玛巴洛沙韦干混悬剂项目信息
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%
111.219892798597984519881398753987080.19
211.279885099030989400.13
单位质量响应值RSD%判断
8805.358779.060.22数据可信
供试品溶液-B2021B01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%
5min137446-3744638.24339.252.5438.2439.252.54
237125-3712537.91537.92
338665-3866539.48839.49
439654-3965440.49840.50
539135-3913539.96839.97
638561-3856139.38239.38
10min143807-4380744.73945.211.9744.9545.431.97
244257-4425745.19945.41
342906-4290643.81944.04
445492-4549246.46046.69
544688-4468845.63945.86
644479-4447945.42645.64
15min146756-4675647.75148.261.0848.2148.721.08
247016-4701648.01748.48
348170-4817049.19549.66
447359-4735948.36748.85
546880-4688047.87848.35
647316-4731648.32348.79
20min149084-4908450.12949.840.9250.8550.580.90
248382-4838249.41250.14
349338-4933850.38851.12
448475-4847549.50750.26
549184-4918450.23150.97
648343-4834349.37250.11
30min149405-4940550.45651.092.2051.4652.102.15
251714-5171452.81553.82
349647-4964750.70451.72
448499-4849949.53150.56
550422-5042251.49552.52
650453-5045351.52752.54
45min148629-4862949.66451.182.4850.9552.482.44
249885-4988550.94752.24
349531-4953150.58551.88
451455-5145552.55053.85
551796-5179652.89854.21
649410-4941050.46251.76
60min151934-5193453.03953.252.0354.6054.841.98
252568-5256853.68755.27
351986-5198653.09254.67
453621-5362154.76256.36
552352-5235253.46655.07
650387-5038751.45953.04
90min150037-5003751.10253.212.5852.9655.092.51
252277-5227753.39055.27
352558-5255853.67755.55
454159-5415955.31257.21
551591-5159152.68954.59
651979-5197953.08554.95
120min149801-4980150.86152.872.5353.0055.052.45
252180-5218053.29055.46
351686-5168652.78654.96
450965-5096552.05054.26
553637-5363754.77856.97
652367-5236753.48155.64
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151303-5130352.39552.821.4254.8255.291.37
251845-5184552.94855.42
352335-5233553.44955.91
452793-5279353.91756.41
550969-5096952.05454.55
651084-5108452.17154.63
玛巴洛沙韦干混悬剂项目信息
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%
111.219907999119994419889999142991360.20
211.279904799068990580.02
单位质量响应值RSD%判断
8843.538789.530.44数据可信
供试品溶液-B2021B01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%
5min137904-3790438.60438.632.3238.6038.632.31
237032-3703237.71637.72
337172-3717237.85937.86
437525-3752538.21838.22
539206-3920639.93039.93
638748-3874839.46439.46
10min143884-4388444.69544.731.8844.9144.941.87
243709-4370944.51644.73
342452-4245243.23643.45
444486-4448645.30845.52
544148-4414844.96345.19
644817-4481745.64545.86
15min147287-4728748.16047.511.6148.6247.971.60
246349-4634947.20547.66
345713-4571346.55747.01
445926-4592646.77447.24
547220-4722048.09248.56
647400-4740048.27648.75
20min148341-4834149.23449.081.6049.9649.801.57
248750-4875049.65050.37
349058-4905849.96450.67
446837-4683747.70248.43
548169-4816949.05949.80
647963-4796348.84949.59
30min151280-5128052.22750.602.2953.2351.602.24
248935-4893549.83950.83
350481-5048151.41352.40
450172-5017251.09952.09
548964-4896449.86850.88
648282-4828249.17450.19
45min149477-4947750.39151.092.1851.6852.372.13
250291-5029151.22052.49
350517-5051751.45052.72
450403-5040351.33452.61
551777-5177752.73354.02
648520-4852049.41650.70
60min151087-5108752.03151.972.2353.6053.542.16
251710-5171052.66554.22
352075-5207553.03754.60
451917-5191752.87654.43
549164-4916450.07251.65
650231-5023151.15952.72
90min150244-5024451.17252.782.0253.0454.641.94
251095-5109552.03953.89
352583-5258353.55455.41
452124-5212453.08754.94
551752-5175252.70854.57
653147-5314754.12955.97
120min148956-4895649.86051.752.8152.0153.892.70
251034-5103451.97754.11
351493-5149352.44454.59
451940-5194052.89955.05
552277-5227753.24355.39
649149-4914950.05752.20
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153090-5309054.07153.261.9756.4955.701.87
252690-5269053.66356.09
353499-5349954.48756.93
452220-5222053.18555.63
550732-5073251.66954.12
651535-5153552.48754.91
玛巴洛沙韦干混悬剂项目信息
