Pharma

Butylhydroxytoluene (BHT) Ph. Eur./USP-NF/JPE

Butylhydroxytoluene (BHT) GMP Grade Production Overview

Manufactured by LANXESS at a dedicated facility in Leverkusen, Germany
Manufacturing complies with requirements of IPEC-PQG GMP Guidelines for Bulk Pharmaceutical Excipients
Dedicated process Equipment
Full traceability to raw materials and their analysis data

+ GMP (Good Manufacturing Practices)

Butylhydroxytoluene (BHT) is manufactured by LANXESS based on IPEC PQG GMP Guidelines. There are special procedures in place at the manufacturing site to achieve this compliance and a program is ongoing to improve compliance permanently.

+ Hedinger's testing, release and repackaging of Butylhydroxytoluene (BHT) Ph. Eur. /USP-NF/JPE

Testing in the Hedinger GMP Quality Control Laboratory according to Ph. Eur., USP and JPE using test methods of the pharmacopoeias
Batch release by a Qualified Person according to EU-GMP

+ Specification Butylhydroxytoluene Ph. Eur. / USP-NF/ JPE

Testing specifications: Ph. Eur. / USP-NF / JPE / LSM 216
The material meets all requirements of Ph. Eur., USP-NF and JPE
Product code: 216

Download Specification

+ Classification according to regulation (EC) No 1272/2008

Aquatic Acute 1, H400 Aquatic Chronic 1, H410

Purity ≥ 99.0 %
Compliance with Ph. Eur., USP and JPE
No risk of contamination from BSE/TSE (bovine spongiform encephalopathy/ transmission spongiform encephalopathy)
No risk of contamination from GMO (genetically modified organism)
Virtually free from aflatoxins
Virtually free from allergens
Fulfills ICH residual solvents guidelines

+ Repackaging in cleanrooms by Hedinger

Butylhydroxytoluene (BHT) is repackaged by Hedinger under clean room conditions into customized packaging sizes following IPEC-PQG GMP requirements for excipients:

Cleanrooms according to EU-GMP Part I, Annex 1 and ISO 14644
Class D (100.000) / ISO 8
Qualification of the HVAC(Heating, Ventilation & Air-Conditioning) system according to EU-GMP PartI, annex 15 and ISO 14644
Regular validation of cleanroom conditions (monitoring)
- Airborne particles
- Microbiology
State-of-the-art preventive maintenance of HVAC systems
Hygiene program for staff and premises
- Regular hygiene training
- Monitoring of staff health
- Appropriate gowning and sanitation practices
Qualified packaging material
- Audited suppliers
- Defined specifications
- Incoming inspection with verification of key quality
parameters and batch release
No reuse of primary packaging materials (except stainless steel IBCs)

+ Distribution of Butylhydroxytoluene (BHT) according to GTDP (Good Trade and Distribution Practice) by Hedinger

Compliance with WHO/IPEC Good Distribution Practice Guide for Pharmaceutical Excipients

Full traceability through documentation of the entire supply chain
Prevention of cross-contamination through appropriate GMP handling and use of dedicated equipment
Ideal storage conditions

Transparent and short supply chain

For further information, please contact bhthedingerde.

We would also welcome your telephone call

Aug. Hedinger GmbH & Co. KG
Headquarters in Stuttgart, Germany
phone: +49 - (0)711 - 40 20 50