依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.851622401623711623861623701624061623550.05
29.911637741647851642800.44
单位质量响应值RSD%判断
16482.7416577.190.41数据可信
供试品溶液-2022092001批-依折麦布-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%
5min16445-64453.4983.2312.913.503.2312.90
25358-53582.9082.91
34895-48952.6562.66
45642-56423.0623.06
56890-68903.7393.74
66459-64593.5053.51
10min114469-144697.8527.891.777.877.901.80
214256-142567.7367.75
314241-142417.7287.74
414859-148598.0648.08
514741-147418.0008.02
614645-146457.9477.97
15min115001-150018.1418.371.868.208.431.87
215532-155328.4298.49
315374-153748.3438.40
415679-156798.5098.57
515743-157438.5438.61
615197-151978.2478.31
20min115219-152198.2598.341.068.378.451.05
215383-153838.3488.45
315335-153358.3228.43
415680-156808.5098.62
515380-153808.3468.46
615263-152638.2838.39
30min114279-142797.7498.001.757.908.161.74
214656-146567.9538.11
314895-148958.0838.23
414910-149108.0918.25
514979-149798.1298.29
614773-147738.0178.17
45min114129-141297.6677.962.057.868.162.01
214757-147578.0088.20
314978-149788.1288.32
414678-146787.9658.17
514886-148868.0788.28
614576-145767.9108.11
60min113617-136177.3907.662.077.637.912.04
214310-143107.7668.01
314023-140237.6107.85
414472-144727.8548.10
514173-141737.6917.94
614151-141517.6797.92
极限113663-136637.4157.611.707.707.891.66
214135-141357.6717.95
313951-139517.5717.85
414104-141047.6547.94
514359-143597.7928.08
613890-138907.5387.82
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003110353111463112243113383113843112250.05
211.053142873157123150000.32
单位质量响应值RSD%判断
28293.1828506.790.54数据可信
供试品溶液-2022092001批-阿托伐他汀钙-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%
5min1103978-10397830.24231.3016.0030.2431.3016.00
294234-9423427.40827.41
3109245-10924531.77431.77
484990-8499024.71924.72
5121706-12170635.39835.40
6131630-13163038.28538.28
10min1183747-18374753.44356.003.4953.6156.183.46
2199502-19950258.02558.18
3193520-19352056.28556.46
4198353-19835357.69157.83
5184958-18495853.79553.99
6195173-19517356.76656.98
15min1198017-19801757.59360.313.7258.0660.793.68
2215960-21596062.81263.29
3206616-20661660.09460.58
4214243-21424362.31262.77
5198631-19863157.77258.27
6210628-21062861.26161.79
20min1207045-20704560.21962.184.3261.0063.004.28
2223132-22313264.89865.72
3211878-21187861.62562.45
4217837-21783763.35864.16
5199965-19996558.16058.98
6222786-22278664.79765.67
30min1209828-20982861.02864.314.5962.1565.474.57
2230399-23039967.01168.20
3223075-22307564.88166.05
4220608-22060864.16465.32
5209159-20915960.83461.97
6233530-23353067.92269.15
45min1225339-22533965.54067.754.4867.0069.284.44
2245136-24513671.29872.85
3235450-23545068.48070.01
4227046-22704666.03667.55
5220220-22022064.05165.53
6244482-24448271.10772.71
60min1230325-23032566.99069.714.8768.8171.604.82
2248856-24885672.38074.33
3238312-23831269.31371.22
4248297-24829772.21774.10
5221850-22185064.52566.36
6250342-25034272.81274.81
极限1267565-26756577.82179.665.1080.0281.945.04
2285296-28529682.97885.33
3271584-27158478.99081.28
4287689-28768983.67485.95
5250243-25024372.78374.97
6280924-28092481.70784.11
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.851627061626581628101628701627951627680.06
29.911619001624351621680.24
单位质量响应值RSD%判断
16524.6716364.080.70数据可信
供试品溶液-2022092001批-依折麦布-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%
5min16979-69793.8074.119.693.814.119.67
26586-65863.5933.59
38360-83604.5604.56
47510-75104.0974.10
58403-84034.5844.58
67383-73834.0274.03
10min114239-142397.7678.064.327.798.094.34
213878-138787.5717.59
315381-153818.3908.42
414638-146387.9858.01
515447-154478.4268.45
615100-151008.2378.26
15min115532-155328.4738.481.148.548.551.12
215593-155938.5068.57
315560-155608.4888.56
415828-158288.6348.70
515516-155168.4648.54
615277-152778.3348.40
20min115210-152108.2978.391.408.418.501.38
215596-155968.5088.62
315396-153968.3998.52
415665-156658.5458.66
515169-151698.2758.39
615211-152118.2988.41
30min114295-142957.7988.012.997.968.172.93
214647-146477.9908.15
315019-150198.1938.36
415293-152938.3428.50
514711-147118.0258.19
614113-141137.6997.86
45min114357-143577.8328.043.398.038.243.34
214610-146107.9708.17
314954-149548.1588.37
415623-156238.5228.73
514590-145907.9598.17
614261-142617.7797.98
