非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833767843756373772193772093770663767830.18
210.903812063814393813220.05
单位质量响应值RSD%判断
34790.6734983.670.40数据可信
供试品溶液-BXKBZ61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%
5min169072-6907289.023101.379.2489.02101.379.24
277485-7748599.86799.87
390278-90278116.355116.35
482706-82706106.596106.60
574356-7435695.83495.83
678004-78004100.535100.54
10min1167146-167146215.426234.717.41215.92235.277.41
2177291-177291228.502229.06
3189994-189994244.874245.52
4203351-203351262.089262.68
5184699-184699238.049238.58
6170172-170172219.326219.88
15min1239909-239909309.207329.644.51310.90331.514.52
2248862-248862320.746322.57
3261510-261510337.047339.05
4271486-271486349.905351.95
5262899-262899338.837340.69
6249933-249933322.126323.90
20min1283862-283862365.856382.512.78369.26386.202.80
2297402-297402383.307386.91
3294137-294137379.099382.98
4308091-308091397.083401.08
5302499-302499389.876393.61
6294689-294689379.810383.38
30min1326695-326695421.061429.521.52426.50435.341.54
2333717-333717430.111435.85
3328605-328605423.523429.51
4339323-339323437.337443.53
5338295-338295436.012441.91
6332899-332899429.057434.73
45min1351401-351401452.903456.721.22460.68464.931.22
2355978-355978458.802466.93
3347954-347954448.461456.80
4355993-355993458.822467.45
5360474-360474464.597472.92
6354360-354360456.717464.78
60min1359815-359815463.748468.631.48474.04479.381.47
2366456-366456472.307482.98
3354747-354747457.216468.05
4365538-365538471.124482.30
5369651-369651476.425487.33
6365417-365417470.968481.57
极限1363918-363918469.036472.981.72481.91486.331.69
2370689-370689477.763491.06
3355782-355782458.550471.92
4369264-369264475.926489.72
5373367-373367481.214494.77
6368850-368850475.392488.61
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833797643800023794063805523800723799590.12
210.903819303816423817860.06
单位质量响应值RSD%判断
35083.9335026.240.12数据可信
供试品溶液-BXKBZ61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%
5min184407-84407108.266109.495.93108.27109.495.93
285156-85156109.227109.23
392417-92417118.540118.54
482986-82986106.443106.44
589310-89310114.555114.56
677876-7787699.88999.89
10min1191895-191895246.138245.405.49246.74246.015.49
2192694-192694247.162247.77
3205582-205582263.693264.35
4193349-193349248.003248.59
5191554-191554245.700246.34
6172859-172859221.721222.28
15min1259032-259032332.252345.712.28334.22347.682.27
2274647-274647352.281354.26
3272697-272697349.780351.90
4274830-274830352.516354.48
5269937-269937346.240348.24
6265990-265990341.177342.96
20min1297848-297848382.040392.861.39385.85396.751.39
2308262-308262395.398399.33
3308925-308925396.248400.31
4308932-308932396.257400.18
5307313-307313394.180398.11
6306430-306430393.048396.73
30min1329359-329359422.458432.181.16428.40438.261.16
2337655-337655433.099439.23
3339615-339615435.613441.88
4337904-337904433.419439.55
5340004-340004436.112442.23
6337095-337095432.381438.25
45min1346770-346770444.791455.941.29453.07464.411.29
2355376-355376455.829464.37
3360082-360082461.866470.55
4355708-355708456.255464.79
5357407-357407458.434466.97
6357426-357426458.459466.73
60min1356859-356859457.732467.621.21468.49478.631.21
2361916-361916464.218475.29
3367359-367359471.200482.45
4365836-365836469.246480.32
5368543-368543472.718483.80
6366900-366900470.611481.43
极限1360221-360221462.044470.281.40475.34483.891.38
2363825-363825466.667480.32
3370486-370486475.210489.08
4362306-362306464.718478.40
5371718-371718476.791490.50
6371306-371306476.262489.69
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833818383823953825733811203804403816730.24
210.903791953817743804840.48
单位质量响应值RSD%判断
35242.2034906.790.68数据可信
供试品溶液-BXKBZ61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%
5min1113026-113026144.898172.219.37144.90172.219.37
2150909-150909193.463193.46
3139963-139963179.431179.43
4135410-135410173.594173.59
5129650-129650166.210166.21
6137036-137036175.678175.68
10min1265622-265622340.524346.852.95341.33347.812.95
2279031-279031357.714358.79
3279411-279411358.201359.20
4266028-266028341.044342.01
5273361-273361350.445351.37
6259878-259878333.160334.14
15min1339905-339905435.754436.671.75438.45439.561.74
2343295-343295440.100443.16
3332483-332483426.239429.23
4336851-336851431.838434.70
5350028-350028448.731451.60
6341161-341161437.364440.19
