盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.071891291894161890771893151893581892590.08
211.061890931894231892580.13
单位质量响应值RSD%判断
17096.5717111.930.07数据可信
供试品溶液-4批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min150611-5061126.56228.337.7626.5628.337.77
249036-4903625.73525.73
360462-6046231.73131.73
452448-5244827.52627.53
554673-5467328.69328.69
656647-5664729.72929.73
10min182674-8267443.38946.435.3743.4346.485.38
283893-8389344.02844.07
392501-9250148.54648.60
487178-8717845.75245.80
589935-8993547.19947.25
694640-9464049.66949.72
15min1104458-10445854.82157.033.5454.9457.153.55
2105441-10544155.33755.45
3110617-11061758.05458.19
4106860-10686056.08256.20
5109832-10983257.64257.77
6114779-11477960.23860.37
20min1119365-11936562.64564.322.9062.8564.542.91
2119698-11969862.82063.03
3124330-12433065.25065.48
4120578-12057863.28163.50
5122683-12268364.38664.61
6128682-12868267.53567.77
30min1136354-13635471.56173.462.5671.8773.782.57
2137332-13733272.07472.39
3141388-14138874.20374.54
4138503-13850372.68973.01
5139945-13994573.44673.78
6146274-14627476.76777.11
45min1153057-15305780.32781.972.1080.7682.422.11
2153931-15393180.78681.22
3156890-15689082.33982.80
4155304-15530481.50681.95
5155691-15569181.70982.16
6162271-16227185.16385.64
60min1163829-16382985.98087.491.7486.5588.071.75
2164277-16427786.21586.78
3168038-16803888.18988.79
4166469-16646987.36687.94
5165838-16583887.03587.62
6171733-17173390.12890.74
极限1172297-17229790.42491.601.5091.1392.341.51
2172318-17231890.43591.15
3175270-17527091.98592.73
4174147-17414791.39592.12
5173881-17388191.25691.99
6179350-17935094.12694.89
盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.071897091895981891691891711890111893320.17
211.061895271893091894180.09
单位质量响应值RSD%判断
17103.1617126.400.10数据可信
供试品溶液-1批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min167610-6761035.46133.635.5535.4633.635.56
266243-6624334.74434.74
366932-6693235.10535.11
462344-6234432.69932.70
563412-6341233.25933.26
658198-5819830.52530.52
10min1100006-10000652.45350.934.7052.5150.994.70
2100479-10047952.70152.76
3101488-10148853.23053.29
495723-9572350.20650.26
595649-9564950.16750.22
689295-8929546.83546.89
15min1118960-11896062.39460.863.9362.5461.003.93
2119255-11925562.54962.69
3120709-12070963.31163.46
4115009-11500960.32260.46
5113748-11374859.66059.80
6108514-10851456.91557.04
20min1131495-13149568.96867.773.2369.2268.013.23
2131898-13189869.18069.43
3133899-13389970.22970.48
4128724-12872467.51567.75
5126832-12683266.52366.76
6122405-12240564.20164.42
30min1147030-14703077.11676.412.5377.4876.772.53
2147519-14751977.37377.74
3150404-15040478.88679.26
4146104-14610476.63176.98
5143149-14314975.08175.43
6139901-13990173.37773.71
45min1161545-16154584.72984.381.5085.2284.861.51
2161735-16173584.82985.32
3164397-16439786.22586.73
4161322-16132284.61285.09
5157982-15798282.86183.34
6158307-15830783.03183.48
60min1169793-16979389.05589.191.4589.6989.821.46
2171211-17121189.79990.43
3173560-17356091.03191.68
4171082-17108289.73290.35
5167916-16791688.07188.68
6166784-16678487.47788.07
极限1175382-17538291.98793.412.2992.7794.182.26
2177491-17749193.09393.88
3178693-17869393.72394.52
4177030-17703092.85193.62
5174228-17422891.38292.14
6185765-18576597.43398.17
盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.071892701888991887141887941888921889140.12
211.061898131897851897990.02
单位质量响应值RSD%判断
17065.4017160.850.40数据可信
供试品溶液-1批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min168028-6802835.68434.907.4035.6834.907.41
265188-6518834.19434.19
373959-7395938.79538.80
458836-5883630.86230.86
567729-6772935.52735.53
665464-6546434.33934.34
10min198520-9852051.67950.905.9051.7450.955.91
295697-9569750.19850.25
3105820-10582055.50855.57
488177-8817746.25346.30
598411-9841151.62151.68
695553-9555350.12250.18
15min1120633-12063363.27862.695.4863.4262.845.48
2116015-11601560.85661.00
3127275-12727566.76266.92
4109304-10930457.33557.46
5118482-11848262.15062.29
6125417-12541765.78765.93
20min1133350-13335069.94969.403.9670.2069.653.96
2130478-13047868.44268.68
3141314-14131474.12674.39
4125255-12525565.70265.93
5132311-13231169.40469.65
6131150-13115068.79569.04
