Metacresol Ph. Eur. /USP parenteral grade

Metacresol (m-Cresol) is manufactured by LANXESS based on IPEC PQC 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.

• Testing of O2-content in gas phase
• Sampling and optimized blanketing of drums with Argon [max. 0.1 % O2-content in gas phase]
• Testing in the Hedinger GMP Quality Control Laboratory according to Ph. Eur. and USP using test methods of the pharmacopoeias
• Endotoxin specification for parenteral grade
• Batch release by a Qualified Person according to EU-GMP
• Sub-batches (separate testing and release) for every repackaging process
• Repackaging at Hedinger in a clean-room class D with Argon blanketing into 1 L and 2.5 L brown glass bottles (polystyrene case)
• Qualification of the LANXESS production site according to IPEC GMPs for excipients Quality agreement between LANXESS and Hedinger including change control in place
• All processes are designed to comply with IPEC GMPs and WHO GTDP Guidelines
• UV-Absorption specification
• Ongoing stability testing program (data available, but confidential)

Testing specifications: Ph. Eur. / USP / LSM 024.
The material meets all requirements of Ph. Eur. and USP.
Product code: 024

Download Specification

Acute Tox. 3, H301
Acute Tox. 3, H311
Skin Corr. 1B, H314
Aquatic Chronic 3, H412

Storage: In airtight containers, protected from light, under argon, storage temperature > 13 °C is recommended

• 1L, 2.5L: manufacturing date plus 24 months
• 100 mL: 12 months after repackaging date, not more than 24 months after manufacturing date

Lanxess Deutschland GmbH, D-Leverkusen

Aug. Hedinger GmbH & Co. KG, D-Teutschenthal

06311857 [M-Cresol high purity (Hedinger)]

Solvents of class 1- 3 except toluene are excluded by the manufacturing process. Toluene content complies with ICH limit of 890 ppm and the additional stricter limit of 100 ppm, typical content: < 10 ppm.

Every batch is analysed according to all parameters of this specification. The Certificate of Analysis (CoA) provides all results like above plus analysis date, date of manufacture and residual solvents statement. All CoAs are signed by a Qualified Person (QP) according to GMP (Article 49, 2001/83/EEC).

Metacresol Ph. Eur./ USP parenteral grade / m-Cresol Ph. Eur./ USP parenteral grade 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
• Standard quantities (1 and 2.5 L brown glass bottle)
• Qualification of the HVAC (Heating, Ventilation & Air-Conditioning) system according to EU-GMP Part I, 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)