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%
19.805485065483715489215491985490775488150.07
29.825513055509655511350.05
单位质量响应值RSD%判断
56001.5356123.730.16数据可信
供试品溶液-2024052811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%
5min1457391-45739172.68669.055.5772.6969.055.58
2451159-45115971.69571.70
3390858-39085862.11362.11
4433012-43301268.81168.81
5447389-44738971.09671.10
6427181-42718167.88567.88
10min1526368-52636883.64784.472.5183.7784.592.51
2541319-54131986.02386.14
3506816-50681680.54080.64
4535195-53519585.05085.16
5539270-53927085.69785.82
6540381-54038185.87485.99
15min1550917-55091787.54888.001.7587.8188.261.75
2561996-56199689.30989.57
3535594-53559485.11385.35
4556638-55663888.45788.71
5557820-55782088.64588.91
6559756-55975688.95389.21
20min1557663-55766388.62088.971.4889.0389.371.48
2566028-56602889.95090.36
3544055-54405586.45886.84
4563571-56357189.55989.96
5563028-56302889.47389.88
6564791-56479189.75390.16
30min1572105-57210590.91590.171.5291.4790.721.53
2573243-57324391.09691.66
3550210-55021087.43687.96
4568639-56863990.36490.92
5568746-56874690.38190.94
6571400-57140090.80391.36
45min1581485-58148592.40691.492.1893.1192.192.17
2576521-57652191.61792.33
3556002-55600288.35689.03
4594201-59420194.42795.13
5571756-57175690.86091.57
6574399-57439991.28091.99
60min1582407-58240792.55291.551.6093.4192.411.60
2579295-57929592.05892.92
3558514-55851488.75589.57
4575266-57526691.41892.28
5583896-58389692.78993.65
6577384-57738491.75492.61
极限1615932-61593297.88097.301.0298.8998.311.02
2621132-62113298.70699.73
3612351-61235197.31198.28
4605756-60575696.26397.28
5604648-60464896.08797.10
6613881-61388197.55498.56
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%
19.805467675467205470195472575467185468960.05
29.825453195451635452410.03
单位质量响应值RSD%判断
55805.7155523.520.36数据可信
供试品溶液-2024052911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%
5min1383402-38340261.36463.304.7461.3663.304.75
2423588-42358867.79667.80
3385491-38549161.69861.70
4414566-41456666.35266.35
5378358-37835860.55660.56
6387510-38751062.02162.02
10min1490270-49027078.46882.963.3878.5783.073.38
2521734-52173483.50483.62
3505577-50557780.91881.02
4538822-53882286.23986.35
5526529-52652984.27184.37
6527246-52724684.38684.49
15min1517105-51710582.76387.343.3883.0087.583.37
2539890-53989086.41086.66
3534614-53461485.56585.80
4564612-56461290.36790.62
5561130-56113089.80990.05
6556699-55669989.10089.34
20min1527887-52788784.48989.033.4384.8689.423.42
2549824-54982488.00088.40
3543127-54312786.92887.31
4573493-57349391.78892.19
5575216-57521692.06492.45
6568030-56803090.91491.31
30min1550888-55088888.17090.562.8688.6891.092.85
2555450-55545088.90089.44
3548823-54882387.83988.36
4579659-57965992.77593.33
5586641-58664193.89294.44
6573279-57327991.75492.30
45min1570718-57071891.34491.552.4792.0092.242.46
2559190-55919089.49990.19
3552914-55291488.49489.17
4583530-58353093.39494.11
5589675-58967594.37895.08
6575910-57591092.17592.87
60min1575630-57563092.13091.852.4092.9492.692.39
2562239-56223989.98790.83
3554376-55437688.72889.55
4583838-58383893.44494.31
5591782-59178294.71595.57
6575433-57543392.09892.95
极限1613498-61349898.19198.101.1499.1699.101.14
2620937-62093799.381100.37
3601169-60116996.21797.18
4609565-60956597.56198.59
5617896-61789698.89599.91
6614676-61467698.37999.38
