Welcome to our Pharmaceutical Public Testing Laboratory, where quality meets transparency. Our state-of-the-art facility is dedicated to ensuring the safety, efficacy, and reliability of pharmaceutical products through rigorous testing and analysis.
With a commitment to upholding the highest industry standards, we provide an independent and unbiased assessment of medicines, contributing to the well-being of communities. Equipped with cutting-edge technology and a team of experienced experts, we play a pivotal role in safeguarding public health by delivering accurate and trustworthy results. Partner with us in our mission to advance healthcare through comprehensive and credible pharmaceutical testing.
The testing lab at Callidus is an approved testing facility by the FDA, Maharashtra state in accordance with the Indian Drugs and Cosmetics Act of 1940
The testing services are conducted in a state-of-the-art modern public testing laboratory set up with a vast scientific knowledge pool confirming international standards.
We are a state-of-the-art public testing laboratory facility spread over 10000 sq. ft. (930 square meters) built as per international quality standards.
Callidus has adequate equipment and instruments to carry out public testing services with the highest quality standards.
- We provide testing for following R&D as well as Commercial Sample (PTL)
- Analytical testing and QC release of API and finished formulations
- Dissolution Testing
- Pre-Formulation Studies
- Analytical method development, Validation Transfer- Drug Product
- API verification and transfer of API methods to a manufacturing site
- Innovator characterization studies
- Reverse engineering studies of the innovator product
- Pharmaceutical equivalence studies / Multimedia dissolution
- Stability studies as per ICH guidelines
Tests of Active Pharmaceutical Ingredients and Excipients:
- Solubility
- Identification by HPLC
- Identification by UV
- Identification by TLC
- Acidity or Alkalinity
- pH
- Specific optical rotation
- Sulphated Ash
- Heavy metals
- Specific gravity/Density
- Content (By HPLC, UV, TLC and Titrimetric)
- Assay (By HPLC, UV and Titrimetric)
- Related Substances (By HPLC, TLC)
- Chromatographic purity
- Chiral purity
- Bulk density
- Tapped density
- Water content by KF
- Loss on Drying
Test of Pharmaceutical Drug Product:
Description
- Identification by HPLC
- Identification by UV
- Identification by TLC
- Identification by colour
- pH
- Specific gravity/Density
- Assay (By HPLC, UV and Titrimetric)
- Viscosity
- Preservative content by HPLC and UV
- Dissolution (USP type I, II, III and VII)
- Related Substances by HPLC/TLC
- Chromatographic Purity
- Chiral purity
- Bulk Density
- Tapped Density
- Friability
- Hardness
- Thickness of Tablets
- PSD (Particle size determination by Sieving)
- Water Content by KF
- Potentiometric /Manual Titrations (Assay and Content Determination)
- Content uniformity of Dosage units (by HPLC/UV/Titration)
- Content uniformity of Dosage units by Weight variation)
- Average Fill Volume/Weight
- Disintegration time of Tablets
- Osmolarity/Osmolality
- Loss on Drying
- Loss of Water (by weight loss)
- Blend uniformity
- Deliverable volume
- Stability studies as per ICH guidelines
- Long term : 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/75% RH ± 5% RH or 25°C ± 2°C/40% RH ± 5% RH
- Intermediate: 30°C ± 2°C/65% RH ± 5% RH
- Accelerated : 40°C ± 2°C/75% RH ± 5% RH or 40°C ± 2°C/25% RH ± 5% RH
- Photo stability: As per ICH
