依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.131737491739771737941738301735421737780.10
210.251741021736451738740.19
单位质量响应值RSD%判断
17154.7916963.320.80数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1102720-10272054.19552.9816.0554.1952.9816.04
281213-8121342.84842.85
393725-9372549.44949.45
4125956-12595666.45466.45
588860-8886046.88246.88
6110047-11004758.06058.06
10min1161206-16120685.05280.377.3485.3580.667.37
2139168-13916873.42473.66
3145953-14595377.00477.28
4169300-16930089.32289.69
5145739-14573976.89177.15
6152651-15265180.53880.86
15min1179335-17933594.61691.573.2095.3992.313.25
2165796-16579687.47388.12
3168707-16870789.00989.71
4178914-17891494.39495.26
5172474-17247490.99791.68
6176165-17616592.94493.71
20min1181084-18108495.53994.183.0796.8495.433.12
2173079-17307991.31692.45
3171250-17125090.35191.55
4185201-18520197.71199.10
5177948-17794893.88595.08
6182478-18247896.27597.56
30min1178819-17881994.34496.031.6996.1797.801.72
2178643-17864394.25195.89
3180608-18060895.28896.99
4185588-18558897.91599.85
5184913-18491397.55999.27
6183504-18350496.81698.64
45min1183888-18388897.01997.010.6299.3799.320.62
2185288-18528897.75799.92
3181814-18181495.92498.15
4184089-18408997.12599.60
5184259-18425997.21499.47
6183918-18391897.03499.39
60min1183041-18304196.57296.420.8499.4699.270.92
2180853-18085395.41798.12
3181372-18137295.69198.45
4184999-18499997.605100.62
5182621-18262196.35099.15
6183689-18368996.91499.81
极限1184264-18426497.21797.080.86100.65100.460.85
2184054-18405497.106100.34
3181464-18146495.74099.03
4183986-18398697.070100.63
5186410-18641098.349101.68
6183825-18382596.985100.42
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954197784181164186644194014195154190950.17
211.054188844194884191860.11
单位质量响应值RSD%判断
38273.5237935.380.63数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1263211-26321161.85959.8615.5961.8659.8615.59
2208243-20824348.94148.94
3235881-23588155.43655.44
4316923-31692374.48274.48
5225478-22547852.99152.99
6278595-27859565.47465.47
10min1382172-38217289.81785.316.6690.1685.656.69
2333422-33342278.36078.63
3350096-35009682.27882.59
4399050-39905093.78394.20
5348670-34867081.94382.24
6364681-36468185.70686.07
15min1412635-41263596.97694.142.7497.8294.952.79
2385122-38512290.51091.22
3391203-39120391.93992.70
4410680-41068096.51797.45
5398542-39854293.66494.41
6405271-40527195.24596.09
20min1408297-40829795.95795.072.8097.3496.402.85
2396382-39638293.15694.37
3389150-38915091.45792.73
4420010-42001098.709100.18
5400594-40059494.14695.42
6412826-41282697.02198.39
30min1399696-39969693.93595.511.5895.8597.371.61
2398740-39874093.71095.44
3404794-40479495.13396.92
4414299-41429997.36799.39
5411797-41179796.77998.57
6409046-40904696.13398.04
45min1406293-40629395.48695.320.7897.9297.710.73
2411162-41116296.63098.88
3402942-40294294.69897.01
4406213-40621395.46798.03
5404076-40407694.96597.30
6402828-40282894.67197.11
60min1404293-40429395.01694.530.7097.9897.450.79
2398582-39858293.67396.46
3400956-40095694.23197.07
4406568-40656895.55098.64
5401151-40115194.27797.14
6401860-40186094.44497.41
极限1404863-40486395.15094.630.7198.6498.070.71
2403552-40355294.84198.15
3397551-39755193.43196.79
4402936-40293694.69798.32
5405302-40530295.25398.63
6401607-40160794.38497.88
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.131734091738241739141736601738431737300.12
210.251754041755901754970.08
单位质量响应值RSD%判断
