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%
111.325810595806695821855823955820635816740.14
211.305818935814435816680.06
单位质量响应值RSD%判断
51384.6351475.040.13数据可信
长期24月-供试品溶液-XU4U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%
5min1504929-50492988.09591.203.5888.1091.203.57
2535152-53515293.36893.37
3500748-50074887.36687.37
4549146-54914695.81095.81
5516509-51650990.11690.12
6529857-52985792.44592.44
10min1573163-573163100.00096.892.91100.1597.042.90
2566163-56616398.77998.93
3537985-53798593.86394.01
4563659-56365998.34298.50
5533245-53324593.03693.19
6557865-55786597.33197.49
15min1580199-580199101.22897.962.91101.5498.282.91
2572737-57273799.926100.25
3544554-54455495.00995.31
4567735-56773599.05399.38
5538793-53879394.00494.31
6564914-56491498.56198.88
20min1580452-580452101.27298.042.91101.7598.522.91
2573445-573445100.049100.54
3545430-54543095.16295.62
4568089-56808999.11599.60
5538808-53880894.00694.47
6565355-56535598.63899.12
30min1581678-581678101.48698.262.83102.1498.902.83
2573709-573709100.095100.75
3547544-54754495.53096.15
4569112-56911299.29399.95
5540401-54040194.28494.90
6566854-56685498.89999.54
45min1580800-580800101.33398.052.88102.1598.862.88
2573263-573263100.018100.84
3546093-54609395.27796.06
4567100-56710098.94299.76
5538925-53892594.02794.80
6565751-56575198.70799.52
60min1584222-584222101.93097.933.08102.9298.903.07
2571594-57159499.726100.71
3545422-54542295.16096.10
4565724-56572498.70299.69
5537281-53728193.74094.67
6563683-56368398.34699.32
极限1577670-577670100.78797.592.88101.9598.722.88
2571303-57130399.676100.83
3543088-54308894.75395.85
4564582-56458298.50399.65
5536783-53678393.65394.74
6562643-56264398.16599.30
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%
111.325818385820835809575814995819375816630.08
211.305814585820755817660.08
单位质量响应值RSD%判断
51383.6651483.720.14数据可信
中间条件24月-供试品溶液-XU4U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%
5min1536598-53659893.61492.961.7193.6192.961.71
2524039-52403991.42391.42
3528338-52833892.17392.17
4522713-52271391.19191.19
5543955-54395594.89794.90
6541344-54134494.44294.44
10min1570265-57026599.48798.733.6899.6498.893.67
2538579-53857993.95994.11
3558700-55870097.47097.62
4556347-55634797.05997.21
5600901-600901104.832104.99
6570850-57085099.58999.75
15min1574215-574215100.17699.613.59100.5099.933.59
2543913-54391394.89095.20
3566191-56619198.77699.09
4561586-56158697.97398.29
5606118-606118105.742106.07
6573914-573914100.124100.45
20min1573560-573560100.06299.703.59100.55100.183.59
2544079-54407994.91995.39
3567322-56732298.97499.45
4563271-56327198.26798.74
5606933-606933105.884106.39
6573635-573635100.075100.57
30min1573590-573590100.06799.893.54100.72100.543.54
2545061-54506195.09095.72
3569359-56935999.32999.97
4565244-56524498.61199.25
5607489-607489105.981106.67
6574827-574827100.283100.94
45min1573072-57307299.97799.813.43100.80100.633.43
2544521-54452194.99695.78
3568347-56834799.15399.96
4567177-56717798.94899.75
5605493-605493105.633106.50
6574048-574048100.147100.97
60min1576493-576493100.57499.733.48101.56100.723.47
2543998-54399894.90595.85
3567630-56763099.027100.00
4563898-56389898.37699.35
5604859-604859105.522106.56
6573200-57320099.999100.99
极限1569875-56987599.41999.303.43100.58100.453.43
2543352-54335294.79295.89
3566821-56682198.886100.03
4561680-56168097.98999.12
5603340-603340105.257106.47
6570130-57013099.464100.62
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%
111.321157764115922911582561159229115870411586360.06
