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 11.143911453891963911063902773889423901330.27
2 11.093848233859263853740.21
单位质量响应值RSD%判断
35020.9234749.680.55数据可信
供试品溶液-BXJUS91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%
5min156561-5656114.58117.5712.7314.5817.5712.73
278285-7828520.18120.18
373327-7332718.90318.90
459197-5919715.26015.26
573802-7380219.02519.03
667704-6770417.45317.45
10min1111012-11101228.61740.8116.2828.6440.8416.28
2175970-17597045.36345.40
3179803-17980346.35146.38
4160678-16067841.42141.45
5173236-17323644.65844.69
6149266-14926638.47938.51
15min1156105-15610540.24255.7214.8240.3155.8114.82
2242549-24254962.52662.63
3233976-23397660.31660.42
4223434-22343457.59857.69
5234789-23478960.52560.63
6205969-20596953.09653.19
20min1201135-20113551.85065.3010.5551.9965.4910.56
2272288-27228870.19270.41
3267725-26772569.01669.22
4261502-26150267.41267.60
5267382-26738268.92769.13
6249761-24976164.38564.57
30min1255406-25540665.84076.016.6766.0776.306.69
2307198-30719879.19179.52
3302928-30292878.09178.41
4300092-30009277.35977.66
5306070-30607078.90179.22
6297394-29739476.66476.95
45min1293116-29311675.56182.954.4875.9083.374.51
2328712-32871284.73785.20
3324533-32453383.66084.11
4323496-32349683.39383.82
5332498-33249885.71386.17
6328242-32824284.61685.03
60min1308333-30833379.48485.973.9179.9586.533.93
2337417-33741786.98187.58
3333377-33337785.94086.53
4335138-33513886.39486.96
5342248-34224888.22788.82
6344356-34435688.77089.33
极限1350337-35033790.31291.790.9090.9192.500.94
2356824-35682491.98492.73
3354856-35485691.47792.21
4357846-35784692.24892.96
5357093-35709392.05492.80
6359548-35954892.68693.39
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 11.143839423849703862093855933835043848440.30
2 11.093878433893853886140.29
单位质量响应值RSD%判断
34546.1435041.841.01数据可信
供试品溶液-BXJUS91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%
5min169559-6955917.97919.559.4317.9819.559.42
279571-7957120.56720.57
366184-6618417.10717.11
475076-7507619.40519.41
577311-7731119.98319.98
686088-8608822.25122.25
10min1161287-16128741.68841.298.7141.7241.328.71
2164097-16409742.41442.45
3132260-13226034.18534.21
4164832-16483242.60442.64
5171699-17169944.37944.41
6164350-16435042.48042.52
15min1220165-22016556.90657.068.8457.0157.178.84
2227963-22796358.92259.03
3183290-18329047.37547.46
4231834-23183459.92260.03
5238651-23865161.68461.79
6222771-22277157.58057.69
20min1259579-25957967.09466.236.3567.2966.426.35
2262622-26262267.88068.08
3225103-22510358.18358.35
4262530-26253067.85768.06
5272378-27237870.40270.61
6255177-25517765.95666.16
30min1300488-30048877.66876.543.6277.9776.853.63
2300345-30034577.63177.95
3276861-27686171.56171.82
4299402-29940277.38777.70
5307815-30781579.56179.89
6291927-29192775.45575.77
45min1328596-32859684.93383.582.3885.3784.022.39
2329921-32992185.27585.72
3313368-31336880.99781.38
4322327-32232783.31283.76
5330859-33085985.51885.98
6315208-31520881.47281.91
60min1343920-34392088.89486.932.2289.4787.512.22
2341609-34160988.29688.88
3329494-32949485.16585.68
4334846-33484686.54887.13
5342249-34224988.46289.06
6325920-32592084.24184.82
极限1360673-36067393.22492.031.0193.9592.751.02
2359593-35959392.94593.68
3352848-35284891.20191.86
4354714-35471491.68392.41
5356629-35662992.17892.93
6351879-35187990.95191.67
