盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944405164405134414984415764408044409810.12
210.014430764430054430400.02
单位质量响应值RSD%判断
44364.2944259.740.17数据可信
供试品溶液-24071801批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1327984-32798473.64777.384.6073.6577.384.59
2329914-32991474.08074.08
3335062-33506275.23675.24
4357365-35736580.24480.24
5366135-36613582.21482.21
6351147-35114778.84878.85
10min1372669-37266983.68190.827.9483.9091.057.92
2362351-36235181.36481.59
3426732-42673295.82096.05
4407964-40796491.60691.85
5409931-40993192.04892.29
6447159-447159100.407100.64
15min1383330-38333086.07592.407.0186.5592.907.00
2374088-37408883.99984.47
3431863-43186396.97297.49
4412370-41237092.59593.11
5416709-41670993.57094.09
6450540-450540101.166101.70
20min1390801-39080187.75293.296.2888.4894.086.28
2381635-38163585.69486.41
3433934-43393497.43798.24
4414721-41472193.12393.92
5420576-42057694.43895.24
6451244-451244101.324102.17
30min1402799-40279990.44694.674.9891.4495.734.99
2395313-39531388.76589.74
3435880-43588097.87498.97
4418737-41873794.02595.10
5424672-42467295.35896.44
6452168-452168101.532102.68
45min1415184-41518493.22795.883.6494.4997.233.67
2409192-40919291.88293.12
3436722-43672298.06399.45
4421370-42137094.61695.97
5427668-42766896.03097.40
6451977-451977101.489102.94
60min1422417-42241794.85196.462.8796.4098.102.90
2417886-41788693.83495.35
3436823-43682398.08699.77
4421855-42185594.72596.36
5427642-42764296.02597.69
6450883-450883101.243103.00
极限1436552-43655298.02597.342.1799.8599.262.17
2429761-42976196.50098.30
3436728-43672898.065100.04
4422295-42229594.82496.75
5426804-42680495.83697.79
6448808-448808100.777102.84
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944429384429224428704422614423824426750.08
210.014437714433364435540.07
单位质量响应值RSD%判断
44534.7144311.090.36数据可信
供试品溶液-2095120批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1402765-40276590.21379.469.9490.2179.469.94
2321383-32138371.98571.98
3375232-37523284.04684.05
4307356-30735668.84368.84
5365652-36565281.90181.90
6356285-35628579.80279.80
10min1438715-43871598.26689.605.6598.5489.845.66
2397529-39752989.04189.26
3408790-40879091.56391.81
4371401-37140183.18883.39
5388750-38875087.07487.32
6395003-39500388.47588.71
15min1444012-44401299.45290.955.35100.0291.465.36
2406293-40629391.00491.49
3412760-41276092.45292.98
4380422-38042285.20985.66
5392524-39252487.91988.43
6400334-40033489.66990.17
20min1445948-44594899.88691.555.16100.7592.335.17
2410432-41043291.93192.69
3414279-41427992.79293.60
4385487-38548786.34387.06
5393806-39380688.20788.98
6402463-40246390.14690.92
30min1448570-448570100.47392.604.75101.6493.664.76
2417292-41729293.46794.50
3416088-41608893.19794.28
4394180-39418088.29089.26
5397275-39727588.98490.02
6407186-40718691.20492.25
45min1450503-450503100.90693.744.25102.3795.074.26
2423469-42346994.85196.16
3418742-41874293.79295.15
4403471-40347190.37191.61
5402187-40218790.08491.39
6412583-41258392.41293.73
60min1450084-450084100.81294.223.83102.5895.843.85
2425372-42537295.27796.87
3418585-41858593.75795.40
4409977-40997791.82993.34
5404321-40432190.56292.13
6415703-41570393.11194.71
极限1449454-449454100.67194.823.42102.7496.713.44
2427245-42724595.69697.58
3418730-41873093.78995.71
4419969-41996994.06795.85
5406260-40626090.99692.84
6418279-41827993.68895.56
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944426674425794426994430084432384428380.07
