Mineral Salts Low in Endotoxins for Pharmaceutical Applications
Why do Mineral Salts Low in Endotoxins offer various advantages for the use in pharmaceutical and medical products and applications?
Endotoxins or pyrogens are lipopolysaccharides – outer membrane components of gram-negative bacteria. During decomposition or metabolism, these bacteria release lipopolysaccharides, which are toxic. Parenteral-induced quantities as low as 0.1ng/kg of bodyweight can cause various immune reactions, including fever, inflammation and sickness in humans and animals. Moreover, endotoxins can cause undesirable effects on cell proliferation or cell function for biopharmaceutical fermentation and purification processes.
To avoid this, the manufacture of products for parenteral administration requires particular caution; it is subject to specific regulatory requirements and is regulated by chapter 2.6.14 of the European Pharmacopoeia (Ph.Eur).
Dr. Paul Lohmann’s state-of-the-art production unit allows a manufacturer to comply with quality and regulatory requirements by a Quality by Design (QbD) approach. The dedicated purpose built plant is GMP certified and LAL tests according to Ph.Eur are performed on each batch. Customers can seamlessly integrate Dr. Paul Lohmann® products, which are Low in Endotoxins, into their process chain for the manufacture of parenteral dosage forms.
Low-endotoxin mineral compounds can be used for the production of two pharmaceutical forms and routes of administration:
- Parenteral:
- Dialysis: peritoneal dialysis, haemofiltration and osmotherapy
Dr. Paul Lohmann® offer Low in Endotoxin qualities for the following broad product lines:
Acetates | Aspartates | Citrates | EDTAs | Glycerophosphates | Gluconates | Lactates | Phosphates | Succinates | Sulfates
Applications of Mineral Salts Low in Endotoxins
- Solutions for parenterals
- Injections
- Infusions
- Nutrition
- Solutions for inhalation
- Solutions for
- Dialysis
- Peritoneal dialysis
- Haemofiltration
- Osmotherapy
- Ophthalmic preparations
- Biopharmaceuticals
SEE Dr. Paul Lohmann EXCIPIENTS IN The SHOP
Read more on the website here
Source: Dr. Paul Lohmann, website Mineral Salts Low in Endotoxins for Pharmaceutical Applications
See also the full brochure on “Mineral Salts Low in Endotoxins” here
(click the picture to download the brochure)
Source: Dr. Paul Lohmann, full brochure “Mineral Salts Low in Endotoxins“
Read also our introduction article on Mineral Salts Low in Endotoxins here:
