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%
110.131425246142438514244931421587142183614235090.12
210.251423156142394514235500.04
单位质量响应值RSD%判断
140524.09138882.930.84数据可信
供试品溶液-2024052411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%
5min1985978-98597862.87960.968.4162.8860.968.41
2992726-99272663.31063.31
31017154-101715464.86864.87
4819017-81901752.23252.23
5898832-89883257.32257.32
61021219-102121965.12765.13
10min11284272-128427281.90379.973.4382.0180.073.44
21252174-125217479.85679.96
31292561-129256182.43182.54
41202495-120249576.68876.77
51201186-120118676.60476.70
61291301-129130182.35182.46
15min11351887-135188786.21584.662.6986.4684.892.69
21317614-131761484.02984.27
31363820-136382086.97687.22
41294004-129400482.52382.74
51279687-127968781.61081.83
61357634-135763486.58186.83
20min11368258-136825887.25986.112.5087.6486.482.50
21337964-133796485.32785.71
31389604-138960488.62089.01
41323451-132345184.40184.75
51303831-130383183.15083.51
61377913-137791387.87588.26
30min11378696-137869687.92587.312.7288.4587.832.73
21347131-134713185.91286.43
31415229-141522990.25490.79
41346679-134667985.88386.38
51320489-132048984.21284.71
61405971-140597189.66490.20
45min11384632-138463288.30388.052.8188.9888.712.81
21355258-135525886.43087.09
31434700-143470091.49692.18
41360007-136000786.73387.37
51333381-133338185.03585.67
61415898-141589890.29790.98
60min11389124-138912488.59088.392.7689.4189.202.76
21359335-135933586.69087.50
31438867-143886791.76292.60
41366915-136691587.17387.95
51339919-133991985.45286.23
61422172-142217290.69791.53
极限11490860-149086095.07895.671.0196.0596.631.02
21492942-149294295.21096.16
31514510-151451096.58697.58
41514075-151407596.55897.48
51477847-147784794.24895.17
61510558-151055896.33497.32
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%
110.131412179141237014113131412213141188314119920.03
210.251431120143067414308970.03
单位质量响应值RSD%判断
139387.17139599.710.11数据可信
供试品溶液-2024052411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%
5min1979149-97914962.53657.027.1162.5457.027.12
2851834-85183454.40554.40
3800076-80007651.09951.10
4897038-89703857.29257.29
5941274-94127460.11760.12
6887209-88720956.66456.66
10min11339198-133919885.53180.533.6685.6480.633.66
21244681-124468179.49579.59
31225277-122527778.25578.34
41227800-122780078.41778.51
51294514-129451482.67782.78
61234187-123418778.82578.92
15min11427964-142796491.20186.443.1091.4586.673.10
21348344-134834486.11586.34
31325895-132589584.68284.90
41328233-132823384.83185.06
51373843-137384387.74487.98
61316518-131651884.08384.31
20min11444406-144440692.25188.092.6892.6588.462.68
21369609-136960987.47487.84
31354291-135429186.49586.85
41368787-136878787.42187.79
51396960-139696089.22089.60
61341533-134153385.68086.05
30min11458755-145875593.16789.562.6093.7290.082.60
21391711-139171188.88589.40
31371837-137183787.61688.12
41405047-140504789.73790.25
51426491-142649191.10691.64
61360086-136008686.86587.37
45min11463291-146329193.45790.052.4794.1690.712.48
21399897-139989789.40890.07
31384382-138438288.41789.06
41420618-142061890.73191.39
51426513-142651391.10891.79
61364557-136455787.15187.80
60min11466338-146633893.65190.382.4294.5191.202.42
21405280-140528089.75290.56
31387657-138765788.62689.42
41426206-142620691.08891.90
51433578-143357891.55992.40
61371768-137176887.61188.41
极限11532387-153238797.87096.571.6398.8997.541.63
21490869-149086995.21896.18
31518723-151872396.99797.94
41542055-154205598.48799.45
51511223-151122396.51897.51
61477063-147706394.33695.28
