艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493790293783893784613782573784073785090.08
214.403768153758603763380.18
单位质量响应值RSD%判断
26122.0826134.580.04数据可信
供试品溶液-2026032521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1228856-22885660.48462.554.8560.4862.554.85
2234429-23442961.95761.96
3244699-24469964.67164.67
4227045-22704560.00560.01
5228934-22893460.50560.50
6256030-25603067.66667.67
10min1287571-28757176.00278.583.6376.1078.683.63
2290732-29073276.83776.94
3307248-30724881.20281.31
4294407-29440777.80877.91
5289938-28993876.62776.73
6314073-31407383.00683.12
15min1313737-31373782.91784.652.7083.1484.892.71
2312601-31260182.61782.85
3326741-32674186.35486.60
4321793-32179385.04685.28
5313307-31330782.80383.03
6333672-33367288.18688.44
20min1322480-32248085.22886.672.3285.5987.052.33
2319207-31920784.36384.73
3335574-33557488.68889.08
4330827-33082787.43487.81
5322421-32242185.21285.58
6337201-33720189.11889.52
30min1331344-33134487.57088.572.3788.0889.092.37
2325874-32587486.12586.63
3343692-34369290.83491.37
4336687-33668788.98289.50
5328345-32834586.77887.29
6344725-34472591.10791.65
45min1333868-33386888.23789.552.2788.8990.222.28
2329881-32988187.18487.84
3348595-34859592.13092.82
4343466-34346690.77491.44
5332494-33249487.87488.53
6344650-34465091.08791.79
60min1343121-34312190.68390.602.2691.4891.422.26
2334576-33457688.42589.22
3352179-35217993.07793.92
4346269-34626991.51592.33
5332615-33261587.90688.71
6348071-34807191.99192.84
极限1357362-35736294.44794.881.7595.4095.851.75
2359380-35938094.98095.93
3365090-36509096.48997.48
4364926-36492696.44697.42
5347988-34798891.96992.92
6359242-35924294.94495.95
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493784413796523795683799813801433795570.18
214.403788383784233786300.08
单位质量响应值RSD%判断
26194.4126293.750.27数据可信
供试品溶液-2026032521批-pH4.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1240972-24097263.40562.971.8263.4162.971.82
2244979-24497964.46064.46
3232745-23274561.24161.24
4235766-23576662.03662.04
5240447-24044763.26763.27
6240967-24096763.40463.40
10min1306468-30646880.63980.601.9880.7480.701.97
2308700-30870081.22681.33
3298363-29836378.50678.61
4302576-30257679.61579.72
5305541-30554180.39580.50
6316246-31624683.21283.32
15min1332126-33212687.39086.381.8587.6386.621.86
2327570-32757086.19186.43
3323340-32334085.07885.31
4321168-32116884.50784.74
5327517-32751786.17886.42
6337945-33794588.92189.17
20min1339320-33932089.28388.561.9189.6788.941.91
2338126-33812688.96989.36
3332136-33213687.39387.77
4327971-32797186.29786.67
5335307-33530788.22788.61
6346596-34659691.19891.59
30min1343752-34375290.44989.571.7890.9890.101.78
2342875-34287590.21990.75
3336246-33624688.47488.99
4333200-33320087.67388.19
5336785-33678588.61689.15
6349560-34956091.97892.52
45min1346463-34646391.16390.482.1091.8591.162.09
2347983-34798391.56392.25
3337566-33756688.82289.49
4337545-33754588.81689.48
5338603-33860389.09589.77
6355159-35515993.45194.15
60min1349284-34928491.90591.671.6792.7492.501.67
2355117-35511793.44094.28
3343551-34355190.39691.21
4341497-34149789.85690.67
5345908-34590891.01791.84
6355051-35505193.42294.28
极限1357276-35727694.00894.132.1295.0095.122.12
2365023-36502396.04697.04
3350137-35013792.12993.10
4353282-35328292.95793.92
5351968-35196892.61193.59
6368836-36883697.05098.06
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493798803793173795013796703767973790330.34
