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%
19.864311424312504310834313184308394311260.05
29.864313574309794311680.07
单位质量响应值RSD%判断
43724.7543729.010.01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%
5min1-0.00045.7950.860.0045.7950.86
2251511-25151157.23157.23
3207394-20739447.19247.19
4272706-27270662.05462.05
5210460-21046047.89047.89
6265405-26540560.39360.39
10min1360134-36013481.94874.3013.5081.9574.4313.47
2350839-35083979.83380.00
3284618-28461864.76464.91
4358481-35848181.57281.76
5257434-25743458.57958.72
6347538-34753879.08279.26
15min1381463-38146386.80179.0412.1087.0579.4012.07
2367797-36779783.69284.10
3308817-30881770.27170.61
4379556-37955686.36886.80
5281027-28102763.94764.27
6365467-36546783.16283.58
20min1389821-38982188.70381.1511.1889.2181.7511.16
2374846-37484685.29685.96
3319928-31992872.79973.35
4388001-38800188.28988.98
5294108-29410866.92467.44
6373168-37316884.91485.58
30min1394858-39485889.84983.319.3790.6284.169.36
2381545-38154586.82087.74
3335062-33506276.24377.01
4394137-39413789.68590.64
5312283-31228371.06071.77
6378938-37893886.22787.15
45min1401422-40142291.34385.437.5492.3986.527.55
2387522-38752288.18089.36
3350300-35030079.71080.70
4398671-39867190.71791.94
5331360-33136075.40176.33
6383392-38339287.24088.42
60min1404093-40409391.95187.005.8493.2788.355.88
2391460-39146089.07690.52
3363151-36315182.63583.87
4400714-40071491.18292.68
5347672-34767279.11280.26
6387054-38705488.07489.52
极限1407393-40739392.70291.061.4094.2992.661.41
2399536-39953690.91492.62
3401591-40159191.38292.86
4404603-40460392.06793.84
5395536-39553690.00491.39
6392380-39238089.28690.99
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%
19.864330724330524331784332944334594332110.04
29.864318994315394317190.06
单位质量响应值RSD%判断
43936.2143784.890.25数据可信
供试品溶液-24082101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%
5min1201766-20176645.77250.8825.5245.7750.8825.52
2145734-14573433.06133.06
3298705-29870567.76367.76
4267616-26761660.71060.71
5248730-24873056.42656.43
6183189-18318941.55841.56
10min1295217-29521766.97272.2811.2167.1172.4311.23
2265619-26561960.25760.36
3368193-36819383.52783.73
4329287-32928774.70174.88
5314031-31403171.24071.41
6339266-33926676.96577.09
15min1314415-31441571.32776.578.2371.6776.948.25
2302591-30259168.64568.92
3376658-37665885.44785.90
4341637-34163777.50277.91
5330138-33013874.89475.28
6359809-35980981.62581.98
20min1325925-32592573.93879.206.5274.4979.806.55
2327910-32791074.38874.87
3381637-38163786.57787.29
4348426-34842679.04379.68
5340273-34027377.19377.80
6370591-37059184.07184.67
30min1340254-34025477.18982.085.5277.9682.925.56
2347130-34713078.74979.46
3390708-39070888.63489.60
4357114-35711481.01381.89
5354001-35400180.30781.15
6381710-38171086.59387.45
45min1359549-35954981.56684.583.9682.5785.664.00
2363352-36335282.42983.37
3394284-39428489.44690.68
4365174-36517482.84283.96
5365900-36590083.00784.09
6388783-38878388.19889.31
60min1370516-37051684.05486.113.2385.3087.453.28
2370903-37090384.14285.33
3394134-39413489.41290.92
4371751-37175184.33485.70
5373769-37376984.79286.12
6396421-39642189.93091.31
极限1406009-40600992.10690.401.4293.6192.001.39
2394903-39490389.58691.03
3395909-39590989.81491.59
4392458-39245889.03190.65
5396593-39659389.97091.55
6405098-40509891.89993.55
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%