17150.0517121.660.12数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min194752-9475249.76549.0018.9649.7749.0018.96
278493-7849341.22641.23
3117599-11759961.76561.76
4108267-10826756.86356.86
570551-7055137.05437.05
690054-9005447.29847.30
10min1149984-14998478.77477.309.4079.0577.589.43
2134464-13446470.62270.85
3165232-16523286.78287.13
4150074-15007478.82179.14
5127680-12768067.05967.27
6155672-15567281.76182.02
15min1169324-16932488.93189.993.7889.6590.703.83
2163087-16308785.65686.28
3181445-18144595.29896.12
4172001-17200190.33791.09
5166982-16698287.70188.28
6175253-17525392.04592.76
20min1178924-17892493.97494.921.6495.1896.121.69
2178181-17818193.58394.68
3186085-18608597.73599.09
4178550-17855093.77795.03
5181400-18140095.27496.34
6181174-18117495.15596.38
30min1187626-18762698.54498.692.64100.27100.422.59
2188259-18825998.876100.49
3194103-194103101.946103.84
4184912-18491297.11998.90
5192175-192175100.933102.53
6180400-18040094.74996.51
45min1188945-18894599.23799.442.09101.51101.712.11
2187953-18795398.716100.88
3196813-196813103.369105.83
4187279-18727998.362100.68
5189568-18956899.564101.72
6185379-18537997.36499.65
60min1188203-18820398.847100.271.38101.68103.101.37
2193005-193005101.369104.08
3194380-194380102.091105.13
4188575-18857599.042101.91
5192284-192284100.990103.70
6189055-18905599.295102.12
极限1190577-190577100.094100.251.52103.47103.641.48
2190805-190805100.214103.49
3193530-193530101.645105.25
4187033-18703398.233101.65
5194697-194697102.258105.53
6188595-18859599.053102.43
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954198904187014190214193594184694190880.14
211.054218134226894222510.15
单位质量响应值RSD%判断
38272.8838212.760.12数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1242557-24255756.79855.4117.8556.8055.4117.85
2203167-20316747.57447.57
3293959-29395968.83468.83
4272036-27203663.70063.70
5180583-18058342.28642.29
6227479-22747953.26753.27
10min1356444-35644483.46681.898.8583.7882.208.88
2321988-32198875.39775.66
3388578-38857890.99091.37
4357115-35711583.62383.98
5304803-30480371.37371.61
6369439-36943986.50886.80
15min1392968-39296892.01892.993.1592.8093.753.21
2380158-38015889.01889.70
3415966-41596697.40398.29
4399468-39946893.54094.36
5389402-38940291.18391.81
6404662-40466294.75695.53
20min1409514-40951495.89396.511.1397.1897.781.17
2408186-40818695.58296.76
3420630-42063098.49599.92
4408853-40885395.73897.08
5413823-41382396.90298.04
6411815-41181596.43197.73
30min1419958-41995898.33898.462.36100.16100.282.31
2421875-42187598.787100.50
3431858-431858101.125103.10
4416105-41610597.43699.31
5428962-428962100.446102.12
6404180-40418094.64396.48
45min1420602-42060298.48998.241.95100.86100.601.98
2414387-41438797.03499.29
3435033-435033101.868104.41
4417049-41704997.657100.07
5418087-41808797.900100.13
6412091-41209196.49698.86
60min1417880-41788097.85298.841.00100.77101.741.02
2423849-42384999.249102.05
3429179-429179100.497103.60
4419379-41937998.203101.16
5423101-42310199.074101.85
6419100-41910098.137101.04
极限1418534-41853498.00598.291.18101.46101.751.14
2418793-41879398.065101.41
3424278-42427899.350103.01
4414135-41413596.975100.47
5426969-42696999.980103.31
6415890-41589097.386100.83
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号ZT-705-231101-1-D 对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)100.00对照品水分(%)0对照品稀释倍数5000
标示量(mg)10供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.131762531760041757461755451752861757670.22
210.251757591760561759080.12
单位质量响应值RSD%判断
