玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159706096874967999678896906968850.12
211.119686297282970720.31
单位质量响应值RSD%判断
8689.248737.350.40数据可信
长期6月-供试品溶液-2025062621批-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%
5min129885-2988530.79832.362.5230.8032.362.52
231645-3164532.61132.61
331618-3161832.58432.58
431439-3143932.39932.40
531624-3162432.59032.59
632218-3221833.20233.20
10min139083-3908340.27639.861.2640.4540.041.25
238122-3812239.28639.47
338395-3839539.56739.75
438820-3882040.00540.19
538305-3830539.47539.66
639364-3936440.56640.75
15min141795-4179543.07142.680.5643.4743.080.56
241235-4123542.49442.89
341157-4115742.41442.81
441484-4148442.75143.15
541497-4149742.76443.16
641304-4130442.56542.98
20min143301-4330144.62343.991.3145.2644.631.30
242588-4258843.88844.52
341742-4174243.01743.65
442883-4288344.19244.83
542484-4248443.78144.42
643137-4313744.45445.10
30min145549-4554946.94046.111.2747.8246.991.24
244963-4496346.33647.22
345106-4510646.48347.36
444013-4401345.35746.24
544460-4446045.81846.70
644357-4435745.71246.60
45min145935-4593547.33847.500.8348.4848.640.82
245527-4552746.91748.05
346143-4614347.55248.69
446703-4670348.12949.27
546167-4616747.57748.71
646089-4608947.49648.64
60min146376-4637647.79248.230.6549.2049.640.63
246735-4673548.16249.56
347206-4720648.64850.05
446642-4664248.06649.47
547094-4709448.53249.93
646771-4677148.19949.61
90min147668-4766849.12449.360.9750.7951.030.93
248072-4807249.54051.20
348488-4848849.96951.64
448129-4812949.59951.27
547883-4788349.34551.01
647130-4713048.56950.25
120min147244-4724448.68749.270.8850.6351.210.84
248440-4844049.91951.86
347617-4761749.07151.02
448117-4811749.58651.53
547750-4775049.20851.15
647685-4768549.14151.09
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限149061-4906150.55949.791.2852.7752.011.22
247857-4785749.31851.54
348376-4837649.85352.07
448632-4863250.11752.34
548638-4863850.12352.34
647350-4735048.79651.02
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159659696544966599644496614965710.09
211.119685597068969620.16
单位质量响应值RSD%判断
8661.088727.450.54数据可信
长期6月-供试品溶液-2025062721批-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%
5min132374-3237433.43634.352.0033.4434.352.00
233000-3300034.08234.08
334181-3418135.30235.30
433679-3367934.78434.78
533562-3356234.66334.66
632765-3276533.84033.84
10min138703-3870339.97240.701.2040.1640.891.20
240115-4011541.43141.62
339468-3946840.76340.96
439105-3910540.38840.58
539539-3953940.83641.03
639490-3949040.78540.97
15min142582-4258243.97943.880.4344.3944.300.43
242206-4220643.59044.01
342609-4260944.00744.43
442475-4247543.86844.29
542699-4269944.10044.52
642362-4236243.75144.17
20min143405-4340544.82945.351.0245.4846.011.01
244028-4402845.47246.13
344160-4416045.60846.28
444369-4436945.82446.49
543305-4330544.72545.39
644193-4419345.64346.30
30min145432-4543246.92247.190.9247.8248.100.91
246153-4615347.66748.58
345650-4565047.14748.07
445161-4516146.64247.56
545507-4550747.00047.91
646223-4622347.73948.65
45min147676-4767649.24049.190.6450.4050.360.62
247240-4724048.78949.97
347461-4746149.01850.20
447500-4750049.05850.23
547745-4774549.31150.49
648126-4812649.70550.88
60min146512-4651248.03849.491.6349.4750.941.60
248288-4828849.87251.32
347757-4775749.32350.78
447781-4778149.34850.80
548486-4848650.07651.52
648673-4867350.26951.72
90min148641-4864150.23650.001.4151.9451.721.36
248815-4881550.41652.14
347949-4794949.52251.25
447690-4769049.25450.98
549469-4946951.09252.82
647915-4791549.48751.22
120min148783-4878350.38349.731.1452.3651.731.08
247319-4731948.87150.88
348466-4846650.05652.06
447939-4793949.51151.51
547829-4782949.39851.41
648550-4855050.14252.15
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限146950-4695048.49050.121.8350.7552.401.77
248919-4891950.52452.80
348964-4896450.57052.85
448010-4801049.58551.86
549182-4918250.79553.08
649166-4916650.77953.06
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159618696370962229632096332962860.09
