Aminosyn PF 10% Sulfite Free


Aminosyn®-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below:

Aminosyn-PF 10%
An Amino Acid Injection — Pediatric Formula
Essential Amino Acids (mg/100 mL)

Isoleucine 760
Leucine 1200
Lysine (acetate)* 677
Methionine 180
Phenylalanine 427
Threonine 512
Tryptophan 180
Valine 673
*Amount cited is for lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)
Alanine 698
Arginine 1227
Aspartic Acid 527
Glutamic Acid 820
Glycine 385
Histidine 312
Proline 812
Serine 495
Taurine 70
Tyrosine 44
Electrolytes (mEq/L)
Sodium (Na+) None
Potassium (K+) None
Chloride (Cl) None
Acetate (C2H3O2) a 46
Product Characteristics
Protein Equivalent (Approx. grams/L) 100
Total Nitrogen (grams/L) 15.2
Osmolarity (mOsmol/L) 788
pH (range) 5.5 (5.0 to 6.5)
Specific Gravity 1.03
a From lysine acetate.

The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:

Essential Amino Acids

Isoleucine CH3CH2CH(CH3)CH(NH2)COOH
Leucine (CH3)2CHCH2CH(NH2)COOH
Lysine Acetate H2N(CH2)4CH(NH2)COOH • CH3COOH
Methionine CH3S(CH2)2CH(NH2)COOH
Phenylalanine Phenylalanine Structural Formula IllustrationCH2CH(NH2)COOH
Threonine CH3CH(OH)CH(NH2)COOH
Tryptophan 2CH(NH2)COOH
Valine (CH3)2CHCH(NH2)COOH

Nonessential Amino Acids

Alanine CH3CH(NH2)COOH
Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH
L-Aspartic Acid HOOCCH2CH(NH2)COOH
L-Glutamic Acid HOOC(CH2)2CH(NH2)COOH
Glycine H2NCH2COOH H
Histidine 2CH(NH2)COOH
Taurine H2N – CH2CH2 – SO3H

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.

The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.

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