非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153921745392175339219923922606392323739222670.02
210.193954278395646039553690.04
单位质量响应值RSD%判断
386430.25388161.830.32数据可信
供试品溶液-2024091311批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11008909-100890923.44524.3213.7623.4524.3213.75
21031381-103138123.96723.97
3940287-94028721.85121.85
41297167-129716730.14430.14
5891998-89199820.72820.73
61109559-110955925.78425.78
10min12243764-224376452.14153.366.9852.1953.416.99
22411448-241144856.03856.09
32312976-231297653.74953.80
42489867-248986757.86057.93
52023319-202331947.01847.06
62295599-229559953.34553.40
15min12887773-288777367.10767.293.9767.2767.463.98
22986864-298686469.40969.59
32970400-297040069.02769.19
42992837-299283769.54869.74
52697436-269743662.68362.83
62838696-283869665.96666.14
20min13205645-320564574.49374.442.4174.8174.762.42
23249593-324959375.51575.85
33268189-326818975.94776.27
43265721-326572175.88976.24
53070791-307079171.36071.65
63159739-315973973.42773.75
30min13516793-351679381.72481.621.3382.2182.111.35
23521257-352125781.82882.33
33560500-356050082.73983.23
43559512-355951282.71683.24
53443925-344392580.03080.48
63472816-347281680.70281.19
45min13742175-374217586.96187.071.1687.6387.741.17
23754633-375463387.25187.93
33807086-380708688.47089.14
43777163-377716387.77488.48
53712497-371249786.27286.90
63687234-368723485.68586.35
60min13873614-387361490.01690.040.9690.8790.900.97
23877327-387732790.10290.98
33925239-392523991.21592.09
43901734-390173490.66991.57
53848181-384818189.42590.24
63821892-382189288.81489.67
极限13968278-396827892.21592.651.3993.2793.711.38
23982808-398280892.55393.63
34040934-404093493.90494.98
44029834-402983493.64694.75
54010682-401068293.20194.22
63889220-388922090.37891.43
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153922644392257339222493925843392736239241340.06
210.193951443395824139548420.13
单位质量响应值RSD%判断
386614.19388110.110.28数据可信
供试品溶液-2024091311批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11293269-129326930.04823.6119.9930.0523.6119.99
21217055-121705528.27728.28
3762842-76284217.72417.72
4995872-99587223.13823.14
5956159-95615922.21622.22
6871883-87188320.25720.26
10min12508943-250894358.29352.288.0258.3652.338.03
22397967-239796755.71555.78
32016827-201682746.85946.90
42262191-226219152.56052.61
52189171-218917150.86450.91
62125730-212573049.39049.43
15min13006477-300647769.85367.103.0670.0567.273.08
22937224-293722468.24468.43
32769966-276996664.35864.50
42939164-293916468.28968.46
52817253-281725365.45765.62
62857219-285721966.38566.54
20min13260873-326087375.76474.471.4976.1274.791.51
23241762-324176275.32075.66
33142463-314246373.01273.30
43237154-323715475.21375.53
53172556-317255673.71274.02
63176924-317692473.81374.12
30min13522035-352203581.83281.530.4982.3582.010.52
23534675-353467582.12582.63
33486320-348632081.00281.45
43502403-350240381.37581.86
53508343-350834381.51381.99
63500736-350073681.33781.80
45min13734512-373451286.76886.950.4687.4787.610.47
23754624-375462487.23687.92
33723644-372364486.51687.14
43745360-374536087.02087.69
53767813-376781387.54288.19
63727151-372715186.59787.24
60min13846418-384641889.36889.830.5190.2690.690.49
23861481-386148189.71890.60
33882355-388235590.20391.02
43863630-386363089.76890.63
53895795-389579590.51691.36
63848056-384805689.40690.25
极限13947462-394746291.71692.190.5492.8193.250.53
23975907-397590792.37793.46
33972227-397222792.29193.31
43978179-397817992.43093.49
53995549-399554992.83393.88
63938191-393819191.50192.54
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153982505397993539859863981226398000639819320.07
