非布司他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241101对照品来源ZZ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%
110.907055870568706047058970651705940.06
210.997175771843718000.09
单位质量响应值RSD%判断
6476.516533.210.62数据可信
供试品溶液-6041601批-多替诺雷-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%
5min144378-4437861.21152.8612.9261.2152.8612.92
231354-3135443.24743.25
337340-3734051.50451.50
435470-3547048.92448.92
543599-4359960.13760.14
637789-3778952.12352.12
10min159661-5966182.29181.615.2382.3981.705.23
253214-5321473.39973.47
360465-6046583.40083.49
458794-5879481.09681.18
561573-6157384.92985.03
661276-6127684.51984.61
15min163464-6346487.53789.903.8987.7890.123.89
260971-6097184.09884.29
366200-6620091.31191.54
465544-6554490.40690.62
567305-6730592.83593.08
667570-6757093.20093.43
20min165444-6544490.26892.152.6090.6592.522.61
263984-6398488.25488.59
367359-6735992.90993.29
467551-6755193.17493.54
567967-6796793.74894.14
668542-6854294.54194.92
30min166539-6653991.77893.952.0692.3194.482.07
266140-6614091.22891.71
368885-6888595.01495.55
468700-6870094.75995.28
569104-6910495.31695.87
669333-6933395.63296.17
45min167074-6707492.51694.791.9393.2095.471.94
267156-6715692.62993.26
368988-6898895.15695.85
469211-6921195.46496.14
569602-6960296.00396.71
670304-7030496.97297.67
60min167424-6742492.99995.271.9493.8496.121.95
267552-6755293.17693.96
369270-6927095.54596.39
469511-6951195.87896.72
569861-6986196.36097.23
670821-7082197.68598.55
极限167955-6795593.73296.291.5494.7397.301.54
269392-6939295.71496.66
369937-6993796.46597.47
470017-7001796.57697.58
570529-7052997.28298.31
671046-7104697.99599.02
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.865308275309225305735309845307945308200.03
211.105431725433115432420.02
单位质量响应值RSD%判断
48878.4548940.720.10数据可信
供试品溶液-6041601批-非布司他-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%
5min1391860-39186072.03562.8012.4772.0462.8012.47
2280905-28090551.63951.64
3337655-33765562.07162.07
4314870-31487057.88257.88
5387427-38742771.22071.22
6336884-33688461.92961.93
10min1484116-48411688.99588.904.8789.1189.014.88
2439202-43920280.73880.82
3497496-49749691.45491.56
4479948-47994888.22888.32
5503618-50361892.58092.70
6497367-49736791.43191.53
15min1503918-50391892.63594.612.6392.9094.862.64
2492910-49291090.61190.83
3521562-52156295.87896.13
4516916-51691695.02495.27
5525534-52553496.60896.88
6527059-52705996.88997.14
20min1512355-51235594.18696.152.0194.6196.562.01
2507949-50794993.37693.75
3527517-52751796.97397.39
4525543-52554396.61097.01
5533265-53326598.03098.46
6531688-53168897.74098.16
30min1517899-51789995.20597.291.6195.7897.861.62
2519661-51966195.52996.06
3532702-53270297.92698.50
4530872-53087297.59098.15
5538245-53824598.94599.54
6536005-53600598.53399.11
45min1520119-52011995.61397.921.5496.3598.651.54
2525800-52580096.65797.34
3534810-53481098.31499.05
4534505-53450598.25898.98
5541598-54159899.561100.32
6539063-53906399.09599.84
60min1521176-52117695.80798.141.4696.7199.041.46
2529027-52902797.25198.10
3535529-53552998.44699.35
4535308-53530898.40599.29
5543164-54316499.849100.78
6539069-53906999.097100.01
极限1520666-52066695.71498.361.4896.7799.421.47
2537889-53788998.88099.89
3535682-53568298.47499.54
4533448-53344898.06399.12
5543976-54397699.999101.09
6538611-53861199.012100.09
