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%
111.331013611012301014131014851014181013810.10
211.341015121015371015240.02
单位质量响应值RSD%判断
8948.018952.730.04数据可信
供试品溶液-2025051521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%
5min124779-2477924.85923.827.0724.8623.827.06
225043-2504325.12425.12
324148-2414824.22624.23
424097-2409724.17524.17
523978-2397824.05524.06
620434-2043420.50020.50
10min137621-3762137.74336.333.1138.0236.603.13
236501-3650136.61936.90
336734-3673436.85337.12
436171-3617136.28836.56
536029-3602936.14536.41
634227-3422734.33834.57
15min142265-4226542.40241.222.5943.1041.892.61
240629-4062940.76041.45
341280-4128041.41342.09
441633-4163341.76842.44
541517-4151741.65142.32
639209-3920939.33639.95
20min144782-4478244.92743.691.8346.0944.821.82
243754-4375443.89545.03
342645-4264542.78343.92
443986-4398644.12845.26
542804-4280442.94244.07
643332-4333243.47244.52
30min148141-4814148.29747.291.8249.9648.901.79
247549-4754947.70349.33
346227-4622746.37647.99
447631-4763147.78549.41
545964-4596446.11347.72
647294-4729447.44748.98
45min148660-4866048.81749.132.2151.0251.272.16
248681-4868148.83851.00
350439-5043950.60252.73
449908-4990850.06952.23
548784-4878448.94251.06
647366-4736647.51949.58
60min149999-4999950.16150.271.0752.9152.961.01
250495-5049550.65853.36
350824-5082450.98853.68
449248-4924849.40752.12
550056-5005650.21852.88
650041-5004150.20352.79
90min151337-5133751.50351.720.8154.8154.960.72
250800-5080050.96454.23
351801-5180151.96855.23
451864-5186452.03255.29
551694-5169451.86155.08
651807-5180751.97455.12
120min150660-5066050.82451.821.3554.7055.641.23
251268-5126851.43455.26
352347-5234752.51656.35
452446-5244652.61656.46
551329-5132951.49555.29
651876-5187652.04455.76
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152512-5251252.68252.181.0557.1256.581.02
251692-5169251.85956.26
352130-5213052.29856.72
452630-5263052.80057.23
551160-5116051.32555.70
651956-5195652.12456.42
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%
111.331016691016621017161018271017141017180.07
211.341014011014111014060.01
单位质量响应值RSD%判断
8977.768942.330.28数据可信
供试品溶液-2025051621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%
5min123063-2306323.11325.356.2023.1125.356.20
223808-2380823.85923.86
325440-2544025.49525.49
425787-2578725.84325.84
526877-2687726.93526.93
626820-2682026.87826.88
10min135351-3535135.42736.742.5735.6837.022.58
236989-3698937.06937.33
336663-3666336.74237.03
436217-3621736.29536.58
538208-3820838.29038.59
636539-3653936.61836.92
15min140825-4082540.91341.501.4741.5642.181.49
241234-4123441.32342.00
341100-4110041.18841.88
440948-4094841.03641.73
542083-4208342.17442.90
642248-4224842.33943.04
20min143552-4355243.64644.141.3144.7545.281.33
244082-4408244.17745.31
343362-4336243.45544.60
443973-4397344.06845.21
544972-4497245.06946.26
644313-4431344.40845.58
30min146504-4650446.60447.000.7248.1948.640.72
246913-4691347.01448.64
346855-4685546.95648.59
447190-4719047.29248.93
546587-4658746.68748.38
647373-4737347.47549.14
45min148158-4815848.26249.141.6750.3751.301.66
248351-4835148.45550.60
348449-4844948.55350.71
449679-4967949.78651.95
549485-4948549.59251.80
650095-5009550.20352.40
60min150126-5012650.23450.280.9652.8853.000.93
250584-5058450.69353.38
349986-4998650.09452.79
449544-4954449.65152.37
550881-5088150.99153.75
649934-4993450.04252.80
90min150128-5012850.23651.651.7953.4454.921.76
251078-5107851.18854.44
351134-5113451.24454.49
452143-5214352.25555.52
552597-5259752.71056.04
652155-5215552.26755.58
120min151754-5175451.86552.210.8655.6356.060.79
252482-5248252.59556.41
352677-5267752.79056.61
452031-5203152.14355.99
552184-5218452.29656.21
651483-5148351.59455.49
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152006-5200652.11852.120.9556.4556.540.87
252461-5246152.57456.98
352164-5216452.27656.68
451079-5107951.18955.62
551983-5198352.09556.59
652334-5233452.44756.91
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%
111.331019921018601015871017721017261017870.15
211.341026011027861026940.13
单位质量响应值RSD%判断
8983.859055.910.57数据可信
供试品溶液-2025051622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%
5min120766-2076620.67322.926.3620.6722.926.37
222738-2273822.63622.64
324682-2468224.57124.57
422528-2252822.42722.43
524610-2461024.50024.50
622845-2284522.74322.74
10min135146-3514634.98835.452.3735.2235.712.37
236531-3653136.36736.62
336328-3632836.16536.44
434222-3422234.06934.32
535792-3579235.63235.90
635648-3564835.48835.74
15min139160-3916038.98439.681.7339.6040.331.76
240293-4029340.11240.77
340497-4049740.31540.99
438872-3887238.69839.33
540423-4042340.24240.91
639887-3988739.70840.36
20min144097-4409743.89943.522.3344.9544.612.29
245303-4530345.10046.20
343895-4389543.69844.82
442223-4222342.03443.09
543335-4333543.14144.26
643443-4344343.24844.34
30min146671-4667146.46246.390.6248.0047.960.64
246819-4681946.60948.21
346705-4670546.49648.10
446386-4638646.17847.70
546869-4686946.65948.25
646118-4611845.91147.48
45min148278-4827848.06248.410.7350.1250.500.73
248582-4858248.36450.48
349161-4916148.94151.07
448822-4882248.60350.64
548685-4868548.46750.58
648222-4822248.00650.08
60min148893-4889348.67449.771.3251.2652.401.25
250309-5030950.08352.74
349703-4970349.48052.15
450742-5074250.51553.09
549908-4990849.68452.34
650428-5042850.20252.81
90min150350-5035050.12449.802.1453.2552.982.01
248883-4888348.66451.88
351749-5174951.51754.74
450558-5055850.33153.47
549304-4930449.08352.29
649294-4929449.07352.24
120min152376-5237652.14151.481.3755.8355.211.28
251885-5188551.65255.41
351574-5157451.34355.13
450395-5039550.16953.87
551828-5182851.59655.34
652221-5222151.98755.70
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150965-5096550.73751.301.2955.0055.601.24
252153-5215351.91956.25
352310-5231052.07656.44
451740-5174051.50855.76
551381-5138151.15155.47
650628-5062850.40154.69
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