二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.89 9220792107919609211091961920690.12
29.929246392366924140.08
单位质量响应值RSD%判断
9309.309315.930.06数据可信
供试品溶液-206397批-恩格列净-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min152851-5285150.56138.3616.0750.5638.3616.07
235267-3526733.73933.74
337222-3722235.60935.61
437147-3714735.53735.54
537995-3799536.34936.35
640079-4007938.34238.34
10min194991-9499190.87577.838.8690.9677.898.87
277716-7771674.34974.40
378705-7870575.29575.35
474635-7463571.40171.46
579064-7906475.63875.70
683025-8302579.42879.49
15min1106805-106805102.17796.384.05102.4196.574.06
2100560-10056096.20396.38
3100518-10051896.16396.35
494736-9473690.63190.81
598685-9868594.40994.60
6103165-10316598.69598.89
20min1107488-107488102.831100.661.84103.24101.011.85
2105791-105791101.207101.55
3106057-106057101.462101.81
4101715-10171597.30897.64
5105399-105399100.832101.18
6104832-104832100.290100.65
30min1107787-107787103.117101.211.38103.69101.731.40
2106926-106926102.293102.80
3105904-105904101.315101.83
4103674-10367499.18299.67
5105576-105576101.001101.51
6104884-104884100.339100.87
45min1107352-107352102.700101.251.28103.45101.941.29
2107230-107230102.584103.26
3106157-106157101.557102.24
4103882-10388299.381100.04
5105481-105481100.911101.59
6104911-104911100.365101.06
60min1107318-107318102.668101.141.27103.59102.001.28
2107015-107015102.378103.23
3105576-105576101.001101.85
4103769-10376999.273100.10
5105840-105840101.254102.10
6104814-104814100.272101.13
极限1107426-107426102.771101.421.63103.86102.441.63
2108684-108684103.975105.00
3105511-105511100.939101.96
4103988-10398899.482100.47
5105341-105341100.777101.79
6105101-105101100.547101.58
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.151095948108923210898321090966109068110913320.25
210.101090473109254010915060.14
单位质量响应值RSD%判断
107520.39108069.900.37数据可信
供试品溶液-206397批-二甲双胍-水
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1683158-68315857.03845.4512.8057.0445.4512.80
2498995-49899541.66241.66
3512867-51286742.82042.82
4508472-50847242.45342.45
5519086-51908643.34043.34
6543614-54361445.38845.39
10min11072465-107246589.54379.486.7989.6479.556.79
2928526-92852677.52577.59
3925204-92520477.24777.32
4886568-88656874.02274.09
5929701-92970177.62377.70
6968917-96891780.89780.97
15min11164656-116465697.24093.473.1797.4893.683.17
21137692-113769294.98895.19
31114667-111466793.06693.27
41063806-106380688.82089.01
51098597-109859791.72491.93
61137555-113755594.97795.19
20min11168995-116899597.60296.241.4898.0196.601.50
21169034-116903497.60597.96
31156481-115648196.55796.91
41123005-112300593.76294.10
51150342-115034296.04596.40
61148188-114818895.86596.23
30min11170712-117071297.74596.691.1098.3197.221.11
21175843-117584398.17498.69
31157325-115732596.62897.14
41144539-114453995.56096.06
51153131-115313196.27796.79
61147126-114712695.77696.30
45min11172015-117201597.85496.531.3098.5997.221.31
21175813-117581398.17198.85
31156046-115604696.52197.20
41137858-113785895.00295.66
51150208-115020896.03396.71
61145303-114530395.62496.31
60min11167950-116795097.51596.331.2498.4197.181.25
21172731-117273197.91498.76
31152677-115267796.24097.08
41135450-113545094.80195.62
51150235-115023596.03696.87
61143311-114331195.45896.31
极限11164926-116492697.26296.211.2498.3297.211.24
21173099-117309997.94598.95
31149819-114981996.00197.00
41134850-113485094.75195.73
51147871-114787195.83896.83
61143171-114317195.44696.45
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.89 9210992262923049211491944921470.16