214.403794163792413793280.04
单位质量响应值RSD%判断
26158.2526342.220.50数据可信
供试品溶液-2026032521批-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%
5min1244723-24472364.37862.985.2964.3862.985.30
2218292-21829257.42557.42
3239812-23981263.08663.09
4257200-25720067.66067.66
5240118-24011863.16663.17
6236263-23626362.15262.15
10min1312047-31204782.08881.643.5482.2081.753.55
2289616-28961676.18876.28
3310132-31013281.58581.69
4322307-32230784.78784.90
5314291-31429182.67982.78
6313741-31374182.53482.64
15min1339207-33920789.23388.692.3789.4888.932.38
2322576-32257684.85885.08
3335221-33522188.18588.43
4345466-34546690.88091.13
5342474-34247490.09390.34
6337899-33789988.88989.13
20min1345118-34511890.78891.411.8491.1891.801.84
2336990-33699088.65089.01
3345523-34552390.89591.28
4354755-35475593.32393.73
5351925-35192592.57992.97
6350691-35069192.25492.64
30min1352961-35296192.85193.151.4693.4093.691.47
2346543-34654391.16391.67
3351585-35158592.48993.03
4358547-35854794.32194.88
5361016-36101694.97095.52
6353842-35384293.08393.63
45min1357093-35709393.93893.491.2494.6494.191.25
2348209-34820991.60192.27
3352197-35219792.65093.34
4356368-35636893.74894.47
5359880-35988094.67295.38
6358622-35862294.34195.04
60min1354026-35402693.13293.271.0093.9994.121.02
2348692-34869291.72892.54
3352550-35255092.74393.59
4356647-35664793.82194.70
5358195-35819594.22895.09
6357107-35710793.94294.80
极限1359830-35983094.65893.671.0395.6794.681.04
2350880-35088092.30493.27
3352747-35274792.79593.80
4355538-35553893.52994.56
5358645-35864594.34795.37
6358850-35885094.40195.41
艾托格列净片项目信息
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741-2407001-D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)5供试品稀释倍数1系数0.7719
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.493777403778813790823779493812593787820.40
214.403807403787983797690.37
单位质量响应值RSD%判断
26140.9226372.850.63数据可信
供试品溶液-2026032521批-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%
5min1230052-23005260.50460.857.7260.5060.857.72
2227916-22791659.94259.94
3211881-21188155.72555.72
4262072-26207268.92568.92
5217326-21732657.15757.16
6239062-23906262.87362.87
10min1309514-30951481.40280.823.8481.5080.923.84
2307966-30796680.99581.09
3292666-29266676.97177.06
4322343-32234384.77684.89
5294647-29464777.49277.59
6316618-31661883.27083.38
15min1336337-33633788.45788.113.3488.6988.353.34
2334096-33409687.86788.10
3321195-32119584.47484.70
4348907-34890791.76292.02
5323964-32396485.20285.43
6345700-34570090.91991.16
20min1343667-34366790.38490.422.4590.7790.802.46
2344141-34414190.50990.89
3334310-33431087.92388.29
4354996-35499693.36493.77
5334617-33461788.00488.37
6351107-35110792.34192.74
30min1347884-34788491.49392.102.2092.0392.632.21
2354597-35459793.25993.79
3341806-34180689.89590.40
4358979-35897994.41194.98
5341167-34116789.72790.24
6356597-35659793.78594.33
45min1349732-34973291.97992.460.9492.6793.150.95
2350284-35028492.12592.81
3348826-34882691.74192.40
4353961-35396193.09293.81
5349414-34941491.89692.56
6357180-35718093.93894.64
60min1353688-35368893.02093.170.5193.8694.010.51
2352916-35291692.81793.66
3355535-35553593.50694.32
4353894-35389493.07493.95
5352335-35233592.66493.48
6357147-35714793.93094.79
极限1347729-34772991.45393.371.3392.4594.371.32
2350961-35096192.30393.30
3358426-35842694.26695.23
4359703-35970394.60295.63
5357721-35772194.08195.05
6355620-35562093.52894.55
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