非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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 11.163107773109313108153107133104833107440.06
2 11.243113333113833113580.02
单位质量响应值RSD%判断
27844.4427700.890.37数据可信
供试品溶液-25090401批-恩格列净-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%
5min159213-5921318.86217.3614.2018.8617.3514.20
258680-5868018.69318.69
345557-4555714.51214.51
10min146751-4675114.89312.0241.5914.9212.0541.46
219610-196106.2476.28
346816-4681614.91314.94
15min177134-7713424.57122.7410.1324.6322.7910.13
273749-7374923.49323.53
363267-6326720.15420.20
20min172527-7252723.10417.3540.3023.2017.4440.14
230038-300389.5699.65
360861-6086119.38719.47
30min189008-8900828.35426.268.6728.4926.388.65
283499-8349926.59926.70
374839-7483923.84023.96
45min194803-9480330.20021.4542.6130.3821.6142.38
237564-3756411.96612.11
369643-6964322.18522.34
60min197239-9723930.97628.897.8831.2129.087.90
291749-9174929.22729.39
383069-8306926.46226.65
极限1107062-10706234.10524.1341.9934.3924.3841.72
243467-4346713.84714.06
376732-7673224.44324.68
非奈利酮恩格列净片项目信息
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250201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)20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 22.207902147903607911297899987903947904190.06
2 22.277918047916367917200.02
单位质量响应值RSD%判断
35604.4635550.970.11数据可信
供试品溶液-25090401批-非奈利酮-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%
5min1269519-26951934.09030.7811.7134.0930.7811.71
2247501-24750131.30531.30
3213023-21302326.94426.94
10min1193223-19322324.44021.6027.4624.5021.6627.39
2116893-11689314.78514.84
3202245-20224525.58125.63
15min1378834-37883447.91643.628.9848.0143.708.97
2337333-33733342.66742.74
3318314-31831440.26240.35
20min1315883-31588339.95433.7523.4940.1333.9123.41
2196212-19621224.81824.97
3288346-28834636.47136.63
30min1455455-45545557.60852.149.1757.8552.359.17
2395588-39558850.03550.22
3385588-38558848.77148.99
45min1417287-41728752.78043.0724.2053.1243.3724.11
2253487-25348732.06232.33
3350687-35068744.35644.65
60min1510817-51081764.61058.568.9665.0458.948.98
2440958-44095855.77456.10
3437246-43724655.30555.68
极限1483071-48307161.10149.8323.2861.6450.3123.18
2299885-29988537.93138.35
3398991-39899150.46650.93
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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 11.163126163124683123513119453121143122990.09
2 11.243110273110223110240.01
单位质量响应值RSD%判断
27983.7827671.170.80数据可信
供试品溶液-25090402批-恩格列净-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%
5min1191241-19124160.80263.607.5560.8063.607.54
2217472-21747269.14269.14
3191452-19145260.86960.87
10min1208072-20807266.15352.0139.7166.2552.1139.64
2193623-19362361.55961.67
389041-8904128.30928.41
15min1283158-28315890.02585.685.9590.2485.875.93
2251845-25184580.07080.29
3273429-27342986.93287.08
20min1243227-24322777.33075.777.8277.6976.107.82
2253987-25398780.75181.10
3217740-21774069.22769.52
30min1296382-29638294.23089.076.2994.7289.536.25
2261436-26143683.11983.61
3282629-28262989.85790.27
45min1255466-25546681.22183.297.2381.8783.917.20
2283305-28330590.07290.70
3247185-24718578.58879.15
60min1300914-30091495.67190.395.9496.4591.145.89
2267178-26717884.94585.72
3284817-28481790.55391.24
极限1261630-26163083.18185.676.0884.1286.576.04
2288270-28827091.65192.57
3258449-25844982.17083.01
非奈利酮恩格列净片项目信息
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250201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)20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 22.207938307935057931087935677929677933950.05
2 22.277899317905227902260.06
单位质量响应值RSD%判断
35738.5135483.880.51数据可信
供试品溶液-25090402批-非奈利酮-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%
5min153870-538706.80710.2441.176.8110.2441.17
270980-709808.9698.97
3118270-11827014.94514.95
10min188665-8866511.2049.6014.7211.229.6214.66
271920-719209.0889.10
367441-674418.5228.55
15min1187540-18754023.69923.771.3323.7323.801.31
2190802-19080224.11124.14
3185930-18593023.49523.53
20min1196813-19681324.87122.4314.5124.9422.5014.46
2187433-18743323.68523.76
3148266-14826618.73618.81
30min1268459-26845933.92432.227.4234.0432.337.40
2263075-26307533.24433.35
3233366-23336629.49029.60
45min1263928-26392833.35231.2512.4233.5231.4112.37
2266055-26605533.62033.79
3211861-21186126.77226.93
60min1331243-33124341.85839.1410.5842.0839.3510.54
2325893-32589341.18241.40
3272016-27201634.37434.58
极限1318739-31873940.27838.2011.6540.5738.4811.61
2326194-32619441.22041.51
3261864-26186433.09133.35
