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%
19.922420372419242416932414942419442418180.10
29.982428622434572431600.18
单位质量响应值RSD%判断
24376.8124364.730.04数据可信
供试品溶液-2095120批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1130555-13055553.30266.4515.0153.3066.4515.01
2137442-13744256.11456.11
3168347-16834768.73268.73
4166400-16640067.93767.94
5180083-18008373.52473.52
6193704-19370479.08579.08
10min1149917-14991761.20882.3013.3161.3782.5013.31
2202245-20224582.57282.74
3201348-20134882.20682.41
4217564-21756488.82689.03
5214213-21421387.45887.68
6224213-22421391.54191.78
15min1159419-15941965.08785.3912.0965.4385.8412.09
2215640-21564088.04188.46
3208940-20894085.30585.76
4223389-22338991.20491.67
5218846-21884689.35089.83
6228656-22865693.35593.87
20min1165589-16558967.60686.9211.2268.1487.6211.23
2220811-22081190.15290.83
3213032-21303286.97687.68
4226391-22639192.43093.17
5221342-22134290.36991.12
6230155-23015593.96794.76
30min1176026-17602671.86788.679.5472.6189.639.56
2226498-22649892.47493.42
3217474-21747488.78989.76
4227695-22769592.96293.98
5223740-22374091.34892.37
6231614-23161494.56295.64
45min1188531-18853176.97390.257.4677.9391.487.51
2229605-22960593.74294.97
3221478-22147890.42491.66
4228430-22843093.26294.56
5224527-22452791.66992.97
6233706-23370695.41796.77
60min1196962-19696280.41591.196.0181.6092.696.08
2231228-23122894.40595.91
3223827-22382791.38392.89
4229365-22936593.64495.22
5225361-22536192.00993.58
6233430-23343095.30496.95
极限1226702-22670292.55794.301.5093.9996.071.59
2234072-23407295.56697.36
3231332-23133294.44796.23
4230437-23043794.08295.94
5227729-22772992.97694.82
6235513-23551396.15498.08
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%
19.922418092421362421042421372420052420380.06
29.982435392436902436140.05
单位质量响应值RSD%判断
24398.9924410.220.04数据可信
供试品溶液-24090401批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1151536-15153661.78354.0812.7661.7854.0812.76
2114395-11439546.64046.64
3131993-13199353.81553.81
4112344-11234445.80445.80
5135031-13503155.05355.05
6150605-15060561.40361.40
10min1196005-19600579.91374.244.3880.1074.404.38
2171581-17158169.95570.10
3180684-18068473.66773.83
4180888-18088873.75073.89
5179596-17959673.22373.39
6183802-18380274.93875.12
15min1203778-20377883.08278.454.0083.5178.844.01
2181453-18145373.98074.33
3190629-19062977.72178.10
4196124-19612479.96280.32
5187645-18764576.50576.89
6194906-19490679.46579.87
20min1207012-20701284.40180.603.7085.0881.233.71
2186678-18667876.11076.68
3197029-19702980.33180.95
4202504-20250482.56383.16
5192470-19247078.47279.09
6200512-20051281.75182.40
30min1210575-21057585.85483.263.1486.7884.123.15
2194310-19431079.22280.02
3204024-20402483.18384.04
4209847-20984785.55786.40
5199216-19921681.22282.07
6207307-20730784.52185.41
45min1213958-21395887.23385.832.2888.4286.942.29
2204724-20472483.46884.51
3209437-20943785.39086.50
4216701-21670188.35189.45
5205528-20552883.79684.89
6212716-21271686.72687.87
60min1216117-21611788.11387.381.8389.5688.751.84
2210544-21054485.84187.13
3213324-21332486.97488.34
4220274-22027489.80891.18
5209778-20977885.52986.87
6215826-21582687.99489.40
极限1229621-22962193.61994.170.8895.3395.800.88
2230296-23029693.89495.44
3230086-23008693.80895.43
4234831-23483195.74397.38
5229450-22945093.54995.15
6231553-23155394.40696.08
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%
19.922433922433862430622431762431862432400.06
29.982431592430272430930.04
单位质量响应值RSD%判断
24520.1624358.020.47数据可信
供试品溶液-24090402批-pH6.8
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1142705-14270558.10156.5918.7258.1056.5918.73
292900-9290037.82337.82
3133737-13373754.45054.45
4165424-16542467.35167.35
5137457-13745755.96455.96
6161736-16173665.84965.85
10min1208946-20894685.07074.0211.9285.2474.1911.92
2153513-15351362.50162.61
3165386-16538667.33567.50
4197879-19787980.56480.77
5170777-17077769.53069.70
6194370-19437079.13679.33
15min1218012-21801288.76178.209.7889.1978.609.80
2168825-16882568.73569.04
3177963-17796372.45672.82
4205512-20551283.67284.12
5181904-18190474.06074.44
6200268-20026881.53781.97
20min1220223-22022389.66180.508.0690.3681.128.09
2177488-17748872.26272.77
3186173-18617375.79876.38
4208588-20858884.92485.62
5189811-18981177.27977.88
6204018-20401883.06483.74
30min1221499-22149990.18183.016.0991.1583.886.14
2188174-18817476.61377.34
3195079-19507979.42480.23
4213364-21336486.86987.82
5197971-19797180.60281.43
6207198-20719884.35885.29
45min1224859-22485991.54985.494.7492.7886.614.80
2198257-19825780.71881.67
3202504-20250482.44783.50
4217294-21729488.46989.68
5205216-20521683.55184.62
6211732-21173286.20487.39
60min1224451-22445191.38386.823.6192.8988.193.68
2204258-20425883.16184.36
3207776-20777684.59485.89
4219657-21965789.43190.91
5209140-20914085.14986.47
6214138-21413887.18488.62
极限1229956-22995693.62494.190.7395.4195.830.74
2232653-23265394.72296.17
3230100-23010093.68395.23
4233774-23377495.17996.92
5229706-22970693.52295.10
6231928-23192894.42796.13
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