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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 5392165391805397285396175396675394820.05
29.825409125412435410780.05
单位质量响应值RSD%判断
55049.1855099.590.07数据可信
供试品溶液-F56971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%
5min1290074-29007446.92452.2614.2646.9252.2614.26
2337670-33767054.62354.62
3380732-38073261.58961.59
4362000-36200058.55958.56
5257424-25742441.64241.64
6310579-31057950.24150.24
10min1456581-45658173.85974.055.7073.9474.145.70
2462627-46262774.83774.93
3483456-48345678.20678.31
4485147-48514778.48078.58
5416202-41620267.32767.40
6442581-44258171.59471.68
15min1497133-49713380.41979.093.8580.6279.303.86
2488250-48825078.98279.20
3501892-50189281.18881.42
4509923-50992382.48882.72
5457566-45756674.01874.20
6478695-47869577.43677.64
20min1510186-51018682.53080.413.5582.8780.763.56
2493937-49393779.90280.25
3505885-50588581.83482.20
4516998-51699883.63284.00
5469068-46906875.87976.18
6486523-48652378.70279.03
30min1515587-51558783.40481.273.2483.8881.753.25
2498986-49898680.71881.20
3510775-51077582.62583.13
4519955-51995584.11084.62
5476902-47690277.14677.58
6492174-49217479.61680.08
45min1518405-51840583.86081.982.8884.4782.592.89
2503021-50302181.37181.99
3513792-51379283.11483.76
4523439-52343984.67485.32
5484448-48444878.36778.93
6497568-49756880.48981.09
60min1519329-51932984.00982.312.7184.7683.062.72
2504665-50466581.63782.39
3515388-51538883.37284.15
4525094-52509484.94285.73
5487718-48771878.89679.59
6500696-50069680.99581.73
极限1597711-59771196.68995.771.6997.5896.661.64
2584071-58407194.48295.37
3581770-58177094.11095.03
4588030-58803095.12396.05
5608768-60876898.47799.30
6591932-59193295.75496.62
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 5429345436285438945441545442315437680.10
29.825499845496685498260.05
单位质量响应值RSD%判断
55486.5355990.430.64数据可信
供试品溶液-F56971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%
5min1363030-36303058.02751.8918.8958.0351.8918.89
2205636-20563632.86932.87
3366650-36665058.60658.61
4337458-33745853.94053.94
5358677-35867757.33157.33
6316349-31634950.56550.57
10min1509144-50914481.38276.428.6781.4876.508.68
2397618-39761863.55663.61
3505708-50570880.83380.93
4488401-48840178.06678.16
5494022-49402278.96579.06
6473578-47357875.69775.78
15min1535482-53548285.59281.795.7685.8282.005.78
2454717-45471772.68272.84
3531054-53105484.88485.12
4518195-51819582.82983.05
5521741-52174183.39583.62
6508963-50896381.35381.56
20min1539774-53977486.27883.344.3586.6583.684.38
2478016-47801676.40676.69
3537392-53739285.89786.27
4528339-52833984.45084.81
5527075-52707584.24884.61
6517623-51762382.73783.08
30min1544046-54404686.96184.303.7087.4884.793.73
2490586-49058678.41678.82
3541010-54101086.47586.99
4533831-53383185.32885.83
5531856-53185685.01285.52
6523138-52313883.61984.10
45min1550166-55016687.93984.953.4688.6085.583.49
2497701-49770179.55380.09
3543348-54334886.84987.51
4536064-53606485.68586.33
5534971-53497185.51086.16
6526452-52645284.14884.77
60min1553160-55316088.41885.383.2189.2386.153.24
2503050-50305080.40881.08
3544206-54420686.98687.79
4537166-53716685.86186.64
5537077-53707785.84786.64
6530246-53024684.75585.52
极限1605312-60531296.75495.511.0697.7196.421.03
2603190-60319096.41497.22
3598130-59813095.60696.56
4592817-59281794.75695.68
5588476-58847694.06295.00
6597114-59711495.44396.35
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 5410225416515423685424875427815420620.14
