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400
标示量(mg)25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%
110.131426834142660314255431422782142460514252730.12
210.251425564142769814266310.11
单位质量响应值RSD%判断
140698.22139183.510.77数据可信
供试品溶液-2024052611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%
5min1804805-80480551.23856.559.0451.2456.559.04
2959852-95985261.10961.11
3988285-98828562.91962.92
4929590-92959059.18359.18
5825413-82541352.55052.55
6821426-82142652.29652.30
10min11133146-113314672.14275.293.0572.2375.383.06
21192751-119275175.93776.04
31235106-123510678.63378.74
41204427-120442776.68076.78
51158270-115827073.74173.83
61171622-117162274.59274.68
15min11208035-120803576.91080.182.5777.1280.402.57
21260139-126013980.22780.46
31304214-130421483.03383.27
41277340-127734081.32281.55
51244079-124407979.20579.42
61262454-126245480.37480.59
20min11231346-123134678.39481.832.3978.7382.182.40
21292247-129224782.27182.63
31321918-132191884.16084.53
41298558-129855882.67383.03
51273118-127311881.05381.40
61294885-129488582.43982.78
30min11250829-125082979.63483.182.3580.1083.672.36
21308289-130828983.29283.79
31337812-133781285.17285.69
41325878-132587884.41284.91
51296984-129698482.57383.05
61319224-131922483.98984.47
45min11260366-126036680.24183.932.3180.8484.562.31
21317775-131777583.89684.53
31345189-134518985.64286.30
41331092-133109284.74485.38
51317509-131750983.87984.49
61337722-133772285.16685.79
60min11265804-126580480.58884.102.2081.3284.872.20
21324259-132425984.30985.09
31346356-134635685.71686.52
41334194-133419484.94285.72
51316968-131696883.84584.60
61338253-133825385.20085.96
极限11493088-149308895.05896.661.0395.9297.571.03
21525301-152530197.10998.03
31510091-151009196.14097.08
41529516-152951697.37798.30
51536205-153620597.80398.70
61515513-151551396.48597.39
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400
标示量(mg)25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%
110.131423916142493714225191425591142348814240900.09
210.251420299142324014217700.15
单位质量响应值RSD%判断
140581.44138709.270.95数据可信
供试品溶液-2024052611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%
5min1943916-94391660.22355.785.6060.2255.785.60
2919666-91966658.67658.68
3831798-83179853.06953.07
4855009-85500954.55054.55
5820662-82066252.35952.36
6874974-87497455.82455.82
10min11266977-126697780.83477.693.1680.9377.793.16
21227893-122789378.34178.44
31252332-125233279.90079.99
41190990-119099075.98676.08
51165920-116592074.38774.47
61202434-120243476.71676.81
15min11335046-133504685.17783.012.8985.4183.232.88
21315661-131566183.94084.17
31347679-134767985.98386.20
41280618-128061881.70581.92
51251688-125168879.85980.07
61275968-127596881.40881.63
20min11354482-135448286.41784.582.8186.7984.942.81
21333317-133331785.06785.44
31380150-138015088.05588.42
41308032-130803283.45483.81
51282492-128249281.82482.17
61295591-129559182.66083.02
30min11373501-137350187.63185.882.8388.1586.382.83
21352162-135216286.26986.78
31403245-140324589.52890.04
41332068-133206884.98785.48
51303923-130392383.19183.67
61311554-131155483.67884.17
45min11385898-138589888.42286.642.7089.0987.282.70
21359938-135993886.76587.42
31413658-141365890.19390.85
41341051-134105185.56086.19
51314250-131425083.85084.47
61332914-133291485.04185.67
60min11389944-138994488.68087.002.5389.4987.792.53
21367533-136753387.25088.05
31414692-141469290.25991.07
41346362-134636285.89986.68
51319949-131994984.21484.97
61343102-134310285.69186.47
极限11501107-150110795.77296.621.1496.7397.551.14
21519774-151977496.96397.91
31525150-152515097.30698.27
41527007-152700797.42498.34
51485628-148562894.78495.68
61527376-152737697.44898.37
