依折麦布瑞舒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%
110.221755601765821770331767931766361765210.33
210.151751551770371760960.76
单位质量响应值RSD%判断
17272.1117349.360.32数据可信
供试品溶液-2023121421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%
5min111805-118056.1175.1313.296.125.1313.34
210409-104095.3945.39
39859-98595.1095.11
49907-99075.1345.13
59690-96905.0215.02
67728-77284.0054.00
10min115625-156258.0977.896.258.137.926.25
215394-153947.9778.01
316268-162688.4308.46
415423-154237.9928.02
515152-151527.8527.88
613439-134396.9646.99
15min116381-163818.4898.683.538.578.753.55
216865-168658.7398.81
317179-171798.9028.98
416832-168328.7228.80
517434-174349.0349.11
615784-157848.1798.24
20min116119-161198.3538.592.368.488.712.29
216507-165078.5548.68
316399-163998.4988.62
417206-172068.9169.04
516373-163738.4848.61
616854-168548.7348.84
30min116296-162968.4458.572.478.628.742.40
216593-165938.5988.77
316276-162768.4348.61
417132-171328.8789.05
516064-160648.3248.49
616890-168908.7528.91
45min115847-158478.2128.462.448.438.682.38
216206-162068.3988.62
316215-162158.4038.62
416837-168378.7258.95
516094-160948.3408.55
616795-167958.7038.91
60min115558-155588.0628.301.988.338.561.87
216223-162238.4078.67
315849-158498.2138.48
416337-163378.4668.73
515835-158358.2068.47
616308-163088.4518.70
极限115486-154868.0258.332.458.338.632.35
216256-162568.4248.74
316053-160538.3198.63
416188-161888.3898.70
515793-157938.1848.49
616625-166258.6158.91
依折麦布瑞舒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5000
标示量(mg)10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%
110.403182143201433205693200733197133197420.29
210.403177333209473193400.72
单位质量响应值RSD%判断
30744.4230705.770.09数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-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%
5min1102661-10266127.59931.6916.5827.6031.6816.59
299737-9973726.81326.81
3118824-11882431.94431.94
4150225-15022540.38640.39
5105616-10561628.39328.39
6130104-13010434.97734.98
10min1215832-21583258.02356.3513.9458.1856.5313.92
2153262-15326241.20241.35
3212938-21293857.24557.42
4219438-21943858.99359.22
5216715-21671558.26158.42
6239455-23945564.37464.57
15min1253852-25385268.24465.6611.6968.7266.1511.69
2190895-19089551.31951.70
3240375-24037564.62165.12
4246812-24681266.35266.90
5259607-25960769.79270.27
6273865-27386573.62574.18
20min1269838-26983872.54269.5910.3373.4070.4410.34
2213073-21307357.28257.94
3246641-24664166.30667.16
4265709-26570971.43272.35
5265648-26564871.41672.28
6292162-29216278.54479.50
30min1294960-29496079.29676.697.9480.5577.937.96
2254777-25477768.49369.47
3261667-26166770.34571.57
4289245-28924577.75979.08
5296968-29696879.83681.10
6313997-31399784.41485.81
45min1314878-31487884.65082.446.8286.3584.116.81
2296728-29672879.77181.13
3273798-27379873.60775.22
4301621-30162181.08782.84
5318553-31855385.63887.35
6334393-33439389.89791.76
60min1323706-32370687.02484.886.5289.1987.006.50
2309660-30966083.24885.05
3280163-28016375.31877.34
4312753-31275384.07986.28
5327957-32795788.16790.35
6340051-34005191.41893.78
极限1350866-35086694.32596.001.5696.9898.591.65
2356692-35669295.89298.16
3351696-35169694.54896.99
4358532-35853296.38699.05
5358535-35853596.38799.06
6366147-36614798.433101.31
依折麦布瑞舒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%
110.221780061786171788121791961792041787670.28
210.151750021769511759760.79
单位质量响应值RSD%判断
17491.8817337.540.63数据可信
供试品溶液-2023121421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%
5min110466-104665.3914.9710.775.394.9710.74
29566-95664.9284.93
37819-78194.0284.03
49292-92924.7864.79
510011-100115.1575.16
610700-107005.5125.51
10min115837-158378.1587.7410.168.197.7710.15
214455-144557.4467.47
312382-123826.3786.40
414980-149807.7167.74
515746-157468.1118.14
616800-168008.6548.68
15min116665-166658.5848.384.708.668.464.70
215448-154487.9578.03
315158-151587.8087.87
416729-167298.6178.69
516881-168818.6968.77
616785-167858.6468.72
20min116128-161288.3088.342.648.438.452.68
215571-155718.0218.13
315919-159198.2008.30
416634-166348.5688.69
516694-166948.5998.72
616157-161578.3238.45
30min116135-161358.3118.352.338.488.512.21
216038-160388.2618.42
316587-165878.5448.69
416721-167218.6138.78
516051-160518.2688.44
615712-157128.0938.27
45min115458-154587.9638.182.378.188.392.26
215817-158178.1478.35
316313-163138.4038.60
416281-162818.3868.60
515909-159098.1958.41
615463-154637.9658.18
60min115115-151157.7868.041.858.058.291.77
215628-156288.0508.30
315605-156058.0388.28
415985-159858.2348.49
515755-157558.1168.38
615511-155117.9908.25
极限115395-153957.9308.021.958.238.321.87
215291-152917.8778.17
315913-159138.1978.48
415871-158718.1758.48
515748-157488.1128.42
615235-152357.8488.15
依折麦布瑞舒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5000
标示量(mg)10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%
110.403221983233963237393243503241273235620.27
210.403178083213713195900.79
单位质量响应值RSD%判断
31111.7330729.810.88数据可信
供试品溶液-2023121421批-瑞舒伐他汀钙-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%
5min1208009-20800955.56849.2427.2455.5749.2427.24
2195838-19583852.31752.32
3131913-13191335.24035.24
4117479-11747931.38431.38
5202303-20230354.04454.04
6250384-25038466.88966.89
10min1273841-27384173.15568.559.3673.4668.829.42
2264293-26429370.60470.90
3234605-23460562.67362.87
4223949-22394959.82760.00
5255110-25511068.15168.45
6287738-28773876.86877.24
15min1301423-30142380.52476.136.3481.2476.786.37
2287466-28746676.79577.48
3295057-29505778.82379.37
4253183-25318367.63668.14
5275537-27553773.60874.29
6297192-29719279.39380.19
20min1304384-30438481.31578.695.5482.4879.775.58
2300904-30090480.38581.49
3306066-30606681.76482.75
4265181-26518170.84271.72
5285508-28550876.27277.36
6305313-30531381.56382.80
30min1321365-32136585.85181.956.0487.4783.466.05
2322252-32225286.08887.64
3315613-31561384.31485.75
4278214-27821474.32375.60
5289096-28909677.23078.74
6314023-31402383.89085.58
45min1325710-32571087.01283.635.8989.1085.605.90
2332225-33222588.75290.79
3322509-32250986.15788.06
4283588-28358875.75977.45
5298717-29871779.80181.74
6315526-31552684.29186.45
60min1331836-33183688.64886.366.3191.2288.796.28
2343093-34309391.65594.18
3343224-34322491.69094.07
4293724-29372478.46780.58
5304797-30479781.42583.81
6322884-32288486.25788.88
极限1357006-35700695.37294.362.5698.4497.272.56
2345548-34554892.31195.35
3343433-34343391.74694.64
4354076-35407694.58997.14
5350732-35073293.69696.53
6368469-36846998.434101.54
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