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%
111.071919841918651916081918891916361917960.09
211.061914281916001915140.07
单位质量响应值RSD%判断
17325.7517315.910.05数据可信
供试品溶液-4批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1121144-12114462.78366.863.4862.7866.863.48
2130521-13052167.64367.64
3129404-12940467.06467.06
4127460-12746066.05766.06
5131084-13108467.93567.93
6134417-13441769.66269.66
10min1150986-15098678.24981.062.2778.3581.172.27
2158240-15824082.00982.12
3156653-15665381.18681.30
4154051-15405179.83879.95
5157206-15720681.47381.59
6161280-16128083.58483.70
15min1162928-16292884.43887.061.7384.6787.311.73
2167866-16786686.99787.25
3170057-17005788.13388.38
4168038-16803887.08687.33
5167638-16763886.87987.13
6171449-17144988.85489.11
20min1171459-17145988.85991.071.3489.2491.461.34
2177218-17721891.84492.24
3176592-17659291.52091.91
4175353-17535390.87891.27
5175496-17549690.95291.35
6178194-17819492.35092.75
30min1178118-17811892.31094.401.3892.8394.941.38
2184183-18418395.45496.00
3183116-18311694.90195.45
4182561-18256194.61395.15
5180242-18024293.41193.96
6184669-18466995.70696.26
45min1185630-18563096.20497.041.2096.8897.741.20
2188958-18895897.92898.63
3188502-18850297.69298.40
4188708-18870897.79998.50
5183427-18342795.06295.76
6188272-18827297.57398.29
60min1187520-18752097.18397.811.0798.0298.671.07
2190004-19000498.47099.34
3190035-19003598.48799.35
4190011-19001198.47499.33
5185124-18512495.94196.80
6189639-18963998.28199.16
极限1188980-18898097.94098.221.2898.9499.251.27
2190986-19098698.979100.01
3190928-19092898.94999.98
4191116-19111699.047100.07
5184876-18487695.81396.83
6190261-19026198.60499.65
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%
111.071921301924251925161923451924851923800.09
211.061926161924681925420.06
单位质量响应值RSD%判断
17378.5017408.860.13数据可信
供试品溶液-1批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1142407-14240773.49470.722.8473.4970.722.83
2139574-13957472.03272.03
3130827-13082767.51867.52
4136020-13602070.19870.20
5136856-13685670.62970.63
6136489-13648970.44070.44
10min1169646-16964687.55284.242.3587.6784.362.35
2165131-16513185.22285.34
3158316-15831681.70481.82
4161684-16168483.44383.56
5162718-16271883.97684.09
6161855-16185583.53183.65
15min1180635-18063593.22390.102.0393.4990.362.03
2176450-17645091.06391.33
3170349-17034987.91488.16
4173367-17336789.47289.73
5173493-17349389.53789.79
6173261-17326189.41789.67
20min1186114-18611496.05193.391.5396.4793.801.53
2181726-18172693.78694.20
3178567-17856792.15692.55
4180238-18023893.01893.42
5179024-17902492.39192.80
6180124-18012492.95993.36
30min1190407-19040798.26696.091.2398.8596.651.24
2186839-18683996.42596.99
3184253-18425395.09095.64
4186043-18604396.01496.57
5184464-18446495.19995.76
6185092-18509295.52396.08
45min1192206-19220699.19597.650.9599.9498.380.96
2190141-19014198.12998.86
3187869-18786996.95697.66
4189511-18951197.80498.52
5187351-18735196.68997.41
6188257-18825797.15697.88
60min1193598-19359899.91398.031.14100.8398.921.15
2190779-19077998.45899.35
3188699-18869997.38598.25
4190388-19038898.25699.14
5187419-18741996.72497.60
6188823-18882397.44998.33
极限1193998-193998100.11998.311.08101.2099.361.08
2191033-19103398.58999.65
3188740-18874097.40698.44
4190927-19092798.53499.58
5188283-18828397.17098.21
6190019-19001998.06699.11
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%
