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%
1 10.151372390137416213739681374074137483513738860.07
2 10.201375695137595113758230.02
单位质量响应值RSD%判断
135358.23134884.610.25数据可信
供试品溶液-2024052511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%
5min1906321-90632159.75854.939.4559.7654.939.45
2840788-84078855.43755.44
3906614-90661459.77759.78
4745348-74534849.14449.14
5870933-87093357.42457.42
6728311-72831148.02148.02
10min11224606-122460680.74377.794.1180.8477.884.11
21158497-115849776.38576.48
31217596-121759680.28180.38
41146959-114695975.62475.71
51221919-122191980.56680.66
61109086-110908673.12773.21
15min11319198-131919886.98084.772.6487.2184.992.65
21271192-127119283.81584.03
31311598-131159886.47986.71
41263533-126353383.31083.52
51312889-131288986.56486.79
61235463-123546381.45981.66
20min11364891-136489189.99387.762.5690.3788.122.57
21319941-131994187.02987.39
31363288-136328889.88790.26
41321903-132190387.15987.51
51342293-134229388.50388.88
61273886-127388683.99384.33
30min11413255-141325593.18291.172.9993.7191.682.99
21404151-140415192.58293.09
31419165-141916593.57294.10
41378004-137800490.85891.35
51374548-137454890.63091.15
61307257-130725786.19386.67
45min11457766-145776696.11793.592.8596.8094.252.85
21445314-144531495.29695.95
31452044-145204495.73996.42
41412146-141214693.10993.75
51396486-139648692.07692.75
61353327-135332789.23189.85
60min11482868-148286897.77294.483.9898.6295.303.97
21460833-146083396.31997.14
31474326-147432697.20998.05
41442514-144251495.11195.91
51406379-140637992.72993.55
61330854-133085487.74988.52
极限11513879-151387999.81699.510.80100.82100.480.77
21490539-149053998.27899.26
31506481-150648199.329100.33
41515004-151500499.891100.85
51503683-150368399.144100.13
61525827-1525827100.604101.52
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%
1 10.151379163138023113803941380685138082713802600.05
2 10.201375019137559013753040.03
单位质量响应值RSD%判断
135986.21134833.730.61数据可信
供试品溶液-2024052511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%
5min1918808-91880860.45358.167.4660.4558.167.46
2862895-86289556.77456.77
3812065-81206553.43053.43
4999087-99908765.73565.73
5855933-85593356.31656.32
6854869-85486956.24656.25
10min11193697-119369778.53977.094.1778.6477.184.17
21145410-114541075.36275.46
31136940-113694074.80574.89
41261081-126108182.97283.08
51157550-115755076.16176.25
61135154-113515474.68774.78
15min11257368-125736882.72882.552.6182.9682.772.62
21251398-125139882.33582.56
31238950-123895081.51681.73
41315119-131511986.52886.78
51246786-124678682.03282.25
61217956-121795680.13580.35
20min11275308-127530883.90984.342.3784.2884.702.38
21280039-128003984.22084.58
31268281-126828183.44683.80
41337994-133799488.03388.43
51282356-128235684.37284.73
61246844-124684482.03682.39
30min11299581-129958185.50686.562.5886.0187.062.58
21305431-130543185.89086.39
31297394-129739485.36285.85
41356683-135668389.26389.80
51358328-135832889.37189.87
61276233-127623383.96984.46
45min11309965-130996586.18988.043.9786.8488.683.96
21319697-131969786.82987.47
31306341-130634185.95086.58
41370211-137021190.15390.84
51431257-143125794.16994.82
61290819-129081984.92985.56
60min11316836-131683686.64188.584.3087.4489.374.27
21325282-132528287.19787.98
31310639-131063986.23387.01
41377141-137714190.60991.45
51450098-145009895.40996.21
61297473-129747385.36786.14
极限11526812-1526812100.456100.400.95101.40101.350.94
21545548-1545548101.689102.62
31501354-150135498.78199.70
41522127-1522127100.148101.14
51529502-1529502100.633101.60
61530682-1530682100.711101.62
