XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335075115080935080435078145077895078500.05
210.335071075070795070930.01
单位质量响应值RSD%判断
49162.6349089.350.11数据可信
长期12月-供试品溶液-第1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1387636-38763678.90781.229.7278.9181.229.72
2412647-41264783.99884.00
3366507-36650774.60674.61
4422103-42210385.92385.92
5349746-34974671.19471.19
6455444-45544492.70992.71
10min1559035-559035113.796108.214.54113.95108.374.54
2525189-525189106.907107.07
3506148-506148103.031103.18
4550799-550799112.120112.29
5501941-501941102.174102.32
6546473-546473111.239111.42
15min1553178-553178112.604108.103.78112.99108.483.79
2526072-526072107.086107.47
3507583-507583103.323103.68
4553590-553590112.688113.08
5510501-510501103.917104.26
6535410-535410108.987109.40
20min1550772-550772112.114107.414.30112.72108.004.31
2516132-516132105.063105.66
3502852-502852102.360102.92
4548478-548478111.647112.27
5503501-503501102.492103.05
6544206-544206110.778111.40
30min1502574-502574102.303105.274.06103.14106.084.06
2513422-513422104.511105.32
3501119-501119102.007102.77
4543699-543699110.674111.52
5498897-498897101.555102.31
6543092-543092110.551111.40
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335080135083305073785075985072225077080.10
210.335094815095375095090.01
单位质量响应值RSD%判断
49148.8949323.230.26数据可信
长期12月-供试品溶液-第1批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1155780-15578031.64058.7626.6831.6458.7626.68
2326654-32665466.34566.34
3371938-37193875.54275.54
4247118-24711850.19150.19
5302952-30295261.53161.53
6331365-33136567.30167.30
10min1505197-505197102.607101.732.73102.67101.842.72
2494415-494415100.418100.55
3523689-523689106.363106.51
4504372-504372102.440102.54
5493368-493368100.205100.33
6484129-48412998.32898.46
15min1516674-516674104.938103.552.05105.21103.882.04
2494777-494777100.491100.82
3521654-521654105.950106.31
4517772-517772105.161105.47
5505189-505189102.606102.93
6503066-503066102.175102.51
20min1523152-523152106.254104.211.81106.73104.741.80
2501291-501291101.814102.35
3524669-524669106.562107.14
4509267-509267103.434103.95
5513420-513420104.278104.81
6506675-506675102.908103.44
30min1525035-525035106.637103.232.07107.33103.972.05
2498362-498362101.219101.96
3513718-513718104.338105.13
4497229-497229100.989101.71
5510733-510733103.732104.47
6504501-504501102.466103.21
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335076395078655071295075365076125075560.06
210.335077775075735076750.03
单位质量响应值RSD%判断
49134.1749145.690.02数据可信
长期12月-供试品溶液-第2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1412317-41231783.90783.414.5483.9183.414.54
2403638-40363882.14182.14
3439278-43927889.39389.39
4385704-38570478.49178.49
5420027-42002785.47685.48
6398301-39830181.05481.05
10min1534515-534515108.774108.313.40108.94108.483.39
2521519-521519106.129106.29
3548881-548881111.698111.88
4555939-555939113.134113.29
5507216-507216103.219103.39
6525347-525347106.908107.07
15min1538877-538877109.662107.783.46110.05108.163.45
2520231-520231105.867106.24
3541364-541364110.168110.57
4553048-553048112.546112.93
5502066-502066102.171102.55
6522188-522188106.266106.64
20min1534984-534984108.870105.693.32109.47106.293.31
2511809-511809104.153104.74
3507086-507086103.192103.81
4545236-545236110.956111.56
5500473-500473101.846102.43
6516686-516686105.146105.73
30min1526691-526691107.182104.993.49108.00105.803.48
2509138-509138103.610104.41
3527955-527955107.439108.27
4538883-538883109.663110.49
5493692-493692100.467101.25
6499020-499020101.551102.35
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335090895085035085835090015087085087770.06