29.929237192118922440.20
单位质量响应值RSD%判断
9317.199298.790.14数据可信
供试品溶液-206397批-恩格列净-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min153031-5303150.75842.0612.1150.7642.0612.11
242422-4242240.60440.60
346883-4688344.87444.87
439431-3943137.74137.74
538765-3876537.10437.10
643130-4313041.28241.28
10min194609-9460990.55583.187.5390.6483.257.53
287173-8717383.43783.50
393462-9346289.45789.53
479315-7931575.91675.98
579580-7958076.17076.23
687273-8727383.53383.60
15min1107116-107116102.52698.813.29102.7699.013.30
2104097-10409799.63699.84
3105894-105894101.356101.58
4100319-10031996.02096.21
598162-9816293.95594.14
6103788-10378899.34099.55
20min1105809-105809101.275101.440.73101.68101.810.73
2106257-106257101.704102.08
3106698-106698102.126102.52
4106785-106785102.209102.56
5104772-104772100.282100.63
6105538-105538101.015101.39
30min1105530-105530101.008101.761.06101.58102.311.05
2106710-106710102.137102.68
3106487-106487101.924102.49
4108095-108095103.463103.98
5104790-104790100.299100.81
6106314-106314101.758102.30
45min1105548-105548101.025101.901.13101.77102.621.12
2107038-107038102.451103.16
3106886-106886102.306103.04
4108390-108390103.745104.44
5105195-105195100.687101.37
6105738-105738101.207101.92
60min1105210-105210100.701101.801.36101.61102.681.35
2107876-107876103.253104.14
3106399-106399101.839102.74
4108331-108331103.689104.55
5105290-105290100.778101.63
6105026-105026100.525101.41
极限1105200-105200100.692101.521.17101.77102.581.16
2106770-106770102.195103.25
3106144-106144101.595102.67
4108164-108164103.529104.57
5105040-105040100.539101.55
6105102-105102100.598101.65
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.151087270109142710886051087454108791510885340.16
210.101088288108833110883100.01
单位质量响应值RSD%判断
107244.73107753.470.34数据可信
供试品溶液-206397批-二甲双胍-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1692125-69212557.94649.679.9357.9549.679.93
2578763-57876348.45548.46
3626789-62678952.47652.48
4541408-54140845.32845.33
5534288-53428844.73244.73
6586019-58601949.06349.06
10min11068533-106853389.46083.766.2089.5683.846.20
21000806-100080683.79083.87
31064457-106445789.11989.21
4929449-92944977.81577.89
5927604-92760477.66177.74
61011873-101187384.71684.80
15min11150845-115084596.35194.712.2396.6094.942.24
21142690-114269095.66895.89
31153216-115321696.55096.79
41112391-111239193.13293.34
51089484-108948491.21491.42
61139047-113904795.36395.59
20min11145843-114584395.93296.410.8796.3496.790.86
21155000-115500096.69997.08
31155958-115595896.77997.18
41166703-116670397.67998.04
51138075-113807595.28295.64
61147396-114739696.06296.44
30min11142674-114267495.66796.610.9896.2397.160.98
21159128-115912897.04597.59
31156599-115659996.83397.39
41171252-117125298.06098.58
51140669-114066995.49996.01
61153633-115363396.58597.13
45min11142118-114211895.62196.461.0896.3597.161.06
21158403-115840396.98497.69
31154898-115489896.69097.41
41172405-117240598.15698.84
51139573-113957395.40796.08
61145425-114542595.89796.60
60min11140006-114000695.44496.461.1896.3397.321.17
21168525-116852597.83198.70
31151817-115181796.43397.31
41168983-116898397.87098.72
51141463-114146395.56696.40
61141806-114180695.59496.46
极限11137585-113758595.24196.061.0596.2997.081.03
21153279-115327996.55597.58
31149721-114972196.25797.30
41167452-116745297.74298.75
51136571-113657195.15696.15
61139741-113974195.42296.44
二甲双胍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对照品来源中检院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2000
标示量(mg)5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%
