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 1370937137124213721501373094137241313719670.07
29.821370876137189413713850.06
单位质量响应值RSD%判断
139996.63139652.240.18数据可信
供试品溶液-304468批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11009919-100991964.34865.847.4764.3565.847.47
2992685-99268563.25063.25
31131563-113156372.09972.10
4969195-96919561.75461.75
51129984-112998471.99972.00
6966703-96670361.59561.59
10min11268882-126888280.84982.113.5080.9682.223.50
21243963-124396379.26179.37
31353463-135346386.23886.36
41246002-124600279.39179.49
51330041-133004184.74584.87
61289842-128984282.18482.29
15min11330228-133022884.75786.232.9185.0086.482.91
21304137-130413783.09583.33
31392592-139259288.73188.99
41322057-132205784.23784.47
51376231-137623187.68987.95
61394817-139481788.87389.11
20min11348836-134883685.94387.513.2686.3387.903.26
21321462-132146284.19984.57
31400490-140049089.23489.65
41335581-133558185.09885.47
51397784-139778489.06289.47
61436215-143621591.51091.90
30min11370951-137095187.35288.473.3387.8889.013.32
21330773-133077384.79285.31
31407349-140734989.67190.23
41348934-134893485.94986.47
51421818-142181890.59391.15
61451490-145149092.48493.02
45min11388755-138875588.48789.323.4589.1690.003.45
21339621-133962185.35686.01
31412001-141200189.96890.68
41362095-136209586.78887.45
51439228-143922891.70292.41
61469376-146937693.62394.32
60min11396777-139677788.99889.733.4089.8290.563.39
21345841-134584185.75286.55
31413422-141342290.05890.92
41371947-137194787.41688.22
51444607-144460792.04592.90
61476993-147699394.10994.96
极限11499444-149944495.53996.691.4896.5197.671.49
21494235-149423595.20796.15
31548368-154836898.65699.67
41505543-150554395.92896.88
51516804-151680496.64597.66
61540619-154061998.16399.17
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 1382739138455513847731384010138487913841910.07
29.821389446138972313895840.02
单位质量响应值RSD%判断
141243.98141505.500.14数据可信
供试品溶液-304468批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11043535-104353565.76167.875.4165.7667.875.41
21027503-102750364.75164.75
31030615-103061564.94764.95
41168099-116809973.61173.61
51129191-112919171.15971.16
61063388-106338867.01267.01
10min11297831-129783181.78682.521.1181.9082.641.11
21289748-128974881.27781.38
31325786-132578683.54883.66
41324508-132450883.46783.59
51306305-130630582.32082.44
61313111-131311182.74982.86
15min11354000-135400085.32686.892.7785.5787.142.76
21402388-140238888.37588.62
31436002-143600290.49490.74
41359837-135983785.69485.96
51330419-133041983.84084.10
61390480-139048087.62587.87
20min11361072-136107285.77288.383.9986.1688.783.98
21453261-145326191.58191.97
31473997-147399792.88893.29
41363149-136314985.90286.31
51337980-133798084.31684.71
61425723-142572389.84690.24
30min11369580-136958086.30889.804.8686.8490.344.84
21498540-149854094.43594.98
31501175-150117594.60195.15
41371890-137189086.45387.00
51349701-134970185.05585.59
61459404-145940491.96892.51
45min11375823-137582386.70190.295.2787.3890.985.24
21512043-151204395.28595.99
31512710-151271095.32796.04
41372591-137259186.49787.19
51348251-134825184.96485.64
61474847-147484792.94193.64
60min11373461-137346186.55290.415.3887.3791.255.35
21516308-151630895.55496.41
31511215-151121595.23396.10
41369254-136925486.28787.12
51352904-135290485.25786.08
61485008-148500893.58294.44
极限11491898-149189894.01695.640.9394.9896.640.93
21529731-152973196.40097.42
31519492-151949295.75596.78
41516116-151611695.54296.52
51530652-153065296.45897.42
61518556-151855695.69696.71