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%
110.131420743141962414194691420574141929314199410.05
210.251420942142311314220280.11
单位质量响应值RSD%判断
140171.87138734.440.73数据可信
供试品溶液-2024052511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%
5min1881540-88154056.32055.645.2156.3255.645.21
2851333-85133354.39054.39
3899435-89943557.46357.46
4859830-85983054.93354.93
5933142-93314259.61659.62
6800451-80045151.13951.14
10min11180298-118029875.40676.681.7275.5076.781.72
21182318-118231875.53675.63
31199896-119989676.65976.75
41216521-121652177.72177.81
51232313-123231378.73078.83
61190326-119032676.04776.13
15min11251143-125114379.93382.101.8880.1582.321.87
21270561-127056181.17381.39
31279475-127947581.74381.97
41320868-132086884.38784.61
51289769-128976982.40082.63
61299042-129904282.99383.20
20min11273431-127343181.35783.901.8981.7184.261.88
21306318-130631883.45883.81
31309096-130909683.63583.99
41342304-134230485.75786.12
51311314-131131483.77784.14
61336938-133693885.41485.76
30min11291412-129141282.50585.472.0182.9985.972.00
21356323-135632386.65287.14
31332930-133293085.15885.66
41358993-135899386.82387.33
51326911-132691184.77385.28
61360617-136061786.92787.42
45min11317856-131785684.19587.142.0884.8287.782.07
21396842-139684289.24189.88
31357945-135794586.75687.40
41373093-137309387.72488.37
51351351-135135186.33586.98
61386582-138658288.58589.22
60min11325214-132521484.66587.812.1185.4388.592.10
21411075-141107590.15090.93
31373061-137306187.72288.51
41380646-138064688.20689.00
51365060-136506087.21088.00
61391460-139146088.89789.68
极限11518088-151808896.98796.520.9797.8997.450.96
21491697-149169795.30196.24
31510669-151066996.51397.45
41528318-152831897.64198.58
51495121-149512195.52096.46
61520393-152039397.13498.07
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%
110.131420890141975214196461421795142033914204840.07
210.251421190142210214216460.05
单位质量响应值RSD%判断
140225.47138697.170.78数据可信
供试品溶液-2024052511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%
5min1945433-94543360.39857.786.5660.4057.786.55
2989937-98993763.24163.24
3867652-86765255.42955.43
4834871-83487153.33553.34
5927589-92758959.25859.26
6861502-86150255.03655.04
10min11283808-128380882.01581.773.8882.1281.873.88
21342088-134208885.73885.84
31258887-125888780.42380.52
41220321-122032177.95978.05
51333857-133385785.21285.31
61241054-124105479.28479.38
15min11362947-136294787.07187.782.6587.3188.012.66
21420566-142056690.75291.00
31354923-135492386.55886.78
41332401-133240185.11985.34
51417610-141761090.56390.80
61356038-135603886.62986.85
20min11383580-138358088.38989.472.5288.7789.852.52
21446107-144610792.38392.78
31379812-137981288.14888.52
41358630-135863086.79587.16
51440623-144062392.03392.42
61394050-139405089.05889.43
30min11399371-139937189.39890.972.3289.9391.502.32
21463263-146326393.47994.03
31402886-140288689.62290.14
41388011-138801188.67289.18
51463242-146324293.47894.02
61427073-142707391.16791.68
45min11404802-140480289.74591.592.3490.4292.262.34
21471583-147158394.01194.72
31410784-141078490.12790.79
41400999-140099989.50290.15
51474905-147490594.22394.92
61438593-143859391.90392.57
60min11403807-140380789.68192.122.2890.5192.962.28
21474664-147466494.20895.07
31412136-141213690.21391.03
41429722-142972291.33792.14
51484039-148403994.80795.66
61447877-144787792.49693.32
极限11513928-151392896.71696.760.8897.6997.740.90
21536339-153633998.14899.17
31502320-150232095.97496.94
41504916-150491696.14097.09
51524003-152400397.36098.38
61506109-150610996.21697.19
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