9048-49-1 Usage
Description
SeruM AlbuMin Iodine is a sterile, nonpyrogenic preparation of serum albumin obtained from healthy human donors. It is available in various concentrations and may contain stabilizing agents such as sodium acetyltryptophanate or sodium caprylate, but no antimicrobial preservatives. Aqueous albumin solutions are slightly viscous and range in color from almost colorless to amber, while in the solid state, albumin appears as brownish amorphous lumps, scales, or powder.
Uses
Used in Pharmaceutical Industry:
SeruM AlbuMin Iodine is used as a pharmaceutical ingredient for its ability to stabilize and carry drugs, as well as its viscosity and protein content. It can improve the solubility, stability, and bioavailability of various drugs, making it a valuable component in drug formulations.
Used in Diagnostic Imaging:
SeruM AlbuMin Iodine is used as a contrast agent in diagnostic imaging, particularly in X-ray and computed tomography (CT) scans. Its high protein content and iodine binding properties allow for better visualization of blood vessels and tissues, improving the accuracy of medical imaging.
Used in Research and Development:
SeruM AlbuMin Iodine is used as a research tool in various scientific applications, such as studying protein interactions, drug binding, and the development of new drug delivery systems. Its unique properties make it a valuable resource for researchers in the field of biochemistry and pharmaceuticals.
Production Methods
Albumin human (USP 32) Albumin human is a sterile nonpyrogenic
preparation of serum albumin that is obtained by
fractionating material (source blood, plasma, serum, or placentas)
from healthy human donors. The source material is tested
for the absence of hepatitis B surface antigen. It is made by a
process that yields a product safe for intravenous use.
Human albumin solution (PhEur 6.0) Human albumin solution
is an aqueous solution of protein obtained from plasma.
Separation of the albumin is carried out under controlled
conditions so that the final product contains not less than 95%
albumin. Human albumin solution is prepared as a concentrated
solution containing 150–250 g/L of total protein or as an
isotonic solution containing 35–50 g/L of total protein. A
suitable stabilizer against the effects of heat such as sodium
caprylate (sodium octanoate) or N-acetyltryptophan or a
combination of these two at a suitable concentration, may be
added, but no antimicrobial preservative is added at any stage
during preparation. The solution is passed through a bacteriaretentive
filter and distributed aseptically into sterile containers,
which are then closed so as to prevent contamination. The
solution in its final container is heated to 60±1.08℃ and
maintained at this temperature for not less than 10 hours. The
containers are then incubated at 30–328℃ for not less than 14
days or at 20–258℃ for not less than 4 weeks and examined
visually for evidence of microbial contamination.
Pharmaceutical Applications
Albumin is primarily used as an excipient in parenteral pharmaceutical
formulations, where it is used as a stabilizing agent for
formulations containing proteins and enzymes.Albumin has also
been used to prepare microspheres and microcapsules for experimental
drug-delivery systems.
As a stabilizing agent, albumin has been employed in protein
formulations at concentrations as low as 0.003%, although
concentrations of 1–5% are commonly used. Albumin has also
been used as a cosolvent for parenteral drugs, as a cryoprotectant
during lyophilization, and to prevent adsorption of other
proteins to surfaces.
Therapeutically, albumin solutions have been used parenterally
for plasma volume replacement and to treat severe acute albumin
loss. However, the benefits of using albumin in such applications in
critically ill patients has been questioned.
Safety
Albumin occurs naturally in the body, comprising about 60% of all
the plasma proteins. As an excipient, albumin is used primarily in
parenteral formulations and is generally regarded as an essentially
nontoxic and nonirritant material. Adverse reactions to albumin
infusion rarely occur but include nausea, vomiting, increased
salivation, chills, and febrile reactions. Urticaria and skin rash
have been reported. Allergic reactions, including anaphylactic
shock, can occur. Albumin infusions are contraindicated in patients
with severe anemia or cardiac failure. Albumin solutions with
aluminum content of less than 200 mg/L should be used in dialysis
patients and premature infants.
LD50 (monkey, IV): >12.5 g/kg
LD50 (rat, IV): >12.5 g/kg
storage
Albumin is a protein and is therefore susceptible to chemical
degradation and denaturation by exposure to extremes of pH, high
salt concentrations, heat, enzymes, organic solvents, and other
chemical agents.
Albumin solutions should be protected from light and stored at a
temperature of 2–258℃ or as indicated on the label.
Regulatory Status
Included in the FDA Inactive Ingredients Database (oral, tablets,
film-coatings; IV injections, IV infusions and subcutaneous injectables).
Included in parenteral products licensed in the UK. Included
in the Canadian List of Acceptable Non-medicinal Ingredients.
Check Digit Verification of cas no
The CAS Registry Mumber 9048-49-1 includes 7 digits separated into 3 groups by hyphens. The first part of the number,starting from the left, has 4 digits, 9,0,4 and 8 respectively; the second part has 2 digits, 4 and 9 respectively.
Calculate Digit Verification of CAS Registry Number 9048-49:
(6*9)+(5*0)+(4*4)+(3*8)+(2*4)+(1*9)=111
111 % 10 = 1
So 9048-49-1 is a valid CAS Registry Number.