210.194054285405602940551570.04
单位质量响应值RSD%判断
392308.57397954.561.02数据可信
供试品溶液-2024091312批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1956866-95686621.79622.5511.5421.8022.5511.54
21029170-102917023.44323.44
31052923-105292323.98423.98
41080025-108002524.60124.60
5772724-77272417.60117.60
61047767-104776723.86623.87
10min12104084-210408447.92850.718.4447.9850.768.45
22236867-223686750.95251.00
32206443-220644350.25950.31
42508110-250811057.13157.19
51963260-196326044.72044.76
62337807-233780753.25153.30
15min12806318-280631863.92365.652.9164.0865.822.92
22868161-286816165.33265.50
32840205-284020564.69564.86
43041004-304100469.26969.45
52839455-283945564.67864.82
62897896-289789666.00966.18
20min13200035-320003572.89272.641.8073.1972.951.81
23198196-319819672.85073.16
33164591-316459172.08472.39
43283899-328389974.80275.14
53109013-310901370.81871.10
63177696-317769672.38372.70
30min13547945-354794580.81680.190.8381.2880.660.84
23530818-353081880.42680.90
33486882-348688279.42679.89
43553447-355344780.94281.44
53517156-351715680.11580.55
63486106-348610679.40879.89
45min13799821-379982186.55485.630.8687.1986.280.86
23778454-377845486.06786.72
33718463-371846384.70185.35
43771358-377135885.90586.59
53764472-376447285.74986.37
63722204-372220484.78685.44
60min13923078-392307889.36188.560.9390.1989.400.91
23904059-390405988.92889.77
33832820-383282087.30588.14
43901008-390100888.85989.73
53912419-391241989.11989.93
63854854-385485487.80788.65
极限14036222-403622291.93990.930.9892.9791.970.96
24015592-401559291.46992.51
33942372-394237289.80190.83
43999877-399987791.11192.18
54011882-401188291.38492.39
63946290-394629089.89090.93
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202104对照品来源中检院对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.153985725398124739788133976926397824539801910.09
210.194062355406117140617630.03
单位质量响应值RSD%判断
392137.04398602.851.16数据可信
供试品溶液-2024091312批-pH5.5
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11097811-109781124.99221.749.4924.9921.749.49
21006458-100645822.91222.91
3924192-92419221.03921.04
4848124-84812419.30819.31
5881799-88179920.07420.07
6971949-97194922.12622.13
10min12831310-283131064.45562.652.5564.5162.702.54
22659579-265957960.54560.60
32679098-267909860.99061.04
42746883-274688362.53362.58
52800336-280033663.75063.79
62796022-279602263.65163.70
15min13092413-309241370.39968.992.1170.6069.182.11
22931813-293181366.74366.93
32971321-297132167.64267.82
43051059-305105969.45769.64
53070377-307037769.89770.08
63066611-306661169.81170.00
20min13249499-324949973.97573.131.4374.3373.471.44
23136153-313615371.39571.73
33175570-317557072.29272.62
43230430-323043073.54173.88
53246070-324607073.89774.24
63235471-323547173.65674.00
30min13462370-346237078.82178.640.9379.3479.140.93
23400954-340095477.42377.92
33432305-343230578.13678.63
43467168-346716878.93079.43
53487043-348704379.38379.89
63475475-347547579.11979.63
45min13703302-370330284.30683.970.7485.0084.650.75
23642442-364244282.92083.58
33671511-367151183.58284.25
43691839-369183984.04584.72
53710481-371048184.46985.15
63712376-371237684.51285.20
60min13831137-383113787.21686.890.7388.1087.750.73
23774186-377418685.91986.77
33801195-380119586.53487.39
43821263-382126386.99187.85
53856023-385602387.78288.65
63816288-381628886.87887.75
极限13934748-393474889.57589.290.7190.6590.350.72
23881539-388153988.36389.40
33907204-390720488.94889.99
43918919-391891989.21490.27
53964125-396412590.24391.31
63927120-392712089.40190.47
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