19.864331624325704323004312524318234322210.17
29.864347364343354345360.07
单位质量响应值RSD%判断
43835.8044070.590.38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%
5min1273632-27363261.94460.328.9761.9460.328.97
2280653-28065363.53463.53
3276417-27641762.57562.57
4248460-24846056.24656.25
5292156-29215666.13866.14
6227510-22751051.50351.50
10min1368142-36814283.34076.896.6483.5377.086.64
2350634-35063479.37679.57
3332223-33222375.20875.40
4334857-33485775.80575.97
5350145-35014579.26579.46
6301992-30199268.36568.52
15min1386108-38610887.40780.086.2187.8480.496.21
2364083-36408382.42182.85
3347254-34725478.61179.02
4347972-34797278.77379.17
5357443-35744380.91881.35
6319610-31961072.35372.71
20min1395053-39505389.43282.005.8790.1382.655.88
2370059-37005983.77484.45
3357734-35773480.98381.63
4356448-35644880.69281.32
5364320-36432082.47483.15
6329625-32962574.62075.20
30min1397669-39766990.02484.044.5790.9984.944.59
2375915-37591585.09986.03
3372930-37293084.42385.32
4363627-36362782.31783.19
5371574-37157484.11685.04
6345631-34563178.24479.04
45min1396729-39672989.81186.472.8391.0587.622.87
2385247-38524787.21288.39
3386498-38649887.49588.64
4374939-37493984.87886.00
5383286-38328686.76887.95
6365160-36516082.66483.70
60min1398750-39875090.26987.941.9491.7789.351.98
2391202-39120288.56090.00
3392927-39292788.95090.36
4381617-38161786.39087.77
5388040-38804087.84489.28
6378378-37837885.65786.94
极限1400321-40032190.62491.311.7892.4092.981.70
2403756-40375691.40293.11
3406895-40689592.11293.79
4393090-39309088.98790.62
5401567-40156790.90692.61
6414540-41454093.84395.38
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%
19.864315854315794316724317544317784316740.03
29.864311804310854311320.02
单位质量响应值RSD%判断
43780.3243725.350.09数据可信
供试品溶液-24082102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%
5min1227968-22796851.84358.3215.1051.8458.3215.11
2270052-27005261.41461.41
3191342-19134243.51443.51
4274610-27461062.45062.45
5284662-28466264.73664.74
6290160-29016065.98665.99
10min1278772-27877263.39777.9617.2963.5578.1417.28
2347438-34743879.01279.20
3261772-26177259.53159.66
4402154-40215491.45591.64
5378416-37841686.05786.25
6388417-38841788.33188.53
15min1301990-30199068.67782.3613.3169.0282.7713.32
2366883-36688383.43483.86
3304075-30407569.15169.46
4413501-41350194.03694.50
5389860-38986088.66089.11
6396643-39664390.20290.67
20min1315839-31583971.82684.4611.1372.3885.1211.16
2376703-37670385.66786.34
3325725-32572574.07474.59
4416025-41602594.61095.35
5392829-39282989.33590.05
6401252-40125291.25091.98
30min1334788-33478876.13586.838.4676.9087.748.51
2384325-38432587.40188.33
3351614-35161479.96280.70
4418051-41805195.07196.10
5397613-39761390.42391.41
6404485-40448591.98692.99
45min1345909-34590978.66588.646.8979.6689.816.95
2391426-39142689.01690.21
3372178-37217884.63885.62
4419583-41958395.41996.73
5401427-40142791.29092.55
6408099-40809992.80794.09
60min1356129-35612980.98990.196.0682.2291.636.14
2395791-39579190.00891.47
3382460-38246086.97788.21
4418782-41878295.23796.84
5411725-41172593.63295.16
6414735-41473594.31795.88
极限1400932-40093291.17894.081.7192.6595.781.85
2414661-41466194.30096.03
3411579-41157993.59995.09
4421416-42141695.83697.72
5415827-41582794.56596.38
6417699-41769994.99196.84
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