拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205704665712655723185733275718305718410.19
211.265693935704595699260.14
单位质量响应值RSD%判断
51057.2350615.100.62数据可信
长期36月-供试品溶液-2022101711批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1535760-53576094.56895.881.2194.5795.881.21
2536239-53623994.65294.65
3543793-54379395.98695.99
4545642-54564296.31296.31
5544535-54453596.11796.12
6553270-55327097.65997.66
10min1548942-54894296.89599.041.6297.0599.201.62
2563269-56326999.42399.58
3559076-55907698.68398.84
4576697-576697101.794101.95
5557471-55747198.40098.56
6561168-56116899.05399.22
15min1551841-55184197.40699.441.7697.7399.761.75
2564936-56493699.718100.04
3561425-56142599.09899.42
4581404-581404102.625102.95
5558976-55897698.66698.99
6561627-56162799.13499.46
20min1553320-55332097.66799.591.7498.15100.081.73
2563673-56367399.49599.98
3562600-56260099.30599.80
4582439-582439102.807103.31
5559438-55943898.74799.24
6563923-56392399.539100.03
30min1555113-55511397.98499.791.7098.63100.451.70
2566206-56620699.942100.60
3560743-56074398.97899.63
4583280-583280102.956103.63
5561711-56171199.14899.80
6565056-56505699.739100.40
45min1555171-55517197.99499.741.6398.80100.561.63
2565270-56527099.777100.60
3562581-56258199.302100.12
4582357-582357102.793103.64
5561101-56110199.04199.86
6563942-56394299.542100.37
60min1555004-55500497.96599.401.4598.94100.391.45
2563930-56393099.540100.53
3559293-55929398.72299.71
4578439-578439102.101103.12
5558975-55897598.66699.65
6563244-56324499.419100.41
极限1556084-55608498.15599.421.6399.29100.571.63
2564678-56467899.672100.83
3559048-55904898.67899.83
4580546-580546102.473103.66
5556416-55641698.21499.36
6562628-56262899.310100.47
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205695195712175724565723205726085716240.23
211.265749125740615744860.11
单位质量响应值RSD%判断
51037.8651020.070.03数据可信
长期36月-供试品溶液-2022101811批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1546739-54673996.13998.151.5496.1498.151.54
2567324-56732499.75999.76
3564263-56426399.22199.22
4550498-55049896.80096.80
5555131-55513197.61597.61
6565180-56518099.38299.38
10min1554458-55445897.49799.631.1797.6699.791.17
2570620-570620100.339100.50
3569688-569688100.175100.34
4567418-56741899.77699.94
5564329-56432999.23299.40
6572878-572878100.736100.90
15min1554403-55440397.48799.661.1497.8199.991.15
2571953-571953100.573100.91
3570021-570021100.233100.57
4567916-56791699.863100.19
5565622-56562299.46099.79
6570716-570716100.355100.69
20min1551484-55148496.97499.321.2697.4699.821.26
2570863-570863100.381100.88
3568116-56811699.898100.40
4569004-569004100.054100.55
5562762-56276298.95799.45
6566813-56681399.669100.17
30min1553705-55370597.36499.471.1798.01100.131.17
2569494-569494100.141100.81
3567950-56795099.869100.53
4570439-570439100.307100.97
5562460-56246098.90499.56
6570083-570083100.244100.91
45min1550336-55033696.77299.191.3197.58100.021.31
2567769-56776999.837100.67
3566029-56602999.531100.36
4571610-571610100.513101.34
5562377-56237798.88999.71
6566554-56655499.624100.46
60min1549448-54944896.61699.041.3097.59100.031.29
2566588-56658899.630100.63
3566282-56628299.576100.57
4568624-56862499.988100.98
5560822-56082298.61699.60
6567544-56754499.798100.80
极限1547966-54796696.35598.871.4397.49100.021.42
2567131-56713199.725100.89
3564170-56417099.204100.37
4567934-56793499.866101.03
5557885-55788598.09999.25
6568399-56839999.948101.11
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.205722035721855711875734855730815724280.16
211.265731185731575731380.01
单位质量响应值RSD%判断
51109.6450900.360.30数据可信
