非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.173823973823643823313821253823823823200.03
211.233799163802423800790.07
单位质量响应值RSD%判断
34227.3933844.970.80数据可信
供试品溶液-1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%
5min158590-5859015.48115.6814.2315.4815.6814.24
265175-6517517.22117.22
370394-7039418.60018.60
455313-5531314.61514.61
560784-6078416.06016.06
645881-4588112.12312.12
10min1140477-14047737.11738.509.7637.1438.529.76
2156194-15619441.27041.30
3163274-16327443.14043.17
4138758-13875836.66336.69
5151682-15168240.07840.10
6123793-12379332.70932.73
15min1175925-17592546.48348.836.9246.5748.926.92
2194358-19435851.35451.45
3197445-19744552.16952.27
4173746-17374645.90745.99
5197186-19718652.10152.19
6170284-17028444.99345.07
20min1195979-19597951.78254.505.7651.9554.675.77
2214818-21481856.75956.94
3215787-21578757.01657.21
4194953-19495351.51151.67
5220258-22025858.19758.38
6195703-19570351.70951.86
30min1220230-22023058.18961.004.0358.4461.264.04
2238268-23826862.95563.23
3237073-23707362.64062.92
4221835-22183558.61458.86
5241780-24178063.88364.16
6225936-22593659.69759.93
45min1240982-24098263.67366.332.9964.0266.693.00
2257095-25709567.93068.31
3254738-25473867.30767.70
4243786-24378664.41364.76
5259710-25971068.62169.00
6249860-24986066.01866.35
60min1253986-25398667.10969.452.4267.5669.922.44
2267850-26785070.77271.27
3265944-26594470.26870.77
4256392-25639267.74468.20
5269699-26969971.26071.76
6263176-26317669.53769.98
极限1266060-26606070.29971.651.5770.8772.241.59
2274576-27457672.54973.16
3272007-27200771.87072.49
4265946-26594670.26970.83
5275933-27593372.90773.52
6272504-27250472.00172.56
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.173793243795033793293793353791833793350.03
211.233783973785963784960.04
单位质量响应值RSD%判断
33960.1633704.010.54数据可信
供试品溶液-1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%
5min162087-6208716.50317.5927.7116.5017.5927.72
264460-6446017.13417.13
334328-343289.1259.12
471594-7159419.03019.03
575373-7537320.03520.03
689278-8927823.73123.73
10min1129493-12949334.42135.0811.4934.4535.1111.50
2119983-11998331.89331.92
3111320-11132029.59029.61
4143461-14346138.13338.17
5134804-13480435.83235.87
6152789-15278940.61340.65
15min1164300-16430043.67344.387.2943.7644.467.31
2153111-15311140.69940.78
3155568-15556841.35241.42
4178002-17800247.31547.41
5166736-16673644.32044.41
6183965-18396548.90049.01
20min1185893-18589349.41250.435.1849.5750.605.19
2176651-17665146.95647.11
3184318-18431848.99449.13
4199109-19910952.92553.10
5189390-18939050.34250.51
6203074-20307453.97954.17
30min1211716-21171656.27657.843.6956.5258.093.70
2205823-20582354.71054.94
3217948-21794857.93358.15
4224550-22455059.68859.95
5217961-21796157.93658.19
6227616-22761660.50360.78
45min1234292-23429262.27764.132.7362.6164.472.74
2232332-23233261.75662.08
3244561-24456165.00765.32
4246209-24620965.44565.81
5241572-24157264.21264.56
6248522-24852266.06066.44
60min1248401-24840166.02867.912.2366.4768.362.24
2248561-24856166.07066.49
3259825-25982569.06469.48
4259252-25925268.91269.38
5255795-25579567.99368.45
6261000-26100069.37769.87
极限1256469-25646968.17269.942.0068.7270.512.01
2257550-25755068.46068.99
3266890-26689070.94271.48
4266375-26637570.80571.39
5262298-26229869.72270.29
6269227-26922771.56372.17
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.173793673794033794793792413795603794100.04
