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[Long-term stability of Kallidinogenase Reference Standard]
Eisei Shikenjo Hokoku. Bulletin of National Institute of Hygienic Sciences
|January 1, 1989
Summary
Kallidinogenase Reference Standard is stable for long-term storage. Stored at -5°C, the standard maintained its kallidinogenase activity for at least 60 months, demonstrating excellent stability.
Area of Science:
- Biochemistry
- Pharmacology
- Analytical Chemistry
Context:
- Reference standards are crucial for accurate drug quantification and quality control.
- Kallidinogenase is an enzyme used in pharmaceutical preparations.
- Ensuring the stability of reference standards is vital for reliable scientific research and clinical applications.
Purpose:
- To evaluate the long-term stability of the Kallidinogenase Reference Standard from the National Institutes of Hygienic Sciences.
- To determine optimal storage conditions for maintaining the integrity of the kallidinogenase standard over time.
Summary:
- The kallidinogenase reference standard was stored at various temperatures (-5°C, 20°C, 37°C, and 50°C) for up to 60 months.
- No significant decrease in kallidinogenase activity was observed at -5°C (60 months) and 20°C (28 months).
- Activity loss was minimal at 37°C (7% at 10 months), but significant degradation occurred at 50°C within 4 months.
Impact:
- The study confirms that the Kallidinogenase Reference Standard is stable for prolonged storage, particularly at -5°C.
- This finding supports the reliable use of this standard in pharmaceutical analysis and quality control for approximately five years.
- Establishes -5°C as the recommended storage condition for long-term preservation of kallidinogenase activity.