达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
1 12.171994711991931990531995331991621992820.11
2 12.111988701983871986280.18
单位质量响应值RSD%判断
16374.8616401.980.12数据可信
供试品溶液-2025041711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%
5min1172969-17296984.85783.611.5484.8683.621.54
2173619-17361985.17685.18
3169494-16949483.15283.15
4167614-16761482.23082.23
5167622-16762282.23482.23
6171303-17130384.04084.04
10min1189551-18955192.99291.381.2793.1291.501.27
2186504-18650491.49791.62
3186081-18608191.29091.41
4184909-18490990.71590.84
5182707-18270789.63489.76
6187790-18779092.12892.25
15min1197227-19722796.75894.801.3797.0295.061.37
2192299-19229994.34094.61
3193928-19392895.13995.40
4191542-19154293.96994.23
5189675-18967593.05393.31
6194701-19470195.51895.78
20min1201334-20133498.77396.841.3299.1897.251.32
2195070-19507095.70096.11
3198687-19868797.47497.88
4195767-19576796.04196.44
5194820-19482095.57795.97
6198733-19873397.49797.90
30min1205049-205049100.59598.471.53101.1699.021.53
2198221-19822197.24597.80
3203235-20323599.705100.26
4199146-19914697.69998.24
5197213-19721396.75197.29
6201486-20148698.84799.40
45min1205996-205996101.06099.261.54101.7799.951.54
2199314-19931497.78298.48
3206014-206014101.069101.77
4200853-20085398.53799.23
5199186-19918697.71998.40
6202557-20255799.373100.07
极限1206032-206032101.07799.251.29101.94100.101.29
2199667-19966797.95598.80
3204864-204864100.504101.36
4201240-20124098.72699.57
5200004-20000498.12098.95
6202086-20208699.14299.99
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
1 12.171999151999651998862000351998291999260.04
2 12.111996951996741996840.01
单位质量响应值RSD%判断
16427.7716489.180.27数据可信
供试品溶液-2025041711批-pH4.4
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1163833-16383380.03380.141.7180.0380.141.71
2166603-16660381.38681.39
3165966-16596681.07581.08
4160078-16007878.19978.20
5166448-16644881.31081.31
6161329-16132978.81078.81
10min1180357-18035788.10588.901.4788.2389.021.47
2183805-18380589.78989.91
3184431-18443190.09590.22
4179515-17951587.69487.81
5184864-18486490.30790.43
6178914-17891487.40087.52
15min1186980-18698091.34092.201.4791.5992.451.47
2190274-19027492.95093.21
3192047-19204793.81694.07
4185879-18587990.80391.05
5191251-19125193.42793.68
6185990-18599090.85791.11
20min1191396-19139693.49894.161.4493.8994.561.44
2193967-19396794.75495.15
3196600-19660096.04096.44
4189775-18977592.70693.09
5194780-19478095.15195.55
6190038-19003892.83493.22
30min1195906-19590695.70196.271.6296.2396.811.62
2197694-19769496.57497.11
3201625-20162598.49599.04
4193064-19306494.31294.84
5199539-19953997.47698.02
6194654-19465495.08995.61
45min1197730-19773096.59297.481.8897.2698.151.88
2202206-20220698.77899.46
3204314-20431499.808100.50
4195004-19500495.26095.93
5201786-20178698.57399.26
6196196-19619695.84296.51
极限1200053-20005397.72797.721.7598.5498.541.75
2199982-19998297.69298.52
3204849-204849100.070100.91
4194448-19444894.98995.80
5202250-20225098.80099.63
6198680-19868097.05697.87
达格列净片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号101568-202301对照品来源中检院对照品使用方法直接使用
对照品含量(%)80.4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%
1 12.172008482013522010802005692010202009740.15
2 12.111985641990271987960.17
单位质量响应值RSD%判断
16513.8916415.850.43数据可信
供试品溶液-2025041711批-pH4.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1158614-15861477.45480.622.7977.4580.622.79
2171157-17115783.57983.58
3165443-16544380.78980.79
4161181-16118178.70778.71
5165812-16581280.96980.97
6168410-16841082.23782.24
10min1180570-18057088.17590.591.7688.2990.711.76
2190194-19019492.87593.00
3184059-18405989.87990.00
4184610-18461090.14890.27
5186421-18642191.03291.15
6187189-18718991.40891.53
15min1189641-18964192.60594.391.7192.8594.651.71
2198501-19850196.93197.20
3190806-19080693.17493.43
4191460-19146093.49393.75
5195127-19512795.28495.54
6194291-19429194.87695.14
20min1194105-19410594.78596.471.8495.1796.861.83
2202864-20286499.06299.47
3194186-19418694.82495.22
4195086-19508695.26495.66
5199742-19974297.53797.94
6199299-19929997.32197.72
30min1196518-19651895.96398.422.2596.4998.962.25
2206600-206600100.886101.44
3197711-19771196.54697.08
4198585-19858596.97297.51
5206494-206494100.834101.38
6203443-20344399.34599.89
45min1200470-20047097.89399.511.9798.57100.201.97
2209101-209101102.108102.82
3200963-20096398.13498.82
4199389-19938997.36598.05
5206664-206664100.917101.62
6206080-206080100.632101.33
极限1203194-20319499.223100.202.29100.04101.042.29
2209647-209647102.374103.24
3201015-20101598.15998.99
4199612-19961297.47498.30
5211175-211175103.120103.97
6206532-206532100.853101.70
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