多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.196572765817660256560165390657120.37
210.206615966645664020.52
单位质量响应值RSD%判断
6448.686510.000.67数据可信
供试品溶液-25041501批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min127020-2702037.41637.215.4337.4237.215.43
227867-2786738.58938.59
328179-2817939.02139.02
427872-2787238.59638.60
525799-2579935.72535.73
624476-2447633.89333.89
10min141447-4144757.39457.253.4757.4657.313.47
242996-4299659.53959.60
342807-4280759.27759.34
441407-4140757.33957.40
539817-3981755.13755.20
639593-3959354.82754.88
15min149011-4901167.86866.922.8068.0367.082.81
249811-4981168.97669.14
349609-4960968.69668.86
447940-4794066.38566.55
546888-4688864.92865.08
646711-4671164.68364.83
20min152869-5286973.21172.412.6273.4872.682.63
253921-5392174.66774.95
353528-5352874.12374.40
451703-5170371.59671.87
550401-5040169.79370.05
651319-5131971.06471.32
30min157423-5742379.51778.702.4579.9179.092.45
258479-5847980.97981.38
358153-5815380.52880.93
455950-5595077.47777.87
555009-5500976.17476.55
655973-5597377.50977.88
45min160700-6070084.05583.231.8684.5883.751.87
261497-6149785.15885.70
361041-6104184.52785.06
459264-5926482.06682.59
558772-5877281.38581.89
659335-5933582.16482.67
60min162139-6213986.04785.231.7886.7185.891.78
263042-6304287.29887.98
362122-6212286.02486.70
460668-6066884.01084.67
560071-6007183.18483.82
661235-6123584.79685.44
90min163197-6319787.51287.841.6688.3288.641.66
265232-6523290.33091.16
363649-6364988.13888.96
462385-6238586.38887.18
562431-6243186.45287.23
663688-6368888.19288.97
120min164351-6435189.11088.901.4990.0789.851.49
265643-6564390.90091.88
363838-6383888.40089.37
463017-6301787.26388.20
563493-6349387.92288.84
664861-6486189.81790.75
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166311-6631191.82590.981.6592.9392.081.65
267268-6726893.15094.28
366164-6616491.62192.74
464583-6458389.43290.52
564510-6451089.33190.40
665363-6536390.51291.59
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.196608566108657916597465979659870.20
210.206581265635657240.20
单位质量响应值RSD%判断
6475.666443.530.36数据可信
供试品溶液-25041801批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min121043-2104329.22831.3411.5929.2331.3411.58
224097-2409733.47033.47
324866-2486634.53834.54
423659-2365932.86232.86
517927-1792724.90024.90
623774-2377433.02133.02
10min137493-3749352.07649.206.9152.1349.256.92
235311-3531149.04649.10
337927-3792752.67952.74
435066-3506648.70548.76
531045-3104543.12043.16
635673-3567349.54949.60
15min144655-4465562.02458.025.8862.1658.165.88
240888-4088856.79256.93
344095-4409561.24661.39
441862-4186258.14558.28
537847-3784752.56852.68
641305-4130557.37157.51
20min148573-4857367.46663.364.8167.7163.594.81
245016-4501662.52662.76
347438-4743865.89066.14
445118-4511862.66762.90
542265-4226558.70558.91
645277-4527762.88863.12
30min153070-5307073.71269.983.9074.0670.323.91
249517-4951768.77769.11
352139-5213972.41972.78
449753-4975369.10569.44
547590-4759066.10166.40
650242-5024269.78470.12
45min156958-5695879.11376.032.6879.5976.482.69
254022-5402275.03575.49
355529-5552977.12877.61
454569-5456975.79476.25
552595-5259573.05373.46
654743-5474376.03676.49
60min159444-5944482.56679.672.4483.1780.242.45
256403-5640378.34278.92
358351-5835181.04881.65
457096-5709679.30479.88
555510-5551077.10177.63
657333-5733379.63480.21
90min161646-6164685.62483.481.5386.3784.191.55
259276-5927682.33283.04
360478-6047884.00284.74
459543-5954382.70383.41
559301-5930182.36783.03
660357-6035783.83484.55
120min163221-6322187.81285.931.4888.7086.791.49
261299-6129985.14285.99
362330-6233086.57487.46
460762-6076284.39685.25
561258-6125885.08585.88
662339-6233986.58787.44
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163697-6369788.47386.451.4789.5187.451.49
261591-6159185.54886.53
362869-6286987.32388.35
461249-6124985.07386.06
561733-6173385.74586.68
662325-6232586.56787.57
多替诺雷片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D241101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(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.196593366085659856575766108659740.22
210.206508965500652940.45
单位质量响应值RSD%判断
6474.396401.370.81数据可信
供试品溶液-25041802批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min126626-2662637.10835.5912.8737.1135.5812.88
228130-2813039.20439.20
325712-2571235.83435.83
419778-1977827.56427.56
528834-2883440.18640.19
624123-2412333.62033.62
10min141550-4155057.90856.974.9457.9757.034.95
243071-4307160.02760.09
341044-4104457.20257.26
437593-3759352.39352.44
542468-4246859.18759.25
639549-3954955.11955.17
15min148963-4896368.23967.192.9068.4067.352.91
249627-4962769.16569.33
348104-4810467.04267.20
446497-4649764.80264.94
549490-4949068.97469.14
646601-4660164.94765.10
20min153011-5301173.88173.202.1074.1573.472.10
253886-5388675.10075.38
352300-5230072.89073.16
451852-5185272.26572.51
553268-5326874.23974.52
650826-5082670.83671.09
30min157146-5714679.64479.851.8280.0480.241.82
258331-5833181.29581.70
357863-5786380.64381.03
457713-5771380.43480.80
557354-5735479.93480.34
655337-5533777.12277.50
45min160135-6013583.80984.241.8684.3484.761.85
261331-6133185.47686.02
361450-6145085.64286.16
461240-6124085.34985.85
559941-5994183.53984.08
658569-5856981.62782.13
60min161656-6165685.92986.091.6286.6086.751.61
262428-6242887.00587.69
362428-6242887.00587.67
462714-6271487.40488.04
561357-6135785.51286.19
660034-6003483.66984.31
90min163356-6335688.29888.151.7189.1188.961.71
263892-6389289.04589.87
364165-6416589.42690.24
464097-6409789.33190.11
562608-6260887.25688.08
661391-6139185.56086.34
120min163825-6382588.95289.011.4889.9189.961.47
263931-6393189.10090.08
365135-6513590.77891.74
464564-6456489.98290.91
563281-6328188.19489.16
662462-6246287.05287.97
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164628-6462890.07190.001.1291.1891.101.12
264425-6442589.78890.91
365259-6525990.95192.06
465415-6541591.16892.25
564294-6429489.60690.72
663420-6342088.38889.45
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