卡波姆的残留溶剂

药典上很多，神话想要哪一种呢：

好象苯的残留是必须检的，其它溶剂应该是根据工艺情况按通则进行。

Limit of benzene— Standard solution— Quantitatively dissolve an accurately weighed quantity of benzene in methanol to obtain a solution having a known concentration of about 0.2 mg per mL. Quantitatively dilute this solution with organic-free water (see Residual Solvents 467) to obtain a solution having a known concentration of about 1.0 µg per mL. Test solution— Transfer about 1 g of Carbomer 934P, accurately weighed, to a 100-mL volumetric flask. Add about 75 mL of sodium chloride solution (2 in 100), and mix by mechanical means until homogenous (usually about 30 minutes). Dilute with sodium chloride solution (2 in 100) to volume, and mix until homogenous (usually less than 1 minute). [note—This preparation must be analyzed within 3 hours of preparation.] Chromatographic system (see Chromatography 621)— The gas chromatograph is equipped with a flame-ionization detector, a 0.53-mm × 30-m fused silica analytical column coated with a 3.0-µm G43 stationary phase, a 0.53-mm × 5-m silica guard column deactivated with phenylmethyl siloxane, and a splitless injection system. The carrier gas is helium flowing at a linear velocity of about 35 cm per second. The injection port and detector temperatures are maintained at 140 and 260, respectively. The column temperature is programmed according to the following steps: it is held at 40 for 20 minutes, then increased rapidly to 240, and maintained at 240 for 20 minutes. Chromatograph the Standard solution, and record the responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 15%. Procedure— Separately inject equal volumes (about 1 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the responses for the benzene peaks. Calculate the percentage of benzene in the portion of Carbomer 934P taken by the formula:

10(C/W)(rU / rS)

in which C is the concentration, in µg per mL, of benzene in the Standard solution; W is the weight, in mg, of Carbomer 934P taken to prepare the Test solution; and rU and rS are the benzene peak responses obtained from the Test solution and the Standard solution, respectively: not more than 0.01% is found.

我们来的料没有说，不知道是哪种，但苯的残留检验方法是一样的吧？

看看厂家的报告单，索取质量标准。

没有仔细比较过，你手头没有usp？

药典上已经有了。索取厂家的标准意义不大吧？

如果是中国药典的品种，厂家的注册标准有多于或严于药典的项目，要按注册标准来做的。

特别是残留溶剂，不同厂家不同工艺很可能检测的残留溶剂项目不一样。

USP的规定就不清楚了。

哦，忘记这事了。usp，ep与中国药典差不多，除了专论里指定的溶剂外还得遵守通则，也就是工艺特有溶剂

我们实际也是这么做的。反过来，就算厂家的注册标准里不包含药典品种正文项下的残留溶剂，我们也全做的。这样才算符合规定。

主要这个项目有问题，苯超，是用红色201单体为填料的填充柱