210.335091105087185089140.06
单位质量响应值RSD%判断
49252.3749265.630.02数据可信
长期12月-供试品溶液-第2批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1355259-35525972.12178.737.4972.1278.747.49
2367952-36795274.69774.70
3427947-42794786.87786.88
4397867-39786780.77080.77
5411910-41191083.62183.62
6366097-36609774.32174.32
10min1522508-522508106.074105.482.00106.22105.642.01
2500793-500793101.665101.81
3527711-527711107.130107.30
4526908-526908106.967107.13
5525167-525167106.613106.78
6514532-514532104.454104.60
15min1536532-536532108.921106.022.51109.28106.382.51
2506414-506414102.806103.16
3531060-531060107.810108.20
4526064-526064106.796107.17
5527677-527677107.123107.50
6505612-505612102.644103.00
20min1539514-539514109.526104.023.95110.10104.603.94
2503783-503783102.272102.83
3524308-524308106.439107.04
4525240-525240106.628107.22
5490061-49006199.487100.08
6491594-49159499.798100.36
30min1521133-521133105.794104.101.57106.59104.881.58
2505784-505784102.678103.44
3520495-520495105.665106.48
4517363-517363105.029105.83
5502054-502054101.921102.71
6509778-509778103.489104.25
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335079745080445081285077995084015080690.05
210.335085235079055082140.09
单位质量响应值RSD%判断
49183.8349197.870.03数据可信
长期12月-供试品溶液-第3批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1357873-35787372.75256.7128.2072.7556.7128.20
2242738-24273849.34649.35
3155270-15527031.56531.56
4317867-31786764.61964.62
5353334-35333471.82971.83
6246665-24666550.14450.14
10min1506842-506842103.036101.871.35103.18101.991.35
2489251-48925199.46099.56
3506246-506246102.915102.98
4497992-497992101.237101.37
5501149-501149101.878102.02
6505288-505288102.720102.82
15min1509656-509656103.608103.971.08103.96104.291.07
2505587-505587102.781103.08
3518650-518650105.436105.71
4506004-506004102.865103.20
5511608-511608104.005104.35
6517215-517215105.145105.45
20min1515739-515739104.844104.461.03105.40104.981.02
2509964-509964103.670104.17
3523511-523511106.424106.90
4511183-511183103.918104.46
5513235-513235104.335104.89
6509369-509369103.550104.07
30min1507309-507309103.131103.651.80103.90104.381.78
2509329-509329103.541104.25
3525587-525587106.846107.54
4509768-509768103.631104.38
5510127-510127103.704104.47
6497032-497032101.042101.76
XXYYYY片项目信息
介质体积(ml)1000取样体积(ml)2补液体积(ml)2
对照品批号x1252对照品来源中检院对照品使用方法直接使用
对照品含量(%)100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%
110.335099515101735102305102845106535102580.05
210.335097715099695098700.03
单位质量响应值RSD%判断
49395.7449358.180.06数据可信
长期12月-供试品溶液-第3批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1366931-36693174.31279.647.9274.3179.647.92
2392465-39246579.48379.48
3454394-45439492.02692.03
4385674-38567478.10878.11
5379581-37958176.87476.87
6380432-38043277.04677.05
10min1504901-504901102.254105.113.09102.40105.263.10
2525227-525227106.371106.53
3545031-545031110.382110.57
4506881-506881102.655102.81
5525932-525932106.514106.67
6505917-505917102.460102.61
15min1507356-507356102.752104.782.49103.10105.152.50
2524957-524957106.316106.69
3534909-534909108.332108.74
4507877-507877102.857103.22
5525875-525875106.502106.87
6503187-503187101.907102.27
20min1516474-516474104.598105.142.88105.16105.722.88
2521497-521497105.615106.20
3545566-545566110.490111.11
4504856-504856102.245102.81
5521218-521218105.559106.14
6505296-505296102.334102.90
30min1500621-500621101.388103.853.41102.16104.643.41
2517274-517274104.760105.56
3543409-543409110.053110.90
4499661-499661101.193101.96
5517713-517713104.849105.64
6498015-498015100.860101.63
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