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%
111.089864399251990159916999014990180.24
211.169946199721995910.19
单位质量响应值RSD%判断
8936.648923.920.11数据可信
供试品溶液-2025032021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%
5min17472-74727.51310.2421.757.5110.2421.75
213974-1397414.05114.05
310104-1010410.15910.16
49331-93319.3829.38
511116-1111611.17711.18
69097-90979.1479.15
10min122904-2290423.03026.888.1423.1126.998.18
229277-2927729.43829.59
326102-2610226.24526.36
426626-2662626.77226.88
527955-2795528.10828.23
627509-2750927.66027.76
15min132158-3215832.33535.184.6732.6735.594.75
236920-3692037.12337.61
334202-3420234.39034.79
435628-3562835.82436.23
535402-3540235.59636.03
635610-3561035.80536.21
20min137886-3788638.09440.413.2738.7941.213.36
241942-4194242.17243.07
340627-4062740.85041.64
440291-4029140.51241.31
540059-4005940.27941.11
640322-4032240.54341.35
30min143963-4396344.20445.441.6345.3346.691.73
246020-4602046.27347.64
345077-4507745.32446.56
445431-4543145.68046.93
544894-4489445.14046.42
645772-4577246.02347.28
45min146556-4655646.81248.571.9648.4250.332.04
249199-4919949.46951.35
348797-4879749.06550.81
448678-4867848.94550.70
547982-4798248.24550.03
648626-4862648.89350.66
60min148610-4861048.87749.431.4651.0151.731.52
250382-5038250.65953.09
349271-4927149.54151.83
449461-4946149.73352.03
548425-4842548.69151.01
648831-4883149.09951.41
90min150478-5047850.75550.700.4553.4353.540.51
250655-5065550.93353.92
350205-5020550.48153.32
450232-5023250.50853.36
550240-5024050.51653.37
650710-5071050.98853.85
120min150615-5061550.89351.791.0854.1355.201.10
251093-5109351.37354.93
351672-5167251.95655.36
452170-5217052.45655.87
551721-5172152.00555.42
651761-5176152.04555.47
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150668-5066850.94651.330.9254.7555.311.01
251972-5197252.25756.38
350936-5093651.21655.19
451043-5104351.32355.32
550845-5084551.12455.12
650824-5082451.10355.11
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%
111.089890198839989149911399058989650.12
211.169969999737997180.03
单位质量响应值RSD%判断
8931.868935.300.03数据可信
供试品溶液-2025032021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%
5min18243-82438.28511.3750.728.2911.3750.71
211049-1104911.10611.11
39542-95429.5919.59
45918-59185.9485.95
510748-1074810.80310.80
622382-2238222.49722.50
10min125132-2513225.26128.3614.5425.3528.4814.70
228576-2857628.72228.85
327530-2753027.67127.78
424148-2414824.27224.34
528098-2809828.24228.36
635792-3579235.97536.23
15min134807-3480734.98536.275.9335.3636.716.15
236872-3687237.06137.50
335421-3542135.60236.02
433856-3385634.02934.37
535605-3560535.78736.22
639958-3995840.16240.81
20min138033-3803338.22840.314.1538.9941.164.36
241131-4113141.34142.20
339624-3962439.82740.64
439046-3904639.24639.96
540024-4002440.22941.06
642773-4277342.99244.09
30min144576-4457644.80445.171.0845.9946.461.26
244711-4471144.94046.25
345056-4505645.28746.54
445230-4523045.46146.61
544379-4437944.60645.88
645688-4568845.92247.50
45min147584-4758447.82847.850.7049.5149.640.76
247951-4795148.19650.01
347230-4723047.47249.23
447946-4794648.19149.85
547202-4720247.44449.22
647698-4769847.94250.03
60min147497-4749747.74049.081.5849.9651.401.62
248760-4876049.01051.36
349469-4946949.72252.00
449478-4947849.73151.92
548463-4846348.71151.01
649302-4930249.55452.17
90min150651-5065150.91050.901.5653.6653.781.30
249939-4993950.19553.09
350874-5087451.13453.97
452059-5205952.32555.07
550389-5038950.64753.49
649943-4994350.19953.37
120min149756-4975650.01150.651.3353.3254.091.33
249648-4964849.90253.35
350564-5056450.82354.23
451402-5140251.66554.99
550173-5017350.43053.83
650827-5082751.08754.81
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150861-5086151.12151.071.0654.9955.070.82
250367-5036750.62554.63
350598-5059850.85754.83
451433-5143351.69655.59
551438-5143851.70155.67
650168-5016850.42554.72
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%
111.089925499058989139923598831990580.20
211.1699686100001998440.23
单位质量响应值RSD%判断
8940.258946.590.06数据可信
供试品溶液-2025032021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%
5min114814-1481414.87310.8821.9414.8710.8821.93
210872-1087210.91610.92
310337-1033710.37810.38
411942-1194211.99011.99
58973-89739.0099.01
68099-80998.1318.13
10min130233-3023330.35428.915.7730.5229.035.83
228927-2892729.04329.16
328508-2850828.62228.74
431039-3103931.16431.30
527386-2738627.49627.60
626651-2665126.75826.85
15min137172-3717237.32136.373.2737.8236.813.33
236198-3619836.34336.79
335629-3562935.77236.21
438052-3805238.20538.68
535027-3502735.16835.57
635246-3524635.38735.78
20min140856-4085641.02040.391.4441.9441.231.53
240399-4039940.56141.41
340319-4031940.48141.31
440652-4065240.81541.72
539279-3927939.43740.23
639848-3984840.00840.79
30min143204-4320443.37743.981.0444.7545.281.03
243897-4389744.07345.37
343636-4363643.81145.09
444582-4458244.76146.12
543870-4387044.04645.28
643660-4366043.83545.06
45min145961-4596146.14546.510.7248.0048.290.58
246226-4622646.41148.20
346458-4645846.64448.41
445981-4598146.16548.02
546817-4681747.00548.73
646497-4649746.68448.40
60min145988-4598846.17246.221.1848.5448.521.05
245895-4589546.07948.38
345457-4545745.63947.92
445535-4553545.71848.09
546472-4647246.65848.90
646856-4685647.04449.28
90min147126-4712647.31547.131.0050.2049.940.94
246063-4606346.24849.06
346815-4681547.00349.80
447094-4709447.28350.16
547187-4718747.37650.14
647371-4737147.56150.31
120min146108-4610846.29346.361.3049.7049.701.25
246322-4632246.50849.84
345877-4587746.06149.38
446833-4683347.02150.42
545197-4519745.37848.67
646696-4669646.88350.17
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145890-4589046.07446.320.6149.9950.170.54
246153-4615346.33850.18
346676-4667646.86350.69
446050-4605046.23550.16
545955-4595546.13949.93
646105-4610546.29050.09
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