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%
111.219915399224992379907199037991440.10
211.279917899062991200.09
单位质量响应值RSD%判断
8844.258795.030.40数据可信
供试品溶液-B2021B01批-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%
5min136664-3666437.32837.376.7337.3337.376.73
241078-4107841.82241.82
337684-3768438.36638.37
435083-3508335.71835.72
534171-3417134.79034.79
635543-3554336.18736.19
10min145478-4547846.30242.948.9546.5143.158.94
245430-4543046.25346.49
345447-4544746.27046.48
437828-3782838.51338.71
537832-3783238.51738.71
641058-4105841.80242.00
15min148351-4835149.22745.617.4249.6946.057.42
248661-4866149.54250.03
345904-4590446.73547.21
442137-4213742.90043.31
540839-4083941.57941.99
642881-4288143.65844.09
20min150086-5008650.99346.545.7451.7347.245.73
247555-4755548.41649.18
343855-4385544.64945.38
444805-4480545.61646.27
543094-4309443.87444.51
644877-4487745.69046.37
30min153389-5338954.35650.198.1155.3851.168.08
252823-5282353.78054.81
351349-5134952.27953.26
445930-4593046.76247.67
543378-4337844.16445.05
648940-4894049.82650.76
45min154539-5453955.52749.417.5756.8550.647.52
250280-5028051.19152.52
347031-4703147.88349.15
446520-4652047.36348.53
543871-4387144.66645.79
648925-4892549.81151.02
60min153400-5340054.36751.176.9056.0052.686.89
253732-5373254.70556.32
350719-5071951.63853.17
447306-4730648.16349.59
544976-4497645.79147.17
651419-5141952.35053.83
90min156139-5613957.15651.667.3459.0953.457.31
252416-5241653.36555.29
352078-5207853.02154.84
447774-4777448.63950.33
545589-4558946.41548.04
650438-5043851.35153.13
120min156027-5602757.04252.178.5759.2954.258.49
254999-5499955.99558.21
353036-5303653.99756.11
447677-4767748.54050.51
544669-4466945.47847.37
651024-5102451.94854.01
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155056-5505656.05352.836.2758.6255.206.29
254745-5474555.73658.26
352592-5259253.54455.96
449649-4964950.54852.78
546557-4655747.40049.54
652752-5275253.70756.06
玛巴洛沙韦干混悬剂项目信息
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%
111.21100034997729995899848100175999570.16
211.279903299162990970.10
单位质量响应值RSD%判断
8916.778792.990.99数据可信
供试品溶液-B2021B01批-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%
5min139574-3957440.13236.616.2240.1336.616.22
237452-3745237.98037.98
336642-3664237.15937.16
433866-3386634.34434.34
533791-3379134.26734.27
635279-3527935.77635.78
10min145364-4536446.00441.316.3246.2341.516.32
241219-4121941.80042.01
340950-4095041.52741.73
439370-3937039.92540.12
537843-3784338.37738.57
639643-3964340.20240.40
15min148805-4880549.49344.167.8949.9744.607.87
245341-4534145.98046.42
344359-4435944.98445.42
441172-4117241.75342.17
538970-3897039.51939.92
642644-4264443.24543.67
20min149709-4970950.41045.287.4751.1645.967.45
245412-4541246.05246.75
345492-4549246.13346.82
441279-4127941.86142.51
540577-4057741.14941.77
645457-4545746.09846.76
30min153898-5389854.65847.739.0555.6948.669.00
248890-4889049.57950.53
347268-4726847.93548.88
444767-4476745.39846.28
541156-4115641.73642.59
646447-4644747.10248.02
45min151431-5143152.15647.697.5753.4948.887.54
249692-4969250.39351.62
345587-4558746.23047.44
445268-4526845.90647.04
541620-4162042.20743.29
648566-4856649.25150.43
60min155363-5536356.14450.137.3557.7751.597.34
249896-4989650.60052.11
348597-4859749.28250.75
446365-4636547.01948.40
545238-4523845.87647.19
651138-5113851.85953.31
90min155342-5534256.12250.758.0858.0652.508.04
253098-5309853.84755.64
351578-5157852.30554.05
447057-4705747.72149.37
544440-4444045.06746.64
648779-4877949.46751.21
120min155472-5547256.25449.347.9558.5051.367.91
248434-4843449.11751.21
349688-4968850.38952.42
445255-4525545.89347.80
544727-4472745.35847.18
648335-4833549.01751.03
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156950-5695057.75352.317.0160.3254.617.02
253509-5350954.26456.63
351053-5105351.77354.08
448246-4824648.92651.09
547086-4708647.75049.83
652665-5266553.40855.70
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