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%
111.055851075852605853745851355850935851940.03
211.145855955844795850370.14
单位质量响应值RSD%判断
52958.7352516.790.60数据可信
中间条件24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%
5min1557245-55724594.81395.872.1794.8195.872.17
2586493-58649399.79099.79
3567213-56721396.50996.51
4556381-55638194.66694.67
5553519-55351994.17994.18
6559723-55972395.23595.24
10min1574868-57486897.81298.511.8997.9798.671.89
2599319-599319101.972102.14
3583259-58325999.24099.40
4574658-57465897.77697.93
5571470-57147097.23497.39
6570420-57042097.05597.21
15min1575041-57504197.84198.571.9998.1698.901.99
2600848-600848102.232102.57
3582785-58278599.15999.49
4575867-57586797.98298.30
5572574-57257497.42297.74
6568982-56898296.81097.13
20min1575391-57539197.90198.481.9998.3998.962.00
2599781-599781102.051102.56
3582988-58298899.19499.69
4575080-57508097.84898.33
5572326-57232697.37997.86
6567049-56704996.48296.96
30min1573420-57342097.56698.301.9398.2198.961.93
2598429-598429101.821102.50
3581335-58133598.91299.57
4574572-57457297.76298.41
5571692-57169297.27297.92
6567119-56711996.49397.14
45min1573304-57330497.54698.221.9198.3699.041.91
2597567-597567101.674102.52
3580468-58046898.76599.59
4574387-57438797.73098.54
5571925-57192597.31198.12
6565854-56585496.27897.08
60min1573312-57331297.54798.041.8998.5299.021.89
2596086-596086101.422102.44
3578443-57844398.42099.41
4573538-57353897.58698.56
5571982-57198297.32198.29
6563803-56380395.92996.89
极限1572425-57242597.39697.961.8998.5399.101.89
2595677-595677101.352102.54
3578035-57803598.35199.50
4572946-57294697.48598.62
5571815-57181597.29298.42
6563501-56350195.87897.00
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%
111.055852145845325851575852665847855849910.06
211.145831215838265834740.09
单位质量响应值RSD%判断
52940.3652376.480.76数据可信
中间条件24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%
5min1571810-57181097.43997.191.0997.4497.191.09
2572331-57233197.52897.53
3567922-56792296.77796.78
4572037-57203797.47897.48
5578220-57822098.53298.53
6559600-55960095.35995.36
10min1574226-57422697.85198.051.0598.0198.211.05
2575669-57566998.09798.26
3579536-57953698.75698.92
4577870-57787098.47298.63
5580800-58080098.97199.14
6564177-56417796.13996.30
15min1574733-57473397.93797.961.0698.2698.291.06
2574686-57468697.92998.26
3579007-57900798.66698.99
4577335-57733598.38198.71
5580194-58019498.86899.20
6563325-56332595.99396.31
20min1573866-57386697.79097.901.0998.2898.391.08
2575371-57537198.04698.54
3578355-57835598.55599.04
4576760-57676098.28398.77
5580098-58009898.85299.35
6562646-56264695.87896.36
30min1572483-57248397.55497.631.1098.2198.281.10
2572240-57224097.51398.17
3577174-57717498.35399.01
4575419-57541998.05498.71
5578979-57897998.66199.32
6561257-56125795.64196.28
45min1570493-57049397.21597.600.9798.0398.410.97
2572380-57238097.53698.35
3576568-57656898.25099.07
4575071-57507197.99598.81
5578780-57878098.62799.45
6563207-56320795.97396.77
60min1569669-56966997.07497.351.0798.0598.331.07
2571520-57152097.39098.37
3573439-57343997.71798.70
4573966-57396697.80798.79
5578738-57873898.62099.61
6560491-56049195.51096.47
极限1569732-56973297.08597.201.0998.2298.341.09
2570995-57099597.30098.44
3573458-57345897.72098.87
4572485-57248597.55498.70
5576970-57697098.31999.47
6558789-55878995.22096.34
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%
111.055828095818335823105832825828235826110.10
211.145838295839475838880.02
单位质量响应值RSD%判断