211.233799943797743798840.05
单位质量响应值RSD%判断
33966.8833827.600.30数据可信
供试品溶液-1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%
5min148071-4807112.75310.3120.3312.7510.3120.31
226419-264197.0097.01
337427-374279.9299.93
436259-362599.6199.62
538180-3818010.12910.13
646790-4679012.41312.41
10min1142894-14289437.90931.7817.3137.9331.8017.30
293057-9305724.68824.70
3119773-11977331.77531.79
497145-9714525.77225.79
5128465-12846534.08134.10
6137430-13743036.46036.48
15min1245024-24502465.00456.2913.3065.0956.3613.31
2171731-17173145.56045.61
3218227-21822757.89557.96
4184269-18426948.88648.95
5223795-22379559.37259.45
6229940-22994061.00261.08
20min1293560-29356077.88173.415.8678.0773.575.87
2260012-26001268.98069.11
3259479-25947968.83969.01
4267425-26742570.94771.09
5292910-29291077.70877.88
6286794-28679476.08676.27
30min1323909-32390985.93283.623.6186.2583.913.61
2314263-31426383.37383.62
3294236-29423678.06078.34
4313706-31370683.22583.48
5325571-32557186.37386.68
6319585-31958584.78585.09
45min1342400-34240090.83889.153.2191.3089.583.21
2337837-33783789.62790.01
3315441-31544183.68684.10
4335516-33551689.01189.41
5346214-34621491.85092.30
6338809-33880989.88590.34
60min1350696-35069693.03991.673.0893.6692.253.08
2347497-34749792.19092.72
3324750-32475086.15586.71
4348160-34816092.36692.91
5355223-35522394.24094.84
6346922-34692292.03792.64
极限1360955-36095595.76094.692.3796.5395.422.37
2361672-36167295.95196.64
3340625-34062590.36791.06
4359045-35904595.25495.95
5363667-36366796.48097.24
6355534-35553494.32295.08
非奈利酮片项目信息
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D231201对照品来源自制对照品使用方法直接使用
对照品含量(%)99.92对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
111.173792953793153792393794373795423793660.04
211.233775423775893775660.01
单位质量响应值RSD%判断
33962.9433621.190.72数据可信
供试品溶液-1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%
5min1116884-11688431.10623.1428.2531.1123.1428.26
298232-9823226.14226.14
344347-4434711.80211.80
494676-9467625.19625.20
590708-9070824.14024.14
676775-7677520.43220.43
10min1238416-23841663.44956.5614.1163.5056.5914.12
2230775-23077561.41661.46
3156669-15666941.69441.71
4226737-22673760.34160.38
5220358-22035858.64458.68
6202138-20213853.79553.83
15min1274334-27433473.00871.414.8173.1771.554.84
2274974-27497473.17873.32
3243769-24376964.87464.96
4279161-27916174.29374.44
5264997-26499770.52370.66
6272826-27282672.60772.73
20min1290695-29069577.36277.753.0077.6478.003.02
2295251-29525178.57578.84
3276013-27601373.45573.65
4300669-30066980.01780.28
5292026-29202677.71677.97
6298280-29828079.38179.63
30min1311908-31190883.00884.602.2383.4284.982.24
2315903-31590384.07184.47
3307810-30781081.91782.24
4323962-32396286.21686.62
5324162-32416286.26986.65
6323642-32364286.13086.51
45min1328061-32806187.30689.722.1687.8590.242.16
2332522-33252288.49489.03
3331997-33199788.35488.81
4342526-34252691.15691.70
5346557-34655792.22992.76
6341118-34111890.78191.30
60min1336136-33613689.45592.412.2790.1593.082.25
2341701-34170190.93691.62
3344872-34487291.78092.38
4351183-35118393.46094.16
5358017-35801795.27995.96
6351441-35144193.52894.20
极限1341548-34154890.89693.922.4091.7494.742.39
2345951-34595192.06792.91
3351102-35110293.43894.19
4356569-35656994.89395.74
5364956-36495697.12597.97
6357247-35724795.07495.90
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