Endotoxin is a type of lipopolysaccharide (LPS) derived from the outer membrane of Gram-negative bacteria. The outer lipid component of the bacterial outer membrane consists of endotoxin molecules, which are released when the bacteria die or lyse. Despite differences in bacterial species, the toxic effects induced by endotoxins are generally similar, as outlined below:

1. Pyrogenicity (Fever-Inducing Effect)

Endotoxin acts on macrophages, triggering the production of a series of cytokines such as interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α). These cytokines are recognized as?endogenous pyrogens; they act on thermosensitive neurons in the thermoregulatory center of the brain, thereby inducing fever.

2. Leukocyte Response

Neutrophils in the peripheral blood adhere extensively to capillary walls. Endotoxin induces target cells to produce neutrophil-releasing factors, which in turn stimulate the bone marrow to release neutrophils into the bloodstream, leading to an increase in the number of leukocytes.

3. Disseminated Intravascular Coagulation (DIC)

Endotoxin also impairs the integrity of vascular endothelial cells and disrupts the function of the coagulation system. This ultimately results in widespread coagulation reactions and organ dysfunction.

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Notably, endotoxin is a?ubiquitous biological risk contaminant?in the environment. It is widely present in water, air, the surfaces of equipment, and many biological raw materials, posing a significant threat to pharmaceutical safety.

Endotoxin Risks in Different Raw Materials

1. Culture Medium Raw Materials (e.g., Amino Acids, Vitamins, Buffer Salts)

Endotoxin exerts toxic effects on cells, increases cellular stress responses, and thereby impairs the normal growth and metabolism of cells.

2. Pharmaceutical Preparation Raw Materials (e.g., Mannitol, Sucrose, Tween)

Bacterial endotoxin is highly stable and difficult to remove during the production process. Therefore, the control of bacterial endotoxin in various raw materials, excipients, and packaging materials must be implemented?at the source.

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To ensure the safety, efficacy, and quality consistency of pharmaceuticals and protect patient health, pharmacopoeias worldwide have established clear requirements for the?detection methods and content limits?of endotoxin.

Comparison Table of Endotoxin/Pyrogen Requirements in Pharmacopoeias Worldwide

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Project	USP	EP	JP	ChP
Endotoxin Limit（EL）公式	EL = K/M （K=5 EU/kg Non-intrathecal） ； 0.2 EU/kg intrathecal ）	Same as USP	Same as USP	Same as USP
Water for Injection Limits	≤0.25 EU/mL	≤0.25 EU/mL	≤0.25 EU/mL	≤0.25 EU/mL
Medical Device	- ISO 10993-11 - Blood contact：≤20 EU/device	同USP	Same as USP	Ref GB/T 14233.2
Specific Product Requirements	- Biological products（21 CFR 610.9） - Cell therapy：≤5 EU/kg	- High-risk products (such as intrathecal injection) are subject to stricter regulations - The recombinant C-factor method is recommended	Same as USP/EP	- Additional requirements for traditional Chinese medicine injections

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As a Long-Term, Trusted Supplier to Multiple Global Leading Culture Medium Manufacturers and Pharmaceutical Enterprises, PanReac AppliChem, leveraging its outstanding product quality and rigorous quality control, provides reliable low-endotoxin products for researchers and pharmaceutical companies worldwide.

Item No.	Product Name	CAS No.
631659	Sodium Chloride (Ph. Eur, BP, USP, JP) low endotoxin, IPEC grade ?	7647-14-5
Z41683	Sodium L-Glutamate 1-hydrate (USP-NF) low endotoxin pure, pharma grade	6106/4/3
Z92018	Sodium di-Hydrogen Phosphate anhydrous (USP) low endotoxin, pharma grade	7558-80-7
Z41678	di-Sodium Hydrogen Phosphate 12-hydrate (USP, BP, Ph. Eur.) low endotoxin pure, pharma grade	10039-32-4
Z4G393	Calcium Trisodium Pentetate x-hydrate (Ph. Eur.) low endotoxin IPEC grade	12111-24-9
636454	Sodium Caprylate (USP-NF, BP, Ph. Eur., ChP) low endotoxin, IPEC grade	1984/6/1
637763	N-Acetyl-DL-Tryptophan (Ph. Eur, BP) low endotoxin, IPEC grade	87-32-1
Z43645	L-Cystine (Ph. Eur.) low endotoxin pure, pharma grade	56-89-3
637765	L-Cystine Dihydrochloride low endotoxin, pharma grade	30925-07-6
Z46543	Guanosine low endotoxin, pure grade	118-00-3
Z94338	Adenine (USP, Ph. Eur.) low endotoxin, pharma grade	73-24-5
Z48216	Folic acid crystalline (Ph. Eur., USP) low endotoxins, pharma grade	59-30-3

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Core Advantages of AppliChem Low-Endotoxin Products

1.?Ultra-Low Endotoxin Levels

2.?Compliance with Stringent Pharmacopoeial Standards (Ph. Eur., BP, USP, JP)

3.?Rigorous Quality Control

4.?Guaranteed Batch-to-Batch Consistency

5.?High-Quality Technical Support and Services

PanReac AppliChem is one of the high-quality manufacturers of biochemical reagents and pharmaceutical raw materials originating from Europe. With a century-long history, it has obtained multiple ISO quality management system certifications and serves as a key supplier to global life science research institutions, renowned CRO/CDMO companies, and large-scale industrial enterprises in the pharmaceutical, diagnostic, food, cosmetics, and other sectors.

As a long-term and stable supplier to numerous well-known global culture medium manufacturers and pharmaceutical enterprises, PanReac AppliChem is among the few manufacturers worldwide capable of providing a wide range of pharmacopoeia-grade and cell culture-grade raw materials. It offers a comprehensive portfolio of chemicals across various grades, including cell culture grade, pharmacopoeia grade, biochemical grade, and ultra-pure grade. These products cover:

·?Culture medium components: Amino acids, vitamins, antibiotics, salts, buffers, stabilizers, surfactants, etc.

·?Chemicals commonly used in pharmaceutical processes: Tris, guanosine, adenine, sodium caprylate, DMSO (dimethyl sulfoxide), dextran, and more.

XMJ is the exclusive general distributor of PanReac AppliChem in China, providing users with comprehensive technical support and after-sales service. If you are interested in the products, please feel free to:

·?Call XMJ’s customer service hotline:?400-050-4006

·?Visit the official website:?www.gp82.cn?to learn more information.