Aminosyn RF 5.2% Sulfite Free


Aminosyn®-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids:

  mg/100 mL Min. Daily
Need (mg**)
Essential Amino Acids
  Isoleucine 462 700
  Leucine 726 1100
  Lysine Acetate* 535 800
  Methionine 726 1100
  Phenylalanine 726 1100
  Threonine 330 500
  Tryptophan 165 250
  Valine 528 800
Nonessential Amino Acids
  Arginine 600 __
  Histidine*** 429 __
* Amount cited is for Lysine alone and does not include the acetate salt.
** The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.)
*** Histidine is considered essential for patients in renal failure.

Electrolytes and Product Characteristics

Acetate (C2H3O2_)a (mEq/Liter) 113
Protein Equivalent (approx. grams/liter) 52.27
Total Nitrogen (grams/liter) 7.93
Osmolarity (mOsmol/liter) 427
pH (Range) 5.2 (4.5 to 6.0b)
a Includes acetate from acetic acid used in processing and from Lysine acetate.
b Adjusted with acetic acid.

Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine. The formulas for the individual amino acids present in Aminosyn-RF 5.2% 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
  Arginine, USP (C6H14N4O2)
  Histidine, USP (C6H9N3O2)

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.

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