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 1368550136774613677691368184136858513681670.03
29.821384002138268713833440.07
单位质量响应值RSD%判断
139608.88140870.060.64数据可信
供试品溶液-2024052611批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1855550-85555054.35255.1415.2254.3555.1415.22
2921535-92153558.54458.54
3871203-87120355.34755.35
4975970-97597062.00262.00
5965907-96590761.36361.36
6617126-61712639.20539.21
10min11340226-134022685.14379.515.9185.2379.605.92
21227177-122717777.96178.06
31285127-128512781.64381.74
41268512-126851280.58780.69
51267750-126775080.53980.64
61120418-112041871.17971.24
15min11428602-142860290.75887.982.7390.9988.202.74
21376598-137659887.45487.68
31417711-141771190.06690.29
41372081-137208187.16787.40
51391433-139143388.39688.63
61322935-132293584.04584.23
20min11456147-145614792.50891.131.2792.8991.501.28
21425170-142517090.54090.91
31452683-145268392.28892.67
41422054-142205490.34290.72
51440344-144034491.50491.89
61410734-141073489.62389.95
30min11473006-147300693.57993.261.4494.1293.781.44
21461831-146183192.86993.39
31474638-147463893.68294.21
41443185-144318591.68492.22
51503175-150317595.49596.03
61452213-145221392.25892.73
45min11486275-148627594.42294.241.3895.1294.921.38
21485807-148580794.39295.07
31483640-148364094.25494.94
41453845-145384592.36193.05
51516840-151684096.36397.06
61474069-147406993.64694.27
60min11490843-149084394.71294.621.2695.5695.461.26
21492976-149297694.84795.68
31490900-149090094.71595.56
41462220-146222092.89393.73
51519455-151945596.53097.39
61480456-148045694.05294.84
极限11501765-150176595.40695.770.9096.4196.760.90
21504792-150479295.59896.59
31510462-151046295.95896.96
41490524-149052494.69295.69
51531271-153127197.28098.30
61506360-150636095.69896.64
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 1394456139327913931371392088139252513930970.07
29.821397826139751213976690.02
单位质量响应值RSD%判断
142152.76142328.820.09数据可信
供试品溶液-2024052611批-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1951424-95142459.59148.5313.1459.5948.5313.14
2694816-69481643.51943.52
3726628-72662845.51245.51
4844638-84463852.90352.90
5719702-71970245.07845.08
6711722-71172244.57844.58
10min11331911-133191183.42374.725.9983.5274.806.00
21202223-120222375.30075.37
31174006-117400673.53373.61
41155596-115559672.38072.47
51138803-113880371.32871.40
61155269-115526972.35972.43
15min11415160-141516088.63784.644.0888.8884.844.07
21370277-137027785.82686.02
31369301-136930185.76585.96
41256172-125617278.67978.89
51374260-137426086.07586.27
61322838-132283882.85583.05
20min11443685-144368590.42488.663.2990.8189.013.28
21421474-142147489.03389.37
31451810-145181090.93391.27
41326331-132633183.07383.41
51441002-144100290.25690.59
61409293-140929388.27088.60
30min11463978-146397891.69591.712.5392.2392.202.52
21461402-146140291.53392.02
31499296-149929693.90794.40
41395324-139532487.39587.87
51491392-149139293.41293.90
61473772-147377292.30892.79
45min11484284-148428492.96792.982.1193.6693.632.10
21484110-148411092.95693.60
31514575-151457594.86495.51
41425136-142513689.26289.89
51498931-149893193.88494.53
61500415-150041593.97794.61
60min11495104-149510493.64493.492.0094.4994.301.99
21494529-149452993.60894.41
31522640-152264095.36996.18
41436477-143647789.97290.75
51511115-151111594.64795.45
61496448-149644893.72894.52
极限11509383-150938394.53994.451.5995.5495.411.59
21502532-150253294.11095.06
31525806-152580695.56796.53
41462990-146299091.63392.56
51521508-152150895.29896.26
61525406-152540695.54296.49
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