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%
19.912374552372552377402380372377522376480.13
29.992394512394302394400.01
单位质量响应值RSD%判断
23980.6323967.970.04数据可信
供试品溶液-2185663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%
5min1181504-18150475.32971.235.7875.3371.235.78
2176614-17661473.30073.30
3162491-16249167.43867.44
4158375-15837565.73065.73
5169010-16901070.14470.14
6181768-18176875.43975.44
10min1200762-20076283.32283.704.5683.5583.914.55
2198194-19819482.25682.48
3185367-18536776.93277.13
4209029-20902986.75386.95
5208204-20820486.41086.62
6208475-20847586.52386.75
15min1205114-20511485.12886.164.0485.6086.634.03
2204125-20412584.71885.18
3193736-19373680.40680.84
4216588-21658889.89090.35
5212577-21257788.22588.70
6213501-21350188.60989.09
20min1208170-20817086.39687.414.1187.1388.144.10
2205612-20561285.33586.06
3197163-19716381.82882.50
4220778-22077891.62992.36
5216117-21611789.69590.43
6215854-21585489.58590.34
30min1209946-20994687.13388.693.3288.1289.673.32
2210578-21057887.39688.37
3203092-20309284.28985.21
4222498-22249892.34393.34
5218624-21862490.73591.74
6217379-21737990.21891.24
45min1213869-21386988.76290.222.6490.0191.472.64
2215525-21552589.44990.69
3209194-20919486.82187.99
4225453-22545393.56994.85
5220494-22049491.51192.79
6219798-21979891.22292.51
60min1215265-21526589.34191.292.4590.8692.812.45
2218851-21885190.82992.34
3213410-21341088.57190.00
4228299-22829994.75096.31
5222605-22260592.38793.94
6221279-22127991.83793.40
极限1222441-22244192.31994.381.6194.1196.181.57
2227274-22727494.32596.10
3230450-23045095.64397.34
4230749-23074995.76797.61
5230005-23000595.45897.29
6223555-22355592.78294.62
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%
19.912379342373182378062377312382022377980.14
29.992397212383992390600.40
单位质量响应值RSD%判断
23995.7623929.930.20数据可信
供试品溶液-2185663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%
5min1149764-14976462.18666.596.2062.1966.596.19
2150804-15080462.61862.62
3168726-16872670.06070.06
4154008-15400863.94863.95
5166872-16687269.29069.29
6172056-17205671.44271.44
10min1178696-17869674.19979.104.7074.3979.304.69
2195864-19586481.32881.52
3198073-19807382.24582.46
4184870-18487076.76376.95
5184648-18464876.67176.88
6200900-20090083.41983.63
15min1190661-19066179.16882.343.5479.5882.783.54
2203350-20335084.43684.87
3204122-20412284.75785.21
4194605-19460580.80581.23
5190968-19096879.29579.73
6206087-20608785.57386.04
20min1196785-19678581.71084.272.8882.3684.962.88
2209955-20995587.17987.86
3207352-20735286.09886.81
4199675-19967582.91083.57
5196918-19691881.76682.44
6207060-20706085.97786.70
30min1204400-20440084.87286.131.8885.7687.071.89
2211831-21183187.95888.90
3210694-21069487.48688.46
4205854-20585485.47686.39
5202100-20210083.91784.84
6209765-20976587.10088.08
45min1210393-21039387.36187.921.1588.5189.121.16
2213544-21354488.66989.88
3214699-21469989.14990.38
4212249-21224988.13189.30
5207838-20783886.30087.47
6211730-21173087.91689.16
60min1214495-21449589.06489.031.1090.4790.491.09
2214178-21417888.93290.41
3216770-21677090.00991.51
4216967-21696790.09191.52
5210623-21062387.45688.89
6213408-21340888.61390.12
极限1227510-22751094.46892.072.3596.1493.792.28
2216949-21694990.08391.83
3219372-21937291.08992.86
4228928-22892895.05796.76
5220320-22032091.48393.18
6217262-21726290.21391.98
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%
