EPICHEM

Site

EPICHEM

Accreditation No.

20126

Site No.

24143

Date of Accreditation

25 Jun 2018

Address

Suite 5, 3 Brodie-Hall Drive, Technology Park
Bentley, WA 6102
Australia

epichem.com.au

Contact

Mr Boon Tan P: +61 0403354885

Availability

Services available to external clients

Scope of Accreditation

ISO 17034 (2016)

Healthcare, Pharmaceutical and Media Products

Service Product Determinant Technique Procedure Limitations
Reference materials for chemical composition, residues and contaminants Active pharmaceutical ingredients Alcohols/phenols; Amides; Amines; Amino acids; Aromatic halides; Carboxylates/acids; Esters; Ethers; Heterocycles; Ketones; Lactams; Lactones; Nitriles; Oligopeptides; Opioids; Polycyclics/alicyclics; Polyenes; Polyols; Propionic acid; Steroids; Thioethers Ash content; Elemental analysis; Fourier transform infrared spectroscopy (FTIR); HPLC; Karl-Fischer titration; LC-MS; Melting point; Nuclear magnetic resonance (NMR) PC0008.WI01
Degradants of active pharmaceutical ingredients Alcohols/phenols; Aldehydes; Amides; Amine oxides; Amines; Amino acids; Amphetamines; Aniline; Aromatic halides; Biphenylenes; Carbohydrates; Carboxylates/acids; Diketopiperazines; Diphenylmethanes; Esters; Ethers; Guanidines; Heterocycles; Isoquinolines; Ketones; Lactams; Lactones; Naphthalene; Nitriles; Nitroaromatics; Oligopeptides; Opioids; Polycyclics/alicyclics; Polyenes; Polyols; Propionic acid; Quinolones; Sulfide; Sulfones; Sulfoxides; Thioethers; Ureas Ash content; Elemental analysis; Fourier transform infrared spectroscopy (FTIR); HPLC; Karl-Fischer titration; LC-MS; Melting point; Nuclear magnetic resonance (NMR) PC008.WI01
Impurities of active pharmaceutical ingredients Alcohols/phenols; Aldehydes; Amides; Amine oxides; Amines; Amino acids; Amphetamines; Aniline; Aromatic halides; Biphenylenes; Carbohydrates; Carboxylates/acids; Diketopiperazines; Diphenylmethanes; Esters; Ethers; Guanidines; Heterocycles; Isoquinolines; Ketones; Lactams; Lactones; Naphthalene; Nitriles; Nitroaromatics; Oligopeptides; Opioids; Polycyclics/alicyclics; Polyenes; Polyols; Propionic acid; Quinolones; Steroids; Sulfones; Sulfoxides; Thioethers; Ureas Ash content; Elemental analysis; Fourier transform infrared spectroscopy (FTIR); HPLC; Karl-Fischer titration; LC-MS; Melting point; Nuclear magnetic resonance (NMR) PC008.WI01
Metabolites of active pharmaceutical ingredients Alcohols/phenols; Aldehydes; Amides; Amine oxides; Amines; Amino acids; Amphetamines; Aniline; Aromatic halides; Biphenylenes; Carbohydrates; Carboxylates/acids; Diketopiperazines; Diphenylmethanes; Esters; Ethers; Guanidines; Heterocycles; Isoquinolines; Ketones; Lactams; Lactones; Naphthalene; Nitriles; Nitroaromatics; Oligopeptides; Opioids; Polycyclics/alicyclics; Polyenes; Polyols; Propionic acid; Steroids; Sulfide; Sulfones; Sulfoxides; Thioethers; Ureas Ash content; Elemental analysis; Fourier transform infrared spectroscopy (FTIR); HPLC; Karl-Fischer titration; LC-MS; Melting point; Nuclear magnetic resonance (NMR) PC008.WI01

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.