塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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100
标示量(mg)100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%
19.711449230144951414484061447177144726214483180.08
29.761450904145444514526740.18
单位质量响应值RSD%判断
149157.36148839.550.16数据可信
供试品溶液-23040N1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%
5min1180260-18026012.05012.7213.0212.0512.7213.02
2158253-15825310.57910.58
3198343-19834313.25913.26
4233089-23308915.58115.58
5186163-18616312.44412.44
6185345-18534512.39012.39
10min1462538-46253830.91932.9313.9230.9432.9513.92
2391400-39140026.16426.18
3530526-53052635.46435.48
4596623-59662339.88239.91
5482260-48226032.23732.26
6492623-49262332.93032.95
15min1722786-72278648.31651.7013.5048.3851.7713.50
2624232-62423241.72841.78
3798391-79839153.37053.44
4943338-94333863.05963.14
5783527-78352752.37652.44
6768386-76838651.36451.43
20min1946582-94658263.27667.3011.0263.4167.4511.02
2839739-83973956.13456.25
31033857-103385769.11069.26
41170687-117068778.25678.43
51054081-105408170.46270.61
6995931-99593166.57466.72
30min11252124-125212483.70084.885.2883.9385.125.30
21154691-115469177.18777.39
31266419-126641984.65684.91
41357300-135730090.73191.03
51291249-129124986.31586.57
61296588-129658886.67286.92
45min11414466-141446694.55293.211.5994.9193.581.59
21372045-137204591.71692.03
31383056-138305692.45292.84
41397396-139739693.41193.84
51373519-137351991.81592.20
61425657-142565795.30095.67
60min11430100-143010095.59794.361.2596.1094.881.25
21403784-140378493.83894.29
31400892-140089293.64594.17
41407368-140736894.07794.65
51391471-139147193.01593.53
61436275-143627596.01096.53
极限11456683-145668397.37496.801.2198.0297.461.21
21441027-144102796.32796.92
31440621-144062196.30096.96
41444606-144460696.56797.28
51427486-142748695.42296.08
61478342-147834298.82299.48
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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100
标示量(mg)100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%
19.712900108289907128965992896981289530628976130.07
29.762900115289638728982510.10
单位质量响应值RSD%判断
298415.35296951.950.35数据可信
供试品溶液-23003N1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%
5min1306069-30606910.24112.2112.4910.2412.2112.48
2315822-31582210.56710.57
3357134-35713411.94911.95
4400972-40097213.41613.42
5402344-40234413.46213.46
6406594-40659413.60413.60
10min1812609-81260927.18930.589.4327.2030.609.43
2822035-82203527.50427.52
3882016-88201629.51129.53
4975102-97510232.62532.65
5995193-99519333.29833.32
6997629-99762933.37933.40
15min11277422-127742242.74146.436.6542.8046.506.65
21288500-128850043.11143.17
31358623-135862345.45845.52
41459229-145922948.82448.89
51455092-145509248.68548.76
61487462-148746249.76849.84
20min11673519-167351955.99459.264.9856.1159.394.99
21668006-166800655.80955.93
31745529-174552958.40358.53
41856368-185636862.11162.25
51822890-182289060.99161.13
61860828-186082862.26162.41
30min12180678-218067872.96275.552.7373.1775.782.74
22193844-219384473.40373.61
32240623-224062374.96875.19
42313001-231300177.39077.63
52314686-231468677.44677.68
62305609-230560977.14277.38
45min12567683-256768385.91187.331.3686.2287.671.37
22580816-258081686.35086.67
32592718-259271886.74987.08
42630234-263023488.00488.36
52659890-265989088.99689.35
62629614-262961487.98388.34
60min12706645-270664590.56091.450.8091.0091.920.81
22725439-272543991.18991.63
32721430-272143091.05591.52
42743961-274396191.80992.29
52769602-276960292.66793.15
62733182-273318291.44891.93
极限12777883-277788392.94493.610.4793.5294.210.49
22790578-279057893.36993.95
32795617-279561793.53794.13
42806194-280619493.89194.51
52815595-281559594.20694.83
62800109-280010993.68894.31