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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 11.163111473116613113433113033118573114620.10
2 11.243128783132913130840.10
单位质量响应值RSD%判断
27908.7827854.450.14数据可信
供试品溶液-25090403批-恩格列净-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%
5min110651-106513.3807.6748.593.387.6648.57
229955-299559.5059.50
331871-3187110.11310.11
10min125669-256698.1459.1710.038.159.1910.11
229784-297849.4519.47
331258-312589.9189.94
15min119150-191506.07611.6841.586.1011.7141.51
245067-4506714.30014.33
346199-4619914.65914.69
20min137334-3733411.84613.2810.2911.8813.3210.33
242278-4227813.41513.47
345903-4590314.56514.62
30min125718-257188.16014.4337.958.2114.5037.89
253113-5311316.85316.93
357589-5758918.27318.36
45min144488-4448814.11615.629.2414.1815.729.33
249676-4967615.76315.87
353552-5355216.99217.10
60min130618-306189.71516.9237.909.8017.0337.81
259966-5996619.02819.16
369346-6934622.00422.14
极限150213-5021315.93317.588.6516.0417.738.80
256381-5638117.89018.05
359653-5965318.92819.11
非奈利酮恩格列净片项目信息
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250201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)20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 22.207900097914687908037911897917997910540.09
2 22.277950677957587954120.07
单位质量响应值RSD%判断
35633.0635716.750.17数据可信
供试品溶液-25090403批-非奈利酮-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%
5min174301-743019.37214.9432.369.3714.9432.37
2137862-13786217.39017.39
3143147-14314718.05618.06
10min1122310-12231015.42817.108.5515.4417.138.61
2140615-14061517.73717.77
3143778-14377818.13618.17
15min1143753-14375318.13324.4922.4918.1724.5422.50
2217977-21797727.49527.55
3220699-22069927.83927.90
20min1196786-19678624.82226.415.4324.8926.505.48
2212447-21244726.79826.90
3218848-21884827.60527.71
30min1199690-19969025.18932.4219.8325.3032.5619.81
2274251-27425134.59434.74
3297148-29714837.48237.63
45min1252150-25215031.80633.344.3531.9633.534.42
2265822-26582233.53133.74
3274970-27497034.68534.90
60min1244146-24414630.79639.2219.8631.0039.4719.83
2322820-32282040.72040.98
3365909-36590946.15546.43
极限1300954-30095437.96239.403.3538.2239.713.44
2314506-31450639.67240.00
3321502-32150240.55440.90
非奈利酮恩格列净片项目信息
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C5654-24-004M2对照品来源中检院对照品使用方法直接使用
对照品含量(%) 98.3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 11.163107873105643106683099633099203103800.14
2 11.243102093107333104710.12
单位质量响应值RSD%判断
27811.8327621.980.49数据可信
供试品溶液批-恩格列净-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%
5min1202606-20260664.67165.195.3264.6765.195.32
2215799-21579968.88268.88
3194259-19425962.00762.01
10min1257010-25701082.03683.461.6882.1483.561.68
2265756-26575684.82884.94
3261612-26161283.50583.61
15min1271228-27122886.57588.612.9386.8288.862.92
2274830-27483087.72487.98
3286731-28673191.52391.77
20min1280699-28069989.59890.522.8789.9990.922.85
2277311-27731188.51688.92
3292747-29274793.44393.84
30min1295885-29588594.44592.503.1794.9893.053.14
2279256-27925689.13789.69
3294278-29427893.93294.48
45min1297367-29736794.91892.923.0195.6193.622.98
2281122-28112289.73390.43
3294808-29480894.10194.81
60min1296160-29616094.53393.022.4895.3993.882.46
2283138-28313890.37691.22
3294980-29498094.15695.02
极限1296454-29645494.62794.060.5995.6495.070.59
2293013-29301393.52894.53
3294577-29457794.02895.05
非奈利酮恩格列净片项目信息
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250201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)20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 22.207888267888377890247880827878507885240.07
2 22.277871317885027878160.13
单位质量响应值RSD%判断
35519.1035375.660.29数据可信
供试品溶液批-非奈利酮-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%
5min182185-8218510.43310.665.0310.4310.665.01
288796-8879611.27311.27
380949-8094910.27610.28
10min1174408-17440822.14122.1710.2322.1622.1910.21
2156920-15692019.92119.94
3192639-19263924.45524.47
15min1231569-23156929.39830.7914.2829.4530.8514.27
2214761-21476127.26427.32
3281359-28135935.71835.78
20min1255870-25587032.48335.9016.1532.5936.0116.12
2257038-25703832.63132.73
3335545-33554542.59742.71
30min1351361-35136144.60546.0912.0144.7646.2612.00
2326543-32654341.45441.61
3411310-41131052.21552.40
45min1420540-42054053.38755.4510.1953.6255.7010.20
2402721-40272151.12551.35
3487162-48716261.84562.12
60min1479914-47991460.92563.518.0661.2563.858.08
2474271-47427160.20860.51
3546742-54674269.40869.79
极限1725704-72570492.12893.351.5292.5593.791.56
2732670-73267093.01293.42
3747566-74756694.90395.40
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