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101278-202003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%
110.061913014190936619089021908976191071819101950.10
210.171924798192576619252820.04
单位质量响应值RSD%判断
189880.22189309.930.22数据可信
供试品溶液-2024112321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%
5min1981861-98186146.60944.0314.0846.6144.0414.08
2773307-77330736.70936.71
3823060-82306039.07039.07
4970700-97070046.07946.08
51136115-113611553.93153.93
6880753-88075341.80941.81
10min11530464-153046472.65172.681.6572.7572.771.66
21518432-151843272.08072.16
31518768-151876872.09572.18
41541571-154157173.17873.28
51574590-157459074.74574.87
61502039-150203971.30171.39
15min11734156-173415682.32081.960.9782.5882.220.98
21712515-171251581.29381.53
31711490-171149081.24481.49
41746548-174654882.90883.17
51743528-174352882.76583.05
61711784-171178481.25881.51
20min11850809-185080987.85787.541.8188.3187.981.79
21901895-190189590.28290.70
31814924-181492486.15486.58
41810624-181062485.95086.40
51834398-183439887.07887.55
61852081-185208187.91888.35
30min11952575-195257592.68891.890.5693.3392.530.56
21928656-192865691.55392.18
31929977-192997791.61592.23
41946147-194614792.38393.02
51927633-192763391.50492.17
61930027-193002791.61892.25
45min12020146-202014695.89694.760.7596.7495.600.75
21993959-199395994.65395.48
32002319-200231995.04995.87
41974222-197422293.71694.56
51994746-199474694.69095.56
61991895-199189594.55595.39
60min12049445-204944597.28796.730.5898.3597.780.57
22051047-205104797.36398.40
32040893-204089396.88197.91
42035011-203501196.60197.66
52021587-202158795.96497.04
62028011-202801196.26997.31
极限12050599-205059997.34197.070.3998.6298.340.38
22046941-204694197.16898.42
32045830-204583097.11598.36
42039074-203907496.79498.06
52032755-203275596.49497.78
62054452-205445297.52498.78
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101278-202003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%
110.061934332193440619344171932914193106219334260.08
210.171971008197195119714800.04
单位质量响应值RSD%判断
192189.46193852.510.61数据可信
供试品溶液-2024112321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%
5min1563179-56317926.26037.4830.0126.2637.4830.00
2732318-73231834.14634.15
3612033-61203328.53828.54
41145060-114506053.39253.39
51060401-106040149.44449.44
6710148-71014833.11333.11
10min11261905-126190558.84065.459.1458.9065.549.17
21372866-137286664.01464.09
31309576-130957661.06361.13
41575035-157503573.44173.56
51547383-154738372.15172.26
61355310-135531063.19563.27
15min11633042-163304276.14577.224.1376.3377.444.16
21668157-166815777.78378.00
31592128-159212874.23874.44
41751608-175160881.67481.96
51713339-171333979.88980.16
61577739-157773973.56773.78
20min11782347-178234783.10784.322.3483.4784.722.38
21816597-181659784.70485.10
31786463-178646383.29983.66
41870160-187016087.20287.67
51840205-184020585.80586.25
61754681-175468181.81782.19
30min11920628-192062889.55589.961.5290.1090.551.56
21926623-192662389.83490.41
31911938-191193889.15089.70
41983452-198345292.48493.14
51934565-193456590.20590.84
61898719-189871988.53389.09
45min11984459-198445992.53193.160.9793.2793.951.00
22009543-200954393.70194.48
31977231-197723192.19492.94
42028903-202890394.60495.47
51986485-198648592.62693.46
62001196-200119693.31294.07
60min12009518-200951893.70094.191.0194.6595.181.04
22047079-204707995.45196.44
32004820-200482093.48194.43
42038128-203812895.03496.11
52025900-202590094.46495.51
61994745-199474593.01193.97
极限12026615-202661594.49793.611.7395.6594.821.72
22040204-204020495.13096.33
31994464-199446492.99894.16
42025757-202575794.45795.74
52014407-201440793.92895.18
61944441-194444190.66591.84
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101278-202003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%
110.061932663193754519382891935838193612419360920.12
210.171973379197233219728560.04
单位质量响应值RSD%判断
192454.47193987.810.57数据可信
供试品溶液-2024112321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%
5min1221658-22165810.32514.2621.6710.3214.2621.67
2336216-33621615.66115.66
3325094-32509415.14315.14
4289951-28995113.50613.51
5409649-40964919.08119.08
6254876-25487611.87211.87
10min11002666-100266646.70448.344.2846.7348.374.29
21042229-104222948.54648.58
31044115-104411548.63448.67
4998288-99828846.50046.53
51119421-111942152.14252.18
61019745-101974547.49947.53
15min11277105-127710559.48759.763.4459.6159.893.44
21203140-120314056.04256.18
31313055-131305561.16161.30
41286429-128642959.92160.05
51331859-133185962.03762.20
61285653-128565359.88560.02
20min11417558-141755866.02966.341.8966.2966.611.90
