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%
111.163107583104413105883106523105123105900.04
211.243106293104203105240.05
单位质量响应值RSD%判断
27830.6527626.690.53数据可信
供试品溶液-25090401批-恩格列净-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%
5min1120884-12088438.56950.8224.1538.5750.8224.15
2159139-15913950.77550.77
3197798-19779863.11063.11
10min1140965-14096544.97642.808.4145.0442.888.39
2121138-12113838.65038.73
3140342-14034244.77844.88
15min1183672-18367258.60271.1517.9058.7471.3117.89
2221864-22186470.78870.94
3263468-26346884.06284.24
20min1223155-22315571.20073.035.9371.4473.315.89
2244394-24439477.97678.24
3219152-21915269.92370.24
30min1211607-21160767.51578.0313.3467.8778.4313.32
2245308-24530878.26878.67
3276808-27680888.31888.75
45min1245066-24506678.19182.106.4678.6682.636.44
2276242-27624288.13888.67
3250672-25067279.98080.56
60min1243662-24366277.74383.808.2878.3484.478.28
2257953-25795382.30382.98
3286356-28635691.36592.08
极限1259165-25916582.68986.705.3083.4287.515.28
2287446-28744691.71392.52
3268622-26862285.70786.58
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 22.207888407881017885787885677886947885560.04
2 22.277879587886877883220.07
单位质量响应值RSD%判断
35520.5435398.380.25数据可信
供试品溶液-25090401批-非奈利酮-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%
5min184552-8455210.73013.2319.7110.7313.2319.71
2102612-10261213.02213.02
3125528-12552815.93015.93
10min183313-8331310.57310.386.1610.5910.416.20
276222-762229.6739.69
385961-8596110.90910.94
15min1182507-18250723.16127.5315.8923.2027.5715.87
2216917-21691727.52827.57
3251412-25141231.90631.95
20min1204897-20489726.00326.635.0226.0826.714.98
2221881-22188128.15828.24
3202656-20265625.71825.82
30min1254444-25444432.29036.8912.1932.4137.0212.17
2292326-29232637.09837.23
3325226-32522641.27341.41
45min1282007-28200735.78837.376.9435.9637.566.90
2318006-31800640.35740.55
3283348-28334835.95936.17
60min1319260-31926040.51644.298.5940.7544.558.58
2348617-34861744.24244.50
3379217-37921748.12548.39
极限1341660-34166043.35945.025.3743.6645.355.35
2376609-37660947.79448.13
3346043-34604343.91544.26
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%
111.163118713124683131263123083128943125330.16
211.243112053111533111790.02
单位质量响应值RSD%判断
28004.7527684.960.82数据可信
供试品溶液-25090402批-恩格列净-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%
5min1102207-10220732.47550.3734.2132.4750.3734.22
2162975-16297551.78351.78
3210383-21038366.84666.85
10min1214068-21406868.01773.017.2068.0773.097.24
2228229-22822972.51672.60
3247042-24704278.49478.61
15min1164706-16470652.33370.5324.1752.5070.7424.15
2230236-23023673.15473.36
3271016-27101686.11186.35
20min1255157-25515781.07285.415.3281.3385.735.38
2267590-26759085.02385.35
3283663-28366390.13090.52
30min1206744-20674465.69079.0515.4066.0879.5115.40
2257891-25789181.94182.41
3281729-28172989.51590.05
45min1265754-26575484.43988.324.2284.9488.924.30
2279006-27900688.65089.26
3289117-28911791.86392.55
60min1231577-23157773.58083.5610.6874.2284.3110.71
2271730-27173086.33887.09
3285671-28567190.76891.61
极限1270402-27040285.91689.843.8886.6890.723.96
2286537-28653791.04391.94
3291292-29129292.55493.54
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 22.207911867923877938467916907931007924420.14
2 22.277895597892857894220.03
单位质量响应值RSD%判断
35695.5935447.780.50数据可信
供试品溶液-25090402批-非奈利酮-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%
5min157792-577927.3116.7710.837.316.7710.81
255891-558917.0717.07
346935-469355.9385.94
10min159603-596037.5408.469.457.558.479.45
270248-702488.8878.90
370810-708108.9588.97
15min1130603-13060316.52218.8710.8516.5518.9010.83
2156629-15662919.81519.84
3160260-16026020.27420.30
20min1138881-13888117.56920.7315.6717.6220.7915.65
2190170-19017024.05824.12
3162574-16257420.56720.63
30min1202954-20295425.67528.257.9025.7628.347.90
2233613-23361329.55429.65
3233405-23340529.52729.62
45min1197143-19714324.94029.3715.3125.0629.5115.29
2268186-26818633.92734.08
3231095-23109529.23529.38
60min1264738-26473833.49135.675.3333.6635.865.35
2292124-29212436.95637.16
3289133-28913336.57736.77
极限1248157-24815731.39436.1412.9831.6236.3812.94
2322253-32225340.76741.03
3286517-28651736.24636.50
