REFERENCES
1. USP 34–NF 29 General Chapter <1>, "Injections."
2. USP 34–NF 29 General Chapter <788>, "Particulate Matter in Injections."
3. EurPh, 5.0, 2.9.19 "Particulate Contamination: Sub-Visible Particles" (EDQM, Strasbourg, France, 2005), 253–255.
4. Japan Pharmacopoeia XV, 6.06, "Foreign Insoluble Matter Test for Injectables," in General Tests, Processes, and Apparatuses
Section, p. 110–113.
5. ICH, Q4B, Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions — Annex 3 Test for Particulate Contamination:
Subvisible Particles, General Chapter (Jan. 2009).
6. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington DC), Part 211.65, "Equipment."
7. EurPh, 5.0, 2.9.20, "Particulate Contamination: Visible Particles" (EDQM, Strasbourg, France, 2005) 255–256.
8. Code of Federal Regulations, Title 21, Food and Drugs (Government Printing Office, Washington, DC), Part 211.72 "Filters."
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