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%
111.023799183798193795403793083793023795770.08
211.083786113782423784260.07
单位质量响应值RSD%判断
34444.3734153.970.60数据可信
供试品溶液-BXK2XG1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%
5min188885-8888523.30521.4621.9123.3021.4621.91
273942-7394219.38719.39
3107963-10796328.30728.31
483240-8324021.82521.82
583560-8356021.90921.91
653420-5342014.00614.01
10min1199256-19925652.24348.2813.4252.2848.3213.43
2186757-18675748.96649.00
3222223-22222358.26558.31
4170021-17002144.57844.61
5175610-17561046.04346.08
6151038-15103839.60139.62
15min1249713-24971365.47363.806.7265.6063.916.74
2253230-25323066.39566.51
3266705-26670569.92870.07
4234181-23418161.40061.51
5235148-23514861.65461.77
6220957-22095757.93358.02
20min1281056-28105673.69172.903.7573.9373.123.77
2286484-28648475.11475.34
3292738-29273876.75377.01
4268734-26873470.46070.67
5272368-27236871.41371.63
6266809-26680969.95570.14
30min1319500-31950083.77082.352.0684.1382.702.08
2315587-31558782.74483.09
3322431-32243184.53984.93
4304815-30481579.92080.25
5309901-30990181.25381.59
6312340-31234081.89382.20
45min1343451-34345190.05088.151.7490.5588.631.75
2333213-33321387.36687.85
3341241-34124189.47190.00
4327864-32786485.96386.43
5333069-33306987.32887.80
6338396-33839688.72589.16
60min1352336-35233692.38090.581.5393.0391.211.53
2341655-34165589.57990.21
3348097-34809791.26891.95
4337916-33791688.59989.21
5344160-34416090.23690.85
6348723-34872391.43292.02
极限1364774-36477495.64195.210.8296.4495.990.81
2361197-36119794.70395.49
3361201-36120194.70495.53
4359681-35968194.30595.06
5367621-36762196.38797.15
6364393-36439395.54196.28
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%
111.023783393780803783353774653766883777810.19
211.083781553783133782340.03
单位质量响应值RSD%判断
34281.4034136.640.30数据可信
供试品溶液-BXK2XG1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%
5min175869-7586919.94419.466.8219.9419.466.82
266755-6675517.54917.55
373804-7380419.40219.40
470361-7036118.49618.50
575913-7591319.95619.96
681357-8135721.38721.39
10min1155085-15508540.76943.274.0540.8043.304.05
2164325-16432543.19843.23
3174222-17422245.79945.83
4159586-15958641.95241.98
5166736-16673643.83143.86
6167609-16760944.06144.10
15min1209991-20999155.20260.355.5355.3060.455.52
2229964-22996460.45360.55
3229902-22990260.43660.55
4247519-24751965.06865.17
5222992-22299258.62058.73
6236982-23698262.29862.41
20min1254818-25481866.98670.104.0567.1870.304.04
2267955-26795570.44070.64
3262974-26297469.13069.34
4284852-28485274.88275.09
5258107-25810767.85168.05
6271270-27127071.31171.52
30min1305235-30523580.24080.721.9880.5481.041.98
2307689-30768980.88581.20
3300773-30077379.06779.39
4318284-31828483.67084.00
5303207-30320779.70780.02
6307084-30708480.72681.06
45min1339020-33902089.12187.901.4489.5688.361.43
2333120-33312087.57088.02
3326676-32667685.87686.33
4338880-33888089.08589.56
5336762-33676288.52888.98
6331858-33185887.23987.70
60min1351656-35165692.44390.841.4293.0391.451.40
2344750-34475090.62891.23
3338857-33885789.07889.68
4346797-34679791.16691.79
5349851-34985191.96992.57
6341464-34146489.76490.38
极限1367386-36738696.57895.291.0097.3296.050.99
2364599-36459995.84596.60
3359127-35912794.40795.16
4364650-36465095.85996.63
5361122-36112294.93195.68
6358110-35811094.14094.90
