SPL Set ID: 2d212e10-7e08-4aeb-b63f-dcc927897769

Aminosyn ® -PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn ® -PF 7% is oxygen sensitive. The formulation is described below: Aminosyn-PF 7% An Amino Acid Injection — Pediatric Formula Essential Amino Acids (mg/100 mL) Isoleucine 534 Leucine 831 Lysine (acetate)* 475 Methionine 125 Phenylalanine 300 Threonine 360 Tryptophan 125 Valine 452 * Amount cited is for lysine alone and does not include the acetate salt. Nonessential Amino Acids (mg/100 mL) Alanine 490 Arginine 861 L-Aspartic Acid 370 L-Glutamic Acid 576 Glycine 270 Histidine 220 Proline 570 Serine 347 Taurine 50 Tyrosine 44 Electrolytes (mEq/L) Sodium (Na + ) (mEq/L) None Potassium (K + ) (mEq/L) None Chloride (Clˉ) (mEq/L) None Acetate (C 2 H 3 O 2 ˉ) a (mEq/L) 32.5 a From lysine acetate. Product Characteristics Protein Equivalent (Approx. grams/L) 70 Total Nitrogen (grams/L) 10.69 Osmolarity (mOsmol/L) 561 pH (range) 5.5 (5.0 to 6.5) The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows: Essential Amino Acids Isoleucine, USP C 6 H 13 NO 2 Leucine, USP C 6 H 13 NO 2 Lysine Acetate, USP C 6 H 14 N 2 O 2 • CH 3 COOH Methionine, USP C 5 H 11 NO 2 S Phenylalanine, USP C 9 H 11 NO 2 Threonine, USP C 4 H 9 NO 3 Tryptophan, USP C 11 H 12 N 2 O 2 Valine, USP C 5 H 11 NO 2 Nonessential Amino Acids Alanine, USP C 3 H 7 NO 2 Glycine, USP C 2 H 5 NO 2 Arginine, USP C 6 H 14 N 4 O 2 L-Aspartic Acid C 4 H 7 NO 4 HO 2 CCH 2 CH(NH 2 )CO 2 H L-Glutamic Acid C 5 H 9 NO 4 HO 2 CCH 2 CHCH(NH 2 )CO 2 H Histidine, USP C 6 H 9 N 3 O 2 Proline, USP C 5 H 9 NO 2 Serine, USP C 3 H 7 NO 3 Taurine C 2 H 7 NO 3 S Tyrosine, USP C 9 H 11 NO 3 The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.