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%
19.805481265476685478065480165478625478960.04
29.825454655451305452980.05
单位质量响应值RSD%判断
55907.7655529.330.49数据可信
供试品溶液-2024052911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%
5min1406814-40681465.04865.118.5765.0565.118.58
2382585-38258561.17461.17
3471742-47174275.43075.43
4406701-40670165.03065.03
5404398-40439864.66264.66
6371013-37101359.32459.32
10min1524308-52430883.83583.283.5883.9483.383.59
2505556-50555680.83780.94
3551111-55111188.12188.25
4524304-52430483.83483.94
5522337-52233783.52083.63
6497282-49728279.51479.61
15min1550987-55098788.10187.972.4988.3588.222.50
2537301-53730185.91386.15
3571255-57125591.34291.61
4556126-55612688.92389.17
5552041-55204188.26988.52
6533302-53330285.27385.50
20min1561957-56195789.85589.582.2890.2589.972.29
2547039-54703987.47087.85
3578651-57865192.52492.95
4566096-56609690.51790.91
5563348-56334890.07790.47
6544276-54427687.02887.40
30min1568433-56843390.89090.671.8191.4491.211.82
2552609-55260988.36088.89
3582084-58208493.07393.65
4569968-56996891.13691.68
5570265-57026591.18391.73
6558863-55886389.36089.88
45min1572637-57263791.56391.461.6292.2692.161.63
2555717-55571788.85789.53
3583054-58305493.22893.96
4577755-57775592.38193.08
5573213-57321391.65592.35
6569688-56968891.09191.76
60min1575424-57542492.00891.931.6692.8692.781.67
2557911-55791189.20890.03
3585617-58561793.63894.53
4581566-58156692.99093.84
5576371-57637192.16093.01
6572690-57269091.57192.39
极限1605822-60582296.86996.961.8497.8797.961.85
2594124-59412494.99895.97
3618159-61815998.84199.89
4621216-62121699.330100.34
5602495-60249596.33797.34
6596542-59654295.38596.36
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%
19.805478385477945477195474635472775476180.05
29.825492335490785491560.02
单位质量响应值RSD%判断
55879.3955922.200.06数据可信
供试品溶液-2024052811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%
5min1390195-39019562.18764.556.2162.1964.546.21
2413081-41308165.83465.83
3446459-44645971.15471.15
4397571-39757163.36263.36
5410468-41046865.41865.42
6372237-37223759.32559.32
10min1522390-52239083.25584.992.1583.3685.102.16
2549738-54973887.61487.72
3542888-54288886.52286.64
4528310-52831084.19984.30
5535293-53529385.31185.42
6521179-52117983.06283.16
15min1553686-55368688.24389.891.5188.4990.141.51
2576780-57678091.92392.18
3566842-56684290.34090.60
4555351-55535188.50888.75
5566588-56658890.29990.55
6564879-56487990.02790.26
20min1562525-56252589.65291.441.7590.0491.841.74
2585498-58549893.31393.72
3571514-57151491.08491.50
4562086-56208689.58289.98
5578507-57850792.19992.60
6582238-58223892.79393.18
30min1566835-56683590.33892.512.0190.8893.062.00
2593232-59323294.54595.11
3574821-57482191.61192.18
4569219-56921990.71891.26
5587038-58703893.55894.11
6591767-59176794.31294.85
45min1569486-56948690.76193.092.2791.4593.792.26
2598669-59866995.41296.13
3576408-57640891.86492.58
4571794-57179491.12991.82
5589595-58959593.96694.68
6598543-59854395.39296.09
60min1572267-57226791.20493.292.3192.0494.152.30
2600667-60066795.73096.61
3575989-57598991.79792.67
4572156-57215691.18692.03
5591753-59175394.31095.18
6599423-59942395.53296.39
极限1592371-59237194.40896.341.6795.4097.361.66
2609872-60987297.19798.24
3600754-60075495.74496.77
4602700-60270096.05497.05
5599656-59965695.56996.59
6621545-62154599.058100.08
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