19.912373502378432388602372492372272377060.30
29.992392822375592384200.52
单位质量响应值RSD%判断
23986.4823865.870.36数据可信
供试品溶液-2180621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%
5min1162764-16276467.68875.4211.2267.6975.4211.22
2164048-16404868.22268.22
3201244-20124483.69083.69
4178712-17871274.32074.32
5211286-21128687.86787.87
6170129-17012970.75170.75
10min1189422-18942278.77486.257.4478.9886.487.44
2200696-20069683.46283.67
3219516-21951691.28991.54
4199204-19920482.84283.06
5231749-23174996.37696.64
6203800-20380084.75384.97
15min1198524-19852482.55989.206.1683.0089.696.17
2216684-21668490.11190.57
3222886-22288692.69193.22
4204625-20462585.09685.57
5234892-23489297.68398.24
6209335-20933587.05587.52
20min1198662-19866282.61790.726.2783.3091.486.27
2226138-22613894.04394.77
3224724-22472493.45594.26
4208031-20803186.51387.24
5236440-23644098.32799.17
6214960-21496089.39490.12
30min1201654-20165483.86192.265.7684.8093.285.76
2233364-23336497.04898.06
3227526-22752694.62095.70
4215961-21596189.81190.80
5235473-23547397.92599.07
6217073-21707390.27391.27
45min1206344-20634485.81193.495.0387.0094.805.04
2235526-23552697.94799.25
3229649-22964995.50396.87
4221022-22102291.91593.17
5236011-23601198.14999.58
6220357-22035791.63992.91
60min1208941-20894186.89193.664.3288.3495.244.34
2234196-23419697.39498.99
3228914-22891495.19796.85
4223898-22389893.11194.64
5234709-23470997.60799.34
6220602-22060291.74193.28
极限1217574-21757490.48195.243.3892.1997.103.40
2237287-23728798.679100.56
3228937-22893795.20797.15
4233247-23324796.99998.81
5234880-23488097.67899.70
6222127-22212792.37594.19
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%
19.912388702404512386552402002389022394160.36
29.992370672359872365270.33
单位质量响应值RSD%判断
24159.0323676.381.43数据可信
供试品溶液-2180621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%
5min1190557-19055779.28271.546.9979.2871.546.99
2154185-15418564.14964.15
3172193-17219371.64171.64
4177858-17785873.99874.00
5168606-16860670.14970.15
6168307-16830770.02470.02
10min1217170-21717090.35483.565.6490.5983.785.64
2193494-19349480.50480.70
3198215-19821582.46882.68
4212827-21282788.54788.77
5190656-19065679.32379.53
6192704-19270480.17580.38
15min1210396-21039687.53685.714.0088.0486.184.00
2201880-20188083.99384.43
3210237-21023787.47087.93
4217943-21794390.67691.16
5195861-19586181.48881.94
6199742-19974283.10383.55
20min1221687-22168792.23388.894.4093.0089.614.39
2203726-20372684.76185.45
3213764-21376488.93789.66
4221932-22193292.33593.09
5200679-20067983.49384.19
6220090-22009091.56992.27
30min1224518-22451893.41188.743.9194.4689.733.91
2210209-21020987.45888.40
3217583-21758390.52691.52
4218867-21886791.06092.10
5204756-20475685.18986.13
6203861-20386184.81785.79
45min1227633-22763394.70791.533.3396.0492.793.34
2213040-21304088.63689.84
3222423-22242392.54093.80
4228648-22864895.13096.44
5211751-21175188.09989.30
6216515-21651590.08291.31
60min1227970-22797094.84792.324.1596.4693.844.15
2210969-21096987.77489.24
3231969-23196996.51198.05
4230021-23002195.70197.30
5212955-21295588.60090.06
6217424-21742490.46091.96
极限1232921-23292196.90794.193.0098.8096.003.01
2219528-21952891.33593.07
3234610-23461097.61099.44
4229134-22913495.33297.21
5219010-21901091.12092.85
6223188-22318892.85894.63
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