60min113557-135577.3957.672.157.647.922.14
214180-141807.7357.98
314186-141867.7398.00
414400-144007.8558.11
514204-142047.7488.00
613873-138737.5687.81
极限113958-139587.6147.701.047.908.001.06
214172-141727.7318.02
314332-143327.8188.12
414130-141307.7088.01
514184-141847.7378.03
613952-139527.6117.90
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003113593114203115873117573114223115090.06
211.053098483106743102610.19
单位质量响应值RSD%判断
28319.0028077.920.61数据可信
供试品溶液-2022092001批-阿托伐他汀钙-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%
5min1103104-10310430.20229.4331.7030.2029.4331.70
283854-8385424.56324.56
3148999-14899943.64643.65
452592-5259215.40615.41
5102038-10203829.89029.89
6112285-11228532.89232.89
10min1205150-20515060.09454.578.2660.2654.748.30
2173678-17367850.87551.01
3206651-20665160.53460.78
4176285-17628551.63951.72
5175103-17510351.29351.46
6180976-18097653.01353.20
15min1222938-22293865.30557.678.9265.8158.148.93
2183670-18367053.80254.22
3214521-21452162.83963.42
4193151-19315156.58056.95
5182568-18256853.47953.93
6184368-18436854.00754.48
20min1224115-22411565.65058.697.9466.5159.487.95
2190204-19020455.71656.43
3215893-21589363.24164.17
4197361-19736157.81358.50
5185779-18577954.42055.17
6188817-18881755.31056.09
30min1224525-22452565.77059.218.4467.0060.328.45
2188358-18835855.17656.20
3222500-22250065.17766.46
4198397-19839758.11659.12
5191869-19186956.20457.25
6187048-18704854.79255.88
45min1233973-23397368.53861.188.8870.1362.628.89
2191572-19157256.11757.45
3230484-23048467.51569.16
4201044-20104458.89260.22
5201658-20165859.07260.43
6194396-19439656.94458.33
60min1242003-24200370.89062.389.3372.8764.169.31
2192564-19256456.40858.05
3232532-23253268.11570.13
4208319-20831961.02362.68
5204817-20481759.99761.69
6197459-19745957.84259.55
极限1285854-28585483.73578.185.1786.1080.305.24
2259584-25958476.04078.00
3278039-27803981.44683.84
4270111-27011179.12381.12
5248218-24821872.71074.73
6259473-25947376.00778.03
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.851630891631361632671633731633521632430.08
29.911641491646711644100.23
单位质量响应值RSD%判断
16572.8916590.310.08数据可信
供试品溶液-2022092201批-依折麦布-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%
5min18673-86734.6925.0710.274.695.0710.31
28986-89864.8614.86
310668-106685.7715.77
48216-82164.4454.44
510362-103625.6065.61
69369-93695.0685.07
10min115059-150598.1478.241.318.178.261.31
215139-151398.1908.22
315583-155838.4308.46
415327-153278.2928.32
515111-151118.1758.21
615121-151218.1808.21
15min115467-154678.3678.331.128.448.401.11
215235-152358.2428.31
315583-155838.4308.51
415567-155678.4218.49
515176-151768.2108.29
615336-153368.2968.37
20min115387-153878.3248.361.868.448.481.83
215570-155708.4238.54
315553-155538.4148.54
415779-157798.5368.65
515552-155528.4138.54
614936-149368.0808.20
30min114865-148658.0428.031.098.218.201.09
214880-148808.0508.21
315067-150678.1518.32
414923-149238.0738.24
514610-146107.9048.07
614711-147117.9588.12
45min114496-144967.8427.891.758.058.111.73
214414-144147.7988.01
314995-149958.1128.33
414802-148028.0088.22
514516-145167.8538.07
614328-143287.7517.96
60min114665-146657.9338.053.358.198.303.22
215845-158458.5728.82
314834-148348.0258.29
414893-148938.0578.31
514471-144717.8298.08
614577-145777.8868.14
极限114785-147857.9988.136.658.298.436.43
217040-170409.2189.52
314665-146657.9338.24
414660-146607.9318.23
514305-143057.7398.04
614725-147257.9668.26
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003111653113483114703115743114053113920.05
211.053140433141713141070.03
单位质量响应值RSD%判断
28308.3628425.970.30数据可信
供试品溶液-2022092201批-阿托伐他汀钙-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%
5min1163004-16300447.46443.2919.3847.4643.2919.38
2120181-12018134.99534.99
3168518-16851849.07049.07
4159077-15907746.32146.32
5175977-17597751.24251.24
6105271-10527130.65330.65
10min1220325-22032564.15563.834.5164.4264.074.55
2208864-20886460.81861.01
3218096-21809663.50663.78
4233797-23379768.07868.34
5225973-22597365.79966.08
6208269-20826960.64460.81
15min1231680-23168067.46166.833.8268.0867.433.86
2219597-21959763.94364.48
3226034-22603465.81766.44
4241351-24135170.27770.91
5237220-23722069.07469.72
6221246-22124664.42364.93
20min1234461-23446168.27168.603.3469.2769.573.39
2226406-22640665.92666.81
