Oxiteno is EXCiPACT™ certified at its Guadalajara plant in Mexico, for pharmaceutical excipients in its polyethylene glycol – OXIPURITY 4000 line – further underscoring its commitment to the quality and safety of its products. The EXCiPACT™ GMP Certificate is issued by SGS.
EXCiPACT™ certification confirms that Oxiteno follows good manufacturing practices (GMP) applied in the manufacture and distribution of pharmaceutical excipient ingredients. In addition to attesting to safety, this certification enables a reduction in additional audits, which can reduce costs for our customers.
EXCiPACT™ is an international voluntary project run by the IPEC Federation, a global organization that promotes quality in pharmaceutical excipients (visit www.ipecfed.org). The project provides independent third parties with certifications from manufacturers, suppliers, and distributors of pharmaceutical excipients worldwide, helping ensure quality and safety in the audited suppliers’ products.
This achievement confirms Oxiteno’s commitment to offering high quality excipient ingredients to the pharmaceutical market and shows that the Polyethylene glycol – OXIPURITY 4000 line – follows Good Manufacturing Practice (GMP) standards.
Benefits:
Applications:
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BRAND | GRADE | KEY FUNCTIONALITIES | TYPICAL APPLICATIONS |
OXIPURITY® 4003 U | PEG 300 | Solvent, Plasticizer, Base/Carrier | Ointment base, Liquid Formulations, Suppositories, Chemical intermediates |
OXIPURITY® 4004 U | PEG 400 | Solvent, Plasticizer, Base/Carrier | Gelatin capsules, Ointment base, Liquid formulations, Suppositories, Chemical intermediates |
OXIPURITY® 4006 U | PEG 600 | Solvent, Plasticizer, Base/Carrier | Gelatin capsules, Ointment base, Liquid formulations, Suppositories, Chemical intermediates |
OXIPURITY® 4010 U | PEG 1000 | Solvent, Plasticizer, Base/Carrier | Gelatin capsules, Ointment base, Liquid formulations, Suppositories, Chemical intermediates |
OXIPURITY® 4014 U | PEG 1450 | Solvent, Plasticizer, Base/Carrier | Gelatin capsules, Tablet binding or coating, Ointment base, Suppositories, Chemical intermediates, Processing Aids |
OXIPURITY® 4015 U | PEG 1500 | Solvent, Plasticizer, Base/Carrier | Gelatin capsules, Tablet binding or coating, Ointment base, Suppositories, Chemical intermediates, Processing Aids |
OXIPURITY® 4033 U | PEG 3350 | Solvent, Plasticizer, Granulation aid, Plasticizer, Binder | Tablet binding or coating, Ointment base, Suppositories, Chemical intermediates, Processing Aids |
OXIPURITY® 4040 U | PEG 4000 | Solvent, Plasticizer, Granulation aid, Plasticizer, Binder | Tablet binding or coating, Ointment base, Suppositories, Chemical intermediates, Processing Aids |
OXIPURITY® 4060 U | PEG 6000 | Lubricant, Granulation aid, Plasticizer, Binder | Tablet binding or coating, Suppositories, Chemical intermediates, Processing Aids |
OXIPURITY® 4080 U | PEG 8000 | Lubricant, Granulation aid, Plasticizer, Binder | Tablet binding or coating, Suppositories, Chemical intermediates, Processing Aids |