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DRUG DESCRIPTION
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 (Cl–) (mEq/L) | None |
| Acetate (C2H3O2–)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 | C6H13NO2 |
| Leucine, USP | C6H13NO2 |
| Lysine Acetate, USP | C6H14N2O2 • CH3COOH |
| Methionine, USP | C5H11NO2S |
| Phenylalanine, USP | C9H11NO2 |
| Threonine, USP | C4H9NO3 |
| Tryptophan, USP | C11H12N2O2 |
| Valine, USP | C5H11NO2 |
Nonessential Amino Acids
| Alanine, USP | C3H7NO2 |
| Glycine, USP | C2H5NO2 |
| Arginine, USP | C6H14N4O2 |
| L-Aspartic Acid | C4H7NO4 HO2CCH2CH(NH2)CO2H |
| L-Glutamic Acid | C5H9NO4 HO2CCH2CHCH(NH2)CO2H |
| Histidine, USP | C6H9N3O2 |
| Proline, USP | C5H9NO2 |
| Serine, USP | C3H7NO3 |
| Taurine | C2H7NO3S |
| Tyrosine, USP | C9H11NO3 |
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.