210.014450914452004451460.02
单位质量响应值RSD%判断
44551.1144470.130.13数据可信
供试品溶液-24071801批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1315968-31596870.63273.9710.3170.6373.9610.31
2358137-35813780.05980.06
3272080-27208060.82160.82
4345281-34528177.18577.18
5365231-36523181.64581.64
6328595-32859573.45573.45
10min1366943-36694382.02787.278.4982.2487.498.49
2406224-40622490.80891.05
3337706-33770675.49275.67
4388975-38897586.95287.18
5420907-42090794.09194.34
6421656-42165694.25894.48
15min1383272-38327285.67889.596.8886.1490.076.89
2413733-41373392.48793.00
3356100-35610079.60380.01
4398867-39886789.16489.66
5423355-42335594.63895.16
6429231-42923195.95196.45
20min1389663-38966387.10690.825.8687.8291.585.88
2420644-42064494.03294.82
3367808-36780882.22182.87
4406242-40624290.81291.57
5422626-42262694.47595.29
6430759-43075996.29397.08
30min1402459-40245989.96792.674.4390.9493.704.46
2428448-42844895.77696.85
3384534-38453485.96086.85
4414170-41417092.58593.62
5425051-42505195.01796.11
6432710-43271096.72997.81
45min1410360-41036091.73393.943.1392.9895.243.17
2434397-43439797.10698.47
3400154-40015489.45190.60
4420421-42042193.98295.29
5423690-42369094.71396.09
6432375-43237596.65498.02
60min1417185-41718593.25994.752.5294.7896.332.57
2438938-43893898.12199.77
3408598-40859891.33992.76
4423120-42312094.58596.18
5423401-42340194.64896.31
6431850-43185096.53798.20
极限1425555-42555595.13095.362.1096.9397.232.13
2442434-44243498.903100.85
3416152-41615293.02894.72
4425639-42563995.14897.02
5420945-42094594.09996.05
6428778-42877895.85097.80
盐酸司来吉兰片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号101298-201801对照品来源中检院对照品使用方法减压干燥3h
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数1000
标示量(mg)5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%
19.944491134485984487484488934490374488780.05
210.014500974500774500870.01
单位质量响应值RSD%判断
45158.7544963.740.31数据可信
供试品溶液-2095120批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1342571-34257175.64472.1115.7675.6472.1115.76
2375173-37517382.84382.84
3299512-29951266.13666.14
4373164-37316482.39982.40
5330177-33017772.90772.91
6238774-23877452.72452.72
10min1396594-39659487.57384.975.0587.8085.195.08
2400938-40093888.53288.78
3372691-37269182.29582.49
4402357-40235788.84589.09
5383599-38359984.70384.92
6352727-35272777.88678.04
15min1401760-40176088.71386.833.6389.2087.303.66
2405448-40544889.52890.04
3381660-38166084.27584.72
4407428-40742889.96590.48
5391038-39103886.34686.82
6371967-37196782.13582.53
20min1404750-40475089.37487.832.9390.1388.562.97
2407966-40796690.08490.87
3385707-38570785.16985.87
4409484-40948490.41991.20
5396418-39641887.53488.27
6382263-38226384.40885.05
30min1409136-40913690.34289.302.3691.3790.302.40
2414424-41442491.51092.56
3393153-39315386.81387.77
4413796-41379691.37192.43
5402233-40223388.81889.81
6393891-39389186.97687.87
45min1410532-41053290.65090.771.6291.9592.041.66
2419233-41923392.57293.90
3401490-40149088.65489.87
4417616-41761692.21493.54
5410976-41097690.74892.01
6406654-40665489.79490.95
60min1410162-41016290.56991.341.4792.1492.871.49
2421517-42151793.07694.68
3404245-40424589.26290.74
4418224-41822492.34993.95
5413353-41335391.27392.81
6414389-41438991.50292.92
极限1406818-40681889.83092.082.0591.6793.892.00
2422306-42230693.25095.13
3407691-40769190.02391.77
4419599-41959992.65294.54
5416750-41675092.02393.83
6428809-42880994.68696.38
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