长期36月-供试品溶液-2022101911批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1578923-578923101.84799.071.50101.8599.071.50
2556709-55670997.93997.94
3561771-56177198.82998.83
4562565-56256598.96998.97
5563650-56365099.16099.16
6555276-55527697.68797.69
10min1583146-583146102.590100.061.59102.76100.231.59
2559934-55993498.50698.67
3566554-56655499.67199.84
4573016-573016100.808100.97
5570989-570989100.451100.62
6559012-55901298.34498.51
15min1583967-583967102.734100.001.50103.07100.331.50
2560213-56021398.55598.88
3566119-56611999.59499.93
4570980-570980100.449100.78
5567092-56709299.765100.10
6562073-56207398.88399.21
20min1584198-584198102.775100.021.52103.29100.521.52
2560347-56034798.57999.07
3566325-56632599.631100.13
4570740-570740100.407100.91
5568097-56809799.942100.44
6561481-56148198.77899.27
30min1583179-583179102.59699.891.52103.28100.551.52
2559279-55927998.39199.05
3564999-56499999.397100.06
4571165-571165100.482101.15
5566457-56645799.654100.32
6561558-56155898.79299.45
45min1583077-583077102.57899.591.63103.43100.421.63
2557785-55778598.12898.95
3563990-56399099.220100.05
4566889-56688999.730100.56
5566532-56653299.667100.50
6558222-55822298.20599.03
60min1582639-582639102.50199.541.66103.53100.541.66
2556288-55628897.86598.85
3562864-56286499.022100.02
4568202-56820299.961100.96
5566143-56614399.599100.60
6558858-55885898.31799.30
极限1580914-580914102.19799.241.64103.39100.401.63
2554381-55438197.52998.68
3561165-56116598.72399.88
4564322-56432299.278100.45
5565648-56564899.511100.68
6558165-55816598.19599.34
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201131876113508711339041133232113407611336350.11
211.261136495113357311350340.19
单位质量响应值RSD%判断
101217.41100802.310.30数据可信
长期36月-供试品溶液-2022102011批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11123370-112337099.793100.081.5199.79100.081.51
21120687-112068799.55499.55
31115094-111509499.05799.06
41106311-110631198.27798.28
51148992-1148992102.069102.07
61145433-1145433101.753101.75
10min11139696-1139696101.243101.441.30101.41101.601.30
21130243-1130243100.403100.57
31129452-1129452100.333100.50
41131076-1131076100.477100.64
51161364-1161364103.168103.34
61159498-1159498103.002103.17
15min11136938-1136938100.998101.601.31101.33101.931.31
21134377-1134377100.770101.10
31133044-1133044100.652100.98
41131911-1131911100.551100.88
51163302-1163302103.340103.68
61162390-1162390103.259103.60
20min11137065-1137065101.009101.431.22101.51101.931.22
21133824-1133824100.721101.22
31129859-1129859100.369100.87
41131244-1131244100.492100.99
51161831-1161831103.209103.72
61156795-1156795102.762103.28
30min11129841-1129841100.367101.441.41101.04102.121.41
21135690-1135690100.887101.56
31131391-1131391100.505101.17
41129747-1129747100.359101.03
51162976-1162976103.311104.00
61161860-1161860103.212103.90
45min11133370-1133370100.681101.281.41101.52102.131.41
21130522-1130522100.428101.27
31128330-1128330100.233101.07
41127407-1127407100.151100.98
51161587-1161587103.188104.05
61159758-1159758103.025103.88
60min11121633-112163399.638100.891.40100.65101.901.40
21125674-112567499.997101.00
31126478-1126478100.069101.07
41128656-1128656100.262101.26
51153752-1153752102.492103.52
61158131-1158131102.881103.91
极限11129156-1129156100.307100.851.12101.48102.021.12
21126709-1126709100.089101.26
31124983-112498399.936101.10
41127668-1127668100.174101.34
51152177-1152177102.352103.55
61150625-1150625102.214103.41
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201139760113744111385431137616113833911383400.09
211.261140629113542611380280.33
单位质量响应值RSD%判断
101637.50101068.210.40数据可信
长期36月-供试品溶液-2022102111批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11115761-111576198.78298.941.6298.7898.941.62
