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Star Product Recommendation | Human Serum Albumin Stabilizer

Plasma derivatives, also known as "liquid products" in Chinese, refer to substances isolated and purified from the 8% plasma proteins in blood plasma. Plasma proteins consist of 60% albumin, 15% immunoglobulins, 4% coagulation factors, and 21% other protein components. Different types of plasma derivatives can be extracted from different plasma protein components.

 

As a representative product among plasma derivatives, albumin is the main source of maintaining plasma colloid osmotic pressure, and it plays roles in regulating the fluid balance inside and outside blood vessels and maintaining blood volume. Clinically, albumin is mainly used for the treatment of critical conditions such as shock caused by blood loss, trauma, and burns, cerebral edema, as well as edema or ascites caused by liver cirrhosis and kidney diseases; it is also used for patients with hypoproteinemia. Due to the important clinical role of albumin, pharmacopoeias in China, Europe, and other regions have detailed descriptions of it as follows:

Pharmacopoeia

 

Chapter

 

Definition

Chinese Pharmacopoeia (ChP) 2020 Edition

 

Volume III, Page 245

This product is prepared from healthy human plasma, which is isolated and purified by the low-temperature ethanol protein separation method or other approved separation methods, followed by virus inactivation via heating at 60°C for 10 hours. An appropriate amount of stabilizer shall be added to the product: for every 1g of protein, 0.16mmol of sodium caprylate, or 0.08mmol of sodium caprylate plus 0.08mmol of sodium acetyltryptophanate shall be added.

Ph. Eur. 2020 10th

Volume 2, Page 2082

Sterile liquid preparation of a plasma protein fraction
containing human albumin. It is obtained from plasma that complies with the monograph Human plasma for fractionation (0853). The preparation may contain excipients such as sodium caprylate (sodium octanoate) or N-acetyl tryptophan or a combination of the two.

Ph.USP 2023

(USP46-NF41)

Albumin Human

Albumin Human is a sterile nonpyrogenic preparation of serum albumin obtained by fractionating merial (source blood, plasma, serum, orlacentas)from healthy human donors, the source materiabeing tested for the absence of hepatitis B surface antigen. lt is a solution containing, in each 100 mL. lt contains no added antimicrobial agent, but maycontain sodium acetyl tryptophanate with or without sodium caprylate as a stabilizing agent.

From the definitions of finished albumin products in pharmacopoeias worldwide, it can be seen that there are two extremely important components in albumin preparations: sodium caprylate and N-acetyltryptophan. These two chemical components play irreplaceable and crucial roles in albumin preparations, including the following:

Role as Protein Stabilizers

Prevent protein aggregation and agglutination

Inhibit microbial growth

Enhance stability during the storage period

 

Additionally, sodium caprylate and N-acetyltryptophan are also widely used in the production process of other biological products. For example:

In the process of special strain selection, sodium caprylate can be used as an additive in the culture medium to improve strain growth and the expression characteristics of target proteins.

· In basic organic chemistry research, sodium caprylate can be used as an additive or catalyst.

· In biomedical research, N-acetyl-DL-tryptophan is widely used to construct protein microbubbles, which play an important role in contrast imaging, targeted drug delivery, gene therapy, etc.—and it shows particular potential in delivering drugs across the blood-brain barrier.

· In laboratory research, N-acetyl-DL-tryptophan can be used as a diagnostic tool for identifying bacterial strains.

 

To meet the demand for high-quality raw materials in finished albumin products, AppliChem has fully upgraded sodium caprylate and N-acetyltryptophan to the low-endotoxin raw material grade, which complies with pharmacopoeias of multiple countries. Detailed product information is shown in the table below.

Item Number

Product Name

Specification

CAS

636454

Sodium Caprylate (USP-NF, BP, Ph. Eur., ChP) low endotoxin, IPEC grade

10kg/25kg

1984-06-1

637763

N-Acetyl-DL-Tryptophan (Ph. Eur, BP) low endotoxin, pharma grade

5kg/25kg

87-32-1

 

Product Features

· Complies with multiple pharmacopoeias including Ph. Eur. (European Pharmacopoeia), USP (United States Pharmacopeia), BP (British Pharmacopoeia), and ChP (Chinese Pharmacopoeia)

· High purity, low endotoxin, and low residual metal impurities

· Complies with ICH Q3D guidelines, with testing for residual levels of 24 types of metal ions

 

To date, AppliChem’s sodium caprylate and N-acetyltryptophan have been widely used in several international projects related to albumin and other biopharmaceuticals.

 

In addition to sodium caprylate and N-acetyltryptophan, AppliChem also offers other products related to plasma derivatives. For details, please refer to the following. If you are interested, please contact Ximeijie, the exclusive distributor of AppliChem in China, to obtain more information.

Item Number

Product Name

Specification

CAS

63B764

6-Aminohexanoic Acid (Ph. Eur., BP, USP) IPEC grade

5 kg

60-32-2

631632

Sodium Acetate 3-hydrate (Ph. Eur, BP, USP) IPEC grade

5 kg/25 kg

6131-90-4

 

XMJ is the exclusive distributor of PanReac AppliChem in China, providing users with comprehensive technical support and after-sales services. If you are interested in the products, please send email to info@xmjsci.com or visit the website www.gq44.cn for more information.