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%
110.131412815141162114133241412370141321514126690.05
210.251409065141167514103700.14
单位质量响应值RSD%判断
139454.00137597.070.95数据可信
供试品溶液-2024052411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%
5min1822944-82294452.92952.567.4752.9352.567.47
2699551-69955144.99344.99
3858377-85837755.20855.21
4814327-81432752.37552.37
5866362-86636255.72255.72
6841788-84178854.14154.14
10min11177356-117735675.72474.751.8875.8174.841.89
21128600-112860072.58872.66
31148332-114833273.85773.95
41190266-119026676.55476.64
51160051-116005174.61174.70
61168632-116863275.16375.25
15min11264603-126460381.33580.352.2881.5580.562.27
21230591-123059179.14879.34
31211668-121166877.93078.15
41291715-129171583.07983.29
51237948-123794879.62179.84
61259506-125950681.00781.22
20min11286694-128669482.75682.382.0283.1182.732.02
21267737-126773781.53781.86
31250593-125059380.43480.78
41326387-132638785.30985.66
51269201-126920181.63181.98
61284623-128462382.62382.97
30min11308433-130843384.15483.952.1084.6484.432.09
21294772-129477283.27583.74
31274573-127457381.97682.46
41353234-135323487.03587.53
51287554-128755482.81183.30
61312628-131262884.42484.91
45min11322646-132264685.06884.942.1485.7085.562.14
21306229-130622984.01284.61
31294189-129418983.23883.85
41374637-137463788.41289.05
51308095-130809584.13284.76
61317881-131788184.76285.39
60min11325663-132566385.26285.411.9886.0386.181.98
21314483-131448384.54385.29
31306725-130672584.04484.80
41379647-137964788.73489.52
51316967-131696784.70385.47
61324403-132440385.18185.95
极限11500688-150068896.51997.791.0497.4398.701.04
21518805-151880597.68498.57
31515530-151553097.47498.37
41545978-154597899.432100.37
51529953-152995398.40199.31
61511501-151150197.21598.13
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%
110.131410526140810314085761407515140921314087870.09
210.251412033140952714107800.13
单位质量响应值RSD%判断
139070.78137637.070.74数据可信
供试品溶液-2024052411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%
5min1792557-79255751.03754.444.0051.0454.443.99
2845388-84538854.43954.44
3840137-84013754.10154.10
4855824-85582455.11155.11
5840589-84058954.13054.13
6897743-89774357.81057.81
10min11212980-121298078.11078.072.0378.2078.162.03
21207847-120784777.78077.87
31240822-124082279.90379.99
41209094-120909477.86077.95
51170305-117030575.36275.45
61232655-123265579.37779.47
15min11320685-132068585.04684.592.0585.2684.812.06
21304951-130495184.03384.25
31333200-133320085.85286.08
41319919-131991984.99785.22
51264015-126401581.39781.61
61338412-133841286.18786.42
20min11352241-135224187.07886.721.8987.4387.081.88
21334183-133418385.91586.28
31367093-136709388.03488.40
41358823-135882387.50287.87
51301292-130129283.79784.15
61366578-136657888.00188.37
30min11376377-137637788.63288.311.5589.1388.821.55
21356227-135622787.33587.84
31387906-138790689.37589.89
41385503-138550389.22089.73
51335671-133567186.01186.50
61386793-138679389.30389.82
45min11380752-138075288.91488.941.5089.5689.601.51
21368016-136801688.09488.74
31399662-139966290.13290.79
41397672-139767290.00390.66
51346780-134678086.72687.36
61394404-139440489.79390.46
60min11388541-138854189.41589.441.6090.2190.241.60
21376311-137631188.62889.42
31412932-141293290.98691.80
41405217-140521790.48991.30
51352103-135210387.06987.85
61398398-139839890.05090.87
极限11517356-151735697.71198.060.7398.6699.010.72
21521031-152103197.94798.89
31535512-153551298.88099.84
41533660-153366098.76099.72
51523637-152363798.11599.04
61505585-150558596.95397.92