21380749-138074964.31564.58
31431044-143104466.65766.93
41433133-143313366.75567.02
51463170-146317068.15468.45
61419598-141959866.12466.39
30min11568743-156874373.07172.772.9773.4873.192.97
21472745-147274568.60069.01
31589764-158976474.05074.48
41564416-156441672.87073.28
51605001-160500174.76075.21
61572878-157287873.26473.68
45min11698778-169877879.12877.176.3179.7077.756.28
21450865-145086567.58168.14
31691238-169123878.77779.37
41659478-165947877.29877.87
51744360-174436081.25181.87
61695886-169588678.99479.57
60min11755726-175572681.78179.776.6482.5280.526.60
21485278-148527869.18369.90
31763587-176358782.14782.91
41724900-172490080.34581.09
51794452-179445283.58584.38
61751413-175141381.58082.33
极限11924274-192427489.63287.696.1190.5688.626.08
21651646-165164676.93377.80
31922241-192224189.53790.48
41913757-191375789.14290.07
51967657-196765791.65292.63
61915685-191568589.23290.16
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101278-202003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%
110.061952632195360419537881953741195523119537990.05
210.171976202197668819764450.02
单位质量响应值RSD%判断
194214.61194340.710.05数据可信
供试品溶液-2024112321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%
5min1566479-56647926.24221.2114.6926.2421.2114.69
2464737-46473721.52921.53
3392802-39280218.19718.20
4460832-46083221.34821.35
5380623-38062317.63317.63
6481666-48166622.31322.31
10min11205126-120512655.82855.061.3155.8955.111.32
21179656-117965654.64854.70
31179865-117986554.65854.70
41211592-121159256.12856.17
51177644-117764454.55554.59
61177325-117732554.54054.59
15min11440817-144081766.74766.191.2666.9366.361.27
21400613-140061364.88465.05
31417204-141720465.65365.81
41451588-145158867.24567.42
51430042-143004266.24766.41
61432823-143282366.37666.55
20min11581661-158166173.27173.001.0473.6073.321.05
21561470-156147072.33672.65
31571250-157125072.78973.10
41606189-160618974.40774.73
51564903-156490372.49572.80
61569651-156965172.71573.03
30min11736083-173608380.42580.250.4880.9280.730.48
21731833-173183380.22880.70
31727031-172703180.00580.48
41744518-174451880.81681.30
51733620-173362080.31180.78
61720379-172037979.69780.18
45min11875461-187546186.88286.171.0487.5586.821.05
21842956-184295685.37686.03
31852455-185245585.81686.46
41889877-188987787.54988.22
51840386-184038685.25785.90
61858975-185897586.11886.77
60min11936785-193678589.72288.850.7890.5989.700.78
21918204-191820488.86289.70
31920049-192004988.94789.79
41929955-192995589.40690.27
51904928-190492888.24789.08
61897291-189729187.89388.74
极限11972947-197294791.39890.681.0492.4691.731.04
21947892-194789290.23791.28
31931460-193146089.47690.51
41983184-198318491.87292.93
51968143-196814391.17592.21
61941184-194118489.92690.97
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101278-202003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%
110.062007913200445820002801995609199427020005060.29
210.172007997200739820076980.03
单位质量响应值RSD%判断
198857.46197413.770.52数据可信
供试品溶液-2024112321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%
5min1743431-74343133.77032.2510.2333.7732.2510.24
2764153-76415334.71134.71
3803697-80369736.50736.51
4616071-61607127.98427.98
5687234-68723431.21731.22
6645335-64533529.31429.31
10min11331463-133146360.48060.171.1660.5660.241.16
21316873-131687359.81859.89
31320253-132025359.97160.05
41305598-130559859.30659.37
51350655-135065561.35261.42
61322593-132259360.07860.14
15min11550939-155093970.45070.050.9270.6670.260.91
21525168-152516869.27969.49
31528344-152834469.42469.64
41539943-153994369.95070.14
51562457-156245770.97371.18
61546526-154652670.24970.45
20min11674601-167460176.06775.941.0276.4376.301.01
21659363-165936375.37575.74
31650475-165047574.97175.34
41669263-166926375.82576.17
51699680-169968077.20677.57
61678048-167804876.22476.58
30min11823888-182388882.84882.850.9183.3883.380.90
21809300-180930082.18682.72
31801224-180122481.81982.35
41829980-182998083.12583.64
51847153-184715383.90584.44
61831545-183154583.19683.72
45min11929884-192988487.66387.630.8288.3888.340.81
21913382-191338286.91487.63
31912129-191212986.85787.57
41933217-193321787.81588.52
51955077-195507788.80789.53
61930778-193077887.70488.41
60min11986952-198695290.25590.250.8491.1791.160.83
21965571-196557189.28490.19
31969175-196917589.44890.36
41997139-199713990.71891.62
52007683-200768391.19792.12
61994937-199493790.61891.52
极限12017672-201767291.65191.100.8592.7792.200.85
21990050-199005090.39691.50
31997302-199730290.72691.83
41995163-199516390.62891.73
52034202-203420292.40293.52
61998402-199840290.77591.88
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