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1000
标示量(mg)10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%
1 10.831862261855301861951861591861371860490.16
2 10.811844241851721847980.29
单位质量响应值RSD%判断
17179.0417095.100.35数据可信
供试品溶液-2025042521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%
5min116309-163098.5589.3638.998.569.3638.99
225808-2580813.54313.54
314505-145057.6127.61
49421-94214.9444.94
514159-141597.4307.43
626798-2679814.06314.06
10min174332-7433239.00640.6821.1239.0240.6921.13
278358-7835841.11941.14
375627-7562739.68639.70
459257-5925731.09631.10
569559-6955936.50236.51
6107980-10798056.66456.69
15min1121901-12190163.96963.679.1764.0563.759.18
2122424-12242464.24364.33
3127550-12755066.93367.01
4106661-10666155.97156.03
5111670-11167058.60058.67
6137729-13772972.27572.39
20min1143152-14315275.12073.074.8475.3173.264.86
2140087-14008773.51273.71
3143864-14386475.49475.68
4129974-12997468.20568.36
5132003-13200369.27069.44
6146392-14639276.82177.06
30min1153250-15325080.42078.562.6380.7378.872.65
2148372-14837277.86078.18
3152978-15297880.27780.59
4144958-14495876.06876.34
5145503-14550376.35476.64
6153184-15318480.38580.75
45min1159285-15928583.58681.662.0584.0382.102.07
2155072-15507281.37681.83
3158344-15834483.09383.54
4152029-15202979.77980.17
5151838-15183879.67980.09
6157157-15715782.47082.97
60min1161832-16183284.92383.081.8485.5183.661.86
2157267-15726782.52783.11
3161376-16137684.68485.27
4154978-15497881.32681.85
5155520-15552081.61182.16
6158967-15896783.42084.06
极限1173784-17378491.19589.891.0591.9290.601.07
2170665-17066589.55890.28
3173151-17315190.86391.59
4169486-16948688.94089.60
5169643-16964389.02289.70
6171054-17105489.76290.54
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1000
标示量(mg)10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%
1 10.831838831843671839391838541840281840140.12
2 10.811838771838291838530.02
单位质量响应值RSD%判断
16991.1417007.680.07数据可信
供试品溶液-BXK5AZ2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%
5min116422-164228.6877.6422.268.697.6422.25
219107-1910710.10810.11
310336-103365.4685.47
414579-145797.7127.71
514706-147067.7807.78
611451-114516.0586.06
10min161224-6122432.38826.6513.3832.4026.6613.38
254746-5474628.96128.98
344788-4478823.69323.70
449180-4918026.01726.03
549489-4948926.18026.19
642848-4284822.66722.68
15min1104850-10485055.46647.2710.0355.5347.3310.03
294821-9482150.16150.23
387417-8741746.24446.29
483408-8340844.12344.18
584686-8468644.79944.86
680990-8099042.84442.89
20min1122116-12211664.60058.786.9664.7658.926.97
2115993-11599361.36161.51
3114865-11486560.76460.89
4104494-10449455.27855.41
5106981-10698156.59456.72
6102238-10223854.08554.20
30min1131119-13111969.36368.741.7669.6368.981.75
2128948-12894868.21468.47
3132903-13290370.30770.53
4126148-12614866.73366.96
5130501-13050169.03669.26
6130059-13005968.80269.01
45min1137276-13727672.62072.951.5773.0073.301.56
2136037-13603771.96572.33
3140454-14045474.30174.65
4135196-13519671.52071.85
5138169-13816973.09273.43
6140254-14025474.19574.52
60min1140547-14054774.35075.061.5774.8675.531.55
2140532-14053274.34274.83
3144593-14459376.49176.96
4139242-13924273.66074.11
5141908-14190875.07075.53
6144480-14448076.43176.88
极限1175265-17526592.71693.270.7893.3593.870.77