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%
1 10.151371835137285813723751371217137194213720450.05
2 10.201370359137070813705340.02
单位质量响应值RSD%判断
135176.85134366.080.43数据可信
供试品溶液-2024052511批-pH6.7
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1980234-98023464.79961.374.4664.8061.374.46
2952747-95274762.98262.98
3890635-89063558.87658.88
4886166-88616658.58158.58
5897962-89796259.36159.36
6962315-96231563.61563.61
10min11314069-131406986.86884.342.3086.9884.442.30
21266941-126694183.75283.86
31229740-122974081.29381.39
41262529-126252983.46183.56
51289762-128976285.26185.36
61291504-129150485.37685.48
15min11397743-139774392.39990.941.3492.6591.181.34
21361096-136109689.97690.22
31356623-135662389.68189.91
41376341-137634190.98491.22
51398134-139813492.42592.67
61364370-136437090.19390.44
20min11429279-142927994.48493.691.4094.8994.081.40
21405123-140512392.88793.28
31409224-140922493.15893.54
41417067-141706793.67694.06
51449386-144938695.81396.21
61393290-139329092.10592.50
30min11472748-147274897.35796.221.6997.9296.771.68
21451803-145180395.97396.52
31461884-146188496.63997.18
41454067-145406796.12296.67
51481369-148136997.92798.48
61411037-141103793.27893.83
45min11496506-149650698.92897.461.8499.6598.171.83
21473072-147307297.37998.09
31480570-148057097.87498.57
41466159-146615996.92297.63
51502383-150238399.316100.03
61426825-142682594.32195.03
60min11504069-150406999.42897.801.75100.3298.671.74
21478250-147825097.72198.59
31488774-148877498.41799.28
41471544-147154497.27898.14
51500267-150026799.176100.06
61433335-143333594.75295.62
极限11532564-1532564101.31199.141.49102.37100.171.49
21492580-149258098.66899.70
31500376-150037699.184100.21
41495032-149503298.83099.86
51511930-151193099.947101.00
61465473-146547396.87697.90
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%
1 10.151375835137600113762341375696137653013760590.03
2 10.201381654138205713818560.03
单位质量响应值RSD%判断
135572.32135476.080.06数据可信
供试品溶液-2024052511批-pH6.9
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1814305-81430553.53156.443.3253.5356.443.32
2854848-85484856.19656.20
3843716-84371655.46455.46
4898193-89819359.04559.05
5867442-86744257.02457.02
6872822-87282257.37857.38
10min11204542-120454279.18480.571.4079.2780.661.41
21225107-122510780.53680.63
31252183-125218382.31682.41
41222057-122205780.33680.43
51237424-123742481.34681.44
61212622-121262279.71579.81
15min11341431-134143188.18388.031.6388.4088.261.62
21329388-132938887.39187.62
31374342-137434290.34790.58
41325449-132544987.13287.36
51351289-135128988.83189.06
61312909-131290986.30886.54
20min11397916-139791691.89691.641.6892.2692.011.67
21377630-137763090.56390.94
31436664-143666494.44494.82
41383831-138383190.97091.35
51396596-139659691.81092.19
61371247-137124790.14390.52
30min11436054-143605494.40394.551.4394.9295.081.43
21417932-141793293.21293.74
31476512-147651297.06397.60
41428568-142856893.91194.44
51442559-144255994.83195.36
61428120-142812093.88294.40
45min11459480-145948095.94396.181.3696.6296.861.36
21446835-144683595.11295.79
31502077-150207798.74499.44
41453892-145389295.57696.26
51462679-146267996.15496.84
61453519-145351995.55296.23
60min11464135-146413596.24996.981.3297.0997.831.32
21461855-146185596.10096.94
31513728-151372899.510100.37
41473306-147330696.85297.70
51472746-147274696.81697.67
61465892-146589296.36597.20
极限11506842-150684299.05799.551.05100.06100.561.04
21520490-152049099.954100.95
31543301-1543301101.454102.48
41506751-150675199.051100.06
51499325-149932598.56399.57
61509193-150919399.211100.21
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