非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163100203098503097373099503098743098860.04
211.143093653097903095780.10
单位质量响应值RSD%判断
27767.5627789.770.06数据可信
供试品溶液-6022601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%
5min139174-3917463.46063.4024.1863.4663.4024.18
252695-5269585.36385.36
327178-2717844.02744.03
429801-2980148.27648.28
541567-4156767.33667.34
644391-4439171.91171.91
10min154241-5424187.86886.7810.5088.5787.4810.61
260279-6027997.64998.60
344900-4490072.73673.22
449048-4904879.45579.99
556080-5608090.84791.59
656854-5685492.10192.90
15min156034-5603490.77293.696.3792.4595.366.50
260893-6089398.644100.68
351620-5162083.62284.92
457245-5724592.73494.15
561254-6125499.228100.99
659972-5997297.15298.97
20min156978-5697892.30195.164.8594.9997.875.02
263334-63334102.598105.73
355003-5500389.10291.33
458174-5817494.23996.69
558810-5881095.26998.13
660163-6016397.461100.36
30min156242-5624291.10995.582.8994.8299.342.98
259587-5958796.528100.80
358089-5808994.10197.32
459053-5905395.66399.16
559746-5974696.785100.70
661278-6127899.267103.25
45min156488-5648891.50895.702.8896.24100.532.87
258914-5891495.438100.78
359292-5929296.050100.31
458755-5875595.18099.74
559181-5918195.870100.86
661827-61827100.157105.24
60min156116-5611690.90595.072.6696.65100.962.69
258801-5880195.255101.66
358562-5856294.867100.20
458704-5870495.097100.71
558924-5892495.454101.51
661024-6102498.856105.06
90min155934-5593490.61094.482.0797.36101.422.00
258750-5875095.172102.63
358986-5898695.554101.94
459129-5912995.786102.46
558819-5881995.284102.40
658306-5830694.453101.75
120min154847-5484788.84994.142.9696.61102.142.95
259293-5929396.052104.57
358515-5851594.791102.24
458061-5806194.056101.79
558278-5827894.407102.59
659694-5969496.701105.05
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154863-5486388.87593.982.9597.62103.022.93
259072-5907295.694105.28
357931-5793193.845102.34
458899-5889995.413104.20
557690-5769093.455102.68
659635-5963596.606106.03
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.153985733984713984723983353983603984420.03
211.223979343978193978760.03
单位质量响应值RSD%判断
35734.7135461.320.55数据可信
供试品溶液-6022601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%
5min19436-943611.91611.6051.4211.9211.6051.41
216999-1699921.46821.47
34543-45435.7375.74
44759-47596.0106.01
57599-75999.5979.60
611784-1178414.88214.88
10min127736-2773635.02739.1647.0135.1639.2947.02
254510-5451068.83969.08
319578-1957824.72424.79
416789-1678921.20221.27
525014-2501431.58931.70
642419-4241953.57053.74
15min138211-3821148.25652.2432.2148.7852.8032.37
262516-6251678.95079.95
331096-3109639.27039.61
426962-2696234.05034.35
537811-3781147.75048.21
651577-5157765.13565.90
20min145985-4598558.07360.8925.6359.1362.0325.89
268352-6835286.32088.20
339623-3962350.03950.81
434751-3475143.88644.57
543605-4360555.06756.06
656967-5696771.94273.43
30min155011-5501169.47272.4415.7871.1774.2616.22
270279-7027988.75391.59
351438-5143864.96066.29
445839-4583957.88959.06
556016-5601670.74172.34
665565-6556582.80085.08
45min165681-6568182.94785.259.4385.4287.889.95
274384-7438493.93797.76
364678-6467881.68083.73
458865-5886574.33976.15
565781-6578183.07385.46
675642-7564295.52698.73
60min170600-7060089.15992.234.3092.5695.804.89
275961-7596195.929100.80
370645-7064589.21592.18
471494-7149490.28892.93
571518-7151890.31893.63
677973-7797398.470102.73
90min175821-7582195.75296.280.74100.14100.881.27
276499-7649996.608102.54
377049-7704997.303101.25
475434-7543495.26398.90
576318-7631896.380100.69
676321-7632196.383101.74
120min176374-7637496.45097.131.72101.90102.801.95
276902-7690297.117104.13
378897-7889799.637104.67
474851-7485194.52799.23
577296-7729697.615103.00
677154-7715497.435103.87
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175939-7593995.90196.971.27102.42103.721.38
276022-7602296.006104.09
378283-7828398.861105.00
476152-7615296.170101.92
576699-7669996.861103.33
677641-7764198.050105.56
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号101566-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0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5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.163098613101483101833101903101643101090.05
