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

Dr Carol Margaret Worth P: +61 (08) 61675288

Availability

Services available to external clients

Scope of Accreditation

Print scopes

Withdrawn 27 Mar 2024

EPICHEM

ISO 17034 (2016)

Healthcare, Pharmaceutical and Media Products

Withdrawn
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

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