52724.9852413.640.42数据可信
中间条件24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%
5min1585104-58510499.87298.630.9599.8798.630.95
2580498-58049899.08599.09
3579032-57903298.83598.84
4570028-57002897.29897.30
5572884-57288497.78697.79
6579433-57943398.90498.90
10min1593774-593774101.35299.521.28101.5299.691.28
2584825-58482599.82499.99
3583791-58379199.64899.81
4571928-57192897.62397.78
5577971-57797198.65498.82
6586051-586051100.033100.20
15min1592927-592927101.20799.501.25101.5499.831.25
2585560-58556099.949100.28
3583528-58352899.60399.93
4571757-57175797.59397.92
5578089-57808998.67499.00
6585690-58569099.972100.30
20min1590698-590698100.82699.301.16101.3399.801.16
2582530-58253099.43299.93
3583954-58395499.675100.17
4571548-57154897.55898.05
5576737-57673798.44398.94
6585106-58510699.872100.37
30min1588762-588762100.49699.021.16101.1799.681.16
2581348-58134899.23199.89
3581962-58196299.335100.00
4569418-56941897.19497.84
5575837-57583798.29098.95
6583329-58332999.569100.23
45min1586703-586703100.14598.781.23100.9899.611.23
2580093-58009399.01699.85
3581206-58120699.206100.03
4567689-56768996.89997.71
5572984-57298497.80398.62
6583652-58365299.624100.45
60min1585283-58528399.90298.531.14100.9199.521.14
2578649-57864998.77099.76
3579160-57916098.85799.85
4567344-56734496.84097.81
5571833-57183397.60698.59
6581277-58127799.218100.22
极限1585269-58526999.90098.251.19101.0799.411.19
2576950-57695098.48099.64
3577808-57780898.62699.78
4565717-56571796.56297.70
5570123-57012397.31598.46
6577873-57787398.63799.80
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%
111.051167005116661611670301167092116687111669230.02
211.141165514116615311658340.04
单位质量响应值RSD%判断
105603.89104652.960.64数据可信
中间条件24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%
5min11173242-1173242100.14199.380.71100.1499.380.71
21171393-117139399.98499.98
31162484-116248499.22399.22
41161512-116151299.14099.14
51150613-115061398.21098.21
61166831-116683199.59499.59
10min11179898-1179898100.710100.090.97100.88100.250.97
21178989-1178989100.632100.80
31175959-1175959100.373100.54
41176890-1176890100.453100.62
51149886-114988698.14898.31
61173996-1173996100.206100.37
15min11180855-1180855100.791100.040.87101.13100.370.86
21175875-1175875100.366100.70
31175179-1175179100.307100.64
41174754-1174754100.271100.60
51152112-115211298.33898.67
61173405-1173405100.155100.49
20min11175904-1175904100.36999.780.90100.87100.280.90
21173435-1173435100.158100.66
31174851-1174851100.279100.78
41171317-117131799.977100.48
51148135-114813597.99898.49
61170332-117033299.893100.39
30min11178689-1178689100.60699.760.92101.28100.430.92
21170518-117051899.909100.58
31172557-1172557100.083100.75
41171323-117132399.978100.64
51147795-114779597.96998.62
61172079-1172079100.042100.71
45min11172907-1172907100.11399.510.91100.95100.350.90
21171494-117149499.992100.83
31170481-117048199.906100.74
41166253-116625399.545100.38
51144975-114497597.72998.55
61169259-116925999.802100.63
60min11167418-116741899.64499.210.79100.65100.200.79
21166672-116667299.581100.58
31164835-116483599.424100.42
41165499-116549999.481100.48
51143770-114377097.62698.61
61165613-116561399.490100.49
极限11167510-116751099.65299.020.79100.82100.190.80
21164484-116448499.394100.56
31163022-116302299.269100.44
41159798-115979898.994100.16
51142177-114217797.49098.63
61163861-116386199.341100.51
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%
111.051162714116364511631641163113116294711631170.03
211.141164612116404611643290.04