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%
111.163113033110633122483122603117333117210.18
211.243131313144263137780.30
单位质量响应值RSD%判断
27931.9927916.190.05数据可信
供试品溶液-25090403批-恩格列净-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%
5min1160459-16045950.83744.8311.6350.8444.8311.63
2130938-13093841.48441.48
3133121-13312142.17642.18
10min1161811-16181151.26548.0120.6251.3548.0920.59
2176360-17636055.87555.94
3116460-11646036.89736.97
15min1268957-26895785.21274.3421.0085.3874.4920.96
2178180-17818056.45256.61
3256794-25679481.35881.49
20min1269381-26938185.34674.9527.8685.6675.2327.77
2279659-27965988.60288.86
3160707-16070750.91651.18
30min1288164-28816491.29783.0212.8791.7583.4212.82
2223985-22398570.96471.37
3273953-27395386.79587.15
45min1288677-28867791.46081.3223.5392.0781.8623.43
2294303-29430393.24293.76
3187003-18700359.24759.74
60min1294936-29493693.44388.019.6094.2088.699.53
2247076-24707678.27978.96
3291355-29135592.30892.90
极限1295609-29560993.65684.0621.3094.5784.8821.16
2300173-30017395.10295.91
3200135-20013563.40764.16
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 22.207905817894877916977922427910137910040.14
2 22.277942827973307958060.28
单位质量响应值RSD%判断
35630.8135734.440.21数据可信
供试品溶液-25090403批-非奈利酮-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%
5min186135-8613510.8639.7010.3910.869.7010.38
273200-732009.2319.23
371535-715359.0219.02
10min185281-8528110.75510.3613.0010.7710.3812.96
290937-9093711.46811.48
370274-702748.8628.88
15min1190129-19012923.97821.7113.2724.0121.7513.23
2146482-14648218.47318.51
3179927-17992722.69122.72
20min1193270-19327024.37422.2120.1724.4522.2820.12
2199825-19982525.20025.27
3135299-13529917.06317.13
30min1268539-26853933.86630.6912.9633.9830.8012.92
2208021-20802126.23426.34
3253555-25355531.97632.07
45min1267461-26746133.73030.7419.1033.9030.9019.02
2273748-27374834.52334.67
3190142-19014223.97924.13
60min1323046-32304640.74037.4710.3540.9737.6810.30
2263171-26317133.18933.40
3305150-30515038.48338.67
极限1320913-32091340.47137.1117.3940.7737.3817.30
2326590-32659041.18741.45
3235284-23528429.67229.93
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%
111.163111803113353116243124893120103117280.18
211.243154453151443152940.07
单位质量响应值RSD%判断
27932.6228051.070.30数据可信
供试品溶液批-恩格列净-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%
5min1206286-20628665.19865.042.3765.2065.042.37
2200703-20070363.43463.43
3210383-21038366.49366.49
10min1261801-26180182.74484.093.9782.8584.203.97
2258311-25831181.64181.75
3278078-27807887.88988.00
15min1275200-27520086.97988.663.2687.2388.913.25
2275309-27530987.01487.26
3291063-29106391.99392.25
20min1280604-28060488.68791.013.1589.0891.413.15
2285206-28520690.14290.53
3298086-29808694.21294.62
30min1286663-28666390.60293.082.8791.1493.632.88
2293410-29341092.73593.27
3303455-30345595.90996.48
45min1290516-29051691.82094.553.3492.5195.263.34
2296869-29686993.82894.52
3310094-31009498.00898.74
60min1291494-29149492.12994.893.2092.9795.753.19
2298756-29875694.42495.27
3310477-31047798.12999.02
极限1306781-30678196.96197.480.5497.9698.500.56
2308394-30839497.47098.48
3310058-31005897.99699.05
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 22.207890997896387898537919307901497901340.14
2 22.278007337993748000540.13
单位质量响应值RSD%判断
35591.6235925.190.66数据可信
供试品溶液批-非奈利酮-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%
5min168253-682538.5898.1012.298.598.1012.27
269573-695738.7568.76
355268-552686.9556.96
10min1217733-21773327.40122.5930.7027.4222.6030.70
2204365-20436525.71925.73
3116346-11634614.64214.65
15min1312684-31268439.35032.7030.0539.4132.7530.05
2296717-29671737.34137.40
3170164-17016421.41521.45
20min1375428-37542847.24740.2427.3847.3740.3427.39
2364933-36493345.92646.05
3218839-21883927.54027.61
30min1454675-45467557.22050.8120.8257.4250.9820.84
2449787-44978756.60456.80
3306717-30671738.59938.72
45min1523356-52335665.86362.0910.3966.1662.3410.45
2522490-52249065.75466.04
3434198-43419854.64354.82
60min1562770-56277070.82368.665.8371.2369.025.91
2565088-56508871.11571.51
3508889-50888964.04264.32
极限1594296-59429674.79173.623.4275.3274.093.51
2598583-59858375.33075.85
3562014-56201470.72871.11
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