29.825486925485075486000.03
单位质量响应值RSD%判断
55312.4555865.580.71数据可信
供试品溶液-2024053011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%
5min1435215-43521569.75261.738.2269.7561.738.22
2350488-35048856.17356.17
3409510-40951065.63365.63
4381193-38119361.09461.09
5362209-36220958.05258.05
6372349-37234959.67759.68
10min1536775-53677586.03082.684.8586.1582.784.85
2512882-51288282.20082.29
3554776-55477688.91589.02
4490153-49015378.55778.66
5497143-49714379.67879.77
6503545-50354580.70480.80
15min1557117-55711789.29087.335.0089.5587.575.00
2547589-54758987.76387.99
3590929-59092994.70994.97
4513722-51372282.33582.57
5530628-53062885.04485.27
6529232-52923284.82185.05
20min1565285-56528590.59989.034.9791.0189.424.97
2560167-56016789.77990.16
3602715-60271596.59897.01
4523950-52395083.97484.34
5541160-54116086.73287.10
6539674-53967486.49486.87
30min1570104-57010491.37190.124.8491.9390.664.83
2567192-56719290.90591.43
3608937-60893797.59598.17
4530181-53018184.97385.48
5552390-55239088.53289.05
6545013-54501387.35087.87
45min1573586-57358691.92990.954.4592.6491.644.45
2572409-57240991.74192.42
3610928-61092897.91498.65
4538274-53827486.27086.92
5560258-56025889.79390.46
6549489-54948988.06788.73
60min1576943-57694392.46791.334.3893.3392.174.38
2577963-57796392.63193.46
3610873-61087397.90598.81
4541475-54147586.78387.58
5563502-56350290.31391.13
6548437-54843787.89988.71
极限1612294-61229498.13397.571.1699.1598.561.18
2613041-61304198.25399.24
3615271-61527198.61099.68
4599412-59941296.06997.01
5612406-61240698.15199.11
6600158-60015896.18897.15
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DC033-12306002对照品来源分装对照品使用方法直接使用
对照品含量(%)98.99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%
19.80 5457305457805466965465165461865461820.08
29.825448275447465447860.02
单位质量响应值RSD%判断
55732.8655477.190.33数据可信
供试品溶液-2024053011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%
5min1427143-42714368.43863.038.2468.4463.038.25
2433843-43384369.51169.51
3382301-38230161.25361.25
4396900-39690063.59263.59
5352036-35203656.40456.40
6368237-36823759.00059.00
10min1529758-52975884.87981.763.2184.9981.863.21
2528931-52893184.74684.86
3495333-49533379.36379.47
4502878-50287880.57280.68
5492270-49227078.87278.97
6512566-51256682.12482.22
15min1548643-54864387.90586.012.5688.1686.252.56
2548245-54824587.84188.10
3516504-51650482.75582.99
4531156-53115685.10385.34
5527624-52762484.53784.76
6548620-54862087.90188.14
20min1556710-55671089.19787.602.4489.6087.982.45
2557479-55747989.32089.72
3528091-52809184.61284.98
4539890-53989086.50286.88
5537547-53754786.12786.49
6560741-56074189.84390.22
30min1558141-55814189.42688.632.5189.9889.162.51
2566692-56669290.79791.35
3534043-53404385.56586.08
4546647-54664787.58588.11
5544026-54402687.16587.67
6569337-56933791.22091.75
45min1563466-56346690.28089.472.8490.9890.152.84
2575871-57587192.26792.97
3539468-53946886.43587.09
4547754-54775487.76288.43
5547314-54731487.69288.35
6576594-57659492.38393.07
60min1567761-56776190.96890.073.0591.8290.903.04
2582922-58292293.39794.25
3541944-54194486.83187.63
4552349-55234988.49889.32
5548357-54835787.85988.66
6579582-57958292.86293.70
极限1616026-61602698.70197.421.3699.7098.401.37
2617415-61741598.92399.94
3595661-59566195.43896.38
4603826-60382696.74697.71
5605009-60500996.93697.88
6610390-61039097.79898.79
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