Endotoxin limits in formulations for preclinical research

Journal of Pharmaceutical Sciences

Volumn 97, Issue 6, 2008, Pages 2041-2044

  Malyala, Padma ^a   Singh, Manmohan ^a  

^a M S 4355 Inc   (United States)

Author keywords

Excipients; Formulation; Injectables; Preformulation; Vaccines

Indexed keywords

ENDOTOXIN;

CLINICAL RESEARCH; FOOD AND DRUG ADMINISTRATION; NOTE; PHOTOMETRY; ANIMAL; CHEMISTRY; DRUG CONTAMINATION; DRUG SCREENING; MEDICAL LITERATURE; METHODOLOGY; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; STANDARD; UNITED STATES;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; DRUG CONTAMINATION; DRUG EVALUATION, PRECLINICAL; ENDOTOXINS; GUIDELINES AS TOPIC; PHARMACOPOEIAS AS TOPIC; QUALITY CONTROL; REFERENCE STANDARDS; UNITED STATES;

EID: 49249105174     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21152     Document Type: Note

References (6)

1. The quality assurance/quality control task group. 1990. Parenteral Drug Association, Current practices in endotoxin and pyrogen testing in biotechnology. J Parenter Sci Technol 44:39-45.
2. Bacterial Endotoxins Test. USP 30, http://www.uspnf. com/uspnf/pub/index? usp=30&nf=25&s=0.
3. Cooper JK. The Necessity of Reliable Endotoxin Standards http://www.criver.com/flex_content_area/ documents/ qc_lr_n_reliable_end_standards.pdf# search=%22charles%20river%20and%20RSE%22.
4. Dawson ME. 1997. Harmonization of endotoxin standards and units. LAL Update 15:2-3.
5. Variability in the Endotoxins test or Limulus Amebocyte Lysate (LAL)Test. Endosafe times, Vol. 12 No. 1, August 2006 http://www.criver.com/flex_content_ area/documents/qc_lr_n_et_LAL_test_variability_ Aug_06.pdf.
6. Weary ME. 1990. Understanding and setting endotoxin limits. J Parenter Sci Technol 44:16-18.