3233206-23320667.90668.90
4246490-24649071.77472.80
5243507-24350770.90571.94
6229522-22952266.83367.70
30min1243503-24350370.90469.923.6772.2871.273.71
2228416-22841666.51167.76
3235612-23561268.60669.97
4250436-25043672.92374.35
5248755-24875572.43373.86
6234025-23402568.14469.38
45min1254553-25455374.12272.925.0675.8974.665.06
2229734-22973466.89568.52
3250689-25068972.99674.75
4262907-26290776.55478.38
5262170-26217076.33978.17
6242567-24256770.63172.25
60min1267750-26775077.96475.785.0280.1477.925.01
2236711-23671168.92670.92
3258608-25860875.30277.46
4273551-27355179.65381.91
5267551-26755177.90680.16
6257288-25728874.91876.93
极限1294415-29441585.72986.351.7288.3488.911.74
2295091-29509185.92588.30
3288811-28881184.09786.67
4303568-30356888.39491.09
5300237-30023787.42490.11
6297161-29716186.52888.95
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DJ333-221017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(%)99.67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%
19.851628491627591628111628161627741628020.03
29.911652851663961658400.48
单位质量响应值RSD%判断
16528.1216734.610.88数据可信
供试品溶液-2022092201批-依折麦布-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%
5min111015-110155.9415.059.035.945.059.02
29085-90854.9004.90
39444-94445.0945.09
49033-90334.8724.87
58631-86314.6554.66
69018-90184.8644.86
10min115351-153518.2808.121.138.318.151.16
214915-149158.0458.07
315162-151628.1788.21
414955-149558.0668.09
514933-149338.0558.08
615038-150388.1118.14
15min115618-156188.4248.320.798.508.390.80
215521-155218.3728.44
315334-153348.2718.34
415406-154068.3108.38
515333-153338.2708.34
615331-153318.2698.34
20min115372-153728.2918.211.948.428.331.92
215398-153988.3058.42
315175-151758.1858.30
415431-154318.3238.44
515312-153128.2598.38
614650-146507.9028.02
30min114687-146877.9227.931.118.098.091.10
214751-147517.9568.12
314684-146847.9208.09
414977-149778.0788.24
514630-146307.8918.05
614481-144817.8117.97
45min114862-148628.0167.861.318.238.071.32
214733-147337.9478.16
314528-145287.8368.05
414376-143767.7547.96
514502-145027.8228.03
614413-144137.7747.98
60min114624-146247.8887.811.058.158.061.07
214682-146827.9198.17
314404-144047.7698.02
414477-144777.8098.06
514452-144527.7958.04
614266-142667.6957.94
极限114420-144207.7787.720.908.088.020.88
214449-144497.7948.09
314255-142557.6897.98
414316-143167.7228.02
514102-141027.6067.90
614368-143687.7508.04
依折麦布阿托伐他汀钙片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号100590-202005对照品来源中检院对照品使用方法直接使用
对照品含量(%)94.9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0.9671
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003108663107713107753107083107443107730.02
211.053162803176843169820.32
单位质量响应值RSD%判断
28252.0928686.151.08数据可信
供试品溶液-2022092201批-阿托伐他汀钙-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%
5min1179438-17943852.06541.5324.1052.0641.5324.10
2150208-15020843.58443.58
3134940-13494039.15439.15
4165422-16542247.99848.00
5148810-14881043.17843.18
680031-8003123.22123.22
10min1216401-21640162.79063.415.2663.0863.645.30
2222714-22271464.62264.86
3218342-21834263.35363.57
4218024-21802463.26163.53
5235701-23570168.39068.63
6200012-20001258.03558.16
15min1228200-22820066.21467.564.0766.8568.144.06
2237459-23745968.90069.50
3226725-22672565.78666.36
4225758-22575865.50566.12
5250152-25015272.58373.20
6228710-22871066.36266.81
20min1230017-23001766.74168.864.2867.7569.814.27
2242986-24298670.50471.49
3229903-22990366.70867.64
4233190-23319067.66168.64
5255502-25550274.13575.16
6232228-23222867.38268.20
30min1230751-23075166.95470.213.9268.3371.553.88
2245870-24587071.34172.72
3235317-23531768.27969.58
4238273-23827369.13670.49
5257628-25762874.75276.19
6244024-24402470.80572.00
45min1244854-24485471.04673.714.5872.7975.444.51
2257015-25701574.57476.35
3243454-24345470.64072.32
4244969-24496971.07972.82
5272116-27211678.95680.81
6261780-26178075.95777.54
60min1251470-25147072.96576.234.7575.1178.374.65
2261849-26184975.97778.16
3250483-25048372.67974.76
4256939-25693974.55276.69
5280104-28010481.27483.56
6275535-27553579.94881.96
极限1283104-28310482.14486.233.6184.6988.803.54
2306208-30620888.84891.46
3295203-29520385.65588.14
4286071-28607183.00585.56
5305520-30552088.64891.39
6307096-30709689.10691.56
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