111.071914661910691908441907261910491910310.15
211.061917301918011917660.03
单位质量响应值RSD%判断
17256.6417338.700.34数据可信
供试品溶液-1批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1129292-12929267.09669.301.9867.1069.301.98
2135245-13524570.18670.19
3132588-13258868.80768.81
4136730-13673070.95670.96
5132496-13249668.75968.76
6134877-13487769.99569.99
10min1155495-15549580.69483.331.8280.8183.451.82
2162703-16270384.43584.55
3160911-16091183.50583.62
4162720-16272084.44484.56
5158883-15888382.45382.57
6162742-16274284.45584.57
15min1170619-17061988.54390.171.2788.7990.421.27
2176022-17602291.34791.60
3173296-17329689.93290.19
4175563-17556391.10991.37
5171812-17181289.16289.41
6175176-17517690.90891.17
20min1177726-17772692.23194.472.2592.6394.882.25
2183836-18383695.40295.81
3180588-18058893.71694.12
4189149-18914998.15998.57
5179009-17900992.89793.30
6181946-18194694.42194.83
30min1184680-18468095.84097.421.3096.3997.981.30
2190720-19072098.97499.54
3186427-18642796.74797.31
4189326-18932698.25198.83
5185752-18575296.39696.95
6189460-18946098.32198.89
45min1188684-18868497.91899.381.1698.63100.101.16
2193268-193268100.297101.03
3190257-19025798.73499.46
4194079-194079100.718101.46
5189754-18975498.47399.19
6192948-192948100.131100.86
60min1190007-19000798.604100.291.3499.47101.181.34
2194923-194923101.156102.06
3191495-19149599.377100.26
4195472-195472101.440102.35
5191446-19144699.351100.23
6196179-196179101.807102.70
极限1191056-19105699.149100.211.26100.18101.271.26
2192425-19242599.859100.93
3192219-19221999.752100.80
4195284-195284101.343102.42
5190795-19079599.013100.06
6196846-196846102.154103.22
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%
111.071912671911701913391911671910921912070.06
211.061923241923091923160.01
单位质量响应值RSD%判断
17272.5417388.430.48数据可信
供试品溶液-2批-pH3.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1137661-13766171.30573.723.3271.3073.723.32
2148760-14876077.05377.05
3136667-13666770.79070.79
4141658-14165873.37573.37
5146190-14619075.72275.72
6143001-14300174.07074.07
10min1163700-16370084.79287.822.7584.9187.942.74
2175929-17592991.12691.25
3164800-16480085.36285.48
4170754-17075488.44688.57
5172548-17254889.37589.50
6169504-16950487.79887.92
15min1176671-17667191.51194.382.6191.7794.652.61
2186225-18622596.45996.74
3176706-17670691.52991.79
4187657-18765797.20197.47
5184556-18455695.59595.87
6181420-18142093.97094.24
20min1182763-18276394.66697.472.1195.0897.892.11
2192643-19264399.784100.22
3184358-18435895.49295.91
4190678-19067898.76699.20
5190956-19095698.91099.34
6187617-18761797.18097.61
30min1188822-18882297.804100.632.3698.37101.222.36
2197517-197517102.308102.92
3189769-18976998.29598.87
4195990-195990101.517102.11
5200561-200561103.885104.48
6193042-19304299.990100.58
45min1191669-19166999.279101.312.00100.01102.072.00
2199912-199912103.549104.33
3190678-19067898.76699.50
4198760-198760102.952103.72
5198092-198092102.606103.38
6194464-194464100.727101.48
60min1191953-19195399.426102.001.34100.33102.931.34
2199014-199014103.084104.03
3198092-198092102.606103.51
4197010-197010102.046102.98
5198874-198874103.011103.95
6196609-196609101.838102.76
极限1192754-19275499.841101.831.49100.91102.931.49
2200362-200362103.782104.90
3193740-193740100.352101.42
4197752-197752102.430103.54
5198616-198616102.877103.99
6196386-196386101.722102.82
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