20min1356213-356213456.660459.731.09461.78465.041.10
2363660-363660466.207471.71
3355839-355839456.181461.54
4357875-357875458.791464.05
5363272-363272465.710471.07
6354778-354778454.821460.08
30min1360812-360812462.556466.291.20470.21474.161.21
2368550-368550472.476480.57
3362686-362686464.959472.85
4366050-366050469.271477.08
5367230-367230470.784478.73
6357041-357041457.722465.51
45min1359106-359106460.369464.581.61470.59475.041.61
2367667-367667471.344482.07
3361579-361579463.539474.01
4363547-363547466.062476.48
5369185-369185473.290483.86
6353266-353266452.882463.21
60min1358940-358940460.156462.991.24472.94476.021.24
2364594-364594467.405480.75
3361213-361213463.070476.12
4365030-365030467.964480.97
5363790-363790466.374479.57
6353316-353316452.946465.79
极限1361154-361154462.995464.251.09478.33479.861.09
2365857-365857469.024484.96
3362318-362318464.487480.11
4365353-365353468.378483.98
5363135-363135465.534481.32
6354974-354974455.072470.43
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833805863803173804503803483812523805910.11
210.903825343854903840120.55
单位质量响应值RSD%判断
35142.2935230.460.18数据可信
供试品溶液-BXKBZ61批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1126253-126253161.337172.887.46161.34172.887.46
2132728-132728169.611169.61
3141066-141066180.266180.27
4121409-121409155.147155.15
5145442-145442185.858185.86
6144813-144813185.054185.05
10min1273715-273715349.776374.417.55350.67375.377.55
2285051-285051364.262365.20
3292506-292506373.788374.79
4268077-268077342.571343.43
5319809-319809408.678409.71
6318815-318815407.408408.44
15min1352418-352418450.349456.491.17453.19459.531.17
2360288-360288460.406463.37
3352576-352576450.551453.63
4360763-360763461.013463.78
5355834-355834454.714458.02
6361455-361455461.897465.19
20min1353539-353539451.781458.370.94457.12463.950.94
2361341-361341461.752467.28
3355771-355771454.634460.21
4361481-361481461.930467.26
5358856-358856458.576464.41
6361198-361198461.569467.43
30min1357096-357096456.327462.711.07464.18470.831.07
2366554-366554468.413476.50
3357958-357958457.428465.54
4363193-363193464.118472.01
5362323-362323463.006471.38
6365414-365414466.956475.38
45min1356161-356161455.132462.531.06465.52473.221.04
2364567-364567465.874476.57
3361057-361057461.389472.04
4367466-367466469.579480.05
5360742-360742460.986471.94
6361692-361692462.200473.22
60min1357119-357119456.356461.980.86469.27475.240.88
2362398-362398463.102476.38
3359215-359215459.035472.25
4362474-362474463.199476.28
5361802-361802462.341475.85
6366113-366113467.850481.43
极限1354465-354465452.965461.731.21468.42477.561.20
2364850-364850466.236482.09
3358088-358088457.595473.36
4365406-365406466.946482.60
5361081-361081461.419477.50
6364042-364042465.203481.39
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.833831393833833863633852023825983841370.42
210.903839893831923835900.15
单位质量响应值RSD%判断
35469.7135191.740.56数据可信
供试品溶液-BXKBZ61批
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min15790-57907.3696.769.787.376.769.77
25339-53396.7956.79
35076-50766.4606.46
44832-48326.1506.15
56042-60427.6907.69
64766-47666.0666.07
10min117181-1718121.86619.389.1121.9119.429.11
215212-1521219.36019.40
315060-1506019.16719.20
414996-1499619.08519.12
515958-1595820.30920.35
612951-1295116.48216.52
15min130116-3011638.32833.4612.3338.4933.6012.31
224361-2436131.00431.15
324327-2432730.96031.10
426287-2628733.45533.60
530211-3021138.44938.60
622427-2242728.54228.67
20min136445-3644546.38340.6810.8346.7641.0110.83
229146-2914637.09437.41
329751-2975137.86338.18
432303-3230341.11141.44
535739-3573945.48445.85
628413-2841336.16136.44
30min144706-4470656.89651.608.0757.5352.168.09
237854-3785448.17648.70
337683-3768347.95848.48
442156-4215653.65154.21
543450-4345055.29855.92
637434-3743447.64148.13
45min153051-5305167.51762.896.8868.4763.746.90
246090-4609058.65859.45
347693-4769360.69861.49
451421-5142165.44266.29
552748-5274867.13168.06
645508-4550857.91758.67
60min158861-5886174.91170.976.2876.2472.176.31
251538-5153865.59166.71
354384-5438469.21370.34
458467-5846774.41075.63
559177-5917775.31376.62
652179-5217966.40767.48
极限162164-6216479.11576.565.4380.8678.155.47
256145-5614571.45572.94
358127-5812773.97775.49
461564-6156478.35179.98
564902-6490282.59984.32
658026-5802673.84975.29
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