Organic volatile impurity

Organic volatile impurities. By following method 1 in the general procedure <467> meets the requirements. 

Loss on drying Residue on ignition Organic volatile impurities... 

The TC detector and the FID are usually within a factor of two of the same response for an unknown organic compound as for other peaks in the run. This is a desirable property. Not only does it allow estimates to be made for the amount of unknown peaks, but it insures that there are no major volatile impurities if a chromatogram does not show them. This allows manufacturers of chemical products to specify the level of organic volatile impurities without identifying them in each case. 

Organic volatile impurities—Carry out this test as directed in the general procedure <467>, Method IV meet the requirements. 

TLC Shake with CHC1-saturated with nh4oh Silica CHC1, (sat. NH4OH)-EtOH (dehydrated) (9 1) 254 nm USP23,p. 97. chromatographic purity, organic volatile impurities <467> [5]... 

Bulk, parentemal HPLC Dissolve in mobile phase Silica 0.1% H-P04 206 nm Impurities TLC [24] HPLC [554] USP 23 organic volatile impurities p. 129 [5] [30]... 

The United States Pharmacopeia (USP) test (467) describes three different approaches to measuring organic volatile impurities in pharmaceuticals. Method I uses a wide-bore coated open tubular column (G-27, 5% phenyl-95 % methylpolysiloxane) with a silica guard column deactivated with phe-nylmethyl siloxane and a flame-ionization detector. The samples are dissolved in water and about 1 p is injected. Limits are set for benzene, chloroform, 1,4-dioxane, methylene chloride, and trichloroethylene. Methods V and VI are nearly identical to method I except for varying the chromatographic conditions. For the measurement of methylene chloride in coated tablets, the headspace techniques described above are recommended. 

T. D. Cyr, R. C. Lawrence, and E. G. Lovering, Gas chromatographic methods for doxepin isomers related compounds, and organic volatile impurities in raw materials and doxepin isomers in capsules, JAOAC, 75 814 (1992). 

Organic volatile impurities. When dipyridamole is tested according to General Method (467) (Method IV), it meets the requirements. 

Administration (FDA) and other regulatory agencies around the world, more particularly with respect to the determination of organic volatile impurities (OVI s) as well as other impurities and related sub-stances, has resulted in more extensive use being made of GC in modern compendia, such as the USP 24th edition and the 1999 edition of the Perusal of the current USP indicates that many more GC applications have been introduced since the 22nd edition of the USP. New inclusions have been incorporated in the tables in this article. Similarly, the recent edition of the also includes numerous new applications. A list of compounds in the BP (which includes the European Pharmacopoeia) that use GC is included separately as an Appendix. 

Table 9 Compendial applications of GC for the presence of organic volatile impurities in pharmaceutical raw materials and dosage forms...

British Pharmacepoeia (BP) and European Pharmacopoeia (EP) Applications of GC for the Assay Chromatographic Purity Identification Presence of Volatile Matter, Intermediates and Related Substances Organic Volatile Impurities Determination of Water Presence of Isomers and Racemate Ratios Determination of Alcohol and Miscellaneou s Uses of GC in Pharmaceutical Raw Materials and Dosage Forms. 

McClure, G.L. Improved determination of organic volatile impurities in pharmaceutical materials by using automated static headspace GC/MS. PDA J. Pharm. 

For some years, the USP had a requirement on organic volatile impurities. When the EP was adopting a similar requirement, it was clear that toxicologists on different sides of the ocean would come to different conclusions as to appropriate limits on solvents. At the request of the pharmacopeias, this topic was taken... 

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