单位质量响应值RSD%判断
105259.46104517.860.50数据可信
中间条件24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%
5min11133468-113346896.96798.601.3596.9798.601.35
21174434-1174434100.472100.47
31159440-115944099.18999.19
41158397-115839799.10099.10
51136065-113606597.18997.19
61153705-115370598.69898.70
10min11145527-114552797.99999.351.5598.1699.521.55
21188809-1188809101.701101.87
31168565-116856599.969100.13
41165969-116596999.74799.91
51138434-113843497.39297.55
61160892-116089299.31399.48
15min11139341-113934197.46999.311.5997.7999.641.59
21189543-1189543101.764102.10
31169990-1169990100.091100.42
41164651-116465199.63599.97
51143827-114382797.85398.18
61157624-115762499.03399.36
20min11138456-113845697.39499.151.6197.8899.651.61
21189002-1189002101.718102.22
31166142-116614299.762100.26
41163919-116391999.572100.07
51141257-114125797.63398.12
61155435-115543598.84699.34
30min11141606-114160697.66398.901.5298.3199.561.52
21183495-1183495101.247101.92
31165210-116521099.682100.35
41158954-115895499.14799.81
51134338-113433897.04197.69
61152640-115264098.60799.27
45min11138110-113811097.36498.791.6098.1899.621.60
21184730-1184730101.352102.20
31163892-116389299.570100.40
41155340-115534098.83899.67
51134094-113409497.02197.83
61152432-115243298.58999.41
60min11133610-113361096.97998.371.5297.9599.361.52
21178252-1178252100.798101.81
31157512-115751299.024100.02
41150721-115072198.44399.44
51129935-112993596.66597.64
61149046-114904698.30099.29
极限11134132-113413297.02498.291.5298.1699.451.52
21177483-1177483100.732101.91
31155306-115530698.835100.00
41152323-115232398.58099.74
51128166-112816696.51397.65
61146482-114648298.08099.23
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%
111.051163141116260311629051162478116266911627590.03
211.141163282116521511642480.12
单位质量响应值RSD%判断
105227.06104510.590.49数据可信
中间条件24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%
5min11139386-113938697.49296.931.8497.4996.931.84
21110360-111036095.00895.01
31108579-110857994.85694.86
41159346-115934699.19999.20
51128804-112880496.58696.59
61150391-115039198.43398.43
10min11150250-115025098.42198.540.9598.5898.700.96
21138096-113809697.38197.54
31144333-114433397.91598.07
41167708-116770899.915100.08
51148546-114854698.27598.44
61161212-116121299.35999.52
15min11147714-114771498.20498.530.9098.5398.860.90
21140111-114011197.55497.87
31144751-114475197.95198.27
41168358-116835899.971100.30
51149319-114931998.34298.67
61159029-115902999.17299.50
20min11147794-114779498.21198.330.9898.7098.820.98
21136606-113660697.25497.74
31142090-114209097.72398.21
41166645-116664599.824100.32
51144111-114411197.89698.38
61158186-115818699.10099.60
30min11149339-114933998.34398.320.7999.0098.970.79
21137903-113790397.36598.01
31143929-114392997.88098.53
41164290-116429099.623100.29
51146152-114615298.07198.72
61152566-115256698.61999.28
45min11131482-113148296.81597.861.0097.6398.671.00
21133942-113394297.02697.83
31138766-113876697.43998.25
41160745-116074599.319100.15
51143882-114388297.87698.69
61153062-115306298.66299.49
60min11139195-113919597.47597.700.8998.4598.680.89
21129703-112970396.66397.63
31139266-113926697.48198.45
41158738-115873899.147100.14
51136420-113642097.23898.22
61147641-114764198.19899.19
极限11130995-113099596.77497.380.8197.9298.520.80
21126818-112681896.41697.55
31137346-113734697.31798.45
41152495-115249598.61399.77
51137171-113717197.30298.44
61143430-114343097.83898.99
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