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%
110.121420860142101614208391421270142267514213320.06
210.271423248142406814236580.05
单位质量响应值RSD%判断
140447.83138622.980.93数据可信
供试品溶液-E36577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%
5min1786356-78635650.21049.266.0850.2149.266.09
2787287-78728750.26950.27
3814721-81472152.02152.02
4814332-81433251.99652.00
5710003-71000345.33445.33
6716355-71635545.74045.74
10min11130787-113078772.20275.753.5272.2975.833.51
21207757-120775777.11777.20
31200136-120013676.63076.72
41182309-118230975.49275.58
51150359-115035973.45273.53
61246723-124672379.60579.68
15min11261157-126115780.52682.922.6380.7383.132.63
21324779-132477984.58984.80
31313263-131326383.85384.07
41286208-128620882.12682.34
51262630-126263080.62080.82
61344073-134407385.82086.03
20min11305928-130592883.38585.352.4383.7285.702.43
21361951-136195186.96287.32
31356249-135624986.59886.95
41321927-132192784.40684.76
51298051-129805182.88283.21
61376368-137636887.88388.23
30min11337855-133785585.42386.892.2685.9087.382.26
21381464-138146488.20888.71
31384760-138476088.41888.92
41342582-134258285.72586.22
51321514-132151484.38084.85
61396811-139681189.18889.69
45min11349990-134999086.19887.292.2186.8287.922.20
21385479-138547988.46489.11
31342460-134246085.71786.36
41397489-139748989.23189.86
51329298-132929884.87785.49
61397769-139776989.24989.90
60min11360926-136092686.89787.201.2887.6687.981.28
21367357-136735787.30788.10
31395432-139543289.10089.89
41346838-134683885.99786.78
51351541-135154186.29787.05
61372267-137226787.62188.42
极限11493629-149362995.37094.831.3396.2895.761.32
21516942-151694296.85897.80
31493158-149315895.34096.28
41466121-146612193.61394.54
51470689-147068993.90594.80
61470558-147055893.89794.84
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%
110.121421563142130214213391421077142045114211460.03
210.271421298142110414212010.01
单位质量响应值RSD%判断
140429.45138383.741.04数据可信
供试品溶液-E36577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%
5min1894237-89423757.15155.345.2157.1555.345.21
2876405-87640556.01256.01
3930565-93056559.47359.47
4857422-85742254.79854.80
5803135-80313551.32951.33
6833441-83344153.26653.27
10min11266952-126695280.97280.102.7081.0780.192.71
21254955-125495580.20580.30
31292908-129290882.63182.73
41278504-127850481.71081.80
51205879-120587977.06977.15
61220493-122049378.00378.09
15min11362891-136289187.10386.412.0887.3386.642.08
21350465-135046586.30986.54
31378526-137852688.10388.34
41381408-138140888.28788.51
51328891-132889184.93085.14
61310533-131053383.75783.98
20min11384824-138482488.50588.192.0388.8888.562.03
21379293-137929388.15288.52
31399221-139922189.42589.81
41416475-141647590.52890.90
51363789-136378987.16187.52
61336155-133615585.39585.75
30min11395515-139551589.18888.962.0189.7189.482.01
21387440-138744088.67289.19
31408327-140832790.00790.54
41432228-143222891.53592.06
51378470-137847088.09988.60
61349592-134959286.25386.75
45min11394784-139478489.14289.042.1689.8189.702.16
21390330-139033088.85789.52
31410209-141020990.12890.81
41436862-143686291.83192.51
51380303-138030388.21688.86
61346796-134679686.07586.72
60min11389929-138992988.83189.020.3189.6589.830.31
21399273-139927389.42990.24
31388475-138847588.73889.57
41396600-139660089.25890.09
51390464-139046488.86689.66
61392299-139229988.98389.77
极限11509438-150943896.46996.200.5797.4497.160.57
21496687-149668795.65496.62
31507494-150749496.34597.33
41510873-151087396.56197.54
51492740-149274095.40296.34
61513725-151372596.74397.68
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%
