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%
110.032982040298051329827252979036297737829803380.08
29.992987930298473629863330.08
单位质量响应值RSD%判断
297142.37298932.230.43数据可信
中间条件24月-供试品溶液-2023010811批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1400533-40053313.38511.0912.3813.3911.0912.39
2325910-32591010.89210.89
3356389-35638911.91011.91
4311171-31117110.39910.40
5313764-31376410.48610.49
6283566-2835669.4769.48
10min1924359-92435930.89127.227.8530.9127.247.85
2798647-79864726.69026.71
3849802-84980228.39928.42
4789104-78910426.37126.39
5784030-78403026.20126.22
6741974-74197424.79624.81
15min11385992-138599246.31841.696.2246.3841.756.22
21236049-123604941.30741.36
31271617-127161742.49642.56
41224716-122471640.92940.98
51209725-120972540.42840.48
61157059-115705938.66838.72
20min11791059-179105959.85554.335.6359.9954.455.63
21602911-160291153.56853.69
31645185-164518554.98055.10
41615181-161518153.97854.09
51582351-158235152.88053.00
61517921-151792150.72750.84
30min12329508-232950877.85073.283.6178.0873.483.62
22180506-218050672.87073.07
32195672-219567273.37773.58
42197980-219798073.45473.65
52168255-216825572.46172.66
62084533-208453369.66369.85
45min12748928-274892891.86689.372.1592.2189.682.16
22696593-269659390.11790.43
32689124-268912489.86890.18
42695642-269564290.08590.39
52628655-262865587.84788.15
62586836-258683686.44986.74
60min12891440-289144096.62996.101.2697.1196.541.27
22907203-290720397.15697.60
32891209-289120996.62197.07
42901954-290195496.98097.42
52844069-284406995.04695.48
62817887-281788794.17194.59
极限12937320-293732098.16298.391.4198.7998.981.41
22977978-297797899.521100.11
32978274-297827499.531100.13
42972724-297272499.34599.93
52924781-292478197.74398.32
62873598-287359896.03396.59
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%
110.032983803297904329755822975060297653329780040.13
29.992956708295719829569530.02
单位质量响应值RSD%判断
296909.67295991.290.22数据可信
中间条件24月-供试品溶液-2023010811批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1366549-36654912.31511.126.8712.3211.126.88
2333780-33378011.21411.21
3298271-29827110.02110.02
4337969-33796911.35511.35
5317333-31733310.66210.66
6332200-33220011.16111.16
10min1850381-85038128.57127.323.7528.5927.333.75
2818771-81877127.50927.53
3764315-76431525.67925.69
4833015-83301527.98728.00
5792899-79289926.64026.66
6818643-81864327.50427.52
15min11294407-129440743.48941.813.1543.5541.863.15
21247468-124746841.91241.97
31181354-118135439.69139.74
41274616-127461642.82442.88
51229984-122998441.32541.38
61238563-123856341.61341.67
20min11685744-168574456.63754.372.8056.7654.492.80
21626808-162680854.65754.78
31546170-154617051.94852.06
41630908-163090854.79554.92
51603495-160349553.87453.99
61616380-161638054.30654.43
30min12269927-226992776.26473.552.3476.4873.752.34
22190503-219050373.59673.80
32112703-211270370.98271.17
42204220-220422074.05674.26
52188581-218858173.53173.73
62168744-216874472.86573.07
45min12741041-274104192.09290.081.4892.4290.401.48
22691164-269116490.41790.73
32625025-262502588.19588.49
42682333-268233390.12090.44
52694421-269442190.52690.84
62653649-265364989.15689.47
60min12893389-289338997.21196.580.9797.6797.020.98
22898029-289802997.36797.82
32830524-283052495.09995.53
42871136-287113696.46396.91
52899550-289955097.41897.86
62854939-285493995.91996.36
极限12955400-295540099.29498.621.2899.9099.211.28
22963601-296360199.570100.16
32900930-290093097.46498.04
42888718-288871897.05497.65
52982966-2982966100.220100.81
62920240-292024098.11398.70
