塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.133068454303102230320043029079303002530381170.56
210.083039234304029030397620.03
单位质量响应值RSD%判断
299912.83301563.690.39数据可信
供试品溶液-22001N1批-pH1.0(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1354743-35474311.74913.838.2511.7513.848.26
2442235-44223514.64614.65
3454018-45401815.03715.04
4413582-41358213.69713.70
5418196-41819613.85013.85
6423357-42335714.02114.02
10min1896322-89632229.68533.195.9929.7133.215.99
21055880-105588034.96935.00
31064125-106412535.24235.27
4998223-99822333.06033.09
51003273-100327333.22733.25
6994313-99431332.93032.96
15min11383628-138362845.82449.163.8245.9149.253.82
21556415-155641551.54751.65
31507260-150726049.91950.02
41476815-147681548.91049.00
51494305-149430549.49049.58
61487299-148729949.25749.35
20min11771990-177199058.68661.612.7958.8661.812.80
21930887-193088763.94964.15
31862934-186293461.69861.90
41846955-184695561.16961.36
51870254-187025461.94062.13
61879507-187950762.24762.44
30min12277975-227797575.44477.751.8875.7478.071.89
22399121-239912179.45679.79
32348338-234833877.77478.10
42331266-233126677.20977.52
52338839-233883977.45977.78
62390772-239077279.17979.50
45min12631202-263120287.14288.431.0487.5888.901.05
22703090-270309089.52390.01
32679638-267963888.74689.23
42648561-264856187.71788.19
52663525-266352588.21388.68
62694563-269456389.24189.72
60min12744095-274409590.88191.610.7191.5092.260.72
22780455-278045592.08592.75
32775358-277535891.91692.57
42747531-274753190.99591.64
52757069-275706991.31191.96
62792691-279269192.49093.14
极限12796146-279614692.60593.360.6493.4094.190.65
22832478-283247893.80894.66
32828262-282826293.66894.51
42802308-280230892.80993.63
52813119-281311993.16794.00
62841409-284140994.10494.94
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.133029860302999430266063030567303521830304490.11
210.083032163302905730306100.08
单位质量响应值RSD%判断
299155.87300655.750.36数据可信
供试品溶液-22001N1批-pH4.5(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1405645-40564513.47213.598.9913.4713.598.99
2383951-38395112.75112.75
3373586-37358612.40712.41
4466683-46668315.49915.50
5440452-44045214.62814.63
6385478-38547812.80212.80
10min1956870-95687031.77831.454.6131.8131.474.62
2917633-91763330.47530.50
3888527-88852729.50929.53
41001337-100133733.25533.29
5989311-98931132.85632.88
6927506-92750630.80330.83
15min11432431-143243147.57246.503.1347.6646.593.13
21361789-136178945.22645.31
31341664-134166444.55844.64
41439652-143965247.81247.91
51442582-144258247.90948.00
61383649-138364945.95246.04
20min11821655-182165560.49859.052.8160.6859.232.81
21731469-173146957.50357.68
31711787-171178756.85057.02
41813923-181392360.24260.43
51827260-182726060.68460.88
61762437-176243758.53258.71
30min12351785-235178578.10476.651.9478.4176.951.94
22254732-225473274.88175.17
32254352-225435274.86875.16
42316921-231692176.94677.26
52354882-235488278.20778.52
62315475-231547576.89877.19
45min12717778-271777890.25989.781.0690.7290.231.07
22669306-266930688.64989.09
32674146-267414688.81089.25
42693032-269303289.43789.90
52737571-273757190.91691.39
62727587-272758790.58591.03
60min12848199-284819994.59094.140.6095.2394.770.60
22818825-281882593.61594.23
32826487-282648793.86994.48
42815422-281542293.50294.15
52841851-284185194.38095.03
62856829-285682994.87795.51
极限12890890-289089096.00895.800.5096.8496.620.50
22876771-287677195.53996.35
32883359-288335995.75896.56
42866256-286625695.19096.02
52882014-288201495.71496.55
62908896-290889696.60697.43
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号510141-202102对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200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%
110.133025296302460830264503031757302813130272480.10
210.083069052307142030702360.06
单位质量响应值RSD%判断
298839.88304586.901.35数据可信
供试品溶液-22001N1批-pH6.8(内含0.5%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1528204-52820417.43817.834.7517.4417.834.76
2498365-49836516.45316.45
3565708-56570818.67718.68
4537728-53772817.75317.75
5566950-56695018.71818.72
6543329-54332917.93817.94
10min11169687-116968738.61739.012.8738.6539.052.87
21127633-112763337.22837.26
31210716-121071639.97140.01
41184910-118491039.11939.15
51223310-122331040.38740.42
61173955-117395538.75738.79
15min11686040-168604055.66456.022.3655.7856.142.36
21629343-162934353.79253.90
31734508-173450857.26457.38
41704139-170413956.26156.37
51738956-173895657.41157.53
61688456-168845655.74355.86
20min12085087-208508768.83869.182.1069.0669.402.10
22022560-202256066.77466.99
32130557-213055770.33970.57
42100125-210012569.33469.56
52149056-214905670.95071.18
62084541-208454168.82069.04
30min12595401-259540185.68685.761.3186.0586.131.31
22537596-253759683.77784.13
32609726-260972686.15986.53
42607487-260748786.08586.45
52640882-264088287.18787.56
62595315-259531585.68386.05
45min12877773-287777395.00894.680.4095.5495.220.41
22851124-285112494.12894.64
32870237-287023794.75995.30
42867330-286733094.66395.20
52881447-288144795.12995.68
62859451-285945194.40394.94
60min12933165-293316596.83796.150.4397.5696.880.43
22906231-290623195.94896.65
32916106-291610696.27497.01
42898913-289891395.70696.43
52915935-291593596.26897.01
62903976-290397695.87396.60
极限12965308-296530897.89896.870.6498.8197.790.64
22929081-292908196.70297.60
32935727-293572796.92197.85
42907121-290712195.97796.89
52936640-293664096.95297.88
62931660-293166096.78797.70
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