非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.903544935538353683516535351353740.40
210.993590135855358780.10
单位质量响应值RSD%判断
3245.323264.600.42数据可信
供试品溶液-6042701批-多替诺雷-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%
5min12944-29448.1159.389.428.129.389.42
23564-35649.8249.82
33555-35559.7999.80
43797-379710.46610.47
53464-34649.5489.55
63095-30958.5318.53
10min17587-758720.91322.104.2820.9322.124.29
28490-849023.40223.42
38239-823922.71022.73
48177-817722.54022.56
57887-788721.74021.76
67720-772021.28021.29
15min110790-1079029.74230.171.8929.7930.221.90
211139-1113930.70430.76
311114-1111430.63530.69
411140-1114030.70730.76
510791-1079129.74529.80
610696-1069629.48329.53
20min112714-1271435.04635.512.0035.1435.622.01
213127-1312736.18436.29
313188-1318836.35236.46
412931-1293135.64435.75
512841-1284135.39635.50
612501-1250134.45934.56
30min115212-1521241.93142.651.6142.0942.811.61
215808-1580843.57443.74
315620-1562043.05643.22
415483-1548342.67842.84
515557-1555742.88243.04
615159-1515941.78541.94
45min117903-1790349.34949.501.6249.5849.741.62
218287-1828750.40750.65
318223-1822350.23150.47
417985-1798549.57549.81
517877-1787749.27749.51
617478-1747848.17748.40
60min119593-1959354.00754.301.2554.3254.621.26
220024-2002455.19555.52
319892-1989254.83255.15
419663-1966354.20054.52
519717-1971754.34954.66
619315-1931553.24153.55
90min121991-2199160.61760.651.2061.0261.061.20
222286-2228661.43061.85
322206-2220661.21061.62
421963-2196360.54060.95
522036-2203660.74161.15
621532-2153259.35259.75
120min123677-2367765.26565.021.0765.7665.531.07
223813-2381365.64066.16
323792-2379265.58266.10
423488-2348864.74465.25
523622-2362265.11365.62
623139-2313963.78264.28
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限124105-2410566.44566.361.1067.0566.971.11
224471-2447167.45368.08
324117-2411766.47867.10
423996-2399666.14466.76
524104-2410466.44267.06
623648-2364865.18565.78
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.862642292653432645352636952646242644850.23
211.102695112694842694980.01
单位质量响应值RSD%判断
24354.0524279.100.22数据可信
供试品溶液-6042701批-非布司他-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%
5min12136-21360.7900.917.230.790.917.42
22565-25650.9480.95
32416-24160.8930.89
42638-26380.9750.98
52478-24780.9160.92
62558-25580.9460.95
10min14202-42021.5541.523.601.561.523.78
24102-41021.5171.52
34132-41321.5281.53
43847-38471.4221.42
54096-40961.5141.52
64284-42841.5841.59
15min14666-46661.7251.755.061.731.765.14
24693-46931.7351.74
34995-49951.8471.85
45063-50631.8721.88
54430-44301.6381.64
64623-46231.7091.71
20min14873-48731.8021.841.851.811.841.78
25008-50081.8521.86
35037-50371.8621.87
45103-51031.8871.89
54891-48911.8081.82
64916-49161.8181.82
30min15197-51971.9221.862.371.931.872.37
25149-51491.9041.91
35041-50411.8641.87
45014-50141.8541.86
54877-48771.8031.81
64957-49571.8331.84
45min15603-56032.0721.925.442.081.935.32
25328-53281.9701.98
35000-50001.8491.86
45210-52101.9261.94
54777-47771.7661.78
65215-52151.9281.94
60min15429-54292.0071.923.672.021.933.64
25274-52741.9501.97
35122-51221.8941.91
45209-52091.9261.94
54855-48551.7951.81
65197-51971.9221.94
90min15152-51521.9051.912.201.921.942.14
25221-52211.9301.95
35216-52161.9291.95
45353-53531.9792.00
55021-50211.8571.88
65102-51021.8861.91
120min15147-51471.9031.853.171.931.883.24
25069-50691.8741.90
35202-52021.9231.95
44786-47861.7701.79
55007-50071.8511.87
64875-48751.8031.83
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15161-51611.9081.891.951.931.921.83
25006-50061.8511.88
35060-50601.8711.90
45238-52381.9371.96
55022-50221.8571.88
65209-52091.9261.95
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.903516335342352803546735343353190.32
210.993627536215362450.12
单位质量响应值RSD%判断