30min1151242-15124279.33479.253.2379.7079.623.24
2147895-14789577.57877.93
3158429-15842983.10483.50
4144367-14436775.72876.06
5154061-15406180.81381.18
6150530-15053078.96079.33
45min1170971-17097189.68387.552.6590.1888.052.66
2163414-16341485.71986.20
3172952-17295290.72291.25
4161724-16172484.83285.29
5164746-16474686.41786.92
6167671-16767187.95288.45
60min1174524-17452491.54691.751.9892.2092.391.99
2172120-17212090.28590.91
3180908-18090894.89595.58
4172011-17201190.22890.83
5173012-17301290.75391.40
6176849-17684992.76693.41
极限1180471-18047194.66694.861.8795.4795.661.88
2177545-17754593.13193.91
3186231-18623197.68798.53
4178607-17860793.68894.44
5178704-17870493.73994.53
6183495-18349596.25297.05
盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.071891231892921892371890741886891890830.13
211.061917011914721915860.09
单位质量响应值RSD%判断
17080.6717322.421.00数据可信
供试品溶液-2批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min162181-6218132.45135.157.8932.4535.157.89
271913-7191337.53037.53
364074-6407433.43933.44
473146-7314638.17338.17
561519-6151932.10532.11
671248-7124837.18237.18
10min197698-9769850.98652.764.2451.0452.824.25
2105555-10555555.08655.15
398584-9858451.44851.50
4104140-10414054.34854.41
595654-9565449.91949.97
6104991-10499154.79254.85
15min1118004-11800461.58363.793.5261.7263.933.53
2126796-12679666.17266.33
3119460-11946062.34362.48
4124940-12494065.20365.36
5117678-11767861.41361.55
6126474-12647466.00466.16
20min1134807-13480770.35271.582.8270.5971.822.83
2141564-14156473.87974.14
3134167-13416770.01870.26
4139191-13919172.64072.90
5132354-13235469.07269.31
6140821-14082173.49173.75
30min1149830-14983078.19280.512.2678.5580.882.27
2158645-15864582.79383.18
3151534-15153479.08279.44
4155850-15585081.33481.72
5152540-15254079.60779.96
6157255-15725582.06782.45
45min1164479-16447985.83788.172.0286.3388.682.02
2173692-17369290.64591.17
3165977-16597786.61987.11
4169895-16989588.66489.18
5168398-16839887.88388.37
6171234-17123489.36389.89
60min1172550-17255090.04992.381.8590.6893.031.85
2181685-18168594.81795.49
3174225-17422590.92491.56
4177173-17717392.46293.13
5177604-17760492.68793.32
6178873-17887393.34994.02
极限1177674-17767492.72395.061.8093.5195.861.80
2186247-18624797.19898.03
3178907-17890793.36794.16
4182363-18236395.17195.99
5183567-18356795.79996.59
6184104-18410496.07996.91
盐酸鲁拉西酮口崩片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号N877-220209对照品来源自制对照品使用方法直接使用
对照品含量(%)99.74对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
111.071887551896091894761891121895151892930.19
211.061889271895071892170.22
单位质量响应值RSD%判断
17099.6417108.230.04数据可信
供试品溶液-cbzj批-pH6.8(内含0.1%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min113280-132806.97019.9337.356.9719.9437.34
249457-4945725.95625.96
345063-4506323.65023.65
444577-4457723.39523.40
546989-4698924.66124.66
628534-2853414.97514.98
10min168751-6875136.08249.7114.9236.0949.7414.93
2107446-10744656.39156.43
396267-9626750.52350.56
4104481-10448154.83454.87
5101216-10121653.12153.16
690114-9011447.29447.32
15min1127377-12737766.85170.963.5366.9271.073.56
2140507-14050773.74273.88
3136863-13686371.82971.95
4136771-13677171.78171.91
5137921-13792172.38572.51
6131792-13179269.16869.27
20min1141758-14175874.39879.063.2374.5879.293.26
2154927-15492781.31081.57
3153140-15314080.37280.62
4151906-15190679.72479.97
5153573-15357380.59980.85
6148502-14850277.93878.16
30min1162162-16216285.10787.901.8285.4188.271.85
2170263-17026389.35989.75
3170071-17007189.25889.64
4167445-16744587.88088.26
5168831-16883188.60788.99
6166177-16617787.21487.56
45min1177263-17726393.03294.230.9693.4894.750.98
2180679-18067994.82595.37
3182001-18200195.51996.05
4178665-17866593.76894.30
5180169-18016994.55795.09
6178541-17854193.70394.20
60min1184267-18426796.70897.370.7897.3198.040.79
2186228-18622897.73798.44
3187783-18778398.55499.24
4183865-18386596.49797.18
5185939-18593997.58698.28
6185122-18512297.15797.81
极限1187392-18739298.34898.660.8599.1199.490.85
2188537-18853798.94999.81
3190406-19040699.930100.78
4185575-18557597.39598.24
5188318-18831898.83499.69
6187678-18767898.49899.31
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