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%
111.331020441020331021481021051021721021000.07
211.341022101023011022560.07
单位质量响应值RSD%判断
9011.479017.280.05数据可信
供试品溶液-2025051521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%
5min125703-2570325.60325.375.9425.6025.375.94
223049-2304922.95922.96
326753-2675326.64926.65
427080-2708026.97526.97
525831-2583125.73025.73
624399-2439924.30424.30
10min136451-3645136.30936.112.8136.5936.392.83
234565-3456534.43034.69
337173-3717337.02837.32
436989-3698936.84537.14
536840-3684036.69736.98
635509-3550935.37135.64
15min141077-4107740.91740.841.7241.6141.531.75
239906-3990639.75140.39
341458-4145841.29742.00
441343-4134341.18241.89
541794-4179441.63142.32
640446-4044640.28940.95
20min142962-4296242.79543.481.1343.9444.621.14
243306-4330643.13744.22
344284-4428444.11245.28
443643-4364343.47344.64
544102-4410243.93045.09
643589-4358943.41944.53
30min146642-4664246.46146.300.8748.0847.920.85
246307-4630746.12747.69
345781-4578145.60347.26
446845-4684546.66348.31
546834-4683446.65248.30
646477-4647746.29647.89
45min147604-4760447.41948.371.1449.5550.501.12
248398-4839848.21050.28
349195-4919549.00451.17
448963-4896348.77250.94
548601-4860148.41250.57
648574-4857448.38550.49
60min149839-4983949.64549.450.5452.3152.120.57
249263-4926349.07151.68
349975-4997549.78152.49
449513-4951349.32052.03
549768-4976849.57452.27
649491-4949149.29851.94
90min151334-5133451.13450.761.1554.3553.981.07
250668-5066850.47153.62
350275-5027550.07953.34
450399-5039950.20353.46
551651-5165151.45054.70
651429-5142951.22954.42
120min150522-5052250.32551.361.1854.1155.141.12
251607-5160751.40655.12
351300-5130051.10054.92
451885-5188551.68355.50
552312-5231252.10855.93
651711-5171151.51055.27
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151911-5191151.70951.381.0856.0555.740.97
251560-5156051.35955.64
351988-5198851.78656.17
451260-5126051.06155.45
550649-5064950.45254.85
652132-5213251.92956.26
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%
111.331026351027521026711028731027651027390.10
211.341020011017041018520.21
单位质量响应值RSD%判断
9067.878981.660.68数据可信
供试品溶液-2025051621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%
5min123656-2365623.53723.485.6123.5423.485.61
223825-2382523.70623.71
323243-2324323.12623.13
421944-2194421.83421.83
523008-2300822.89322.89
625942-2594225.81225.81
10min135634-3563435.45534.742.9835.7235.013.00
234940-3494034.76535.03
334271-3427134.09934.36
433463-3346333.29533.54
534759-3475934.58534.84
636443-3644336.26036.55
15min140091-4009139.89040.272.1240.5540.922.14
240332-4033240.13040.78
340568-4056840.36541.00
439381-3938139.18339.80
540497-4049740.29440.93
641988-4198841.77742.47
20min143483-4348343.26542.861.5144.3643.951.52
243576-4357643.35744.45
342294-4229442.08243.17
442185-4218541.97343.02
543503-4350343.28544.37
643402-4340243.18444.34
30min147016-4701646.78046.631.8048.3648.201.77
248047-4804747.80649.38
345518-4551845.29046.84
446727-4672746.49348.01
546575-4657546.34147.91
647307-4730747.07048.70
45min148431-4843148.18846.962.1750.2949.052.08
245571-4557145.34247.45
346482-4648246.24948.30
447881-4788147.64149.67
547477-4747747.23949.32
647333-4733347.09649.25
60min149485-4948549.23749.231.8251.8751.841.73
250019-5001949.76852.38
347786-4778647.54650.12
450346-5034650.09452.65
549803-4980349.55352.16
649410-4941049.16251.84
90min150769-5076950.51449.912.0853.7053.071.93
249600-4960049.35152.52
349477-4947749.22952.33
450850-5085050.59553.71
551498-5149851.24054.40
648754-4875448.50951.74
120min150327-5032750.07551.281.2153.8254.991.09
252068-5206851.80755.52
351900-5190051.64055.28
451633-5163351.37455.05
551626-5162651.36755.09
651684-5168451.42555.19
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150705-5070550.45151.280.8754.7555.560.79
251894-5189451.63455.92
351735-5173551.47655.69
451754-5175451.49455.74
551379-5137951.12155.42
651788-5178851.52855.86
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%
111.331025731027011025181025731026081025950.07
211.341029861029131029500.06
单位质量响应值RSD%判断
9055.169078.480.19数据可信
供试品溶液-2025051622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%
5min122238-2223822.02323.3111.6322.0223.3111.62
224436-2443624.20024.20
326933-2693326.67326.67
426222-2622225.96925.97
520838-2083820.63720.64
620556-2055620.35820.36
10min134958-3495834.62134.835.2234.8735.095.26
236512-3651236.16036.43
336749-3674936.39436.69
436767-3676736.41236.70
533613-3361333.28933.52
632425-3242532.11232.34
15min140376-4037639.98639.683.1440.6240.333.20
241306-4130640.90741.58
341275-4127540.87741.58
440402-4040240.01240.71
538566-3856638.19438.79
638505-3850538.13338.72
20min142699-4269942.28742.432.1743.3643.522.21
242657-4265742.24543.37
344572-4457244.14245.30
442548-4254842.13743.28
542801-4280142.38843.41
641765-4176541.36242.37
30min146309-4630945.86245.821.3547.4147.381.40
247312-4731246.85548.45
346609-4660946.15947.80
445897-4589745.45447.06
545836-4583645.39446.89
645638-4563845.19846.66
45min147993-4799347.53048.181.3249.5850.241.24
249294-4929448.81850.93
347768-4776847.30749.47
449231-4923148.75650.87
548664-4866448.19450.19
648933-4893348.46150.43
60min150551-5055150.06349.231.2852.6451.831.17
249251-4925148.77651.43
348829-4882948.35851.04
450138-5013849.65452.31
550003-5000349.52052.05
649486-4948649.00851.52
90min150587-5058750.09950.011.4253.2453.161.45
250912-5091250.42153.62
350565-5056550.07753.30
451474-5147450.97754.18
550029-5002949.54652.63
649401-4940148.92451.98
120min150949-5094950.45750.950.8554.1554.660.83
250994-5099450.50254.26
351816-5181651.31655.09
451998-5199851.49655.27
551323-5132350.82854.46
651612-5161251.11454.71
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150898-5089850.40750.831.2854.6655.101.28
251950-5195051.44955.77
352299-5229951.79456.14
450976-5097650.48454.83
551217-5121750.72354.92
650628-5062850.13954.30
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