中间条件6月-供试品溶液-2024041311批-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%
5min135349-3534971.30072.544.1071.3072.544.10
234662-3466269.91469.91
337096-3709674.82474.82
434333-3433369.25169.25
538149-3814976.94876.95
636203-3620373.02273.02
10min143066-4306686.86589.803.7487.2690.213.74
244222-4422289.19789.59
345800-4580092.38092.80
442508-4250885.74086.12
546957-4695794.71495.14
644584-4458489.92790.33
15min145684-4568492.14694.224.3693.0295.124.35
246552-4655293.89794.78
348776-4877698.38399.31
444352-4435289.45990.32
549534-4953499.912100.87
645379-4537991.53192.44
20min145955-4595592.69396.674.7094.0898.104.69
247314-4731495.43496.84
350800-50800102.465103.94
445415-4541591.60392.96
550467-50467101.793103.30
647623-4762396.05797.47
30min145499-4549991.77396.075.2693.6898.045.24
246483-4648393.75895.69
350565-50565101.991104.04
444892-4489290.54892.42
550696-50696102.255104.33
647652-4765296.11598.06
45min145885-4588592.55195.635.2094.9798.125.18
247157-4715795.11797.57
349508-4950899.859102.47
443903-4390388.55490.92
550756-50756102.376105.02
647255-4725595.31597.80
60min145180-4518091.12995.024.6694.0698.054.65
247072-4707294.94697.93
349045-4904598.925102.09
444248-4424889.24992.11
550004-50004100.860104.07
647114-4711495.03098.04
极限144081-4408188.91393.254.9892.3596.814.96
246201-4620193.18996.70
348000-4800096.817100.53
443253-4325387.24390.60
549356-4935699.552103.32
646507-4650793.80697.34
奥美沙坦酯口崩片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100864-202205对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
19.191007861012541010161015081011201011370.27
29.121014941023241019090.58
单位质量响应值RSD%判断
11005.1111174.231.08数据可信
中间条件6月-供试品溶液-b批-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%
5min135143-3514371.16469.7311.2571.1669.7311.25
231864-3186464.52464.52
337187-3718775.30375.30
430411-3041161.58161.58
531579-3157963.94763.95
640435-4043581.88081.88
10min143095-4309587.26686.887.6487.6687.267.66
239938-3993880.87381.23
346016-4601693.18193.60
440168-4016881.33981.68
540578-4057882.16982.52
647624-4762496.43796.89
15min145224-4522491.57792.945.6292.4693.815.64
243934-4393488.96589.77
349204-4920499.637100.57
443599-4359988.28789.08
544341-4434189.78990.60
649093-4909399.412100.40
20min145616-4561692.37195.455.6993.7696.845.71
245865-4586592.87594.18
350556-50556102.375103.86
445089-4508991.30492.59
545095-4509591.31692.63
650594-50594102.452103.99
30min145755-4575592.65396.594.6694.5598.514.70
246501-4650194.16395.98
350139-50139101.530103.59
446216-4621693.58695.38
546693-4669394.55296.37
650907-50907103.085105.20
45min145897-4589792.94096.303.9495.3698.753.99
246188-4618893.53095.87
349470-49470100.175102.80
446188-4618893.53095.84
547331-4733195.84498.19
650250-50250101.755104.44
60min144957-4495791.03794.903.6893.9797.883.73
246820-4682094.80997.67
349142-4914299.511102.69
445594-4559492.32795.16
545926-4592692.99995.87
648740-4874098.697101.95
极限143834-4383488.76394.715.0792.2098.235.05
245319-4531991.77095.16
348026-4802697.251100.98
446123-4612393.39896.74
546650-4665094.46597.86
650684-50684102.634106.43
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