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%
111.262003802006532003462007592004312005140.10
211.322012552011082011820.06
单位质量响应值RSD%判断
17807.6417772.260.15数据可信
供试品溶液-24091302批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102632-10263251.78749.468.8051.7949.468.80
2107831-10783154.41054.41
392417-9241746.63346.63
496485-9648548.68548.69
584539-8453942.65742.66
6104236-10423652.59652.60
10min1150545-15054575.96374.563.4076.0574.643.41
2155034-15503478.22878.32
3147317-14731774.33574.41
4145423-14542373.37973.46
5140038-14003870.66270.73
6148205-14820574.78374.87
15min1171666-17166686.62185.701.6586.8385.901.65
2174149-17414987.87488.09
3170450-17045086.00786.21
4168349-16834984.94785.15
5166675-16667584.10284.29
6167759-16775984.64984.86
20min1182623-18262392.15091.071.5192.5191.421.52
2183862-18386292.77593.14
3181455-18145591.56091.91
4180141-18014190.89791.24
5176697-17669789.15989.49
6178118-17811889.87690.23
30min1195148-19514898.46996.291.7098.9896.791.70
2193022-19302297.39797.92
3191733-19173396.74697.24
4190651-19065196.20096.70
5188152-18815294.93995.42
6186274-18627493.99294.49
45min1197670-19767099.74298.911.48100.4299.571.48
2197429-19742999.620100.30
3199375-199375100.602101.26
4196429-19642999.11699.77
5193677-19367797.72798.36
6191547-19154796.65297.31
60min1198918-198918100.37299.701.21101.21100.521.21
2198686-198686100.255101.11
3199728-199728100.781101.61
4198769-198769100.297101.12
5195814-19581498.80699.60
6193559-19355997.66898.49
极限1199692-199692100.762100.351.58101.77101.341.56
2198927-198927100.376101.39
3200903-200903101.373102.37
4198932-198932100.379101.37
5201821-201821101.837102.80
6192934-19293497.35298.34
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%
111.262002502005841998402001542002552002170.14
211.322000062000442000250.02
单位质量响应值RSD%判断
17781.2617670.050.45数据可信
供试品溶液-24091302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%
5min171157-7115736.03639.3314.2036.0439.3314.20
289904-8990445.52945.53
393368-9336847.28447.28
469168-6916835.02835.03
573754-7375437.35137.35
668630-6863034.75634.76
10min1121250-12125061.40460.108.9961.4660.168.99
2123149-12314962.36662.44
3133848-13384867.78467.86
4118952-11895260.24060.30
5112812-11281257.13157.19
6102011-10201151.66151.72
15min1144122-14412272.98770.835.5873.1571.005.59
2142271-14227172.04972.23
3151019-15101976.48076.67
4138981-13898170.38370.54
5133829-13382967.77467.93
6129000-12900065.32965.47
20min1152750-15275077.35676.524.4777.6476.804.48
2153664-15366477.81978.12
3162285-16228582.18582.50
4148298-14829875.10275.38
5146420-14642074.15174.42
6143146-14314672.49272.75
30min1169303-16930385.73983.804.0286.1584.214.04
2164138-16413883.12383.55
3176359-17635989.31289.77
4164039-16403983.07383.47
5162039-16203982.06082.45
6156980-15698079.49879.87
45min1180098-18009891.20689.483.2591.7690.043.26
2175316-17531688.78489.35
3186506-18650694.45195.06
4174828-17482888.53789.08
5172624-17262487.42187.95
6170827-17082786.51187.02
60min1187546-18754694.97893.702.2795.6994.402.29
2183843-18384393.10293.82
3192130-19213097.29998.06
4184134-18413493.25093.94
5181497-18149791.91492.59
6180956-18095691.64092.29
极限1202352-202352102.47698.772.81103.3499.622.82
2194555-19455598.52799.40
3201134-201134101.859102.78
4191995-19199597.23198.07
