Polyglykol 400 J
PEG 400 is described by the FDA as a possible demulcent in Ophthalmic Drug Products1. Polyglykol 400 J is a low molecular weight polyethylene glycol API type, which is produced under ICH Q7 GMP conditions, certified by the German authorities. With defined microbiological & endotoxin checks of the final packed product batch, which are given individually on the certificate of analysis, we would like to support you in your individual formulation risk assessment.
1. FDA, Final Administrative Order OTC000023, “Over-the-Counter Monograph 018: Ophthalmic Drug Products for Over-the-Counter Use,” Section M018.12(d)(3) (available at: https://dps.fda.gov/omuf/monographsearch/monograph_m018).
Product Information
- Low endotoxin & microbial load for sensitive applications
- Includes microbiology specification for
- Endotoxin: max. 1 IU/ml
- TAMC: max. 50 cfu/ml
- TYMC: max. 50 cfu/ml
- Salmonella: absent
- Staphylococcus aureus: absent
- Pseudomonas aeruginosa: absent
- Escherichia coli: absent
- Surpass the current international pharmacopoeia requirements
- Polyethylene glycol, average molar mass 400 g/mol
- 溶剂
- 润湿剂
USP-NF: Polyethylene glycol 400
Ph. Eur.: Macrogol 400
JP: Macrogol 400
Clear liquid
- Complies with monograph specifications of USP-NF "Polyyethylene glycol", Ph. Eur. monograph "Macrogols" and JP "Macrogol 400".
- Manufactured according to ICH Q7 (API), certified by German authorities
- Low Endotoxin grade suitable for sensitive formulations
- Control of TAMC, TYMC, objectionable bacteria
- Control of elemental impurities as per ICH Q3D required for parenteral/ophthalmic applications limits.
- Kosher certificate
Demulcent
Germany