非布司他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241101对照品来源ZZ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%
110.907214072119722757212072201721710.10
210.997317073077731240.09
单位质量响应值RSD%判断
6621.196653.690.35数据可信
供试品溶液-6042201批-多替诺雷-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%
5min144368-4436859.97460.136.8659.9760.126.86
241894-4189456.63056.63
339896-3989653.92953.93
447637-4763764.39364.39
546910-4691063.41163.41
646175-4617562.41762.42
10min161500-6150083.13383.280.6883.2383.380.69
261424-6142483.03083.12
361235-6123582.77482.86
462421-6242184.37884.48
561453-6145383.06983.17
661643-6164383.32683.43
15min165482-6548288.51588.510.3288.7588.740.33
265548-6554888.60488.84
365539-6553988.59288.82
465752-6575288.88089.13
565116-6511688.02188.26
665411-6541188.41988.66
20min166891-6689190.42090.390.5090.8190.780.49
266965-6696590.52090.90
367066-6706690.65691.03
467249-6724990.90491.30
566293-6629389.61290.00
666756-6675690.23790.63
30min168061-6806192.00191.480.6392.5492.020.62
268086-6808692.03592.57
367881-6788191.75892.28
467643-6764391.43691.98
567002-6700290.57091.11
667386-6738691.08991.63
45min168687-6868792.84891.990.6993.5492.680.69
268328-6832892.36293.05
368173-6817392.15392.83
468087-6808792.03792.74
567389-6738991.09391.78
667657-6765791.45592.15
60min168985-6898593.25092.590.6694.1093.430.66
268792-6879292.99093.83
368721-6872192.89493.73
468586-6858692.71193.56
567847-6784791.71292.56
668045-6804591.98092.82
极限169325-6932593.71093.230.5794.7194.230.57
268819-6881993.02694.02
369117-6911793.42994.42
469275-6927593.64294.65
568265-6826592.27793.27
669030-6903093.31194.31
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.865429275432575433895433485429915431820.04
211.105526745515415521080.15
单位质量响应值RSD%判断
50016.7649739.460.40数据可信
供试品溶液-6042201批-非布司他-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%
5min1381107-38110768.69969.006.8468.7069.006.84
2360070-36007064.90764.91
3343621-34362161.94161.94
4407036-40703673.37373.37
5404882-40488272.98472.98
6399949-39994972.09572.10
10min1488603-48860388.07688.290.4888.1988.410.48
2489480-48948088.23488.34
3487703-48770387.91488.02
4493487-49348788.95689.08
5487915-48791587.95288.07
6491668-49166888.62888.75
15min1509177-50917791.78591.810.4392.0592.070.43
2508695-50869591.69891.95
3509476-50947691.83992.09
4509526-50952691.84892.12
5506042-50604291.22091.49
6512855-51285592.44892.72
20min1515949-51594993.00593.210.3393.4293.620.33
2516921-51692193.18193.59
3517389-51738993.26593.67
4516133-51613393.03993.46
5515780-51578092.97593.40
6520294-52029493.78994.21
30min1519446-51944693.63693.930.4694.2194.500.46
2519492-51949293.64494.21
3520536-52053693.83294.39
4520155-52015593.76494.34
5520916-52091693.90194.48
6525773-52577394.77695.35
45min1520724-52072493.86694.320.4494.5995.050.44
2522100-52210094.11494.83
3523711-52371194.40595.12
4522564-52256494.19894.93
5523069-52306994.28995.02
6527410-52741095.07195.81
60min1519321-51932193.61394.410.6594.5095.290.65
2520891-52089193.89694.77
3525416-52541694.71295.58
4524473-52447394.54295.43
5523480-52348094.36395.25
6528854-52885495.33296.23
极限1519065-51906593.56794.320.8094.6095.360.80
2518408-51840893.44994.48
3524759-52475994.59395.62
4524147-52414794.48395.53
5523249-52324994.32195.37
6529820-52982095.50696.56
非布司他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241101对照品来源ZZ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%