19.89 9271292844926279240192692926550.18
29.929239292291923420.08
单位质量响应值RSD%判断
9368.559308.670.46数据可信
供试品溶液-206397批-恩格列净-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%
5min134292-3429232.71530.4812.1232.7230.4812.12
225540-2554024.36624.37
332237-3223730.75530.75
436846-3684635.15235.15
532716-3271631.21231.21
630036-3003628.65528.65
10min174464-7446471.04066.0810.5271.0966.1310.52
259257-5925756.53256.57
369433-6943366.24066.29
479020-7902075.38675.44
570595-7059567.34967.40
662852-6285259.96260.01
15min197931-9793193.42889.356.4493.6089.516.45
284274-8427480.39980.53
394644-9464490.29290.45
4101109-10110996.46096.64
594577-9457790.22890.39
689411-8941185.30085.45
20min1104406-10440699.60598.402.5099.9398.702.52
2100182-10018295.57595.84
3102325-10232597.62097.93
4107105-107105102.180102.52
5104035-10403599.25199.57
6100781-10078196.14796.44
30min1104964-104964100.137100.121.41100.63100.591.41
2106408-106408101.515101.94
3103967-10396799.18699.66
4106580-106580101.679102.19
5105068-105068100.237100.72
6102692-10269297.97098.42
45min1104566-10456699.758100.071.22100.42100.711.22
2106156-106156101.275101.87
3104366-10436699.567100.21
4106486-106486101.589102.27
5104788-10478899.970100.62
6102996-10299698.26098.87
60min1104451-10445199.648100.091.21100.48100.901.21
2105799-105799100.934101.70
3104487-10448799.682100.49
4106444-106444101.549102.40
5105450-105450100.601101.41
6102883-10288398.15298.93
极限1104312-10431299.51599.721.11100.51100.701.11
2105966-105966101.093102.03
3103960-10396099.180100.15
4105758-105758100.895101.92
5104265-10426599.471100.45
6102897-10289798.16599.11
二甲双胍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100664-202106对照品来源中检所对照品对照品使用方法105℃烘干2小时
对照品含量(%)100对照品水分(%)0对照品稀释倍数20
标示量(mg)500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%
110.151092591109347610934211094674109296710934260.08
210.101090917109080710908620.01
单位质量响应值RSD%判断
107726.70108006.140.19数据可信
供试品溶液-206397批-二甲双胍-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%
5min1469731-46973139.19336.2610.2739.1936.2610.27
2360814-36081430.10530.11
3437520-43752036.50536.51
4486497-48649740.59240.59
5441057-44105736.80036.80
6411522-41152234.33634.34
10min1837013-83701369.83865.618.6869.9065.678.68
2688811-68881157.47257.52
3789088-78908865.83965.90
4873670-87367072.89672.96
5800823-80082366.81866.88
6728688-72868860.79960.86
15min11026334-102633485.63482.654.9285.8282.824.93
2914444-91444476.29876.44
31002175-100217583.61883.79
41050180-105018087.62487.81
5992100-99210082.77882.95
6957944-95794479.92880.09
20min11071929-107192989.43888.541.7589.7688.841.77
21041002-104100286.85887.13
31055335-105533588.05488.36
41089683-108968390.92091.25
51065889-106588988.93489.24
61043185-104318587.04087.33
30min11073866-107386689.60089.561.0290.0790.011.02
21087338-108733890.72491.14
31067352-106735289.05689.51
41084745-108474590.50890.99
51068100-106810089.11989.58
61058981-105898188.35888.79
45min11072950-107295089.52389.450.9090.1590.060.90
21081925-108192590.27290.84
31068693-106869389.16889.77
41083471-108347190.40191.04
51067759-106775989.09089.70
61057771-105777188.25788.84
60min11070640-107064089.33189.330.8690.1090.080.86
21081637-108163790.24890.97
31066907-106690789.01989.77
41079891-107989190.10390.89
51067490-106749089.06889.82
61056972-105697288.19088.92
极限11066419-106641988.97889.040.9689.9089.940.96
21081346-108134690.22491.09
31063417-106341788.72889.63
41076577-107657789.82690.76
51061240-106124088.54689.45
61053660-105366087.91488.79
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