5190098-19009896.27097.10
6190017-19001796.22997.03
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%
111.262015772020292014542008482013642014540.22
211.321993641993861993750.01
单位质量响应值RSD%判断
17891.1217612.631.11数据可信
供试品溶液-24091302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%
5min126170-2617013.23410.1930.1313.2310.1930.11
214960-149607.5657.57
324957-2495712.62112.62
424521-2452112.40012.40
518891-188919.5539.55
611367-113675.7485.75
10min150178-5017825.37520.9032.7025.4020.9232.70
226851-2685113.57913.59
349306-4930624.93424.96
446647-4664723.58923.61
553345-5334526.97726.99
621615-2161510.93110.94
15min165717-6571733.23330.6526.4333.3030.7026.43
245656-4565623.08823.12
366501-6650133.63033.69
461976-6197631.34131.40
584163-8416342.56142.62
639607-3960720.02920.06
20min187428-8742844.21241.7716.9244.3341.8816.93
277505-7750539.19439.27
384756-8475642.86142.98
474743-7474337.79837.91
5106124-10612453.66753.80
665072-6507232.90732.97
30min1124297-12429762.85760.528.5663.0560.698.59
2117300-11730059.31959.46
3125595-12559563.51463.70
4108041-10804154.63754.81
5134079-13407967.80468.03
6108753-10875354.99755.11
45min1152634-15263477.18775.634.1777.4975.904.21
2148905-14890575.30175.54
3154526-15452678.14478.44
4143488-14348872.56272.83
5156669-15666979.22879.56
6141083-14108371.34671.55
60min1168348-16834885.13483.942.5685.5684.342.60
2165064-16506483.47383.84
3170723-17072386.33586.76
4162675-16267582.26582.65
5169380-16938085.65686.12
6159789-15978980.80681.13
极限1181797-18179791.93591.560.9592.5092.100.97
2180493-18049391.27691.78
3183791-18379192.94393.51
4178643-17864390.34090.86
5181234-18123491.65092.26
6180376-18037691.21691.68
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%
111.262022462024002024322023322024512023720.05
211.322008332010842009580.09
单位质量响应值RSD%判断
17972.6517752.470.88数据可信
供试品溶液-24091302批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min124280-2428012.20213.0910.2012.2013.0910.20
224541-2454112.33312.33
324074-2407412.09912.10
430923-3092315.54115.54
527281-2728113.71013.71
625221-2522112.67512.67
10min138853-3885319.52620.689.1419.5520.709.13
236424-3642418.30518.33
339705-3970519.95419.97
447087-4708723.66423.69
543540-4354021.88121.90
641253-4125320.73220.75
15min150096-5009625.17626.506.1725.2326.556.17
248815-4881524.53224.58
351880-5188026.07326.13
457323-5732328.80828.87
555669-5566927.97728.04
652548-5254826.40826.46
20min158370-5837029.33430.494.3929.4330.594.40
257739-5773929.01729.11
360357-6035730.33330.43
464288-6428832.30832.42
563430-6343031.87731.98
659822-5982230.06430.16
30min168193-6819334.27135.312.9434.4135.462.96
268475-6847534.41334.55
369765-6976535.06135.21
473070-7307036.72236.89
572544-7254436.45736.62
669557-6955734.95635.11
45min176490-7649038.44139.411.9338.6439.621.95
277366-7736638.88139.08
378278-7827839.33939.54
480256-8025640.33340.56
580160-8016040.28540.50
677977-7797739.18839.40
60min181213-8121340.81441.591.3241.0841.871.34
282148-8214841.28441.55
382853-8285341.63841.91
483755-8375542.09242.39
584187-8418742.30942.60
682380-8238041.40141.67
极限185171-8517142.80343.380.7843.1443.730.79
286393-8639343.41743.75
386471-8647143.45743.80
487112-8711243.77944.14
586733-8673343.58843.95
686034-8603443.23743.58
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