110.907317273186731927316273118731660.05
210.997278272927728540.15
单位质量响应值RSD%判断
6712.486629.120.89数据可信
供试品溶液-6042401批-多替诺雷-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%
5min137859-3785950.92254.2710.6450.9254.2710.64
240810-4081054.89154.89
342967-4296757.79257.79
444166-4416659.40559.40
532923-3292344.28344.28
643364-4336458.32658.33
10min160586-6058681.49082.782.3181.5882.882.32
261428-6142882.62382.71
362921-6292184.63184.73
462421-6242183.95884.06
559264-5926479.71279.79
662664-6266484.28584.38
15min166458-6645889.38889.570.3689.6189.800.37
266671-6667189.67589.90
366938-6693890.03490.27
466583-6658389.55689.80
566233-6623389.08689.29
666676-6667689.68189.92
20min167584-6758490.90391.740.5591.2792.120.55
268711-6871192.41992.80
368317-6831791.88992.28
468079-6807991.56991.96
568345-6834591.92692.28
668205-6820591.73892.13
30min168563-6856392.22093.240.9092.7493.780.90
270102-7010294.29094.82
369846-6984693.94594.49
469406-6940693.35393.89
569397-6939793.34193.85
668638-6863892.32092.86
45min169068-6906892.89993.690.7993.5794.370.79
270540-7054094.87995.57
369573-6957393.57894.28
469333-6933393.25593.95
570063-7006394.23794.90
669341-6934193.26693.96
60min169552-6955293.55094.130.7394.3894.970.72
270907-7090795.37296.22
369790-6979093.87094.72
469685-6968593.72994.58
570225-7022594.45595.28
669725-6972593.78394.63
极限170026-7002694.18794.860.6395.1795.860.63
271251-7125195.83596.84
370674-7067495.05996.07
470244-7024494.48195.49
570710-7071095.10796.09
670260-7026094.50295.51
非布司他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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.865551675551145541765548025537655546050.12
211.105556135560455558290.06
单位质量响应值RSD%判断
51068.6050074.681.39数据可信
供试品溶液-6042401批-非布司他-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%
5min1326267-32626758.01261.5510.0458.0161.5510.04
2351364-35136462.47462.47
3366307-36630765.13165.13
4378031-37803167.21667.22
5285732-28573250.80450.80
6369331-36933165.66965.67
10min1488669-48866986.88887.551.3086.9887.661.31
2494145-49414587.86187.97
3498029-49802988.55288.66
4495497-49549788.10288.21
5481290-48129085.57685.66
6496888-49688888.34988.46
15min1526600-52660093.63292.920.8293.8793.170.81
2528491-52849193.96894.22
3522206-52220692.85193.11
4519848-51984892.43192.69
5521415-52141592.71092.94
6517123-51712391.94792.20
20min1529393-52939394.12894.330.8894.5394.730.87
2536297-53629795.35695.76
3531253-53125394.45994.87
4527902-52790293.86394.28
5534705-53470595.07395.45
6523549-52354993.08993.50
30min1535960-53596095.29695.841.3595.8596.401.34
2546738-54673897.21397.78
3545655-54565597.02097.59
4538454-53845495.74096.31
5540331-54033196.07396.61
6526827-52682793.67294.24
45min1537972-53797295.65495.911.3096.3796.631.29
2549076-54907697.62898.36
3540999-54099996.19296.92
4535875-53587595.28196.01
5543787-54378796.68897.39
6528743-52874394.01394.73
60min1538857-53885795.81196.031.5196.6896.911.50
2552913-55291398.31099.20
3541293-54129396.24497.13
4536212-53621295.34196.23
5542987-54298796.54697.41
6528194-52819493.91594.79
极限1539033-53903395.84395.841.3996.8796.881.38
2549532-54953297.70998.76
3540927-54092796.17997.23
4534670-53467095.06796.11
5542555-54255596.46997.49
6527464-52746493.78694.82
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