211.143104823107153105980.06
单位质量响应值RSD%判断
27787.5427881.330.24数据可信
供试品溶液-6022602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%
5min125127-2512740.62339.6820.2140.6239.6820.21
223976-2397638.76238.76
324769-2476940.04440.04
418047-1804729.17729.18
533167-3316753.62153.62
622162-2216235.82935.83
10min145964-4596474.31073.0414.6074.7673.4814.63
243479-4347970.29370.72
348455-4845578.33878.78
437632-3763260.84061.16
555918-5591890.40391.00
639617-3961764.04964.45
15min157007-5700792.16490.737.3793.4491.987.40
255516-5551689.75390.96
360877-6087798.42099.74
456133-5613390.75191.75
558535-5853594.63496.23
648643-4864378.64179.75
20min158800-5880095.06294.936.2397.3697.196.23
259514-5951496.21798.43
363614-63614102.845105.25
459106-5910695.55797.57
559047-5904795.46298.11
652234-5223484.44786.43
30min160015-6001597.02796.342.42100.3899.652.51
257925-5792593.64896.93
361025-6102598.660102.21
460687-6068798.113101.18
560224-6022497.365101.08
657653-5765393.20896.13
45min158414-5841494.43896.643.5398.87101.033.49
257841-5784193.51297.83
361679-6167999.717104.36
462607-62607101.217105.38
560465-6046597.754102.55
657662-5766293.22397.18
60min158668-5866894.84994.821.53100.33100.271.58
257459-5745992.89498.25
359882-5988296.812102.57
459458-5945896.126101.41
558310-5831094.270100.15
658105-5810593.93998.93
90min157179-5717992.44294.322.2898.98100.842.26
256614-5661491.52897.92
358858-5885895.156101.99
460060-6006097.099103.45
559388-5938896.013102.94
657962-5796293.70899.74
120min157632-5763293.17494.222.09100.74101.782.09
256544-5654491.41598.82
359318-5931895.900103.79
459862-5986296.779104.21
558598-5859894.736102.73
657733-5773393.337100.42
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158378-5837894.38096.144.41102.98104.753.91
256676-5667691.628100.05
359853-5985396.765105.72
458681-5868194.870103.38
558849-5884995.142104.19
664377-64377104.079112.19
非奈利酮恩格列净片项目信息
介质体积(ml) 900取样体积(ml)10补液体积(ml)10
对照品批号D250501对照品来源中检院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1000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.153981453981133985733984773986173983850.07
211.223990953993363992160.05
单位质量响应值RSD%判断
35729.6035580.750.30数据可信
供试品溶液-6022602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%
5min16075-60757.6607.7526.917.667.7526.94
25228-52286.5926.59
35254-52546.6246.62
45603-56037.0647.06
59460-946011.92711.93
65271-52716.6466.65
10min121885-2188527.59328.0831.2427.6828.1631.23
220688-2068826.08426.16
322255-2225528.06028.13
416214-1621420.44320.52
535511-3551144.77344.91
617050-1705021.49721.57
15min137066-3706646.73446.4016.2247.1346.8016.33
235006-3500644.13744.50
337983-3798347.89048.28
431413-3141339.60739.91
547670-4767060.10460.73
631689-3168939.95540.27
20min146549-4654958.69058.0011.5059.6058.9111.66
245235-4523557.03457.89
346428-4642858.53859.46
442430-4243053.49754.24
555433-5543369.89271.19
639922-3992250.33551.09
30min159473-5947374.98574.637.0976.5576.197.25
256928-5692871.77773.26
360877-6087776.75678.32
459422-5942274.92176.26
565544-6554482.64084.71
652910-5291066.71168.03
45min168692-6869286.60988.955.7889.0191.345.83
268244-6824486.04488.33
372369-7236991.24593.67
475064-7506494.64396.82
574354-7435493.74896.74
664551-6455181.38883.45
60min174285-7428593.66194.812.7297.0298.182.85
274371-7437193.76997.01
375928-7592895.73299.17
477695-7769597.960101.18
576826-7682696.865100.90
672062-7206290.85893.82
90min176339-7633996.25198.662.09100.65103.102.22
277419-7741997.612101.90
377637-7763797.887102.39
480045-80045100.923105.24
580466-80466101.454106.56
677618-7761897.863101.83
120min177980-7798098.32099.190.64103.79104.710.87
278246-7824698.655104.02
378742-7874299.280104.87
479068-7906899.691105.13
579323-79323100.013106.25
678641-7864199.153104.21
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177050-7705097.14799.873.35103.71106.503.04
277990-7799098.332104.80
378873-7887399.446106.13
477479-7747997.688104.23
579582-79582100.340107.69
684273-84273106.254112.41
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