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%
110.032965407296573129640812965445296371329648750.04
29.992961625295952329605740.06
单位质量响应值RSD%判断
295600.70296353.750.18数据可信
中间条件24月-供试品溶液-2023011011批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1422598-42259814.22111.5611.4514.2211.5611.45
2319781-31978110.76110.76
3333864-33386411.23511.23
4329211-32921111.07811.08
5320058-32005810.77010.77
6335492-33549211.29011.29
10min1965280-96528032.48328.207.9232.5028.227.91
2784338-78433826.39426.41
3830394-83039427.94427.96
4831192-83119227.97127.99
5785431-78543126.43126.45
6832244-83224428.00628.02
15min11435704-143570448.31343.306.0148.3843.366.01
21229823-122982341.38541.44
31272371-127237142.81742.88
41282092-128209243.14443.20
51222469-122246941.13841.19
61278081-127808143.00943.07
20min11835908-183590861.78155.975.3861.9256.095.38
21596635-159663553.72953.85
31644158-164415855.32855.45
41655878-165587855.72255.85
51591157-159115753.54453.66
61655079-165507955.69655.82
30min12306085-230608577.60374.182.7477.8474.392.75
22155776-215577672.54572.74
32192544-219254473.78273.99
42216004-221600474.57174.78
52134620-213462071.83372.03
62221343-222134374.75174.96
45min12687460-268746090.43789.631.2290.7989.951.23
22639979-263997988.83989.15
32665019-266501989.68190.00
42676995-267699590.08490.40
52611880-261188087.89388.20
62699143-269914390.83091.15
60min12825872-282587295.09495.210.5895.5895.660.58
22821997-282199794.96495.40
32823497-282349795.01495.47
42837510-283751095.48695.94
52809638-280963894.54894.99
62857165-285716596.14796.60
极限12876478-287647896.79797.060.4797.4397.650.47
22871345-287134596.62497.21
32883161-288316197.02297.62
42892828-289282897.34797.94
52874468-287446896.73097.31
62906568-290656897.81098.41
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%
110.032958704295868929577652958662296090929589460.04
29.992965575296113429633540.11
单位质量响应值RSD%判断
295009.57296632.030.39数据可信
中间条件24月-供试品溶液-2023011011批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1395814-39581413.32711.658.7813.3311.658.79
2330714-33071411.13511.13
3330930-33093011.14211.14
4370459-37045912.47312.47
5316368-31636810.65210.65
6332206-33220611.18511.19
10min1843861-84386128.41228.095.1628.4328.105.17
2835701-83570128.13728.15
3804177-80417727.07627.09
4909346-90934630.61730.64
5783441-78344126.37826.39
6828729-82872927.90327.92
15min11332306-133230644.85843.402.8344.9243.472.83
21272326-127232642.83842.90
31268153-126815342.69842.76
41338946-133894645.08145.15
51256762-125676242.31442.37
61266342-126634242.63742.70
20min11674035-167403556.36455.632.9756.4955.762.97
21646581-164658155.43955.56
31619321-161932154.52154.64
41735436-173543658.43158.56
51593416-159341653.64953.77
61645173-164517355.39255.51
30min12218843-221884374.70774.151.7274.9274.361.73
22198373-219837374.01874.22
32172488-217248873.14673.35
42264147-226414776.23276.45
52156084-215608472.59472.79
62203842-220384274.20274.41
45min12656395-265639589.43989.520.7489.7789.840.74
22666066-266606689.76590.08
32645781-264578189.08289.39
42679649-267964990.22290.56
52628242-262824288.49188.80
62675884-267588490.09590.41
60min12807205-280720594.51794.930.3594.9895.380.35
22826485-282648595.16695.62
32819177-281917794.92095.37
42819055-281905594.91695.39
52810709-281070994.63595.08
62833659-283365995.40795.86
极限12885581-288558197.15597.791.6097.7698.391.59
22881812-288181297.02997.62
32887133-288713397.20897.80
42998371-2998371100.953101.56
52880040-288004096.96997.55
62894145-289414597.44498.04
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%
