Quality is the most utmost significant thing in the pharmaceutical industry as people’s lives are directly dependent on the quality of medicines given to them for the treatment of diseases. This highlights how important it is to have a reliable partner for testing and certification of pharmaceutical products and their ingredients.
AURUM offers pharmaceutical testing services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Pharmaceuticals and related industries necessitate a commitment to Quality, for GLP and cGMP compliance which AURUM has established.
Our pharmaceutical laboratory frequently commence on
- Pharmaceutical testing based on USP, BP, EP and IP
- Testing using clients won or In House methods
- Documented In- house validated methods
In addition, the company can develop and validate methods for use on raw materials, API, or finished products. The laboratory has also undertaken work in support of process validation, cleaning validation, and stability studies. Whether it is routine QC testing, non-routine analysis, R&D projects, or advice and consultancy, clients can confidence AURUM for a responsive, precise, and reliable analytical support service required by these industries.
AURUM routinely undertakes contract lab testing of Our pharmaceutical laboratory frequently commence on:
- Raw materials
- Finished Products
- Analytical Method Validation
- Stability Testing
- Analytical method development
- Microbiology
AURUM has a state of the art laboratory of International standards with advanced equipments like.
- Chromatography (TLC,GC,HPLC, UHPLC,GC,GCMS,LC/MS)
- Spectroscopy (FTIR, UV/visible, AAS)
- Spectrometry (ICPMS)
- Titrimetry, including Karl Fischer reagent and Oven Disintegration/Dissolution (including extended release)
- Carbon analyzer TOC
- Stability studies by ICH guidelines
- Analytical method validation as per ICH guidelines.
- Analytical method development on HPLC, GC and other sophisticated instruments
- Viscosity
- Viable microbial air sampler
- Malvern particle size analyzer
- Provide purity, contamination and material testing services for a variety of raw material
- Chemical testing, physical characterization and microbiological analysis as per pharmacopoeial requirements.
- Technologies to address a wide spectrum of article specific identifications, impurity and limit tests and assays.
Quality is vital in the pharmaceutical industry as people’s lives are directly dependent on the quality of medicines given to them of the treatment of diseases. This highlights how imperative it is to have a reliable partner for testing and certification of pharmaceutical products and their ingredients. Any pharmaceutical product manufacturer requires as quality control which is one of the pre-requisite to regulatory compliances. A significant portion of the cGMP regulations and all pharmacopeia methods such as USP, IP,EP,JP,BP and In-house methods pertain to the quality control testing of products, Aurum provides expert analytical services in all areas of testing from raw materials, Excipients, API,s and bulk drugs, intermediates to finished products. Data integrity is being handled in compliant with 21 CFR part 11 regulations subsection a to g. All the data acquisition systems are connected through ECM software ensuring data security from generation till archival of electronic data.
ANALYTICAL R&D
- Analytical method development and validation as per ICH guidelines
- Development of stability-indicating methods
- Impurity Identification and quantification
- Method development and validation for Heavy metal estimation by ICPMS.
- Cleaning validations
- Dissolution studies
- Extractable and leachable studies
- Stability studies as per ICH guidelines.
CHEMICAL
- Residual solvents
- Residula ethylene oxide, ethylene glycol and ethylene chlorohydrins
- Heavy metal analysis by ICPMS
- Residual pesticides
- Ochratoxins
- Aflatoxins B1,B2,G1,G2 and M1
- Physico-chemical properties
- BET surface area
