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%
110.031519545151675915165641515561151560815168070.11
29.991519097151695215180240.10
单位质量响应值RSD%判断
151227.02151954.350.34数据可信
中间条件24月-供试品溶液-2023010711批-pH6.8(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%
5min1160927-16092710.57311.6214.9610.5711.6214.97
2153595-15359510.09210.09
3155598-15559810.22310.22
4170913-17091311.23011.23
5212842-21284213.98413.98
6207221-20722113.61513.62
10min1427888-42788828.11428.8011.3428.1328.8211.34
2386195-38619525.37425.39
3388735-38873525.54125.56
4432142-43214228.39328.41
5492981-49298132.39132.41
6501748-50174832.96732.99
15min1692384-69238445.49245.5910.4645.5545.6510.45
2613401-61340140.30340.36
3622228-62222840.88340.94
4683828-68382844.93044.99
5751690-75169049.38949.46
6799880-79988052.55552.62
20min1915724-91572460.16660.339.2860.2960.469.28
2831584-83158454.63854.75
3834413-83441354.82454.94
4904750-90475059.44559.57
5965361-96536163.42863.57
61057174-105717469.46069.61
30min11254921-125492182.45381.246.4382.6781.466.44
21157537-115753776.05476.25
31150019-115001975.56075.76
41221091-122109180.23080.45
51272116-127211683.58383.82
61362904-136290489.54889.80
45min11442874-144287494.80294.711.3095.1495.051.32
21427927-142792793.82094.13
31411589-141158992.74793.06
41449185-144918595.21795.55
51460964-146096495.99196.35
61456588-145658895.70396.09
60min11472826-147282696.77097.260.6197.2597.740.61
21488504-148850497.80098.25
31466154-146615496.33296.78
41487348-148734897.72498.20
51485218-148521897.58498.09
61481192-148119297.32097.85
极限11495971-149597198.29198.490.4498.9299.120.45
21497362-149736298.38298.98
31490168-149016897.90998.50
41509299-150929999.16699.79
51502546-150254698.72399.38
61498990-149899098.48999.17
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%
110.031516972151573115167061515039151550615159910.06
29.991511070150796615095180.15
单位质量响应值RSD%判断
151145.66151102.900.03数据可信
中间条件24月-供试品溶液-2023010711批-pH6.8(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%
5min1156549-15654910.31811.6310.9710.3211.6310.97
2163619-16361910.78310.78
3208671-20867113.75313.75
4183789-18378912.11312.11
5183162-18316212.07112.07
6163170-16317010.75410.75
10min1406305-40630526.77828.748.2126.7928.758.21
2409561-40956126.99327.01
3494542-49454232.59332.61
4459484-45948430.28330.30
5439165-43916528.94428.96
6407206-40720626.83726.85
15min1648857-64885742.76445.607.8742.8245.667.87
2649755-64975542.82342.88
3771737-77173750.86250.93
4746221-74622149.18049.24
5686043-68604345.21445.28
6649011-64901142.77442.83
20min1870007-87000757.33960.416.9957.4660.546.99
2865456-86545657.03957.16
31005709-100570966.28266.43
4988462-98846265.14665.28
5902021-90202159.44959.58
6867786-86778657.19257.31
30min11201462-120146279.18481.394.8779.3981.614.88
21181811-118181177.88878.09
31311645-131164586.44586.69
41310682-131068286.38286.62
51215816-121581680.13080.35
61188600-118860078.33678.54
45min11426386-142638694.00794.860.8694.3395.200.88
21426593-142659394.02194.34
31457369-145736996.04996.42
41449511-144951195.53295.90
51438854-143885494.82995.17
61437135-143713594.71695.04
60min11478126-147812697.41797.380.3397.8897.860.33
21475060-147506097.21597.68
31478487-147848797.44197.96
41477941-147794197.40597.91
51470458-147045896.91297.39
61485258-148525897.88798.35
极限11496247-149624798.61298.600.2499.2299.230.25
21492390-149239098.35798.97
31498753-149875398.77799.44
41495704-149570498.57699.23
51492202-149220298.34598.97
61501397-150139798.95199.56
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%