21115432-111543298.75398.75
31088563-108856396.37496.37
41125590-112559099.65299.65
51144112-1144112101.292101.29
61115790-111579098.78498.78
10min11128017-112801799.86799.951.20100.03100.111.20
21129045-112904599.958100.12
31105265-110526597.85298.01
41145070-1145070101.376101.54
51138524-1138524100.797100.97
61127620-112762099.832100.00
15min11124282-112428299.53699.771.1099.87100.101.10
21130621-1130621100.097100.43
31105552-110555297.87898.20
41143483-1143483101.236101.57
51126988-112698899.776100.11
61130805-1130805100.114100.44
20min11125551-112555199.64899.751.21100.15100.251.21
21126053-112605399.693100.19
31102409-110240997.60098.09
41143668-1143668101.252101.76
51132610-1132610100.273100.78
61129648-1129648100.011100.51
30min11126665-112666599.74799.661.27100.41100.321.27
21129086-112908699.961100.63
31099754-109975497.36598.01
41143291-1143291101.219101.89
51129435-112943599.992100.66
61125878-112587899.677100.34
45min11115873-111587398.79299.301.1399.62100.121.13
21124740-112474099.577100.41
31100167-110016797.40198.21
41137169-1137169100.677101.52
51128450-112845099.905100.74
61122955-112295599.419100.25
60min11119496-111949699.11299.240.98100.11100.230.98
21122026-112202699.336100.33
31101598-110159897.52898.50
41134236-1134236100.417101.43
51127617-112761799.831100.83
61120415-112041599.194100.19
极限11114781-111478198.69598.941.1899.85100.101.18
21120912-112091299.238100.40
31093448-109344896.80697.94
41132492-1132492100.263101.44
51123743-112374399.488100.66
61119712-111971299.131100.29
拉莫三嗪片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)0
对照品批号100775-201902对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数200
标示量(mg)50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%
111.201139550114129911408961140646113983911404460.07
211.261137458113936911384140.12
单位质量响应值RSD%判断
101825.54101102.490.51数据可信
长期36月-供试品溶液-2022102211批-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11113235-111323598.45198.782.2698.4598.782.26
21151824-1151824101.863101.86
31092737-109273796.63896.64
41125825-112582599.56499.56
51084982-108498295.95295.95
61133243-1133243100.220100.22
10min11128458-112845899.797100.571.8499.96100.741.84
21168092-1168092103.302103.47
31112522-111252298.38798.55
41139289-1139289100.755100.92
51121193-112119399.15499.31
61153855-1153855102.043102.21
15min11125518-112551899.537100.631.8699.87100.961.86
21167249-1167249103.227103.57
31113969-111396998.51598.84
41140487-1140487100.861101.19
51122274-112227499.25099.58
61157529-1157529102.368102.70
20min11124163-112416399.417100.431.7999.91100.931.79
21164324-1164324102.969103.48
31111935-111193598.33698.82
41138369-1138369100.673101.18
51121548-112154899.18699.68
61153561-1153561102.017102.52
30min11122450-112245099.265100.391.8399.93101.061.82
21163738-1163738102.917103.60
31112025-111202598.34499.00
41136885-1136885100.542101.21
51120724-112072499.11399.77
61155434-1155434102.182102.86
45min11122487-112248799.269100.201.83100.10101.041.83
21163579-1163579102.903103.76
31108330-110833098.01798.83
41134102-1134102100.296101.13
51119626-111962699.01699.84
61150287-1150287101.727102.58
60min11121569-112156999.188100.161.81100.18101.171.81
21160241-1160241102.608103.64
31107876-110787697.97798.96
41134970-1134970100.373101.38
51118697-111869798.93499.92
61152236-1152236101.900102.92
极限11117406-111740698.81999.791.7899.98100.961.78
21156773-1156773102.301103.50
31105690-110569097.78398.93
41129746-112974699.911101.08
51113680-111368098.49099.64
61147226-1147226101.457102.64
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