Identification
Scotmann uses state of the art, FDA 21 CFR (Code of Federal Regulations Part 11) compliant Shimadzu Prominence i -LC-20AT HPLC and Shimadzu Fourier Transform Infra-Red Spectrophotometer (FTIR) equipped with Attenuated Total Reflectance (ATR) technology to identify and characterize the chemical entity of APIs and finished products.
Elemental Impurities & Heavy Metals
Consumers' safety from any toxic effects of the product, levels of any elemental impurities & heavy metals in APIs is determined on FDA 21 CFR (Code of Federal Regulations Part 11) compliant Shimadzu Atomic Absorption Spectrophotometer.
Residual Solvents
Screening of APIs for any toxicity or carcinogenicity related to residual solvents is analyzed on FDA 21 CFR (Code of Federal Regulations Part 11) compliant Shimadzu GC-MS (Gas Chromatography - Mass Spectrometry) & Agilent GC (Gas Chromatography).
Bioequivalence In-Vitro Studies
In-vitro product dissolution profile / bioequivalence of finished products is determined by extensive dissolution studies.
SGS Certification
SGS S. A. Geneva, Switzerland certified Quality Management System (QMS) for inspection, verification & testing.
Environmental Management Systems Certification
Environmental Management System is certified by TUV Austria Bureau of Inspection and Certification.
TUV Halal Certification
Halal Food Quality Management System is certified by TUV Austria Bureau of Inspection & Certification.
PNAC Certification
Scotmann's Quality Control Lab is ISO/IEC 17025 accredited for regular surveillance and compliance with the requirements of PNAC (Pakistan National Accreditation Council) as per Accreditation Certificate Number: LAB-188.