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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100
标示量(mg)100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%
19.711453668145331814527741452335145150514527200.06
29.761447218144626314467400.05
单位质量响应值RSD%判断
149610.71148231.560.66数据可信
供试品溶液-23040N1批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1183587-18358712.27910.939.3612.2810.929.37
2152018-15201810.16710.17
3149711-14971110.01310.01
4172632-17263211.54611.55
5147943-1479439.8959.89
6174259-17425911.65511.65
10min1477417-47741731.93128.189.2031.9528.209.20
2413230-41323027.63827.65
3373083-37308324.95324.97
4456567-45656730.53630.55
5396292-39629226.50526.52
6411401-41140127.51627.53
15min1746136-74613649.90344.988.2549.9745.048.25
2672154-67215444.95545.01
3594474-59447439.76039.81
4724634-72463448.46548.53
5644697-64469743.11943.17
6653323-65332343.69643.75
20min1974292-97429265.16360.166.6365.3060.296.63
2905336-90533660.55160.68
3805806-80580653.89454.01
4950654-95065463.58263.72
5879862-87986258.84758.97
6880840-88084058.91359.04
30min11297613-129761386.78882.274.4787.0382.494.47
21241742-124174283.05183.27
31134714-113471475.89276.09
41263320-126332084.49484.73
51221499-122149981.69781.90
61221329-122132981.68681.90
45min11432705-143270595.82394.521.3796.1994.861.38
21418599-141859994.87995.22
31377042-137704292.10092.41
41413498-141349894.53894.90
51411994-141199494.43894.77
61425397-142539795.33495.67
60min11447682-144768296.82596.240.9997.3496.720.99
21445840-144584096.70197.18
31414274-141427494.59095.04
41429760-142976095.62696.13
51444676-144467696.62497.10
61451240-145124097.06397.54
极限11457708-145770897.49597.000.7698.1597.620.76
21458295-145829597.53498.16
31438537-143853796.21396.80
41434192-143419295.92296.57
51457228-145722897.46398.08
61455625-145562597.35697.98
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
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100
标示量(mg)100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%
19.712886075288387428851042886661288588828855200.04
29.762898750289864028986950.01
单位质量响应值RSD%判断
297169.93296997.440.05数据可信
供试品溶液-23003N1批-pH6.8(内含0.5%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1374518-37451812.55612.381.8512.5612.381.86
2359172-35917212.04212.04
3378464-37846412.68812.69
4366612-36661212.29112.29
5366173-36617312.27612.28
6370831-37083112.43212.43
10min1892416-89241629.91929.710.5829.9429.720.58
2877675-87767529.42529.44
3885303-88530329.68129.70
4889883-88988329.83429.85
5884485-88448529.65329.67
6886623-88662329.72529.74
15min11374738-137473846.08945.481.3946.1545.541.39
21342526-134252645.00945.07
31372886-137288646.02746.09
41371298-137129845.97446.04
51331207-133120744.63044.69
61346167-134616745.13145.19
20min11782001-178200159.74358.531.6559.8858.661.65
21732126-173212658.07158.20
31769809-176980959.33459.47
41758671-175867158.96159.09
51707140-170714057.23357.36
61725735-172573557.85757.99
30min12343418-234341878.56576.991.7778.7977.211.77
22277699-227769976.36276.58
32331327-233132778.16078.38
42320885-232088577.81078.03
52252401-225240175.51475.73
62252495-225249575.51775.73
45min12723775-272377591.31790.581.0591.6690.921.05
22685678-268567890.04090.37
32735765-273576591.71992.06
42720331-272033191.20291.54
52680369-268036989.86290.19
62665610-266561089.36789.70
60min12841675-284167595.27095.040.5095.7595.500.50
22817410-281741094.45694.92
32848418-284841895.49695.97
42847920-284792095.47995.95
52834809-283480995.04095.50
62817845-281784594.47194.94
极限12885320-288532096.73396.850.5497.3597.460.54
22867907-286790796.14996.76
32901929-290192997.29097.91
42903491-290349197.34297.96
52899839-289983997.22097.83
62873954-287395496.35296.96
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