2174633-17463392.38292.99
3177998-17799894.16294.76
4175568-17556892.87793.45
5176755-17675593.50594.09
6177701-17770194.00594.58
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1000
标示量(mg)10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%
1 10.831847741847241844921847251840681845570.16
2 10.811832391829421830900.12
单位质量响应值RSD%判断
17041.2716937.100.44数据可信
供试品溶液-2025042521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%
5min11302-13020.6890.6153.740.690.6153.79
21461-14610.7730.77
31788-17880.9460.95
41002-10020.5300.53
51352-13520.7160.72
6-0.0000.00
10min15628-56282.9793.0015.162.983.0015.21
26871-68713.6373.64
36119-61193.2393.24
45504-55042.9132.91
55610-56102.9702.97
64252-42522.2512.25
15min19460-94605.0075.3310.695.015.3410.69
210818-108185.7265.73
311647-116476.1656.17
49333-93334.9404.95
510425-104255.5185.52
68765-87654.6404.64
20min112329-123296.5267.016.956.547.036.94
213645-136457.2237.24
314634-146347.7467.76
412350-123506.5376.55
513765-137657.2867.30
612761-127616.7556.77
30min116769-167698.8769.285.618.909.305.64
217561-175619.2969.32
319110-1911010.11510.15
416542-165428.7568.78
518193-181939.6309.66
616959-169598.9779.00
45min121406-2140611.33111.763.7811.3711.803.77
222065-2206511.68011.72
323705-2370512.54812.59
421737-2173711.50611.55
522647-2264711.98812.03
621763-2176311.52011.56
60min124696-2469613.07213.653.0513.1313.723.06
225661-2566113.58313.65
326883-2688314.23014.30
426000-2600013.76313.82
526330-2633013.93714.00
625207-2520713.34313.40
极限136608-3660819.37817.959.7919.4618.039.77
236915-3691519.54019.63
332481-3248117.19317.28
430260-3026016.01816.10
536989-3698919.57919.67
630179-3017915.97516.05
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1000
标示量(mg)10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%
1 10.831836591838961844131836671835771838420.19
2 10.811831891839391835640.29
单位质量响应值RSD%判断
16975.2516980.940.03数据可信
供试品溶液-BXK5AZ2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%
5min11552-15520.8221.0640.780.821.0640.80
23585-35851.8991.90
32044-20441.0831.08
41593-15930.8440.84
51787-17870.9470.95
61389-13890.7360.74
10min15382-53822.8513.3934.972.853.4035.01
210828-108285.7355.74
36470-64703.4273.43
45617-56172.9752.98
55448-54482.8862.89
64689-46892.4842.48
15min110939-109395.7946.1622.265.806.1622.27
216385-163858.6798.69
311223-112235.9445.95
49664-96645.1195.13
512333-123336.5326.54
69211-92114.8794.88
20min114632-146327.7508.0016.777.778.0216.80
219509-1950910.33310.36
314386-143867.6207.64
412905-129056.8356.85
516406-164068.6908.71
612781-127816.7706.78
30min119534-1953410.34710.5411.7810.3810.5811.82
223961-2396112.69112.74
319133-1913310.13410.16
417900-179009.4819.51
521167-2116711.21211.24
617744-177449.3989.42
45min124937-2493713.20813.197.2713.2513.247.31
227623-2762314.63114.70
324182-2418212.80812.86
423410-2341012.40012.44
526362-2636213.96314.01
622885-2288512.12212.16
60min128396-2839615.04114.895.5515.1114.965.60
230146-3014615.96716.06
328194-2819414.93415.00
426634-2663414.10714.17
529272-2927215.50515.58
626020-2602013.78213.84
极限131831-3183116.86017.788.6416.9517.888.62
235450-3545018.77718.89
331097-3109716.47116.56
437190-3719019.69819.78
535712-3571218.91619.02
630163-3016315.97616.06
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