Therapeutic Goods Administration

Site

Laboratories Branch Chemistry – Chemistry

Accreditation No.

2432

Site No.

2928

Date of Accreditation

01 Jun 2017

Address

1 Tindal Lane
Canberra Airport, ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 (02) 62894107

Availability

Services conditionally available to external clients

Scope of Accreditation

Print scopes
Laboratories Branch Chemistry – Chemistry

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure
Analysis for physical and chemical characteristics of human and veterinary medicines including vaccines Antibiotics; Compounding pharmaceuticals constituents; Drugs; Medicinal preparations; Vitamins Identification - Qualitative of active ingredients and other components GC-MS; Gas chromatography (GC); HPLC; Infrared spectrophotometry; Ion chromatography (IC); LC-MS; Thin layer chromatography (TLC); UV-vis spectrophotometry; Ultra performance liquid chromatography (UPLC); Visual examination

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB
Analysis - Quantitative GC-FID; GC-MS; Gas chromatography (GC); HPLC; Ion chromatography (IC); LC-MS; Microwave plasma - Atomic emission spectroscopy (MP-AES); Polarimetry; Titration; UV-vis spectrophotometry; Ultra performance liquid chromatography (UPLC)

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB
Disintegration; Dissolution; Particle size; Specific gravity; Uniformity of weight; pH HPLC; Light obscuration; UV-vis spectrophotometry; Visual examination

By AS, BP, PhEur, USP, Manufacturers' Standards and in-house method LB

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.