The substance is soluble in water at a concentration of 10 mg/mL, but may require ultrasonic treatment and warming, as well as adjustment of the pH to 2-3 with HCl.
Sobre este item
grade
pharmaceutical primary standard
agency
USP
API family
insulin
form
solid
manufacturer/tradename
USP
application(s)
USP Biologics
pharmaceutical (small molecule)
pharmaceutical
format
neat
storage temp.
−20°C
InChI key
PBGKTOXHQIOBKM-FHFVDXKLSA-N
General description
Insulin Human is a recombinant form of the human insulin hormone, comprising two polypeptide chains (A and B) linked by disulfide bonds. It regulates glucose metabolism and is essential in the management of diabetes mellitus.
The USP biologics proteins category provides critical standards and reference materials necessary for the development and manufacturing of therapeutic proteins. These proteins, which can be naturally derived or genetically engineered, are essential in treating various diseases and conditions, ensuring that they meet quality, safety, and efficacy standards.
The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics.
Application
Also, for use with USP monographs such as:
- Insulin Human Injection
- Human Insulin Isophane Suspension and Human Insulin Injection
- Isophane Insulin Human Suspension
Biochem/physiol Actions
Analysis Note
Other Notes
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Classe de armazenamento
11 - Combustible Solids
Ponto de inflamação (°F)
Not applicable
Ponto de inflamação (°C)
Not applicable
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