110.121406909140695214061381404834140441014058490.09
210.271402221140178614020040.03
单位质量响应值RSD%判断
138917.89136514.511.24数据可信
供试品溶液-E36577批-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%
5min1764128-76412849.43752.859.3849.4452.869.38
2893949-89394957.83657.84
3752288-75228848.67148.67
4780987-78098750.52750.53
5933237-93323760.37760.38
6777065-77706550.27450.27
10min11148370-114837074.29675.435.8374.3875.525.83
21233193-123319379.78379.88
31151126-115112674.47474.56
41256108-125610881.26681.35
51071194-107119469.30369.40
61135411-113541173.45773.54
15min11261013-126101381.58383.133.8081.7983.353.79
21288148-128814883.33983.57
31264226-126422681.79182.00
41310935-131093584.81385.03
51221677-122167779.03879.25
61363857-136385788.23788.44
20min11315599-131559985.11586.123.1885.4686.473.18
21335666-133566686.41386.78
31342675-134267586.86787.21
41403386-140338690.79491.16
51276473-127647382.58482.93
61312729-131272984.92985.28
30min11361994-136199488.11689.012.6588.6089.512.64
21350942-135094287.40187.91
31439232-143923293.11493.60
41400314-140031490.59691.11
51351253-135125387.42287.91
61351123-135112387.41387.91
45min11404409-140440990.86190.612.3291.4991.252.30
21371275-137127588.71789.37
31419291-141929191.82392.46
41446843-144684393.60694.27
51404044-140404490.83791.47
61357424-135742487.82188.46
60min11415982-141598291.60991.532.6992.3992.332.68
21426522-142652292.29193.10
31432678-143267892.68993.48
41469528-146952895.07495.89
51364216-136421688.26089.04
61380022-138002289.28390.07
极限11450734-145073493.85895.220.9194.7996.170.91
21469113-146911395.04796.01
31485802-148580296.12697.08
41486308-148630896.15997.14
51472346-147234695.25696.19
61466455-146645594.87595.81
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%
110.121400479140034514003031400289140052714003890.01
210.271407605140824614079260.04
单位质量响应值RSD%判断
138378.36137091.140.67数据可信
供试品溶液-E78779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%
5min1895937-89593757.95355.094.7657.9555.104.76
2890110-89011057.57657.58
3826590-82659053.46853.47
4829865-82986553.67953.68
5795080-79508051.42951.43
6872853-87285356.46056.46
10min11254161-125416181.12579.991.8481.2280.091.84
21272162-127216282.28982.39
31223745-122374579.15779.25
41229800-122980079.54979.64
51209181-120918178.21578.30
61230918-123091879.62179.72
15min11345094-134509487.00786.881.2587.2487.101.25
21372941-137294188.80889.04
31329753-132975386.01486.24
41345793-134579387.05287.27
51325876-132587685.76485.98
61338926-133892686.60886.83
20min11370719-137071988.66488.881.2789.0489.241.27
21405120-140512090.88991.27
31366749-136674988.40788.77
41380154-138015489.27489.64
51354207-135420787.59687.96
61366968-136696888.42288.79
30min11380108-138010889.27290.381.3689.8090.901.36
21424525-142452592.14592.68
31386791-138679189.70490.22
41410395-141039591.23191.75
51376702-137670289.05189.56
61405111-140511190.88991.41
45min11380281-138028189.28390.791.5989.9691.461.59
21437034-143703492.95493.64
31397418-139741890.39191.05
41415382-141538291.55392.22
51379590-137959089.23889.89
61411607-141160791.30991.98
60min11379542-137954289.23590.921.5690.0691.741.56
21435157-143515792.83293.67
31398011-139801190.43091.24
41418385-141838591.74792.57
51384233-138423389.53890.34
61418615-141861591.76292.58
极限11472381-147238195.24097.621.4596.2198.591.43
21527514-152751498.80699.80
31510323-151032397.69498.66
41514774-151477497.98298.96
51531904-153190499.090100.04
61498083-149808396.90397.88
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