Study On Compatibility Of New Type Compound Amino Acids Injection And Packaging Materials

The new type compound amino acids (19) and alanyl glutamine injection, consists of the 8 essential amino acids and the 2 semi-essential amino acids, add another conditions essential amino acids (such as acetylcysteine, taurine, glutamine, etc.), total of 20 components.The compound amino acids injection inner packaging using 250 mL borosilicate glass infusion bottles and injection chlorinated butyl rubber stopper. IND need to provide information about the compatibility study of pharmaceutical products and packaging materials, it is the focus of this paper, the sample of compatibility (inverted) placed in storage chambers under the required conditions.The compatibility study of pharmaceutical products and borosilicate glass bottle, different extraction media were added into the glass bottles, detected by scanning electron microscopy (SEM) to delamination propensity of glass containers, detected by SEM to delamination propensity of under stability condition Sample bottles. using inductively coupled plasma mass spectrometry (ICP-MS) method, detected metal ions in the drug solution.The compatibility study of pharmaceutical products and chlorinated butyl rubber stopper, using liquid chromatography (HPLC) method for the determination stopper extracting test and packaging materials "sulfur" in the migration test; using gas chromatography (GC) method for the determination of the rubber plug in "fatty acid (palmitic acid, stearic acid)" extraction test and packaging materials stability sample migration test; using gas chromatography (GC) method stopper was extracted antioxidant 264 research; using gas chromatography mass spectrometry (GCMS) for the stopper was extracted volatile substances and volatile substances in the sample were compared.The compatibility stability samples of compound amino acid injection need to test:appearance, visible particles, pH, sub-visible particles, content, sterility, bacterial endotoxin and other related research, investigation of various compatibility factors in pharmaceutical products and Packaging Materials.The extraction of chlorinated butyl rubber stopper,"sulfur", "fatty acid" and "volatile substances" are not not detected in the compatibility stability samples, the metal ions were no significant change, to prove the new type compound amino acid used 250 mL borosilicate glass bottles and injection chlorinated butyl rubber stopper has good compatibility.