3240.283298.001.25数据可信
供试品溶液-6042702批-多替诺雷-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%
5min13230-32308.86510.1716.218.8710.1716.19
24522-452212.41212.41
32809-28097.7107.71
43926-392610.77610.78
53891-389110.68010.68
63852-385210.57310.57
10min17735-773521.23022.255.5621.2522.265.56
28696-869623.86823.89
37439-743920.41820.43
48287-828722.74522.76
58156-815622.38622.40
68322-832222.84122.86
15min110614-1061429.13229.663.3729.1829.713.37
211223-1122330.80430.86
310188-1018827.96328.01
411008-1100830.21430.27
510841-1084129.75529.81
610965-1096530.09630.15
20min112563-1256334.48234.991.6834.5835.091.70
213079-1307935.89836.01
312503-1250334.31734.41
412892-1289235.38535.49
512685-1268534.81734.92
612761-1276135.02535.13
30min115068-1506841.35741.951.1441.5142.111.15
215477-1547742.48042.65
315094-1509441.42941.58
415452-1545242.41142.58
515327-1532742.06842.23
615284-1528441.95042.11
45min117715-1771548.62248.840.6648.8549.070.65
217848-1784848.98749.23
317951-1795149.27049.49
417867-1786749.04049.28
517743-1774348.69948.93
617634-1763448.40048.63
60min119365-1936553.15153.320.8053.4653.630.79
219352-1935253.11553.44
319494-1949453.50553.81
419707-1970754.09054.41
519339-1933953.08053.39
619294-1929452.95653.27
90min121710-2171059.58760.160.9159.9860.560.91
221837-2183759.93660.35
322214-2221460.97161.36
422094-2209460.64161.05
521916-2191660.15360.56
621744-2174459.68160.08
120min123292-2329263.93064.200.6364.4264.700.63
223455-2345564.37764.89
323520-2352064.55565.05
423576-2357664.70965.22
523219-2321963.72964.23
623274-2327463.88064.38
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限123838-2383865.42865.380.8966.0365.990.87
223803-2380365.33265.95
324194-2419466.40567.01
423793-2379365.30565.92
523742-2374265.16565.77
623550-2355064.63865.25
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.862637482635682642382641332642352639840.12
211.102755732747362751540.22
单位质量响应值RSD%判断
24307.9224788.651.39数据可信
供试品溶液-6042702批-非布司他-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%
5min13213-32131.1771.199.721.181.199.75
23821-38211.4001.40
33195-31951.1701.17
43191-31911.1691.17
52844-28441.0421.04
63253-32531.1921.19
10min14323-43231.5831.611.881.591.611.72
24537-45371.6621.66
34326-43261.5851.59
44416-44161.6181.62
54338-43381.5891.59
64396-43961.6101.61
15min14786-47861.7531.823.411.761.823.29
25130-51301.8791.88
34941-49411.8101.81
45206-52061.9071.91
54878-48781.7871.79
64836-48361.7711.78
20min14925-49251.8041.863.521.811.873.44
25071-50711.8571.87
35208-52081.9081.92
45257-52571.9261.93
55179-51791.8971.90
64801-48011.7591.77
30min15337-53371.9551.924.311.971.924.21
25137-51371.8821.89
35607-56072.0542.06
45249-52491.9231.93
55023-50231.8401.85
65013-50131.8361.85
45min15453-54531.9971.922.982.011.942.92
25172-51721.8941.91
35341-53411.9561.97
45340-53401.9561.97
55066-50661.8561.87
65092-50921.8651.88
60min15199-51991.9041.884.621.921.904.58
25258-52581.9261.94
35498-54982.0142.03
45023-50231.8401.86
54793-47931.7561.77
65085-50851.8631.88
90min15164-51641.8921.873.001.911.893.04
24969-49691.8201.84
35161-51611.8901.91
45376-53761.9691.99
55006-50061.8341.85
65007-50071.8341.85
120min15349-53491.9591.914.601.981.944.55
24986-49861.8261.85
35371-53711.9671.99
45210-52101.9081.93
54909-49091.7981.82
65530-55302.0262.05
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限15222-52221.9131.892.321.941.922.32
25007-50071.8341.86
35160-51601.8901.92
45354-53541.9611.99
55191-51911.9011.93
65081-50811.8611.89
非布司他多替诺雷片项目信息
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241101对照品来源ZZ对照品使用方法直接使用
对照品含量(%)99.69对照品水分(%)0对照品稀释倍数5000
标示量(mg)2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%
110.903611036253360913617436248361750.21
210.993549635440354680.12