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%
110.131406526140795114102871409743140761714084250.12
210.251415164141675314159580.08
单位质量响应值RSD%判断
139035.04138142.240.46数据可信
供试品溶液-2024052511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%
5min1830121-83012153.36455.609.2453.3655.609.24
21005695-100569564.65164.65
3879139-87913956.51656.52
4762581-76258149.02349.02
5853257-85325754.85254.85
6859000-85900055.22155.22
10min11167432-116743275.04976.043.0175.1476.143.02
21229535-122953579.04179.15
31161480-116148074.66674.76
41134740-113474072.94773.03
51187970-118797076.36976.46
61216119-121611978.17878.27
15min11280018-128001882.28681.701.8982.5081.921.88
21272095-127209581.77782.02
31233710-123371079.30979.53
41267090-126709081.45581.66
51265336-126533681.34281.56
61307626-130762684.06184.28
20min11314936-131493684.53183.792.2484.8884.152.23
21293444-129344483.14983.53
31261163-126116381.07481.42
41311573-131157384.31584.65
51291536-129153683.02783.38
61348201-134820186.66987.03
30min11330960-133096085.56185.262.1386.0585.752.12
21317890-131789084.72185.24
31286992-128699282.73483.22
41344705-134470586.44586.92
51309250-130925084.16584.66
61367403-136740387.90488.41
45min11330612-133061285.53985.892.3186.1786.532.30
21324992-132499285.17785.83
31302082-130208283.70584.33
41367931-136793187.93888.56
51312121-131212184.35084.98
61379168-137916888.66089.31
60min11336590-133659085.92386.172.2086.7086.952.19
21330877-133087785.55686.35
31307637-130763784.06284.82
41371467-137146788.16588.94
51315846-131584684.58985.36
61380024-138002488.71589.52
极限11510463-151046397.10097.651.1998.0298.581.18
21520719-152071997.76098.70
31506577-150657796.85197.75
41553071-155307199.839100.76
51503838-150383896.67497.59
61519736-151973697.69698.65
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%
110.131413589141225414133161412907141422014132570.06
210.251409673141133414105040.09
单位质量响应值RSD%判断
139512.04137610.150.98数据可信
供试品溶液-2024052511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%
5min1901469-90146957.96556.165.4057.9656.165.40
2847462-84746254.49254.49
3918649-91864959.06959.07
4910135-91013558.52258.52
5794496-79449651.08651.09
6867869-86786955.80455.80
10min11231020-123102079.15580.283.8079.2580.373.80
21273377-127337781.87981.97
31299721-129972183.57283.67
41280168-128016882.31582.41
51167442-116744275.06775.15
61239252-123925279.68479.78
15min11307611-130761184.08085.892.8884.3186.122.88
21353026-135302687.00087.23
31387809-138780989.23789.47
41353601-135360187.03787.27
51278660-127866082.21882.43
61334223-133422385.79186.02
20min11336431-133643185.93387.472.7086.3087.842.70
21371896-137189688.21388.59
31416995-141699591.11391.50
41381452-138145288.82889.21
51317930-131793084.74385.09
61337017-133701785.97186.34
30min11357073-135707387.26088.702.6787.7789.222.67
21391794-139179489.49390.01
31439032-143903292.53093.07
41394893-139489389.69290.22
51336847-133684785.96086.45
61357391-135739187.28187.79
45min11360261-136026187.46589.112.3988.1289.782.40
21398328-139832889.91390.58
31441269-144126992.67493.37
41395675-139567589.74290.42
51351520-135152086.90387.53
61368443-136844387.99188.65
60min11368832-136883288.01689.192.3388.8290.012.34
21399556-139955689.99290.81
31437926-143792692.45993.31
41400156-140015690.03090.86
51346335-134633586.57087.35
61369935-136993588.08788.89
极限11527155-152715598.19798.340.3399.1599.300.32
21523938-152393897.99098.96
31532176-153217698.51999.52
41524866-152486698.04999.03
51537241-153724198.84599.77
61530730-153073098.42699.38
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