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DRUG DESCRIPTION
Aminosyn®-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. Aminosyn-HBC 7% is oxygen sensitive. The solution contains the following crystalline amino acids:
| Essential Amino Acids (mg/100 mL) | |
| Isoleucine | 789 |
| Leucine | 1576 |
| Lysine (acetate)* | 265 |
| Methionine | 206 |
| Phenylalanine | 228 |
| Threonine | 272 |
| Tryptophan | 88 |
| Valine | 789 |
| Nonessential Amino Acids (mg/100 mL) | |
| Alanine | 660 |
| Arginine | 507 |
| Histidine** | 154 |
| Proline | 448 |
| Serine | 221 |
| Tyrosine | 33 |
| Glycine | 660 |
| *Amount cited is for lysine alone and does not include the
acetate salt. **Histidine is considered essential for patients in renal failure. |
|
| Crystalline Amino Acids (g/100 mL) | 7 |
| Branched Chain Amino Acids (g/100 mL) | 3.2 |
| Nitrogen (approx. g/100 mL) | 1.12 |
| Acetate (C2H3O2-)a (mEq/Liter) | 71a |
| Osmolarity (mOsmol/liter) | 623 |
| pHb (Range) | 5.2 (4.5 to 6.0) |
| a Includes acetate from acetic acid used in processing
and from lysine acetate. b May contain hydrochloric acid for pH adjustment. |
|
The formulas for the individual amino acids present in Aminosyn-HBC 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 |
| Arginine, USP | C6H14N4O2 |
| Histidine, USP | C6H9N3O2 |
| Proline, USP | C5H9NO2 |
| Serine, USP | C3H7NO3 |
| Tyrosine, USP | C9H11NO3 |
| Glycine, USP | C2H5NO2 |
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.