玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20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%
111.169827698502984019842398606984420.13
211.089898099178990790.15
单位质量响应值RSD%判断
8820.978942.150.97数据可信
供试品溶液-N0001N04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%
5min116460-1646016.64213.9122.2216.6413.9122.22
213126-1312613.27113.27
315276-1527615.44515.44
411892-1189212.02312.02
58919-89199.0189.02
616892-1689217.07917.08
10min130090-3009030.42329.219.4230.6129.379.47
229978-2997830.30930.46
330117-3011730.45030.62
426313-2631326.60426.74
524841-2484125.11625.22
632022-3202232.37632.57
15min137123-3712337.53336.475.3738.0636.955.47
236937-3693737.34537.83
337248-3724837.66038.17
434161-3416134.53934.97
533110-3311033.47633.86
637832-3783238.25038.80
20min140706-4070641.15640.083.7942.1040.963.92
240389-4038940.83541.73
340258-4025840.70341.63
438186-3818638.60839.42
537341-3734137.75438.50
640971-4097141.42442.40
30min143304-4330443.78344.131.4045.1845.461.52
243613-4361344.09545.45
344353-4435344.84346.22
442952-4295243.42744.67
543245-4324543.72344.89
644415-4441544.90646.34
45min144707-4470745.20146.211.4647.0848.031.49
245794-4579446.30048.14
346197-4619746.70848.59
446114-4611446.62448.35
545068-4506845.56647.22
646339-4633946.85148.78
60min147561-4756148.08747.660.9350.4749.990.93
247181-4718147.70250.06
347623-4762348.14950.55
446668-4666847.18449.43
547210-4721047.73249.89
646576-4657647.09149.55
90min147510-4751048.03548.170.6650.9651.030.59
247624-4762448.15051.04
348087-4808748.61851.55
447784-4778448.31251.08
547714-4771448.24150.93
647139-4713947.66050.64
120min147723-4772348.25049.231.3451.7052.631.24
248592-4859249.12952.55
349661-4966150.21053.68
449070-4907049.61252.92
548699-4869949.23752.47
648432-4843248.96752.47
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148429-4842948.96449.770.9752.9553.710.94
249546-4954650.09454.06
349786-4978650.33654.37
449432-4943249.97853.83
549085-4908549.62753.40
649066-4906649.60853.66
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20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%
111.169864298545982979836398532984760.15
211.089918399140991620.04
单位质量响应值RSD%判断
8824.018949.641.00数据可信
供试品溶液-N0001N04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%
5min113872-1387214.01713.785.5614.0213.785.56
212572-1257212.70312.70
313369-1336913.50913.51
413558-1355813.70013.70
514898-1489815.05415.05
613527-1352713.66813.67
10min127210-2721027.49529.183.8727.6529.333.87
229210-2921029.51529.66
328720-2872029.02029.17
428550-2855028.84929.00
530670-3067030.99131.16
628904-2890429.20629.36
15min135111-3511135.47836.881.9235.9437.361.93
236497-3649736.87937.35
336774-3677437.15937.63
436742-3674237.12637.60
536973-3697337.36037.87
636907-3690737.29337.77
20min139183-3918339.59341.322.5340.4542.202.51
241536-4153641.97042.85
340971-4097141.39942.28
442169-4216942.61043.50
541142-4114241.57242.50
640330-4033040.75241.64
30min144704-4470445.17145.180.7946.4746.520.76
244560-4456045.02646.37
344229-4422944.69146.04
444929-4492945.39946.76
544572-4457245.03846.43
645256-4525645.72947.07
45min145522-4552245.99847.091.4147.8048.941.40
246539-4653947.02648.87
347417-4741747.91349.75
446775-4677547.26449.13
547047-4704747.53949.43
646300-4630046.78448.64
60min147713-4771348.21248.060.5950.5250.430.56
247487-4748747.98450.35
347093-4709347.58549.96
447934-4793448.43550.82
547556-4755648.05350.47
647570-4757048.06750.44
90min147852-4785248.35249.120.9051.2052.020.90
248779-4877949.28952.19
348862-4886249.37352.28
449000-4900049.51252.44
548826-4882649.33752.29
648341-4834148.84651.75
120min148415-4841548.92149.580.8752.3053.030.86
249136-4913649.65053.10
349012-4901249.52452.98
449042-4904249.55553.03
549040-4904049.55353.05
649749-4974950.26953.72
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148272-4827248.77749.471.1952.7053.471.15
248264-4826448.76952.77
349594-4959450.11354.11
449375-4937549.89153.92
548892-4889249.40353.45
649356-4935649.87253.88
玛巴洛沙韦片项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号DQTL-4125-250109对照品来源工作对照品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)20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%
111.169931699475994599932799661994480.15
211.089776798186979760.31
单位质量响应值RSD%判断
8911.118842.600.55数据可信
供试品溶液-N0001N04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%
5min18840-88408.94211.9417.638.9411.9417.64
213319-1331913.47313.47
312520-1252012.66512.66
414340-1434014.50614.51
59905-990510.01910.02
611916-1191612.05412.05
10min124899-2489925.18727.325.1125.2927.455.15
227576-2757627.89528.04
327031-2703127.34327.48
429136-2913629.47329.63
526612-2661226.92027.03
626786-2678627.09627.23
15min133808-3380834.19934.871.2634.5835.301.32
234324-3432434.72135.18
334252-3425234.64835.09
434985-3498535.38935.88
534612-3461235.01235.42
634841-3484135.24435.68
20min137749-3774938.18538.391.5738.9439.221.59
238057-3805738.49739.34
338829-3882939.27840.11
438401-3840138.84539.73
537298-3729837.72938.53
637402-3740237.83438.66
30min141161-4116141.63741.760.9642.8243.010.99
241758-4175842.24143.51
340764-4076441.23542.50
441752-4175242.23443.55
541148-4114841.62342.84
641135-4113541.61042.86
45min143324-4332443.82543.781.0545.4745.500.98
243134-4313443.63245.37
343041-4304143.53845.26
443307-4330743.80745.59
544112-4411244.62246.30
642790-4279043.28444.99
60min144749-4474945.26644.601.0047.4046.800.89
244446-4444644.96047.19
343909-4390944.41646.62
443540-4354044.04346.31
544027-4402744.53646.71
643858-4385844.36546.56
90min144545-4454545.06045.571.2647.7048.271.18
244729-4472945.24647.97
344602-4460245.11747.82
444992-4499245.51248.27
545467-4546745.99248.66
645979-4597946.51049.19
120min145884-4588446.41446.101.3849.5549.301.28
245683-4568346.21149.44
346435-4643546.97250.17
445433-4543345.95849.22
545476-4547646.00249.18
644532-4453245.04748.25
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145522-4552246.04845.620.6849.7049.330.61
245377-4537745.90149.64
344690-4469045.20648.93
445008-4500845.52849.30
544907-4490745.42649.12
645072-4507245.59349.29
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