Description

Micrococcus Lysate CAS NO 158765-79-8 is a standardized enzymatic lysate derived from *Micrococcus* species, primarily used as a critical reagent in pharmaceutical and biotechnological quality control. Its core value lies in its consistent enzymatic activity, which is essential for the reliable detection of bacterial endotoxins, a major contaminant in parenteral drugs and medical devices. This product is indispensable for quality assurance professionals and R&D scientists in the pharmaceutical, biotechnology, and medical device manufacturing industries, ensuring product safety and regulatory compliance.

Application

• Limulus Amebocyte Lysate (LAL) Test Reagent: A key component in the preparation of reagents for the bacterial endotoxin test (BET), critical for pyrogen testing of injectable pharmaceuticals, vaccines, and medical devices.
• Pharmaceutical Quality Control: Used in in-process testing and final release testing of sterile products to ensure they are free from harmful levels of endotoxins.
• Biomedical Research: Serves as a tool in immunology and microbiology research for studying innate immune responses to bacterial components.
• Medical Device Manufacturing: Applied in the validation and routine testing of devices like implants, catheters, and dialysis equipment for endotoxin contamination.
• Water for Injection (WFI) & Process Water Testing: Monitors the purity of critical water systems used in pharmaceutical production.
• Raw Material Screening: Tests incoming biological raw materials and active pharmaceutical ingredients (APIs) for endotoxin content.

Basic Information

Product Name	Micrococcus Lysate
CAS No.	158765-79-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Micrococcus Lysate; Lysate of Micrococcus; Bacterial Lysate, Micrococcus; Endotoxin Testing Lysate; BET Reagent Component; LAL Test Component; Microbial Lysate; CAS 158765-79-8
EINECS	Contact for details

Quality Control

Our Micrococcus Lysate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure consistent enzymatic activity, specificity, and low background interference. We provide comprehensive Certificates of Analysis (COA) detailing key parameters such as activity, pH, and appearance. Production adheres to relevant guidelines for reagents used in pharmaceutical testing, supporting compliance with pharmacopeial standards (e.g., USP, EP, JP) for endotoxin detection.

Storage

Preserve in a tightly closed container, protected from light. Store at 2-8°C. This product is easily oxidized and should be handled to minimize exposure to air. For long-term stability, aliquoting and storage under recommended conditions is advised. Keep container dry and in a well-ventilated place.

Specification

Item	Specification
Appearance	Clear to slightly opalescent solution
Identification (IR)	Conforms to reference standard
pH	6.0 - 8.0
Endotoxin Activity	Meets labeled sensitivity (e.g., 0.03 EU/mL, 0.125 EU/mL)
Purity (HPLC)	≥ 95%
Protein Content	Specified range per batch (COA)
Bacterial Endotoxins	< Specified limit
Sterility	Sterile (where applicable)

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.