110.032972609297591429777292974947297333429749070.07
29.992963757296716129654590.09
单位质量响应值RSD%判断
296600.90296842.740.06数据可信
中间条件24月-供试品溶液-2023010811批-pH6.8(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%
5min1389374-38937413.07013.013.8913.0713.013.89
2381779-38177912.81512.82
3386232-38623212.96512.96
4375846-37584612.61612.62
5416444-41644413.97913.98
6376334-37633412.63212.63
10min1904134-90413430.34930.962.9830.3730.982.98
2917002-91700230.78130.80
3921899-92189930.94530.96
4907525-90752530.46330.48
5976773-97677332.78732.81
6907448-90744830.46030.48
15min11387767-138776746.58346.801.5446.6546.871.54
21389002-138900246.62446.69
31397871-139787146.92246.99
41377050-137705046.22346.29
51435465-143546548.18448.25
61379157-137915746.29446.36
20min11793490-179349060.20260.031.0560.3460.171.05
21782817-178281759.84359.98
31793255-179325560.19460.33
41762244-176224459.15359.29
51818455-181845561.04061.18
61780419-178041959.76359.90
30min12337515-233751578.46378.880.5978.6979.110.60
22352767-235276778.97579.20
32343353-234335378.65978.89
42341090-234109078.58378.81
52375929-237592979.75279.99
62349621-234962178.86979.09
45min12754554-275455492.46293.000.6292.8093.340.62
22803665-280366594.11094.45
32766127-276612792.85093.19
42763703-276370392.76993.11
52765281-276528192.82293.18
62770042-277004292.98193.32
60min12879802-287980296.66697.240.8397.1597.730.83
22936893-293689398.58299.07
32891940-289194097.07397.56
42911088-291108897.71698.20
52892049-289204997.07797.57
62869693-286969396.32696.81
极限12929929-292992998.34898.581.3298.9899.211.31
22993363-2993363100.478101.11
32938641-293864198.64199.27
42956885-295688599.25399.88
52925293-292529398.19398.83
62876176-287617696.54497.17
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%
110.032972564297133929689182968830296959129702480.06
29.992982017297798529800010.10
单位质量响应值RSD%判断
296136.39298298.400.52数据可信
中间条件24月-供试品溶液-2023010811批-pH6.8(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%
5min1380456-38045612.75012.962.3212.7512.962.31
2381369-38136912.78012.78
3395951-39595113.26913.27
4385111-38511112.90612.91
5399362-39936213.38313.38
6377475-37747512.65012.65
10min1906444-90644430.37630.891.8030.4030.901.80
2912339-91233930.57430.59
3942886-94288631.59731.62
4913824-91382430.62330.64
5942601-94260131.58831.61
6911795-91179530.55530.57
15min11382665-138266546.33546.710.8046.4046.780.80
21386480-138648046.46346.53
31404030-140403047.05147.12
41389976-138997646.58046.65
51411064-141106447.28747.35
61389144-138914446.55246.62
20min11786103-178610359.85559.840.6159.9959.980.61
21771907-177190759.37959.51
31793367-179336760.09860.24
41790526-179052660.00360.14
51798394-179839460.26660.40
61773812-177381259.44359.58
30min12338547-233854778.36878.360.3178.5978.590.31
22335589-233558978.26978.49
32351670-235167078.80779.04
42330459-233045978.09778.32
52338593-233859378.36978.60
62335784-233578478.27578.50
45min12764593-276459392.64592.520.4292.9992.860.42
22756373-275637392.37092.71
32755550-275555092.34292.69
42744574-274457491.97492.32
52778576-277857693.11493.46
62765540-276554092.67793.02
60min12908443-290844397.46696.970.5797.9597.450.56
22893923-289392396.97997.46
32872859-287285996.27396.76
42880156-288015696.51897.00
52915420-291542097.69998.19
62890411-289041196.86197.34
极限12951710-295171098.91698.320.6699.5498.940.66
22935038-293503898.35798.98
32906009-290600997.38498.01
42925986-292598698.05498.68
52959175-295917599.16699.80
62925432-292543298.03598.66
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