USP对于API不溶性微粒的控制

hongweiwei000

USP附录<788>PARTICULATE MATTER IN INJECTIONS  
METHOD 1 LIGHT OBSCURATION PARTICLE COUNT TEST

Evaluation
For preparations supplied in containers with a nominal volume of more than 100 mL, apply the criteria of Test 1.A.
For preparations supplied in containers with a nominal volume of less than 100 mL, apply the criteria of Test 1.B.
For preparations supplied in containers with a nominal volume of 100 mL, apply the criteria of Test 1.B.
[NOTE—Test 1.A is used in the Japanese Pharmacopoeia.]
If the average number of particles exceeds the limits, test the preparation by the Microscopic Particle Count Test.


TEST 1.A
Solutions for parenteral infusion or solutions for injection supplied in containers with a nominal content of more than 100 mL: The preparation complies with the test if the average number of particles present in the units tested does not exceed 25 per mL equal to or greater than 10 μm and does not exceed 3 per mL equal to or greater than 25 μm.


TEST 1.B
Solutions for parenteral infusion or solutions for injection supplied in containers with a nominal content of less than 100 mL: The preparation complies with the test if the average number of particles present in the units tested does not exceed 6000 per container equal to or greater than 10 μm and does not exceed 600 per container equal to or greater than 25 μm.


问题：参照USP附录<788>PARTICULATE MATTER IN INJECTIONS 控制API的不溶性微粒如何操作

比如：某原料药A，出口国外用于生产注射用无菌粉末，制剂包括0.5g，1.0g，2.0g，3.0g多个规格，最大规格（3.0g）所用西林瓶为20ml。
参照USP附录<788>，样品溶液的体积小于100ml，按照TEST 1.B控制，每瓶样品大于10un的粒子不得过6000个，大于25um的粒子不得过600个，因为制剂最大规格3.0g，API限度：大于10un的粒子不得过2000个/g，大于25um的粒子不得过200个/g

请问各位老师，这样制定不溶性微粒的限度是否合适

yc20160802

你们出口原料药A，国外经过溶解成盐除菌过滤干燥等工艺生产注射用无菌粉末。你们为何控制不溶性微粒？

wolflee11

那个788，preparation应该是指制剂。。。非API

hongweiwei000

yc20160802 发表于 2023-9-21 15:23
你们出口原料药A，国外经过溶解成盐除菌过滤干燥等工艺生产注射用无菌粉末。你们为何控制不溶性微粒？

感谢您的回复，我们出口的原料A国外直接分装成制剂，不需要溶解成盐除菌过滤干燥等工艺。比如说我们将头孢噻肟钠无菌原料出口到国外，国外直接将头孢噻肟钠无菌原料药分装成注射用头孢噻肟钠

hongweiwei000

wolflee11 发表于 2023-9-21 15:41
那个788，preparation应该是指制剂。。。非API

感谢您的回复，请问无菌API按照USP控制不溶性微粒应该如何操作，谢谢

wolflee11

那我觉得你参考制剂的通则呗，但对制剂来说，限度是按每瓶来算，不是按每克，所以不确定你折算成每克是否合理？