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%
111.023776513774033771793777223775273774960.06
211.083783413779153781280.08
单位质量响应值RSD%判断
34255.5434127.080.27数据可信
供试品溶液-BXK2XG1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%
5min140016-4001610.5259.2415.3310.529.2415.32
226872-268727.0687.07
335937-359379.4529.45
440805-4080510.73210.73
536335-363359.5579.56
630813-308138.1048.10
10min199689-9968926.22021.6614.0026.2421.6714.00
270134-7013418.44618.46
379593-7959320.93420.95
492774-9277424.40124.42
578628-7862820.68020.70
673187-7318719.24919.26
15min1137560-13756036.18030.6511.8336.2430.7011.83
2104097-10409727.37927.42
3111638-11163829.36229.41
4129139-12913933.96634.02
5112531-11253129.59729.65
6104167-10416727.39827.44
20min1164723-16472343.32537.739.5243.4537.839.53
2132122-13212234.75034.84
3138694-13869436.47936.58
4155612-15561240.92841.04
5138652-13865236.46836.57
6130889-13088934.42634.52
30min1200931-20093152.84847.966.6853.0448.136.70
2173136-17313645.53745.68
3177160-17716046.59646.76
4193958-19395851.01451.20
5178014-17801446.82046.98
6170926-17092644.95645.10
45min1237754-23775462.53358.344.5362.8158.594.55
2214229-21422956.34556.57
3218829-21882957.55557.79
4230052-23005260.50760.78
5218591-21859157.49357.73
6211518-21151855.63255.86
60min1261239-26123968.71065.303.3169.1065.643.33
2241287-24128763.46263.78
3245215-24521564.49564.83
4254966-25496667.06067.43
5246377-24637764.80165.14
6240452-24045263.24363.56
极限1287121-28712175.51772.322.6176.0272.782.63
2269405-26940570.85871.28
3272248-27224871.60572.05
4280157-28015773.68674.17
5271410-27141071.38571.83
6269473-26947370.87571.30
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%
111.023788133789983787653788133787333788240.03
211.083794633794293794460.01
单位质量响应值RSD%判断
34376.0434246.030.27数据可信
供试品溶液-BXK2XG1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%
5min141699-4169910.9296.9633.6510.936.9633.66
217745-177454.6514.65
320381-203815.3425.34
425031-250316.5616.56
532291-322918.4638.46
622197-221975.8185.82
10min190911-9091123.82819.5714.9023.8519.5814.92
257826-5782615.15615.16
368764-6876418.02318.03
476487-7648720.04720.06
580355-8035521.06121.07
673708-7370819.31919.33
15min1127692-12769233.46829.798.9133.5329.838.93
299737-9973726.14126.17
3104820-10482027.47327.51
4113528-11352829.75529.80
5119563-11956331.33731.39
6116541-11654130.54530.59
20min1155075-15507540.64537.546.5640.7637.646.58
2131827-13182734.55234.63
3132796-13279634.80534.89
4142172-14217237.26337.36
5148903-14890339.02739.13
6148585-14858538.94439.04
30min1194241-19424150.91048.575.0351.0948.725.05
2176566-17656646.27746.41
3172002-17200245.08145.22
4184420-18442048.33648.49
5191606-19160650.21950.39
6193031-19303150.59350.75
45min1232643-23264360.97559.174.0161.2459.404.02
2218390-21839057.23957.45
3211219-21121955.36055.58
4227241-22724159.55959.80
5231407-23140760.65160.90
6233559-23355961.21561.46
60min1259175-25917567.92966.073.3268.3066.403.34
2246888-24688864.70965.02
3237645-23764562.28662.60
4253578-25357866.46266.80
5256690-25669067.27867.63
6258444-25844467.73768.08
极限1282126-28212673.94472.181.8374.4372.621.85
2271854-27185471.25271.67
3267970-26797070.23470.65
4275483-27548372.20372.65
5275869-27586972.30572.77
6278957-27895773.11473.57
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