Analysis of raw materials, APIs and formulations
- Identification and limit test
- FTIR analysis
- HPLC analysis
- UV, Vis analysis
- GC, GC-MS analysis
- Metals analysis by ICP-OES, AAS and UV
- Preservative content in cometics
- Bacterial, yeast & Mould, coliform counts
- Tests for specified micro organisms
- Preservatives efficacy
- Swab studies
Analytical method development and validations
- Validations for Pharmacopoeial and ICH guidelines
- Validations for related substances, Assay(HPLC-UV and GC-FID&ECD), residual solvents ( GC-headspace), trace metals( ICP-OES/ AAS)
- Organic impurities and residual solvents are estimated using high sensitive gas chromotagraph with head space sampler
- Inorganic impurities are estimated using ICP-OES and AAs
- Process impurities are estimated using computer controller gradient HPLC system
- Pestiside residues in herbal products and nutraceuticals and estimated with the aid of GC-MS and GC-ECD
- Impurities are also identified and quantified using high sensitive instruments like GC-MS
Quality Norms and protocols followed for analysis
Analysis is done as per both national and international standards:
- Indian Pharmacopoeia
- United States Pharmacopoeia
- British Pharmacopoeia
- European Pharmacopoeia
- Any other protocols
Analysis of drinking water ( IS-10500) and source water as per US-EPA/WHO/EU standards and purified water as per pharmacopoeial monograph requirements.