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%
1 10.959809298088981339810298011980850.05
211.009813298284982080.11
单位质量响应值RSD%判断
8957.538928.000.24数据可信
供试品溶液-2025051221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%
5min118584-1858418.66018.8025.0418.6618.8025.05
224266-2426624.36524.37
318264-1826418.33918.34
414833-1483314.89414.89
512573-1257312.62412.62
623812-2381223.90923.91
10min131683-3168331.81332.1112.0832.0232.3112.16
236245-3624536.39336.66
332664-3266432.79833.00
428124-2812428.23928.40
527064-2706427.17527.31
636069-3606936.21636.48
15min138117-3811738.27338.625.9738.8339.196.13
241102-4110241.27041.95
338910-3891039.06939.64
436484-3648436.63337.11
535370-3537035.51535.96
640821-4082140.98841.66
20min142115-4211542.28742.083.9243.2743.084.10
243411-4341143.58844.72
342710-4271042.88543.89
440311-4031140.47641.36
539511-3951139.67340.51
643399-4339943.57644.70
30min145444-4544445.63045.871.8047.0947.331.94
246659-4665946.85048.47
346752-4675246.94348.42
445169-4516945.35446.69
544783-4478344.96646.24
645300-4530045.48547.09
45min147876-4787648.07248.850.8450.0350.820.89
248877-4887749.07751.22
348988-4898849.18851.19
448556-4855648.75450.59
548867-4886749.06750.84
648721-4872148.92051.03
60min150598-5059850.80549.851.4753.3052.361.60
249773-4977349.97652.66
349734-4973449.93752.48
449076-4907649.27751.66
548572-4857248.77151.09
650138-5013850.34353.00
90min148939-4893949.13950.831.8652.2053.901.70
250260-5026050.46553.70
351193-5119351.40254.50
451615-5161551.82654.76
550921-5092151.12953.99
650819-5081951.02754.24
120min150820-5082051.02851.530.5954.6455.160.71
251409-5140951.61955.42
351323-5132351.53355.21
451226-5122651.43554.94
551362-5136251.57255.00
651752-5175251.96455.75
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150189-5018950.39451.250.9054.5755.460.89
250984-5098451.19255.57
351044-5104451.25355.50
451342-5134251.55255.63
551193-5119351.40255.41
651493-5149351.70356.06
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%
1 10.959818697978978029790897750979250.18
211.009868198534986080.11
单位质量响应值RSD%判断
8942.928964.360.17数据可信
供试品溶液-2025051321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%
5min123409-2340923.47618.2120.3623.4818.2220.36
216292-1629216.33916.34
318447-1844718.50018.50
415024-1502415.06715.07
521590-2159021.65221.65
614210-1421014.25114.25
10min134896-3489634.99632.267.4435.2632.477.50
233507-3350733.60333.78
331790-3179031.88132.09
430112-3011230.19830.37
533987-3398734.08434.33
628746-2874628.82828.99
15min139377-3937739.49038.333.3340.1438.893.43
239078-3907839.19039.74
338232-3823238.34238.90
437027-3702737.13337.64
539271-3927139.38440.00
636355-3635536.45936.94
20min142536-4253642.65842.021.8843.7543.011.99
242705-4270542.82743.82
342035-4203542.15643.14
441232-4123241.35042.27
542211-4221142.33243.39
640690-4069040.80741.69
30min145838-4583845.96946.130.5147.5347.580.60
246051-4605146.18347.65
345959-4595946.09147.54
445794-4579445.92547.30
546431-4643146.56448.09
645892-4589246.02447.36
45min148108-4810848.24648.340.7050.3250.310.74
248762-4876248.90250.88
348428-4842848.56750.53
448089-4808948.22750.11
548029-4802948.16750.21
647816-4781647.95349.80
60min149644-4964449.78649.811.1852.4052.311.13
250369-5036950.51353.04
350193-5019350.33752.84
449736-4973649.87952.30
548773-4877348.91351.49
649291-4929149.43251.81
90min149497-4949749.63950.701.2352.8053.761.04
250565-5056550.71053.79
351013-5101351.15954.22
451228-5122851.37554.35
550241-5024150.38553.51
650781-5078150.92753.86
120min150136-5013650.28051.251.3053.9954.871.22
251369-5136951.51655.16
351240-5124051.38755.02
451711-5171151.85955.41
551697-5169751.84555.53
650445-5044550.59054.09
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151212-5121251.35951.380.4655.6355.570.49
251182-5118251.32955.55
351275-5127551.42255.63
451552-5155251.70055.82
551336-5133651.48355.74
650843-5084350.98955.05
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%
1 10.959874298765986009876098632987000.08
211.009876599344990540.42
单位质量响应值RSD%判断
9013.709004.910.07数据可信
供试品溶液-2025051421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%
5min114602-1460214.55319.0313.3414.5519.0213.34
219776-1977619.71019.71
319478-1947819.41319.41
418390-1839018.32918.33
522307-2230722.23322.23
619990-1999019.92319.92
10min129767-2976729.66831.563.4629.8331.773.51
232747-3274732.63832.86
332211-3221132.10432.32
432045-3204531.93832.14
532218-3221832.11132.36
630986-3098630.88331.10
15min136162-3616236.04237.211.8536.5337.771.91
237477-3747737.35237.93
337222-3722237.09837.67
438128-3812838.00138.56
537879-3787937.75338.36
637121-3712136.99737.56
20min140268-4026840.13440.851.2741.0341.831.31
241420-4142041.28242.28
341067-4106740.93041.91
441680-4168041.54142.52
540922-4092240.78641.81
640591-4059140.45641.43
30min143847-4384743.70144.621.3245.0446.051.35
244301-4430144.15345.61
344932-4493244.78246.22
445462-4546245.31146.75
545110-4511044.96046.44
644959-4495944.80946.23
45min147040-4704046.88347.581.1148.7149.511.13
247487-4748747.32949.27
347831-4783147.67249.61
448584-4858448.42250.37
547502-4750247.34449.32
648004-4800447.84449.77
60min147803-4780347.64448.671.2549.9951.131.28
248993-4899348.83051.30
349456-4945649.29151.76
449405-4940549.24051.72
548591-4859148.42950.93
648777-4877748.61551.07
90min149238-4923849.07449.991.2651.9552.991.26
249852-4985249.68652.70
350284-5028450.11753.13
450793-5079350.62453.65
549892-4989249.72652.77
650895-5089550.72653.72
120min150102-5010249.93550.631.0853.3554.181.07
251590-5159051.41854.98
351267-5126751.09654.67
450551-5055150.38353.98
550500-5050050.33253.92
650767-5076750.59854.16
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150458-5045850.29050.961.1554.2655.081.12
251013-5101350.84354.98
351214-5121451.04355.18
450812-5081250.64354.80
551107-5110750.93755.09
652197-5219752.02356.14
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