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)0
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 11.143822883820243830423823973821253823750.11
2 11.093817063807423812240.18
单位质量响应值RSD%判断
34324.5134375.470.11数据可信
供试品溶液-2025061021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%
5min191205-9120523.87728.4913.1223.8828.5013.12
2106646-10664627.92027.92
3121836-12183631.89731.90
4112292-11229229.39829.40
5126597-12659733.14333.14
694468-9446824.73224.73
10min1148701-14870138.93043.706.1938.9743.746.19
2169190-16919044.29444.34
3174059-17405945.56945.62
4169212-16921244.30044.35
5177840-17784046.55846.61
6162431-16243142.52442.57
15min1181586-18158647.53951.063.9647.6451.183.98
2196740-19674051.50651.63
3201134-20113452.65752.79
4195617-19561751.21251.34
5203213-20321353.20153.33
6191942-19194250.25050.36
20min1202244-20224452.94755.602.9253.1355.802.93
2214123-21412356.05756.26
3218251-21825157.13857.35
4212021-21202155.50755.72
5218635-21863557.23957.46
6208947-20894754.70254.90
30min1228005-22800559.69261.051.7859.9661.351.80
2232546-23254660.88061.18
3237730-23773062.23862.55
4233144-23314461.03761.34
5238188-23818862.35762.67
6229612-22961260.11260.40
45min1249543-24954365.33065.771.3365.7066.171.35
2250787-25078765.65666.06
3255767-25576766.96067.38
4250368-25036865.54665.95
5254353-25435366.58967.01
6246576-24657664.55364.94
60min1261706-26170668.51468.601.1468.9969.111.16
2260373-26037368.16568.68
3265372-26537269.47470.00
4261451-26145168.44868.96
5265567-26556769.52570.06
6257823-25782367.49867.99
极限1268270-26827070.23370.191.1470.8370.821.15
2267811-26781170.11370.74
3271505-27150571.08071.72
4267936-26793670.14570.77
5270464-27046470.80771.45
6262726-26272668.78169.39
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)0
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 11.143807563806593808193806993813803808630.08
2 11.093804743799873802300.10
单位质量响应值RSD%判断
34188.7834285.840.21数据可信
供试品溶液-2025061021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%
5min195027-9502724.96024.3810.2124.9624.3810.21
2110450-11045029.01129.01
391597-9159724.05924.06
483744-8374421.99622.00
586690-8669022.77022.77
689426-8942623.48923.49
10min1158974-15897441.75640.695.1141.8040.735.12
2168749-16874944.32444.37
3148426-14842638.98639.03
4154484-15448440.57740.61
5150521-15052139.53639.57
6148301-14830138.95338.99
15min1188370-18837049.47848.683.5449.5948.783.55
2196007-19600751.48351.61
3179365-17936547.11247.22
4187420-18742049.22849.33
5181517-18151747.67747.78
6179240-17924047.07947.18
20min1206251-20625154.17453.632.4754.3753.822.48
2212405-21240555.79156.00
3199650-19965052.44052.62
4205599-20559954.00354.19
5202293-20229353.13553.32
6198792-19879252.21552.40
30min1228547-22854760.03059.591.5560.3159.871.56
2232574-23257461.08861.39
3225830-22583059.31759.59
4227411-22741159.73260.01
5224300-22430058.91559.19
6222624-22262458.47558.74
45min1246345-24634564.70564.471.3365.0964.851.34
2251119-25111965.95966.36
3242987-24298763.82364.19
4245516-24551664.48864.86
5244935-24493564.33564.71
6241808-24180863.51463.88
60min1258295-25829567.84467.681.0768.3468.161.08
2262311-26231168.89969.41
3256055-25605567.25667.73
4256907-25690767.48067.96
5258201-25820167.81968.30
6254141-25414166.75367.23
极限1265227-26522769.66570.151.6170.2770.751.59
2268961-26896170.64671.27
3274751-27475172.16672.75
4266029-26602969.87670.47
5264972-26497269.59870.19
6262601-26260168.97569.56
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)0
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 11.143805923799603800563790593795953798520.15
2 11.093802733799043800880.07
单位质量响应值RSD%判断
34098.0334273.040.37数据可信
供试品溶液-2025083121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%
5min19069-90692.3862.9020.142.392.9020.06
29537-95372.5092.51
315297-152974.0244.02
410952-109522.8812.88
510652-106522.8022.80
610606-106062.7902.79
10min121645-216455.6945.6713.715.705.6813.74
219159-191595.0405.04
327142-271427.1407.15
421750-217505.7225.73
520394-203945.3655.37
619257-192575.0665.07
15min128775-287757.5707.4811.367.587.5011.35
226177-261776.8866.90
334451-344519.0639.08
428631-286317.5327.55
527188-271887.1527.17
625419-254196.6876.70
20min133307-333078.7628.819.768.798.849.76
232173-321738.4638.49
339451-3945110.37810.41
434135-341358.9809.01
532100-321008.4448.47
629781-297817.8347.86
30min142404-4240411.15511.037.6611.2011.077.65
241066-4106610.80310.84
347378-4737812.46312.51
442545-4254511.19211.23
540404-4040410.62910.67
637678-376789.9129.95
45min152337-5233713.76813.487.6513.8313.547.66
251335-5133513.50413.56
357615-5761515.15615.23
451541-5154113.55813.62
548606-4860612.78612.84
645965-4596512.09212.15
60min156720-5672014.92115.107.7315.0015.187.75
256685-5668514.91214.99
365277-6527717.17217.27
458038-5803815.26715.35
556169-5616914.77614.85
651618-5161813.57913.65
极限168522-6852218.02517.077.3118.1317.187.31
262348-6234816.40116.50
371942-7194218.92519.05
465357-6535717.19317.30
562293-6229316.38716.49
658878-5887815.48815.59
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)0
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 11.143789143793253798133786913794243792330.12
2 11.093793873791233792550.05
单位质量响应值RSD%判断
34042.4634197.930.33数据可信
供试品溶液-2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%
5min16300-63001.6601.587.701.661.587.77
25431-54311.4311.43
36092-60921.6061.61
45475-54751.4431.44
56601-66011.7401.74
66010-60101.5841.58
10min123092-230926.0865.566.476.095.566.47
219171-191715.0535.06
320263-202635.3415.34
420633-206335.4385.44
521794-217945.7445.75
621572-215725.6865.69
15min135278-352789.2988.348.299.318.358.28
228792-287927.5897.60
328785-287857.5877.60
431434-314348.2858.30
531716-317168.3598.37
633843-338438.9208.93
20min142317-4231711.15310.137.4511.1810.167.45
235276-352769.2979.32
335942-359429.4739.50
437344-373449.8439.87
538397-3839710.12010.15
641351-4135110.89910.93
30min151185-5118513.49112.497.5613.5412.537.57
243251-4325111.39911.44
343527-4352711.47211.51
447055-4705512.40212.44
547663-4766312.56212.61
651567-5156713.59113.64
45min160528-6052815.95314.877.0816.0214.937.08
252333-5233313.79313.85
351469-5146913.56513.62
456150-5615014.79914.86
556909-5690914.99915.06
661026-6102616.08416.15
60min166024-6602417.40216.434.4917.5016.524.52
258935-5893515.53315.61
359179-5917915.59715.68
462672-6267216.51816.61
562970-6297016.59716.69
664199-6419916.92117.02
极限173644-7364419.41019.193.6119.5319.303.59
269995-6999518.44818.55
374280-7428019.57819.69
476776-7677620.23520.35
571951-7195118.96419.08
670127-7012718.48318.61
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