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E14 Current Webpage Stage 6 Monograph Updated 14 Oct 2011 PDF
E14 Current Webpage Stage 6 Monograph Updated 14 Oct 2011 PDF
chloric acid (10 g/L) (2.4: 1.0: 0.4: 6.2) Acceptance criteria: NMT 1.0%
Standard stock solution C: Ferric chloride CS, cobal- ADDITIONAL REQUIREMENTS
tous chloride CS, and cupric sulfate CS (9.6: 0.2: 0.2) • ✦PACKAGING AND STORAGE: Preserve in tight containers.
[NOTE—Prepare the Standard solutions immediately No storage requirements specified.
before use.] • LABELING: Where it is intended for use in dialysis solu-
Standard solution A: Dilute 2.5 mL of Standard stock tions, it is so labeled. Where Anhydrous Citric Acid must
solution A with dilute hydrochloric acid (10 g/L) to 100 be subjected to further processing during the prepara-
mL. tion of injectable dosage forms to ensure acceptable lev-
Standard solution B: Dilute 2.5 mL of Standard stock els of bacterial endotoxins, it is so labeled. Where Anhy-
solution B with dilute hydrochloric acid to (10 g/L) 100 drous Citric Acid is sterile, it is so labeled.
mL.