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400
标示量(mg)25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%
110.131414286141542714145611416805141593114154020.08
210.251425736142549414256150.02
单位质量响应值RSD%判断
139723.79139084.390.33数据可信
供试品溶液-304468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%
5min1832557-83255753.20852.154.9553.2152.154.96
2788840-78884050.41450.41
3755369-75536948.27548.27
4838934-83893453.61553.62
5869950-86995055.59755.60
6810475-81047551.79651.80
10min11135141-113514172.54573.462.8572.6373.542.85
21129904-112990472.21172.29
31099967-109996770.29870.38
41181739-118173975.52475.61
51174474-117447475.05975.15
61175019-117501975.09475.18
15min11227027-122702778.41879.392.6378.6379.602.63
21237637-123763779.09679.30
31186961-118696175.85776.05
41271820-127182081.28081.50
51257539-125753980.36880.59
61272133-127213381.30081.51
20min11256150-125615080.27981.702.0380.6282.042.03
21287441-128744182.27982.61
31238110-123811079.12679.45
41300569-130056983.11883.47
51284834-128483482.11282.46
61303052-130305283.27683.62
30min11284264-128426482.07683.121.5582.5583.601.56
21301459-130145983.17583.65
31271747-127174781.27681.73
41320504-132050484.39284.88
51302502-130250283.24183.73
61323481-132348184.58285.07
45min11301026-130102683.14784.111.1883.7684.721.18
21316446-131644684.13284.74
31297277-129727782.90783.50
41330704-133070485.04485.67
51314887-131488784.03384.66
61336042-133604285.38586.01
60min11302895-130289583.26684.591.2484.0285.351.24
21337446-133744685.47586.23
31307056-130705683.53284.26
41335000-133500085.31886.09
51318840-131884084.28585.05
61340288-134028885.65686.43
极限11549345-154934599.01797.121.3299.9098.021.29
21500245-150024595.87996.77
31539378-153937898.38099.25
41506423-150642396.27497.19
51507622-150762296.35097.26
61515030-151503096.82497.74
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400
标示量(mg)25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%
110.131424831142586614236171424475142350914244600.07
210.251422589142066114216250.10
单位质量响应值RSD%判断
140617.97138695.120.98数据可信
供试品溶液-304468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%
5min1779283-77928349.71552.118.5049.7252.128.50
2862395-86239555.01755.02
3885740-88574056.50756.51
4879221-87922156.09156.09
5713613-71361345.52645.53
6780851-78085149.81549.82
10min11127063-112706371.90273.384.1671.9873.464.17
21179628-117962875.25575.35
31184838-118483875.58875.68
41204263-120426376.82776.92
51076071-107607168.64968.72
61129568-112956872.06272.14
15min11244755-124475579.41079.893.0979.6180.103.09
21263932-126393280.63480.85
31268551-126855180.92881.15
41302871-130287183.11883.34
51185744-118574475.64675.84
61248042-124804279.62079.82
20min11277280-127728081.48582.062.7081.8282.402.70
21296856-129685682.73483.09
31301845-130184583.05283.41
41332587-133258785.01485.37
51227960-122796078.33978.66
61281107-128110781.72982.07
30min11307813-130781383.43383.502.6783.9083.972.68
21315531-131553183.92684.41
31322025-132202584.34084.83
41354922-135492286.43986.94
51247708-124770879.59980.05
61304726-130472683.23683.71
45min11322823-132282384.39184.202.3385.0084.822.35
21323020-132302084.40385.03
31329916-132991684.84385.48
41363310-136331086.97487.62
51268338-126833880.91581.49
61311831-131183183.69084.30
60min11333072-133307285.04584.472.2485.8085.222.25
21325641-132564184.57185.34
31333417-133341785.06785.84
41364174-136417487.02987.82
51274370-127437081.30082.01
61313251-131325183.78084.53
极限11498638-149863895.60795.820.9796.5096.720.97
21492858-149285895.23896.15
31486601-148660194.83995.76
41528366-152836697.50498.44
51500342-150034295.71696.57
61505192-150519296.02596.92
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