211.119658596864967240.21
单位质量响应值RSD%判断
8635.528706.030.58数据可信
长期6月-供试品溶液-2025062821批-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%
5min131252-3125232.36533.772.7432.3633.762.74
233026-3302634.20234.20
333978-3397835.18835.19
432398-3239833.55133.55
532430-3243033.58433.58
632554-3255433.71333.71
10min139383-3938340.78540.561.3840.9640.751.37
238849-3884940.23240.42
339309-3930940.70840.90
440047-4004741.47341.66
538913-3891340.29840.48
638509-3850939.88040.07
15min142511-4251144.02443.580.7544.4343.990.73
242306-4230643.81244.23
341625-4162543.10743.53
441868-4186843.35843.78
542096-4209643.59544.01
642062-4206243.55943.97
20min143671-4367145.22644.921.1645.8845.581.14
242588-4258844.10444.76
343297-4329744.83845.50
443730-4373045.28745.94
543933-4393345.49746.15
643042-4304244.57445.23
30min144568-4456846.15547.201.8447.0648.101.81
245122-4512246.72847.63
346321-4632147.97048.88
446737-4673748.40149.31
545704-4570447.33148.24
644993-4499346.59547.49
45min147168-4716848.84748.740.6650.0149.910.66
246560-4656048.21849.38
347493-4749349.18450.36
447198-4719848.87850.06
547019-4701948.69349.86
646964-4696448.63649.79
60min145913-4591347.54749.182.1148.9850.622.06
247358-4735849.04450.47
349013-4901350.75852.21
447239-4723948.92150.37
547832-4783249.53550.97
647571-4757149.26550.69
90min148122-4812249.83549.900.8851.5351.610.85
248513-4851350.24051.94
347956-4795649.66351.40
448851-4885150.59052.31
547705-4770549.40351.12
647954-4795449.66151.36
120min148708-4870850.44250.451.3752.4152.441.32
248737-4873750.47252.45
348239-4823949.95651.96
449785-4978551.55753.56
547844-4784449.54751.54
649004-4900450.74952.73
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限147965-4796549.67350.161.0051.9252.430.95
248350-4835050.07152.33
347895-4789549.60051.89
448614-4861450.34552.63
549184-4918450.93553.20
648634-4863450.36552.62
玛巴洛沙韦混悬剂项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)0
对照品批号DQTL-4125-250109对照品来源自制对照品使用方法直接使用
对照品含量(%)99.77对照品水分(%)0对照品稀释倍数2500
标示量(mg)40供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.159632596286960569613096139961870.12
211.119571596102959080.29
单位质量响应值RSD%判断
8626.648632.580.05数据可信
中间条件6月-供试品溶液-2025062821批-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%
5min131660-3166032.94333.300.8032.9433.300.80
232031-3203133.32933.33
332425-3242533.73933.74
432013-3201333.31033.31
532035-3203533.33333.33
631840-3184033.13033.13
10min138441-3844139.99940.020.8240.1840.200.82
238696-3869640.26440.45
338482-3848240.04140.23
438845-3884540.41940.60
538348-3834839.90240.09
637933-3793339.47039.65
15min141362-4136243.03842.801.2043.4443.201.19
240444-4044442.08342.49
341691-4169143.38043.79
441312-4131242.98643.40
540607-4060742.25242.66
641374-4137443.05143.45
20min143742-4374245.51544.781.1846.1645.421.16
243460-4346045.22145.86
342469-4246944.19044.84
442782-4278244.51645.16
542593-4259344.31944.96
643161-4316144.91045.55
30min144884-4488446.70346.761.0847.6047.651.06
244957-4495746.77947.67
345187-4518747.01847.91
444458-4445846.26047.16
544414-4441446.21447.10
645709-4570947.56148.45
45min145902-4590247.76247.821.2548.9248.971.22
246152-4615248.02249.18
346165-4616548.03649.19
445711-4571147.56348.72
546766-4676648.66149.81
645039-4503946.86448.02
60min146502-4650248.38648.630.6149.8150.040.60
246862-4686248.76150.18
346859-4685948.75850.18
446983-4698348.88750.30
546265-4626548.14049.55
646927-4692748.82950.25
90min149093-4909351.08250.280.8552.7751.970.82
247988-4798849.93351.62
348226-4822650.18051.88
448072-4807250.02051.71
548445-4844550.40852.09
648123-4812350.07351.76
120min148402-4840250.36350.230.5852.3452.200.56
248134-4813450.08452.05
348280-4828050.23652.21
448651-4865150.62252.59
547833-4783349.77151.73
648367-4836750.32752.29
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限148643-4864350.61450.121.6452.8752.371.58
248679-4867950.65252.90
347571-4757149.49951.75
449220-4922051.21553.46
547188-4718849.10051.34
647714-4771449.64751.89
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