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 11.143855963849203841613855123838323848040.21
2 11.093848003845773846880.05
单位质量响应值RSD%判断
34542.5534687.830.30数据可信
供试品溶液-BXJUS91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%
5min129659-296597.7059.7617.267.719.7717.23
241515-4151510.78510.79
334011-340118.8368.84
438912-3891210.10910.11
547708-4770812.39412.39
633720-337208.7608.76
10min164076-6407616.64721.0712.0916.6621.0912.10
288466-8846622.98323.00
379508-7950820.65620.67
486460-8646022.46222.48
590715-9071523.56723.59
677492-7749220.13220.15
15min196091-9609124.96429.338.7925.0029.388.81
2120978-12097831.42931.49
3109442-10944228.43228.48
4119768-11976831.11531.17
5121510-12151031.56831.63
6109617-10961728.47828.53
20min1122644-12264431.86235.986.4631.9436.086.48
2146663-14666338.10238.21
3135515-13551535.20635.30
4142984-14298437.14637.25
5145688-14568837.84937.96
6137496-13749635.72135.82
30min1161154-16115441.86745.314.5942.0045.474.60
2182835-18283547.50047.67
3169260-16926043.97344.13
4177560-17756046.12946.30
5180397-18039746.86647.04
6175208-17520845.51845.67
45min1199655-19965551.86954.573.7252.0754.803.74
2220925-22092557.39557.65
3202677-20267752.65452.88
4211980-21198055.07155.32
5214409-21440955.70255.96
6210580-21058054.70854.94
60min1226873-22687358.94060.953.3559.2361.283.36
2247083-24708364.19164.54
3225437-22543758.56758.88
4235714-23571461.23761.57
5236926-23692661.55261.90
6235685-23568561.23061.55
极限1255590-25559066.40167.473.0366.7967.903.03
2275199-27519971.49571.95
3254230-25423066.04866.46
4257103-25710366.79467.23
5260223-26022367.60568.05
6255974-25597466.50166.92
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 11.143854503832533860243822513860843846120.46
2 11.093849643835003842320.27
单位质量响应值RSD%判断
34525.3134646.710.25数据可信
供试品溶液-BXJUS91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%
5min132330-323308.4069.226.298.419.226.27
237957-379579.8699.87
333604-336048.7378.74
437770-377709.8219.82
535521-355219.2369.24
635631-356319.2659.26
10min178096-7809620.30620.966.2920.3220.976.30
278831-7883120.49720.51
381224-8122421.11921.13
485661-8566122.27322.29
573104-7310419.00819.02
686657-8665722.53222.55
15min1110824-11082428.81629.476.2828.8629.526.28
2110069-11006928.61928.67
3115969-11596930.15330.20
4117691-11769130.60130.65
5102498-10249826.65126.70
6122976-12297631.97532.03
20min1136561-13656135.50836.205.0935.6036.305.09
2135758-13575835.29935.40
3141515-14151536.79636.90
4143933-14393337.42537.53
5128687-12868733.46033.55
6148859-14885938.70538.81
30min1172566-17256644.86945.512.9845.0245.673.00
2172921-17292144.96245.12
3177437-17743746.13646.30
4177475-17747546.14646.31
5167363-16736343.51743.66
6182430-18243047.43447.61
45min1207923-20792354.06354.851.5654.2955.081.57
2211131-21113154.89755.13
3211285-21128554.93755.18
4214469-21446955.76556.01
5206450-20645053.68053.90
6214390-21439055.74455.99
60min1232362-23236260.41761.081.2060.7461.411.21
2234117-23411760.87461.20
3237108-23710861.65161.98
4237063-23706361.64061.98
5231119-23111960.09460.40
6237811-23781161.83462.18
极限1255130-25513066.33766.660.7766.7667.090.78
2256646-25664666.73167.16
3256221-25622166.62167.05
4259478-25947867.46867.91
5253671-25367165.95866.37
6257115-25711566.85367.30
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