单位质量响应值RSD%判断
3318.813227.301.98数据可信
供试品溶液-6042703批-多替诺雷-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%
5min13645-36459.99410.079.799.9910.079.77
24013-401311.00311.00
33712-371210.17710.18
43137-31378.6018.60
54101-410111.24411.24
63434-34349.4159.42
10min18279-827922.69923.153.7122.7223.173.71
28842-884224.24224.26
38311-831122.78722.80
48004-800421.94521.96
58747-874723.98224.00
68487-848723.26923.28
15min111012-1101230.19230.421.7130.2530.481.71
211159-1115930.59530.65
311138-1113830.53730.59
410763-1076329.50929.56
511204-1120430.71830.78
611304-1130430.99331.05
20min113057-1305735.79935.491.0035.9035.601.00
213033-1303335.73335.84
312873-1287335.29435.40
412721-1272134.87834.98
513028-1302835.71935.83
612956-1295635.52235.63
30min115456-1545642.37642.420.5442.5442.580.53
215598-1559842.76642.93
315517-1551742.54442.71
415477-1547742.43442.59
515355-1535542.09942.27
615430-1543042.30542.47
45min117992-1799249.32949.470.6449.5649.710.64
217899-1789949.07449.31
318139-1813949.73249.97
417951-1795149.21749.45
518188-1818849.86750.11
618096-1809649.61449.85
60min119664-1966453.91454.190.5054.2354.500.49
219788-1978854.25454.58
319942-1994254.67654.99
419742-1974254.12754.44
519695-1969553.99954.32
619752-1975254.15554.47
90min122254-2225461.01560.660.6561.4261.070.64
222157-2215760.74961.16
322317-2231761.18761.60
422052-2205260.46160.86
521944-2194460.16560.58
622033-2203360.40960.82
120min123722-2372265.04064.910.7765.5565.420.76
223582-2358264.65665.17
323931-2393165.61366.12
423805-2380565.26765.77
523570-2357064.62365.14
623428-2342864.23364.74
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限124032-2403265.88966.100.4866.5166.720.47
224065-2406565.98066.60
324287-2428766.58967.21
424131-2413166.16166.77
523964-2396465.70366.32
624171-2417166.27166.89
非布司他多替诺雷片项目信息
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101278-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数250
标示量(mg)40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%
110.862748612750622745852749492744952747900.09
211.102660072658962659520.03
单位质量响应值RSD%判断
25302.9523959.643.86数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-6042703批-非布司他-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%
5min12072-20720.7570.7512.690.760.7512.51
22336-23360.8530.85
32184-21840.7980.80
41760-17600.6430.64
52251-22510.8220.82
61712-17120.6250.63
10min14100-41001.4981.512.301.501.522.24
24299-42991.5701.57
34097-40971.4971.50
44017-40171.4671.47
54150-41501.5161.52
64180-41801.5271.53
15min14659-46591.7021.731.741.711.731.58
24778-47781.7451.75
34820-48201.7611.76
44605-46051.6821.69
54742-47421.7321.74
64778-47781.7451.75
20min15038-50381.8401.773.861.851.783.93
24756-47561.7371.74
35094-50941.8611.87
44885-48851.7841.79
54605-46051.6821.69
64750-47501.7351.74
30min15068-50681.8511.842.501.861.852.50
25089-50891.8591.87
35077-50771.8551.86
45001-50011.8271.84
55191-51911.8961.91
64814-48141.7591.77
45min15199-51991.8991.904.191.911.914.05
24908-49081.7931.81
35554-55542.0292.04
45262-52621.9221.93
55214-52141.9051.92
65051-50511.8451.86
60min15312-53121.9401.893.881.961.903.92
24946-49461.8071.82
35288-52881.9321.95
45360-53601.9581.97
54888-48881.7861.80
65207-52071.9021.92
90min15179-51791.8921.844.051.911.864.14
24967-49671.8141.83
35284-52841.9301.95
45196-51961.8981.92
54825-48251.7631.78
64806-48061.7561.77
120min15327-53271.9461.865.491.971.885.51
24627-46271.6901.71
35243-52431.9151.94
44867-48671.7781.80
55106-51061.8651.89
65302-53021.9371.96
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
极限14765-47651.7411.802.051.771.822.04
24995-49951.8251.85
34813-48131.7581.78
44984-49841.8211.85
54987-49871.8221.85
64946-49461.8071.83
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