211.301155547115419411548700.09
单位质量响应值RSD%判断
102353.00102200.880.11数据可信
长期24月-供试品溶液-9J3E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%
5min11113630-111363097.70196.890.9897.7096.890.98
21098764-109876496.39796.40
31111119-111111997.48197.48
41111905-111190597.55097.55
51105643-110564397.00197.00
61085469-108546995.23195.23
10min11131243-113124399.24798.751.0799.4198.911.07
21119776-111977698.24198.40
31130698-113069899.19999.36
41140156-1140156100.029100.19
51126292-112629298.81298.97
61105274-110527496.96897.13
15min11134776-113477699.55799.080.9599.8899.400.95
21123116-112311698.53498.86
31134286-113428699.51499.84
41141258-1141258100.125100.45
51131161-113116199.24099.57
61111265-111126597.49497.81
20min11134360-113436099.52098.991.14100.0199.481.14
21121880-112188098.42598.91
31133827-113382799.47399.97
41144531-1144531100.412100.91
51128282-112828298.98799.48
61107009-110700997.12197.60
30min11131846-113184699.30098.811.0699.9699.461.05
21117445-111744598.03698.69
31133036-113303699.404100.06
41139949-1139949100.010100.67
51127916-112791698.95599.61
61107436-110743697.15897.80
45min11130263-113026399.16198.621.0499.9999.441.04
21117522-111752298.04398.86
31129022-112902299.05299.88
41137746-113774699.817100.65
51125578-112557898.75099.57
61104368-110436896.88997.70
60min11129355-112935599.08198.371.06100.0799.351.05
21112544-111254497.60698.59
31128096-112809698.97199.96
41133960-113396099.485100.48
51120572-112057298.31199.30
61102691-110269196.74297.71
极限11126728-112672898.85198.261.00100.0199.411.00
21111868-111186897.54798.69
31126013-112601398.78899.94
41133231-113323199.421100.58
51119650-111965098.23099.38
61102736-110273696.74697.88
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%
111.321155472115393711547331153315115429711543510.08
211.301155444115286011541520.16
单位质量响应值RSD%判断
101974.47102137.350.12数据可信
中间条件24月-供试品溶液-9J3E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%
5min11105562-110556297.20497.181.1397.2097.181.13
21121260-112126098.58498.58
31103333-110333397.00897.01
41091326-109132695.95295.95
51117993-111799398.29798.30
61092504-109250496.05696.06
10min11122490-112249098.69298.800.8898.8598.960.88
21135762-113576299.859100.02
31129744-112974499.33099.49
41110903-111090397.67397.83
51129605-112960599.31899.48
61113632-111363297.91398.07
15min11126071-112607199.00799.010.8999.3399.330.89
21139379-1139379100.177100.51
31128704-112870499.23899.57
41112853-111285397.84598.17
51132835-113283599.60299.93
61116524-111652498.16898.49
20min11124628-112462898.88098.810.9099.3799.300.90
21137588-1137588100.020100.52
31126216-112621699.02099.51
41110647-111064797.65198.14
51129996-112999699.35299.85
61113804-111380497.92898.42
30min11122717-112271798.71298.620.8399.3799.280.83
21134679-113467999.764100.43
31123449-112344998.77699.43
41108620-110862097.47398.12
51126662-112666299.05999.72
61113791-111379197.92798.58
45min11126541-112654199.04898.560.9899.8799.380.98
21133208-113320899.634100.47
31121634-112163498.61799.44
41106902-110690297.32298.13
51128944-112894499.260100.09
61108480-110848097.46098.27
60min11115645-111564598.09098.200.9299.0899.180.92
21130778-113077899.421100.42
31119107-111910798.39599.38
41104110-110411097.07698.05
51124859-112485998.90099.89
61106828-110682897.31598.29
极限11114637-111463798.00297.870.8699.1599.020.86
21126580-112658099.052100.21
31114263-111426397.96999.12
41099441-109944196.66697.80
51118194-111819498.31499.47
61105851-110585197.22998.37
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