110.032962073296164029627622963317296329529626170.03
29.992972276297236629723210.01
单位质量响应值RSD%判断
295375.57297529.630.52数据可信
中间条件24月-供试品溶液-2023011111批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1299293-29929310.05610.629.5210.0610.629.52
2295159-2951599.9179.92
3338349-33834911.36811.37
4360232-36023212.10312.10
5279900-2799009.4049.40
6322858-32285810.84710.85
10min1746565-74656525.08326.026.1925.1026.036.19
2747012-74701225.09825.11
3847595-84759528.47728.49
4813385-81338527.32827.35
5719070-71907024.15924.17
6772399-77239925.95125.97
15min11157601-115760138.89340.275.1838.9540.335.18
21177763-117776339.57039.62
31306039-130603943.88043.94
41225805-122580541.18441.24
51129152-112915237.93737.99
61195618-119561840.17040.23
20min11528463-152846351.35352.664.4551.4652.774.45
21537606-153760651.66051.77
31689973-168997356.77956.90
41591655-159165553.47653.60
51488221-148822150.00150.11
61567416-156741652.66252.78
30min12099667-209966770.54471.663.2370.7371.863.23
22109473-210947370.87371.06
32255524-225552475.78075.99
42154795-215479572.39672.60
52052691-205269168.96669.15
62126002-212600271.42971.62
45min12599566-259956687.33987.801.4887.6388.101.49
22607475-260747587.60587.90
32684959-268495990.20990.53
42605147-260514787.52787.84
52568151-256815186.28486.57
62613791-261379187.81788.12
60min12814179-281417994.55094.350.6394.9794.780.64
22800036-280003694.07594.50
32841502-284150295.46895.93
42795082-279508293.90894.35
52798993-279899394.04094.45
62799703-279970394.06494.50
极限12898235-289823597.37496.720.6197.9497.290.61
22874188-287418896.56697.13
32900463-290046397.44998.05
42869658-286965896.41497.00
52874116-287411696.56497.12
62855409-285540995.93596.51
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%
110.032947540294730029432662946921294693929463930.06
29.992932764293266329327140.01
单位质量响应值RSD%判断
293758.03293564.960.05数据可信
中间条件24月-供试品溶液-2023011111批-pH4.5(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1295955-29595510.03810.797.7410.0410.797.75
2349936-34993611.86911.87
3307739-30773910.43710.44
4335396-33539611.37511.38
5287804-2878049.7619.76
6332180-33218011.26611.27
10min1730615-73061524.78026.165.3624.8026.185.35
2826004-82600428.01528.03
3747838-74783825.36425.38
4782623-78262326.54426.56
5730639-73063924.78124.80
6810515-81051527.49027.51
15min11163005-116300539.44540.614.1639.5040.674.16
21271241-127124143.11643.18
31165020-116502039.51439.57
41198362-119836240.64440.70
51145344-114534438.84638.90
61241682-124168242.11442.17
20min11524892-152489251.71952.993.2551.8353.103.25
21637385-163738555.53555.66
31528946-152894651.85751.97
41557936-155793652.84052.96
51514034-151403451.35151.46
61610679-161067954.62954.75
30min12103274-210327471.33672.262.3271.5272.452.33
22189643-218964374.26574.47
32081597-208159770.60170.79
42127205-212720572.14872.34
52088984-208898470.85171.04
62192293-219229374.35574.56
45min12581130-258113087.54388.170.9387.8488.470.94
22624341-262434189.00989.33
32580032-258003287.50687.80
42589199-258919987.81788.12
52587475-258747587.75888.05
62635443-263544389.38589.70
60min12794456-279445694.77894.970.4395.2195.400.43
22821963-282196395.71196.16
32788043-278804394.56194.99
42796672-279667294.85495.29
52795412-279541294.81195.24
62803467-280346795.08495.53
极限12880013-288001397.68097.340.2398.2597.920.23
22874044-287404497.47898.07
32861103-286110397.03997.61
42870292-287029297.35197.93
52865556-286555697.19097.76
62868948-286894897.30597.90
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