17351.1417161.760.78数据可信
供试品溶液-2024012921批-依折麦布-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1135656-13565670.75362.7510.7870.7562.7510.78
2115387-11538760.18160.18
3111605-11160558.20958.21
4115589-11558960.28760.29
5137291-13729171.60571.61
6106356-10635655.47155.47
10min1180344-18034494.06093.592.6994.4593.942.70
2180774-18077494.28494.62
3170426-17042688.88789.21
4184582-18458296.27196.61
5181827-18182794.83495.23
6178741-17874193.22493.53
15min1180706-18070694.24997.572.2395.1698.432.18
2190368-19036899.288100.15
3186487-18648797.26498.08
4185749-18574996.87997.75
5186321-18632197.17898.10
6192765-192765100.539101.36
20min1185331-18533196.66198.751.2998.10100.161.25
2191300-19130099.774101.18
3189540-18954098.856100.21
4188787-18878798.46499.87
5188749-18874998.44499.91
6192364-192364100.329101.71
30min1185105-18510596.54399.321.6998.52101.281.63
2192213-192213100.251102.21
3192748-192748100.530102.44
4191527-19152799.893101.85
5187929-18792998.016100.03
6193040-193040100.682102.62
45min1185296-18529696.64398.931.5199.16101.441.46
2191306-19130699.778102.30
3190570-19057099.394101.86
4190440-19044099.326101.84
5187323-18732397.700100.26
6193162-193162100.746103.25
60min1179015-17901593.36798.092.9996.42101.152.90
2194563-194563101.476104.55
3188468-18846898.297101.31
4187999-18799998.053101.11
5185270-18527096.62999.73
6193106-193106100.716103.78
极限1182230-18223095.04498.232.1898.61101.832.12
2190795-19079599.511103.15
3190239-19023999.221102.78
4188179-18817998.147101.75
5185093-18509396.537100.17
6193504-193504100.924104.54
依折麦布辛伐他汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100601-201906对照品来源工作对照品对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数2500
标示量(mg)20供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.954233894238124230134222354220364228970.18
211.054231164235694233420.08
单位质量响应值RSD%判断
38620.7338311.490.57数据可信
供试品溶液-2024012921批-辛伐他汀-pH7.0(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1341363-34136379.47170.7210.8279.4770.7210.82
2291255-29125567.80667.81
3281479-28147965.53065.53
4291344-29134467.82767.83
5348162-34816281.05481.05
6269030-26903062.63262.63
10min1419434-41943497.64797.402.6098.0997.802.60
2423711-42371198.64299.02
3396999-39699992.42492.79
4427589-42758999.54599.92
5421793-42179398.19698.65
6420780-42078097.96098.31
15min1411436-41143695.78599.082.2796.77100.012.22
2432628-432628100.718101.64
3424854-42485498.90999.79
4420300-42030097.84898.78
5424984-42498498.93999.93
6439232-439232102.256103.15
20min1417280-41728097.14599.051.3898.66100.541.34
2429820-429820100.065101.55
3425707-42570799.107100.53
4420820-42082097.96999.44
5425908-42590899.154100.70
6433356-433356100.888102.35
30min1412663-41266396.07098.511.5798.13100.551.51
2427061-42706199.422101.46
3428790-42879099.825101.80
4423266-42326698.539100.56
5417981-41798197.30999.40
6429187-42918799.917101.94
45min1411308-41130895.75597.611.3298.34100.191.28
2421481-42148198.123100.72
3420792-42079297.963100.50
4419855-41985597.745100.31
5415015-41501596.61899.25
6427239-42723999.464102.04
60min1396872-39687292.39496.692.7695.5299.822.68
2429251-42925199.932103.07
3415550-41555096.74399.82
4414183-41418396.42499.53
5410798-41079895.63698.81
6425351-42535199.024102.15
极限1402372-40237293.67596.421.9697.31100.081.89
2418813-41881397.502101.20
3418390-41839097.404101.02
4411757-41175795.86099.50
5408835-40883595.17998.88
6424817-42481798.900102.58
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